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Valproate use in pregnancy
Evidence shows that 1 in 10 babies (10%) exposed to valproate in pregnancy are born with a congenital malformation (birth defect) – for the general population, the risk is about 2–3%.

NICE launch evidence review on Impetigo: antimicrobial prescribing guideline

The National Institute for Health and Care Excellence (NICE) have launched a consultation for an evidence review on Impetigo: antimicrobial prescribing guideline.

The consultation is open until 11 September 2019 at 5 p.m.

The guideline sets out an antimicrobial prescribing strategy for impetigo. It aims to optimise antibiotic use and reduce antibiotic resistance. The recommendations in this guideline are for the use of antiseptics and antibiotics to manage impetigo in adults, young people and children. It does not cover diagnosis.

Please note that the scope of this guideline is for adults, young people and children aged 72 hours and over. For treatment of children in the first 72 hours of life, please seek specialist advice.

Who is it for?
  • Adults, young people and children with impetigo, their parents and carers
  • Healthcare professionals
The guideline contains:
  • the draft recommendations
  • the rationales
  • summary of the evidence

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NICE to recommend blinatumomab (Blincyto▼) for the treatment of acute lymphoblastic leukaemia

The National Institute for Health and Care Excellence (NICE) have recommended Amgen's acute lymphoblastic leukaemia (ALL) treatment blinatumomab, brand name Blincyto▼, to be made available in England and Wales.

Blincyto has been approved in the EU for treating:
  • a blood cancer called B-precursor acute lymphoblastic leukaemia (ALL) in patients above 1 year of age when the cancer has come back (relapsed) or has not improved with previous treatment (refractory)
  • adults who have been treated for B-precursor ALL and have minimal residual disease (which means that they still have some detectable cancer cells in their body)
Blincyto is used in patients who are ‘Philadelphia-chromosome-negative’ which means that the patients’ cancer cells do not have an abnormal chromosome called the Philadelphia chromosome, and in patients who have the protein CD19 on their cancer cells (CD19-positive).

NICE have recommended blinatumomab as an option for treating Philadelphia chromosome-negative CD19-positive B-precursor acute lymphoblastic leukaemia in adults with minimal residual disease (MRD) of at least 0.1% if:
  • the disease is in first complete remission and
  • the company provides blinatumomab according to the commercial arrangement
Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

You can follow developments with Blincyto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve dacomitinib (Vizimpro▼) for the treatment of non-small cell lung cancer

The National Institute for Health and Care Excellence (NICE) have recommended Pfizer's medicine dacomitinib, brand name Vizimpro▼, as an option for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults.

This means that Vizimpro is available as a treatment option for patients in England and Wales.

You can follow developments with Vizimpro by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve patisiran (Onpattro▼) for the treatment of hereditary transthyretin-mediated amyloidosis

The National Institute for Health and Care Excellence (NICE) have recommended Alnylam's medicine patisiran, brand name Onpattro▼ as an option for treating hereditary transthyretin amyloidosis in adults with stage 1 and stage 2 polyneuropathy.

Onpattro is used to treat nerve damage caused by hereditary transthyretin (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves.

This decision means that Onpattro is available as a treatment option for patients in England and Wales.

You can follow developments with Onpattro by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve ribociclib (Kisqali▼) for the treatment of breast cancer

The National Institute for Health and Care Excellence (NICE) have approved Novartis' medicine ribociclib, brand name Kisqali▼, for use with another medicine, fulvestrant, for treating hormone receptor-positive, HER2-negative, advanced breast cancer.

This means that patients in England and Wales can be treated with the medicine.

Kisqali, with fulvestrant, is available through the Cancer Drugs Fund. It is a possible option for adults who have locally advanced or metastatic breast cancer that:
  • is hormone receptor-positive and human epidermal growth factor 2 (HER2)-negative and
  • has been treated with endocrine therapy previously and
  • if exemestane plus everolimus would be the most appropriate alternative to a cyclin-dependent kinase 4 and 6 inhibitor
More evidence on ribociclib is being collected, until December 2020. After this NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.

You can follow developments with Kisqali by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Iclusig▼ (ponatinib) - patient safety update

Incyte Biosciences, the manufacturer of cancer treatment ponatinib, brand name Iclusig▼, have added new potential side effects of aneurysms and artery dissections with an unknown frequency.

An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches.

As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon.

Aneurysms can develop in any blood vessel in the body, but the 2 most common places are:
  • the artery that transports blood away from the heart to the rest of the body (the abdominal aorta)
  • the brain
Symptoms of a brain aneurysm include:
  • a sudden agonising headache – it's been described as a "thunderclap headache", similar to a sudden hit on the head, resulting in a blinding pain unlike anything experienced before
  • a stiff neck
  • sickness and vomiting
  • pain on looking at light
Symptoms of abdominal aneurysm include:
  • a pulsing sensation in the tummy (like a heartbeat)
  • tummy pain that doesn't go away
  • lower back pain that doesn't go away
Patients taking Iclusig and experiencing any of these symptoms should consult their doctor immediately.

You can follow developments with Iclusig by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Amring launch glibenclamide formulation for treating neonatal diabetes

The European Medicines Agency (EMA) have approved Amring's glibenclamide, brand name Amglidia, for the treatment for neonatal diabetes.

Neonatal diabetes is a disease of early infancy due to genetic mutations which result in failure of insulin secretion.

The prevalence of neonatal diabetes is less than 0.02 per 10,000 individuals in the EU and should be considered as an extremely rare disorder of genetic origin which cannot be prevented.

Amglidia is a liquid formulation of glibenclamide.

You can follow developments with Amglidia by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Tegsedi▼ gets approval for use in Scotland

The Scottish Medicines Consortium (SMC) have approved Akcea Therapeutic's medicine inotersen, brand name Tegsedi▼, for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

This means that Tegsedi will be available as an option for patients being treated under the NHS in Scotland.

You can follow developments with Tegsedi by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Venclyxto▼ gets approval for use in Scotland

The Scottish Medicines Consortium (SMC) have approved AbbVie's medicine venetoclax, brand name Venclyxto▼, in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

Progression-free survival was significantly longer in the venetoclax plus rituximab group compared with chemoimmunotherapy in a phase III study of patients with relapsed or refractory CLL.

This means that Venclyxto will be available as an option for patients being treated under the NHS in Scotland.

You can follow developments with Venclyxto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Glyxambi▼ gets approval for use in Scotland

The Scottish Medicines Consortium (SMC) have approved Boehringer Ingelheim's medicine containing empagliflozin and linagliptin, brand name Glyxambi▼, for the treatment of adults aged 18 years and older with type 2 diabetes mellitus:
  • to improve glycaemic control (blood sugar) when metformin and/or sulphonylurea and one of the components of Glyxambi do not provide adequate glycaemic control
  • When already being treated with the free combination of empagliflozin and linagliptin
In patients for whom this combination is appropriate, Glyxambi offers a single tablet at a lower cost per dose compared with the individual components.

You can follow developments with Glyxambi by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Fycompa gets approval for use in Scotland

The Scottish Medicines Consortium (SMC) have approved Eisai's medicine containing perampanel, brand name Fycompa, for the adjunctive (in addition to other medicines) treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.

Fycompa is to be used as a second-line adjunctive treatment in patients with refractory partial onset epilepsy who are unable to swallow perampanel tablets. Treatment should be initiated only by physicians who have appropriate experience in the treatment of epilepsy.

The SMC has previously accepted perampanel tablets for restricted use as adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.

The oral suspension provides an alternative formulation for patients who have difficulty swallowing tablets. Depending on the dose, it may be more expensive than the tablets but any overall net budget impact is likely to be small.

You can follow developments with Fycompa by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Saxenda▼ (liraglutide) - patient safety update

Novo Nordisk, the manufacturers of weight loss treatment liraglutide, brand name Saxenda▼, have warned that following a drug safety update, that patients taking Saxenda who have type 2 diabetes mellitus, liraglutide must not be used as a substitute for insulin.

They report that diabetic ketoacidosis has been reported in insulin dependent patients after rapid discontinuation or dose reduction of insulin.

Diabetic ketoacidosis (DKA) is a serious problem that can occur in people with diabetes if their body starts to run out of insulin.

This causes harmful substances called ketones to build up in the body, which can be life-threatening if not spotted and treated quickly.

Signs of DKA include:
  • needing to pee more than usual
  • feeling very thirsty
  • being sick
  • tummy pain
  • breath that smells fruity (like pear drop sweets or nail varnish)
  • deep or fast breathing
  • feeling very tired or sleepy
  • confusion
  • passing out
DKA can also cause high blood sugar (hyperglycaemia) and a high level of ketones in your blood or urine, which you can check for using home-testing kits.

Symptoms usually develop over 24 hours, but can come on faster.

You can follow developments with Saxenda by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Herceptin (trastuzumab) - patient safety update

Roche, the manufacturers of cancer treatment trastuzumab, brand name Herceptin, have added a new side effect for the medicine.

Tumour lysis syndrome (TLS) has been added as an adverse event of unknown frequency.

TLS is a condition that occurs when a large number of cancer cells die within a short period, releasing their contents in to the blood.

Diagnosis of TLS is achieved with blood tests and, possibly, and ECG.

Symptoms of TLS include:
  • abdominal pain and distension
  • urinary symptoms
    - dysuria (painful or difficult urination)
    - oliguria (small urine output)
    - haematuria (blood in the urine)
  • pain in the upper back, abdomen or side of the body
  • hypocalcaemia - symptoms of anorexia, vomiting, cramps, seizures, spasms, altered mental status, and tetany
  • hyperkalaemia -symptoms of weakness and paralysis
Patients taking Herceptin who experience any of these symptoms should consult their doctor.

You can follow developments with Herceptin by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve cemiplimab (Libtayo▼) for the treatment of cutaneous squamous cell carcinoma

The National Institute for Health and Care Excellence (NICE) have recommend Sanofi's cancer treatment cemiplimab, brand name Libtayo▼, within the Cancer Drug Fund, as an option for locally advanced or metastatic cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not appropriate.

Treatment should be continued until disease progression or for up to 24 months.

This means that patients in England and Wales with squamous cell carcinoma will be able to receive Libtayo treatment if they meet the criteria and their doctor thinks it is appropriate. The medicine will be funded from the Cancer Drug Fund.

Squamous cell carcinoma starts in the cells lining the top of the epidermis and accounts for about 20% of skin cancers.

You can follow developments with Libtayo by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE publish consultation information for rheumatoid arthritis

The National Institute for Health and Care Excellence (NICE) have started a consultation on Quality Standards for rheumatoid arthritis in patients aged over 16 years.

The consultation will provide the NICE committee with a basis for discussing and prioritising quality improvement areas for development into draft quality statements and measures for public consultation.

This quality standard will cover assessment, diagnosis and management of rheumatoid arthritis in over 16s. It will update and replace the existing NICE quality standard for rheumatoid arthritis in over 16s.

You can follow developments on rheumatoid arthritis by clicking on the Follow Condition button above.

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UK regulator approves Bavencio▼ (avelumab) used in combination with Inlyta (axitinib) in treating kidney cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) have approved Merck-Pfizer's cancer treatment avelumab, brand name Bavencio▼, in combination with Pfizer's axitinib, brand name Inlyta, for first-line treatment of advanced renal (kidney) cancer. The treatment will be funded under the early access to medicines scheme (EAMS) and will be available for use by NHS England.

The aim of the Early Access to Medicines Scheme (EAMS) is to provide earlier availability of promising new unlicensed medicines to UK patients that have a high unmet clinical need.

The combination is not licensed in Europe for advanced renal cell cancer and is currently under review by European Medicines Agency.

You can follow developments with Bavencio and Inlyta by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE start consultation process for colorectal (bowel) cancer

The National Institute for Health and Care Excellence (NICE) have started a consultation to update the guidance on the diagnosis and management of colorectal cancer.

This guideline covers managing colorectal (bowel) cancer in people aged 18 and over. It aims to improve quality of life and survival for adults with colorectal cancer through management of local disease and management of secondary tumours (metastatic disease).

Who is it for?
  • People with colorectal cancer, their families and carers
  • Health professionals working in secondary care
  • Cancer Alliances and cancer clinical networks
  • Commissioners of colorectal cancer preventative and treatment services (including Clinical Commissioning Groups and NHS England Specialised Commissioning)
This draft guideline contains:
  • the draft recommendations
  • recommendations for research
  • rationale and impact sections that explain why the committee made the recommendations and how they might affect practice and services
  • the guideline context

You can follow developments on colorectal cancer by clicking on the Follow Condition button above.

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NICE publish updated guidance for chronic obstructive pulmonary disease in over 16s

The National Institute for Health and Care Excellence (NICE) have published updated guidance on the diagnosis and management of chronic obstructive pulmonary disease in patients aged over 16.

The guideline covers diagnosing and managing chronic obstructive pulmonary disease or COPD (which includes emphysema and chronic bronchitis) in people aged 16 and older. It aims to help people with COPD to receive a diagnosis earlier so that they can benefit from treatments to reduce symptoms, improve quality of life and keep them healthy for longer.

Who is it for?
People with COPD and their families and carers
Healthcare professionals
Commissioners and providers

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NICE publish draft approval documents for the use of olaparib (Lynparza) in the treatment of ovarian, fallopian tube and peritoneal cancer

The National Institute for Health and Care Excellence (NICE) are to recommend use of AstraZeneca's cancer treatment olaparib, brand name Lynparza.

The approval is for use of Lynparza for maintenance treatment of ovarian, fallopian tube or peritoneal cancer in patients that have an inherited mutation of their BRCA genes. This means that patients in England will be able to be treated with Lynparza if they meet the conditions and their doctor thinks it appropriate.

BRCA1 and BRCA2 are human genes that produce tumour suppressor proteins. These proteins help repair damaged DNA and, therefore, play a role in ensuring the stability of each cell’s genetic material. Mutations can result in a greater likelihood of the cells becoming cancerous. 

Lynparza can be used if patients respond to another treatment called first-line platinum-based chemotherapy.

NICE state that there are currently no maintenance treatments for patients with these cancers and the approval of Lynparza is based on the results of clinical trials.

Lynparza is to be funded under the Cancer Drugs Fund for these conditions and will be available as an option for patients in England under the NHS.

NICE have agreed a price for the treatment with the manufacturers.

You can follow developments with Lynparza by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve blinatumomab (Blincyto▼) in the treatment of acute lymphoblastic leukaemia

The National Institute for Health and Care Excellence (NICE) have approved Amgen's treatment for acute lymphoblastic leukaemia (ALL) blinatumomab, brand name Blincyto▼.

Blinatumomab is recommended as an option for treating a form of acute lymphoblastic leukaemia called Philadelphia-chromosome-negative, CD19‑positive B‑precursor ALL. The recommendation is specific for adults with minimal residual disease (MRD) of at least 0.1% and only if the disease is in first complete remission.

Minimal residual disease means that there is still some detectable cancer cells in the body

You can follow developments with Blincyto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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New migraine treatment galcanezumab (Emgality▼) approved for use in EU

The European Medicines Agency (EMA) have approved Eli Lilly's migraine treatment, galcanezumab (brand name Emgality▼) for use in the EU.

Emgality was shown to be more effective than placebo at reducing the number of days of migraine, although the size of the effect is limited particularly for patients with chronic migraine.

The side effects seen with Emgality are considered manageable with most being mild or moderate in severity.

The European Medicines Agency therefore decided that Emgality’s benefits are greater than its risks and it can be authorised for use in the EU.

You can follow developments with Emgality by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE publish updated quality standard for hypertension in pregnancy

The National Institute for Health and Care Excellence (NICE) have published their updated quality standard on hypertension in pregnancy.

This quality standard covers diagnosing and managing hypertension (high blood pressure) and pre-eclampsia during pregnancy, labour and birth. It also covers advice for women with hypertension who may become pregnant and postnatal care for women who have had hypertension or pre-eclampsia. It describes high-quality care in priority areas for improvement.

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NICE publish updated guidance for motor neurone disease

The National Institute for Health and Care Excellence (NICE) have published their updated guidance for motor neurone disease.

NICE guidelines provide advice on the care and support that should be offered to people who use health and care services.

This information explains the advice about motor neurone disease (MND) that is set out in NICE guideline NG42. It also covers advice on non‑invasive ventilation that NICE produced in 2010.

This guideline includes recommendations on:
  • recognition and referral
  • information and support at diagnosis
  • cognitive assessments
  • prognostic factors
  • organisation of care
  • planning for end of life
  • managing symptoms

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NICE publish draft quality standard update for lung cancer

The National Institute for Health and Care Excellence (NICE) have published the draft of their updated quality standard for lung cancer.

The quality standard covers diagnosing and managing lung cancer in adults. It describes high-quality care in priority areas for improvement and is now open for consultation.

The standard is for:
  • the public
  • commissioners
  • health service providers
  • health, public health and social care practitioners
Quality standard consultation
You can now comment on this draft quality standard.

Closing date for comments: Friday 23 August 2019 at 5pm

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New migraine treatment fremanezumab (Ajovy▼) approved for use in EU

The European Medicines Agency (EMA) have approved Teva's migraine treatment, fremanezumab (brand name Ajovy▼) for use in the EU.

The EMA stated that Ajovy can reduce the number of days patients have moderate to severe headaches and migraines. As most of the side effects are manageable and mild or moderate in severity, the European Medicines Agency decided that Ajovy’s benefits are greater than its risks and it can be authorised for use in the EU.

You can follow developments with Ajovy by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Xarelto▼ (rivaroxaban) - patient safety update

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a reminder that Bayer's anti-coagulant medicine rivaroxaban, brand name Xarelto▼, 15 mg and 20 mg tablets should be taken with food. The MHRA has received a small number of reports of patients taking rivaroxaban 15 mg or 20 mg who experienced a thromboembolic event, which the reporter suspected was due to the patient taking the tablets on an empty stomach.

Thromboembolic events arise from the formation in a blood vessel of a clot (thrombus) that breaks loose and is carried by the blood stream to plug another vessel. The clot may plug a vessel in the lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or leg.

The section of the patient leaflet for rivaroxaban 15 mg and 20 mg tablets that advises patients how to take their medicine has been revised to emphasise patients must take rivaroxaban with a meal and the tablets should be swallowed preferably with water.

You can follow developments with Xarelto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Adenuric (febuxostat) - patient safety update

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a warning for Menarini's gout treatment febuxostat, brand name Adenuric.

The Agency warn that an increased risk of cardiovascular death and all-cause mortality seen in a clinical trial in patients with a history of major cardiovascular disease.

The advice given is:

'Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate. Findings from a phase 4 clinical study (the CARES study) in patients with gout and a history of major cardiovascular disease show a higher risk for cardiovascular-related death and for all-cause mortality in patients assigned to febuxostat than in those assigned to allopurinol.'

You can follow developments on Adenuric by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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RoActemra (tocilizumab) - patient safety update

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a warning that there is a rare risk of serious liver injury including cases requiring transplantation in patients taking tocilizumab, brand name RoActemra.

RoActemra is used to treat rheumatoid arthritis, giant cell arteritis and juvenile idiopathic arthritis.

The advice to clinicians is that the levels of the enzymes (chemicals produced by the body that speed up reactions) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be measured before starting treatment with tocilizumab. These enzymes should be monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter. Serious liver injury has been reported on treatment with tocilizumab from 2 weeks to more than 5 years after initiation.

You can follow developments on RoActemra by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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EMA recommends new measures to avoid dosing errors with methotrexate

The European Medicines Agency’s safety committee (PRAC) is recommending new measures to avoid dosing errors that have led to some patients incorrectly taking methotrexate-containing medicines daily instead of weekly.

The new measures include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals.

In addition, to help patients follow the once-weekly dosing, methotrexate tablets for weekly use will be provided in blister packs and not in bottles (or tubes).

Methotrexate is used for treating both inflammatory diseases and cancers. When used for inflammatory diseases, such as arthritis and psoriasis, it is taken once a week but for some types of cancer, a much higher dosage is needed and the medicine is taken more frequently.

Mistakes in prescribing or dispensing methotrexate as well as misunderstandings of the dosing schedule have led to patients taking the medicine daily instead of weekly for inflammatory diseases, with serious consequences, including fatalities.

The risk of dosing errors with methotrexate-containing medicines is well known. However, despite several measures already in place, these errors continue to be reported.

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NICE set to approve dapagliflozin (Forxiga) in the treatment of type 1 diabetes

The National Institute for Health and Care Excellence (NICE) have published a final appraisal document recommending use of AstraZeneca's dapagliflozin, brand name Forxiga, as an option in treating type 1 diabetes.

Dapagliflozin with insulin is recommended as an option for treating type 1 diabetes in adults with a body mass index (BMI), of at least 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, only if:
  • they are on insulin doses of more than 0.5 units/kg of body weight/day and
  • they have completed a structured education programme that includes information about:
    − the risk of diabetic ketoacidosis
    − how to recognise risk factors for diabetic ketoacidosis, and its signs and symptoms
    − how and when to monitor blood ketone levels
    − what actions to take for elevated blood ketones, and
  • treatment is started and supervised in a hospital diabetes clinic.
NICE recommend that the patients haemoglobin A1c (HbA1c) level is assessed after 6 months and regularly after
this. Stop dapagliflozin if there has not been a sustained improvement in glycaemic control (that is, a fall in HbA1c level of at least 0.3%).


You can follow developments on Forxiga by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve atezolizumab (Tecentriq▼) in combination for treating advanced non-squamous non-small-cell lung cancer

The National Institute for Health and Care Excellence (NICE) have approved Roche's lung cancer medicine atezolizumab, brand name Tecentriq▼, as an option in the treatment of a type of lung cancer called non-squamous, non-small cell lung cancer (NSCLC).

This means that atezolizumab prescribed with the other medicines bevacizumab, carboplatin and paclitaxel is available on the NHS.

It is a possible treatment for metastatic non-squamous non-small-cell lung cancer (NSCLC) in adults if:
  • they have not had treatment for their metastatic NSCLC before and their PD-L1 tumour proportion score is below 50% or
  • targeted therapy for epidermal growth factor receptor (EGFR)‑positive or anaplastic lymphoma kinase (ALK)‑positive NSCLC has not worked.
Treatment should be stopped at 2 years of continuous treatment, or earlier if atezolizumab stops working or the disease progresses on bevacizumab.

If you are not eligible for atezolizumab with bevacizumab, carboplatin and paclitaxel but are already taking it, you should be able to continue until you and your doctor decide when best to stop.

You can follow developments on Tecentriq by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Vemlidy▼ (tenofovir alafenamide fumarate) - patient safety update

Gilead,the manufacturers of hepatitis B treatment tenofovir alafenamide fumarate, brand name Vemlidy▼, have added angioedema and urticaria as adverse reactions. This follows a safety review conducted by Gilead, concluding the causal association of these two reactions with tenofovir alafenamide fumarate containing products.

Angioedema is swelling underneath the skin. It's usually a reaction to a trigger, such as a medication or something you're allergic to.

It isn't normally serious, but it can be a recurring problem for some people and can very occasionally be life-threatening if it affects breathing.

Symptoms of angioedema
The swelling most often affects the:
  • hands
  • feet
  • area around the eyes
  • lips and tongue
  • genitals
Many people also have a raised, itchy rash called urticaria (hives).

In more serious cases, angioedema can also cause breathing difficulties, tummy (abdominal) pain and dizziness.

Urticaria is also known as hives. Hives are rashes that can be different sizes and shapes, and appear anywhere on the body in both adults and children.

The rash is often itchy and sometimes feels like it's stinging or burning.

You can follow developments on Vemlidy by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE publish quality standard on the diagnosis and management of Lyme disease

The National Institute for Health and Care Excellence (NICE) have published a quality standard on the diagnosis and management of Lyme disease.

The quality standard covers diagnosing and managing Lyme disease in people of all ages. It also includes raising public awareness about prevention. It describes high-quality care in priority areas for improvement.

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Scottish Medicines Consortium approve acute myeloid leukaemia treatment arsenic trioxide (Trisenox) for use by NHS Scotland

The Scottish Medicines Consortium have approved Teva's acute promyelocytic leukaemia treatment arsenic trioxide, brand name Trisenox for use by NHS Scotland in adult patients.

This means that Trisenox will be funded by NHS Scotland and made available to patients who qualify.

Acute promyelocytic leukemia is an important sub-type of acute myeloid leukaemia. In this sub-type, chromosomal changes in promyelocytes - cells that are at an early stage in the development into mature neutrophils - allow accumulation of these immature cells.

Trisenox is approved as an option, in combination with all-trans-retinoic acid (ATRA [tretinoin]) for the induction of remission, and consolidation in adult patients with newly diagnosed, low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count ≤10 x 103/µl), characterised by the presence of the t(15;17) translocation and/or the presence of the Pro Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene.

In a Phase III study in patients with newly diagnosed, low-to-intermediate risk APL, arsenic trioxide was non-inferior to anthracycline-based chemotherapy (both in combination with tretinoin) measured by event-free survival. A significant difference in overall survival favouring arsenic trioxide was also demonstrated.

You can follow developments on Trisenox by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Scottish Medicines Consortium approve multiple myeloma treatment daratumumab (Darzalex▼) for use by NHS Scotland

The Scottish Medicines Consortium have approved Janssen-Cilag's multiple myeloma treatment daratumumab, brand name Darzalex▼ for use by NHS Scotland in adult patients.

This means that Darzalex will be funded by NHS Scotland and made available to patients who qualify.

Darzalex is approved as an option, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Darzalex should only be used in combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received one prior therapy only.

Progression-free survival was significantly longer in patients who received daratumumab in combination with bortezomib and dexamethasone compared with those who received bortezomib and dexamethasone in a phase III study in patients with multiple myeloma who had received at least one prior therapy.

You can follow developments on Darzalex by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Transthyretin amyloidosis treatment patisiran (Onpattro▼) recommended by NICE (draft)

The National Institute for Health and Care Excellence (NICE) have published draft recommendation for Alnylam's medicine patisiran, brand name Onpattro▼, as an option for treating hereditary transthyretin amyloidosis (hATTR amyloidosis) in adults with stage 1 and stage 2 polyneuropathy.

It is recommended only if the company provides patisiran according to the commercial arrangement. Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

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NICE extend use of spinal muscular atrophy medicine nusinersen (Spinraza▼)

The National Institute for Health and Care Excellence (NICE) have announced that the managed access agreement for Biogen's spinal muscular atrophy medicine nusinersen, brand name Spinraza▼, can now be used in paediatric patients who have recently lost the ability to walk independently.

This replaces the previous criteria that patients, who had previously gained ambulation, should still be able to walk independently at the start of their treatment.

You can follow developments about Spinraza by using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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NICE publish final appraisal documents for dacomitinib (Vizimpro▼) in the treatment of breast cancer

The National Institute for Health and Care Excellence (NICE) have published final appraisal documents recommending the use of Pfizer's lung cancer treatment dacomitinib, brand name Vizimpro▼.

NICE state that dacomitinib is recommended as an option for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults.

You can follow developments about Vizimpro by using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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Keep Me Informed - Patient safety updates added since April 2019

Since April 2019 Keep Me Informed have detailed over 30 patient safety warnings. Most of these relate to specific side effects that have been identified by manufacturers and resulted in amendments to the product information including the patient leaflet. Other safety information relates to interactions and contraindications (situations where a medicine should not be prescribed or prescribed with caution).

By notifying patients, carers and healthcare professionals of these side effects we hope to ensure that the information is targeted to people who have specific interest. This direct service is not available through any other source. In addition to the detailed changes made by the manufacturer we also aim to ensure that:
  • complex medical terms are explained in plain English
  • symptoms of side effects and interaction are described
An important situation we highlight is in the warnings to pregnant or breastfeeding women. Four of the warnings published are specifically about this topic.

For a list of the details please see the full article.

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Public Health England publish guidance on the universal HPV vaccination programme.

Public Health England have published comprehensive guidance about the Human Papilloma Virus universal vaccination. The guidance is aimed at health professionals and provides information about the HPV universal programme eligibility, scheduling and vaccine administration for the adolescent programme.

Since the introduction of the girls programme for vaccination in 2008, the number of diagnoses of genital warts in England has fallen sharply in both girls and boys and there has been a reduction in the prevalence of the types of HPV that the vaccine protects against.

This suggests that boys are already benefiting significantly from the indirect protection (herd protection) that has built up from ten years of the girls programme.

The HPV vaccination programme is being extended to include boys from 12 years of age, and will help prevent more cases of HPV-related cancers in both males and females, such as head, neck and anal and genital cancers, and will also strengthen herd protection.

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NICE publish guideline on depression in children and young people: identification and management

The National Institute for Health and Care Excellence (NICE) have published a guideline on the identification and management of depression in children and young people.

The guideline covers identifying and managing depression in children and young people aged 5 to 18 years. Based on the stepped-care model, it aims to improve recognition and assessment and promote effective treatments for mild and moderate to severe depression.

Recommendations
The guideline includes new and updated recommendations on:
  • psychological therapies for mild depression
  • psychological therapies for moderate to severe depression
These supplement the existing recommendations on:
  • care for all children and young people with depression
  • stepped care
  • detection, risk profiling and referral
  • recognition
  • transfer to adult services
Who is it for?
  • Children and young people with depression and their families and carers
  • Healthcare professionals
  • Commissioners and providers

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NICE publish guideline on hypertension in pregnancy: diagnosis and management

The National Institute for Health and Care Excellence (NICE) have published a guideline on the diagnosis and management of hypertension in pregnancy.

The guideline covers diagnosing and managing hypertension (high blood pressure), including pre-eclampsia, during pregnancy, labour and birth. It also includes advice for women with hypertension who wish to conceive and women who have had a pregnancy complicated by hypertension. It aims to improve care during pregnancy, labour and birth for women and their babies.

Recommendations
This guideline includes new and updated recommendations on:
  • assessing proteinuria (the presence of abnormal quantities of protein in the urine)
  • managing chronic hypertension in pregnancy and gestational hypertension
  • managing pre-eclampsia, including severe pre-eclampsia in critical care settings (eclampsia is where convulsions occur in a pregnant woman suffering from high blood pressure)
  • treatment during the postnatal period (including breastfeeding)
  • advice and follow-up in community care
It also includes recommendations on:
  • reducing the risk of hypertension in pregnancy
  • fetal monitoring and care of women during labour and birth
Who is it for?
  • Women who develop hypertension during pregnancy, who have hypertension and wish to conceive, and who have had a pregnancy complicated by hypertension, and their relatives and carers
  • Healthcare professionals

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MHRA renews early access medicines scheme support for Duchenne muscular dystrophy treatment idebenone

The Medicines and Healthcare products Regulatory Agency (MHRA) has renewed for a further year the Early Access to Medicines Scheme (EAMS) scientific opinion for idebenone (Raxone▼) for patients with Duchenne muscular dystrophy (DMD) in respiratory function decline who are not taking glucocorticoids. With this renewal, the MHRA again confirmed its positive scientific opinion for idebenone under the EAMS.

The aim of EAMS is to provide earlier availability of promising new unlicensed medicines to UK patients that have a high unmet clinical need. The MHRA scientific opinion provides benefit and risk information to doctors who may wish to prescribe the unlicensed medicine under their own responsibility.

When applying for the EAMS renewal, Santhera submitted new efficacy data (including results from the long-term SYROS study) supporting the potential for a clinically relevant preservation of respiratory function during idebenone treatment for up to six years in a real-world setting. By renewing the EAMS, the MHRA has enabled access to idebenone for DMD patients with the highest need.

Recently the manufacturers, Santhera, has submitted a conditional marketing authorization application to the European Medicines
Agency for idebenone (under the trademark Puldysa®) to treat respiratory function decline in DMD.

Raxone is licensed in the EU to treat a rare condition called Leber's hereditary optic neuropathy. It is used as an unlicensed medicine in the treatment of patients with DMD. The manufacturer has applied for approval for idebenone, under the brand name Puldysa, to treat DMD.

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MHRA warning about anti-coagulant treatments

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a warning regarding patients taking anti-coagulant therapies known as direct-acting oral anticoagulants (DOACs) who have antiphospholipid syndrome (APS).

Patients are warned that an increase in the risk of recurrent thrombotic events has been observed in clinical studies for patients taking the anti-coagulant rivaroxaban with a history of thrombosis. They state that other direct-acting oral anticoagulants (DOACs) may be associated with a similarly increased risk.

Antiphospholipid syndrome (APS), sometimes known as Hughes syndrome, is a disorder of the immune system that causes an increased risk of blood clots.

This means people with APS are at greater risk of developing conditions such as:
  • deep vein thrombosis (DVT), a blood clot that usually develops in the leg
  • arterial thrombosis (a clot in an artery), which can cause a stroke or heart attack
  • blood clots in the brain, leading to problems with balance, mobility, vision, speech and memory
Pregnant women with APS also have an increased risk of having a miscarriage, although the exact reasons for this are uncertain.

APS doesn't always cause noticeable problems, but some people have general symptoms that can be similar to those of multiple sclerosis (a common condition affecting the central nervous system).

The DOACs currently available are:
  • rivaroxaban - brand name Xarelto▼; used to prevent venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery, deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults
  • apixaban - brand name Eliquis; used to prevent venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery, prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, deep vein thrombosis and pulmonary embolism, and prevention of recurrent DVT and PE in adults
  • edoxaban - brand name Lixiana▼; used for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, deep vein thrombosis and pulmonary embolism, and prevention of recurrent DVT and PE in adults
  • dabigatran - brand name Pradaxa; used to treat primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery, prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, deep vein thrombosis and pulmonary embolism, and prevention of recurrent DVT and PE
DOACs are approved for the treatment and prevention of venous thromboembolism (VTE) and prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation with one or more risk factors. Apixaban, dabigatran etexilate, and rivaroxaban are also approved for prevention of venous thromboembolism in conjunction with hip or knee replacement surgery.

Rivaroxaban is also approved, in addition to acetylsalicylic acid (aspirin), for the prevention of atherothrombotic events in patients with coronary artery disease or symptomatic peripheral artery disease at high risk of ischaemic events, and in addition to acetylsalicylic acid or acetylsalicylic acid plus clopidogrel or ticlopidine, in patients after an acute coronary syndrome event with elevated cardiac biomarkers.

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NICE to recommend blinatumomab (Blincyto▼) for the treatment of acute lymphoblastic leukaemia

The National Institute for Health and Care Excellence (NICE) have published a final appraisal document recommending that Amgen's acute lymphoblastic leukaemia (ALL) treatment blinatumomab, brand name Blincyto▼, be made available on the NHS in England and Wales.

Blincyto has been approved in the EU for treating:
  • a blood cancer called B-precursor acute lymphoblastic leukaemia (ALL) in patients above 1 year of age when the cancer has come back (relapsed) or has not improved with previous treatment (refractory)
  • adults who have been treated for B-precursor ALL and have minimal residual disease (which means that they still have some detectable cancer cells in their body)
Blincyto is used in patients who are ‘Philadelphia-chromosome-negative’ which means that the patients’ cancer cells do not have an abnormal chromosome called the Philadelphia chromosome, and in patients who have the protein CD19 on their cancer cells (CD19-positive).

NICE are recommending blinatumomab as an option for treating Philadelphia chromosome-negative CD19-positive B-precursor acute lymphoblastic leukaemia in adults with minimal residual disease (MRD) of at least 0.1% if:
  • the disease is in first complete remission and
  • the company provides blinatumomab according to the commercial arrangement
Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

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Tafinlar (dabrafenib) - patient safety update

Novartis the manufacturers of cancer treatment dabrafenib, brand name Tafinlar, have updated the side effect information to report cases of:
  • severe cutaneous (skin) adverse reactions (SCARs), including
    - Stevens‑Johnson syndrome, and
    - drug reaction with eosinophilia and systemic symptoms (DRESS) 
which can be life-threatening or fatal with dabrafenib/trametinib combination therapy. Trametinib is used with dabrafenib in treating melanoma and non-small cell lung cancer. It's brand name is Mekinist.

The advice is that before starting treatment, patients should be advised of the signs and symptoms and monitored closely for skin reactions. If you are starting dabrafenib treatment please ask your doctor to describe the symptoms to look out for.

If signs and symptoms suggestive of SCARs appear, dabrafenib and trametinib should be withdrawn.

Stevens-Johnson syndrome (source NHS)
Stevens-Johnson syndrome is a rare but serious disorder that affects the skin, mucous membrane, genitals and eyes.

The mucous membrane is the soft layer of tissue that lines the digestive system from the mouth to the anus, as well as the genital tract (reproductive organs) and eyeballs.

Stevens-Johnson syndrome is usually caused by an unpredictable adverse reaction to certain medications. It can also sometimes be caused by an infection.

The syndrome often begins with flu-like symptoms, followed by a red or purple rash that spreads and forms blisters. The affected skin eventually dies and peels off.

Stevens-Johnson syndrome is a medical emergency that requires treatment in hospital, often in intensive care or a burns unit.

Treatment aims to identify the underlying cause, control the symptoms and prevent complications.

Erythema multiforme is a similar, but less severe, skin reaction that's usually caused by infection, particularly herpes viral infections, and chest infections.

Symptoms of Stevens-Johnson syndrome
Skin pain is the most common symptom of Stevens-Johnson syndrome.

Flu-like symptoms are also usually present during the initial stages, and may include:
  • feeling generally unwell
  • a high temperature (fever) of 38C (100.4F) or above
  • a headache
  • joint pain
  • a cough
After a few days a rash appears, which consists of individual blemishes that may look like a target – darker in the middle and lighter around the outside.

The rash isn't usually itchy, and spreads over a number of hours or days.

Large blisters then develop on the skin, which leave painful sores after bursting.

Drug reaction with eosinophilia and systemic symptoms (DRESS)
DRESS syndrome is a complex syndrome with a broad spectrum of clinical features.

The clinical manifestations are not immediate and usually appear 2 to 8 weeks after introduction of the triggering drug.

Common features consist of:
  • fever
  • rash
  • swollen lymph nodes - lymphadenopathy
  • haematological findings (eosinophilia, leukocytosis, etc.)
  • abnormal liver function tests, which can mimic viral hepatitis.
Patients taking dabrafenib who experience any unusual symptoms should consult their doctor immediately.

You can follow developments on Tafinlar by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve use of inotersen (Tegsedi▼) in treatment of polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

The National Institute for Health and Care Excellence (NICE) have approved Akcea Therapeutics hereditary transthyretin amyloidosis (hATTR) treatment inotersen, brand name Tegsedi▼, for the treatment of polyneuropathy in adult patients with hATTR.

This means that Tegsedi can be prescribed and funded by the NHS in England and Wales.

Inotersen is recommended as an option for treating stage 1 and stage 2 polyneuropathy in adults with hereditary transthyretin amyloidosis. It is recommended only if the company provides inotersen according to the commercial arrangement.

Polyneuropathy is damage or disease affecting peripheral nerves (peripheral neuropathy) in roughly the same areas on both sides of the body, featuring weakness, numbness, and burning pain.

You can follow developments on Tegsedi by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE guidance: Prostate cancer: diagnosis and management

The National Institute for Health and Care Excellence (NICE) have published updated guidelines on the diagnosis and management of prostate cancer.

This guideline covers diagnosing and managing prostate cancer in secondary care. It offers information on the best way to diagnose and identify different stages of the disease, and how to manage adverse effects of treatment. It includes recommendations on follow-up in primary care for people with a diagnosis of prostate cancer.

The guideline is intended for use by:
  • People with prostate cancer, their families and carers
  • Healthcare professionals.
  • Commissioners and providers of prostate cancer services

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NICE approve use of ocrelizumab (Ocrevus▼) in treatment of primary progressive multiple sclerosis

The National Institute for Health and Care Excellence (NICE) have approved Roche's multiple sclerosis treatment ocrelizumab, brand name Ocrevus▼, for the treatment of primary progressive multiple sclerosis.

This means that Ocrevus can be prescribed and funded by the NHS in England and Wales.

NICE state that ocrelizumab is recommended as an option for treating early primary progressive multiple sclerosis with imaging features characteristic of inflammatory activity in adults. It is recommended only if the company provides it according to the commercial arrangement.

Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

NICE had previously approved Ocrevus in the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

You can follow developments on Ocrevus by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve use of ertugliflozin (Steglatro▼) in treatment of type 2 diabetes

The National Institute for Health and Care Excellence (NICE) have approved the use of Merck Sharp & Dohme's type 2 diabetes treatment ertugliflozin, brand name Steglatro▼. This means the medicine can be prescribed in England and Wales.

The guidance states that 'ertugliflozin is available on the NHS. It is a possible treatment, with drugs called metformin and a DPP‑4 inhibitor, for type 2 diabetes in adults if:
  • your blood glucose levels can't be managed by diet and exercise alone
  • metformin and a DPP‑4 inhibitor are not controlling the diabetes, and
  • pioglitazone or a sulfonylurea are not right for you
The group of medicines called DPP-4 inhibitors include:
  • alogliptin - brand name Vipidia
  • alogliptin with metformin - brand name Vipdomet
  • linagliptin - brand name Trajenta
  • linagliptin with metformin - brand name Jentadueto
  • linagliptin with empagliflozin - brand name Glyxambi
  • saxagliptin - brand name Onglyza
  • saxagliptin with dapagliflozin - brand name Qtern
  • saxagliptin with metformin - brand name Komboglyze
  • sitagliptin - brand name Januvia
  • sitagliptin with metformin - brand name Janumet
  • vildagliptin - brand name Galvus
  • vildagliptin with metformin - brand name Eucreas

You can follow developments on Steglatro by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE recommend letermovir (Prevymis) for treating cytomegalovirus after stem cell transplant

The National Institute for Health and Care Excellence (NICE) have recommended that Merck Sharp and Dohme's treatment for cytomegalovirus, letermovir, brand name Prevymis, for use by the NHS in England.

Letermovir is recommended, within its marketing authorisation, as an option for preventing cytomegalovirus (CMV) reactivation and disease after an allogeneic haematopoietic stem cell transplant (HSCT) in adults who are seropositive for CMV.

CMV is similar to the herpes virus that causes cold sores and chickenpox.

Once you have the virus, it stays in your body for the rest of your life.

Your immune system usually controls the virus and most people don't realise they have it. In patients undergoing stem cell transplant their immune system is compromised and so they are more prone to contracting CMV.

You can follow developments on Prevymis by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE guidance on the diagnosis, assessment and initial management of hyperparathyroidism

The National Institute for Health and Care Excellence (NICE) have updated their guidance on the diagnosis, assessment and initial management of hyperparathyroidism.

The guideline covers diagnosing, assessing and managing primary hyperparathyroidism. It aims to improve recognition and treatment of this condition, reducing long‑term complications and improving quality of life.

The guideline is aimed at:
  • People with suspected or confirmed primary hyperparathyroidism, their families and carers
  • Healthcare professionals

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MHRA - spotlight on the decline in the number of Yellow Card reports

The Medicines and Healthcare products Regulatory Agency (MHRA) have announced that the number of reports of adverse drug reactions from healthcare professionals has declined after increasing for the previous 8 years.

Between 2009 and 2017, the number of reports the MHRA received from UK healthcare professionals doubled. However, in 2018, there was a significant decrease in reports from some healthcare professional groups.

It is estimated that only 10% of serious reactions and between 2 and 4% of non-serious reactions are reported. Under-reporting coupled with a decline in reporting makes it especially important to report all suspicions of adverse drug reactions to the Yellow Card Scheme.

*The importance of ADR reporting cannot be overestimated. Research by the universities of Sheffield, Manchester and York concludes the following:
  • 66 million potentially clinically significant errors occur per year, 71% of these in primary care
  • Prescribing in primary care accounts for 33.9% of all potentially clinically significant errors
  • The estimated cost of avoidable ADRs are £98.5 million per year, consuming 181,626 bed-days, causing 712 deaths, and contributing to 1,708 deaths
  • Primary care ADRs leading to a hospital admission cost £83.7 million and causing 627 deaths
  • Secondary care ADRs leading to a longer hospital stay cost £14.8 million and caused 85 deaths and contributing to 1,081 deaths
[*Citation: Elliot RA, Camacho E, Campbell F, et al. Prevalence and economic burden of medication errors in the NHS England.]

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Xeljanz▼ (tofacitinib) in treating ulcerative colitis - safety update

The Medicines and Healthcare products Regulatory Agency (MHRA) have advised that patients suffering from ulcerative colitis and at a high risk of pulmonary embolism should not be started with tofacitinib, brand name Xeljanz▼.

The European Medicines Agency are conducting a safety review of Xeljanz.

An ongoing study in patients with rheumatoid arthritis showed that when Xeljanz was given at a dose of 10 mg twice daily there was an increased risk of dangerous blood clots in the lungs and death (pulmonary embolism).

You should seek medical attention immediately if you experience the following symptoms which may be signs of a blood clot in your lungs:
  • difficulty breathing
  • chest pain or pain in your upper back
  • coughing up blood
  • excessive sweating
  • bluish skin
If you have any concerns about your medicine, you should discuss them with a healthcare professional.

You can follow developments on Xeljanz by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Lemtrada (alemtuzumab) - patient safety update

The Medicines and Healthcare products Regulatory Agency (MHRA) have published further information on restrictions regarding Genzyme's relapsing remitting multiple sclerosis (RRMS) treatment alemtuzumab, brand name Lemtrada.

The MHRA have stated that serious cardiovascular and immune-mediated adverse reactions are being investigated in patients taking Lemtrada.

While an urgent EU safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requirements have been introduced to monitor vital signs and liver function before and during treatment. All patients on alemtuzumab for multiple sclerosis should be alerted to these risks and what to do if symptoms occur.

Advice for patients highlights being aware of the symptoms of:
  • pulmonary haemorrhage, myocardial infarction, stroke, and arterial dissection within days of infusion – patients should seek urgent medical attention if they develop any symptoms of these disorders (see below), which may occur within a few days of treatment
  • hepatic injury – patients should seek urgent medical help if they develop any symptoms of liver injury including abdominal pain, jaundice, dark urine, and unexplained nausea or vomiting
  • haemophagocytic lymphohistiocytosis – patients should seek immediate medical attention if they develop unexplained fever, lymphadenopathy, bruising or rash, including if these symptoms occur several years after treatment
  • patients should speak to their doctor if they have any questions about alemtuzumab for multiple sclerosis
For more information and symptoms of side effects see full article.

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NICE publish guideline for use of Opdivo▼ with Yervoy in treating kidney cancer under Cancer Drug Fund

The National Institute for Health and Care Excellence (NICE) have published their guideline for the use of the combination of:
  • Nivolumab (brand name Opdivo▼) with
  • Ipilimumab (brand name Yervoy)
as an option for adults with untreated advanced renal cell carcinoma (kidney cancer).

NICE recommend use within the Cancer Drugs Fund.

The criteria for use is that the kidney cancer is intermediate- or poor-risk.

It is recommended only if the conditions in the managed access agreement for nivolumab with ipilimumab are followed.

Managed access schemes are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

You can follow developments on Opdivo and Yervoy by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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World Health Organization (WHO) issues guideline on risk reduction of dementia

The World Health Organization (WHO) has published its first guideline on the prevention and management of dementia, recommending the adoption of specific lifestyle interventions such as encouraging physical activity and smoking cessation for reducing the risk of cognitive decline and dementia.

These new WHO guidelines provide the knowledge base for health care providers, governments, policy-makers and other stakeholders to reduce the risks of cognitive decline and dementia through a public health approach. As many of the risk factors for dementia are shared with those of noncommunicable diseases, the key recommendations can be effectively integrated into programmes for tobacco cessation, cardiovascular disease risk reduction and nutrition.

You can follow developments in dementia by using our Condition Tracker service which provides users with updates about the conditions and medicines they are interested in.

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Reagila▼ - approved for use in Scotland for the treatment of schizophrenia

The Scottish Medicines Consortium have approved the use of Recordati's schizophrenia treatment cariprazine, brand name Reagila▼, in adult patients.

This means that Reagila can be used and funded by NHS Scotland for use as a second-line therapy in schizophrenia patients where predominantly negative symptoms have been identified as an important feature.

In patients with stable schizophrenia with predominantly negative symptoms, cariprazine improved negative symptoms more than another second-generation antipsychotic.

You can follow developments on Reagila by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Keytruda▼ - approved for use in Scotland for the treatment of stage III melanoma

The Scottish Medicines Consortium have approved the use of Merck Sharp and Dohme's cancer medicine pembrolizumab, brand name Keytruda▼, for use in treating stage III melanoma.

This means that Keytruda can be used and funded by NHS Scotland for use as a single therapy for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.

Adjuvant therapy is applied after initial treatment for cancer, especially to suppress secondary tumour formation.

Resection is the process of cutting out tissue or part of an organ, in this case the melanoma.

Recurrence-free survival was significantly longer in the pembrolizumab group compared with placebo in a phase III study of adult patients with completely resected, stage III melanoma with lymph node involvement.


You can follow developments on Keytruda by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approves use of nusinersen (Spinraza▼) in treating spinal muscular atrophy

The National Institute for Health and Care Excellence (NICE) have announced that patients in England and Wales can now receive treatment with Biogen's spinal muscular atrophy treatment nusinersen, brand name Spinraza▼.

The approval comes after NICE, Biogen and the NHS agreed a price for the medicine.

Nusinersen is the first treatment that targets the underlying cause of SMA.

SMA affects the nerves in the spinal cord controlling movement. This causes muscle weakness, progressive loss of movement, and difficulty breathing and swallowing.

People with the most severe forms of SMA usually die before the age of 2. There are currently no active treatments targeting the underlying cause of SMA so the condition is managed through supportive care which aims to minimise the impact of disability, address complications and improve quality of life.

It is estimated there are there are between 600 and 1200 children and adults in the UK living with SMA.

NICE had previously not been able to recommend nusinersen for routine use because of uncertainties over its long-term effectiveness and its high cost.


You can follow developments on Spinraza by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE publish draft guidance for atezolizumab (Tecentriq▼) in combination for treating advanced non-squamous non-small-cell lung cancer

The National Institute for Health and Care Excellence (NICE) have published draft guidance recommending that Roche's cancer medicine atezolizumab, brand name Tecentriq▼, for the treatment of a type of lung cancer called non-squamous, non-small cell lung cancer (NSCLC).

The NICE recommendation is that atezolizumab plus other medicines, bevacizumab, carboplatin and paclitaxel is
recommended as an option for metastatic non-squamous, non-small-cell lung cancer (NSCLC) in adults:
  • who have not had treatment for their metastatic NSCLC before and whose PD-L1 tumour proportion score is between 0% and 49% or
  • when targeted therapy for epidermal growth factor receptor (EGFR)-positive or anaplastic lymphoma kinase (ALK)-positive NSCLC has failed
NICE also state that atezolizumab and bevacizumab should be stopped after 2 years of uninterrupted treatment, or earlier if the disease progresses.

The recommendation also requires that the company provides atezolizumab and bevacizumab according to the commercial arrangements which reduces the cost of the medicine to the NHS.

You can follow developments on Tecentriq by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE guidance on the management of ulcerative colitis

The National Institute for Health and Care Excellence (NICE) have updated their guidance on the management of ulcerative colitis.

This guideline covers the management of ulcerative colitis in children, young people and adults. It aims to help professionals to provide consistent high-quality care and it highlights the importance of advice and support for people with ulcerative colitis.

Ulcerative colitis is a lifelong condition in which the large bowel (colon) becomes inflamed. It can cause abdominal pain, diarrhoea (which may be bloody), tiredness and weight loss. Symptoms usually come and go, suddenly flaring up before easing off for a few weeks or months. Because flare-ups are unpredictable, living with ulcerative colitis can cause anxiety and stress. There is no cure, so the aim of treatment is to control symptoms as much as possible and help people have the best quality of life they can.

NICE want this guideline to make a difference to people with ulcerative colitis by making sure:
  • doctors know the best way to treat flare-ups, depending how severe they are and how much of your bowel is affected
  • your doctor fully explains the pros and cons of different drug treatments to prevent flare-ups, so you can choose what’s right for you
  • you get specialist advice on what to expect if surgery is a possible treatment option for you

You can follow developments in ulcerative colitis by using our Condition Tracker service which provides users with updates about the conditions and medicines they are interested in.

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NICE guidance update on the management of Crohn’s disease

The National Institute for Health and Care Excellence (NICE) have updated their guidance on the management of Crohn's disease.

Crohn’s disease is a lifelong condition that causes inflammation in parts of the digestive system (most commonly in the small intestine). It can cause symptoms like diarrhoea, abdominal pain, tiredness and weight loss. Symptoms usually come and go – they may flare up before easing off again for a few weeks or months. There is no cure for Crohn’s disease, so the aim of treatment is to get good control over symptoms to help people have the best quality of life they can.

The guideline is designed to make a difference to people with Crohn’s disease by making sure:
  • doctors know which drug treatments work best to treat flare ups, and how to prevent future flare-ups
  • your doctor explains the pros and cons of different drug treatments, including any side effects, so you can decide what’s right for you
  • your doctor involves you in decisions about how to manage your condition between flare-ups.


You can follow developments in Crohn's disease by using our Condition Tracker service which provides users with updates about the conditions and medicines they are interested in.

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NICE approve use of Ocrevus▼ in the treatment of primary progressive multiple sclerosis

The National Institute for Health and Care Excellence (NICE) are set to approve Roche's multiple sclerosis medicine ocrelizumab, brand name Ocrevus▼, for the treatment of primary progressive multiple sclerosis in adults. Ocrevus is already approved for use in treating relapsing remitting multiple sclerosis.

For more information and references, see full article.

You can follow developments on Ocrevus by using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.


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NICE recommend abemaciclib (Verzenios▼) in the treatment of advanced breast cancer

The National Institute for Health and Care Excellence (NICE) have provisionally approved Eli Lilly's breast cancer medicine abemaciclib, brand name Verzenios▼, for the treatment of hormone receptor-positive, HER2-negative advanced breast cancer in adults.

NICE state that Verzenios, with another medicine called fulvestrant, is available through the Cancer Drugs Fund rather than the NHS. This will remain the case while more information is collected. It is a possible option for adults who have locally advanced or metastatic breast cancer that:
  • is hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative and
  • has been treated with endocrine therapy previously and
  • if exemestane plus everolimus would be the most appropriate alternative.
For more information and references, see full article.

You can follow developments on Verzenios by using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.


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NICE approve use of lung cancer treatment Imfinzi▼ (durvalumab)

The National Institute for Health and Care Excellence (NICE) have recommended AstraZeneca's durvalumab (brand name Imfinzi▼) as an option for single therapy in treating locally advanced, unresectable (cannot be surgically removed) non-small-cell lung cancer (NSCLC).

The treatment is approved for use in adults whose tumours produce a protein called PD‑L1 on at least 1% of tumour cells and whose disease has not progressed after platinum-based chemoradiation if:
  • they have had concurrent platinum-based chemoradiation
  • the conditions in the managed access agreement are followed
Funding for the treatment will covered by the Cancer Drugs Fund in England.

Managed access schemes are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.


You can follow developments with Imfinzi using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.



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NICE publish guideline on stroke and transient ischaemic attack

The National Institute for Health and Care Excellence (NICE) have published a guideline on the diagnosis and management of stroke and transient ischaemic attack in people aged over 16.

The guideline covers:
  • the care patients can expect
  • making decisions together
  • helping patients decide about treatment

You can follow developments about stroke and transient ischaemic attack by using our Condition Tracking service which provides users with updates about the conditions they are interested in. Condition Tracking includes updates to condition information from the NHS, Patient Organisations, NICE guidelines and advice about the diagnosis, management and treatment of conditions. To track information about conditions please tap this article and follow the 'Select Conditions' link. Login or register to track conditions and medicines.



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NICE publish appraisal for venetoclax (Venclyxto▼) in treating chronic lymphocytic leukaemia

The National Institute for Health and Care Excellence (NICE) have recommended that AbbVie's chronic lymphocytic leukaemia treatment venetoclax, brand name Venclyxto▼, in combination with another medicine rituximab, as an option for treating chronic lymphocytic leukaemia.

The combination treatment is approved in adults who have had at least 1 previous therapy.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.



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NICE publish appraisal for encorafenib (Braftovi▼) in treating melanoma

The National Institute for Health and Care Excellence (NICE) has recommended that Pierre Fabre's melanoma treatment encorafenib, brand name Braftovi▼, in combination with another medicine binimetinib, as an option for treating for unresectable or metastatic BRAF V600 mutation-positive melanoma.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.



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MHRA publish warning for SGLT2 inhibitors: reports of Fournier’s gangrene

The Medicines and Healthcare products Regulatory Agency (MHRA) have published a warning for all medicines in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors.

This class of medicines is used in the treatment of diabetes and the following medicines are affected (with brand names):
  • canagliflozin - Invokana and Vokanamet▼
  • dapagliflozin - Forxiga, Qtern, Edistride, Ebymect and Xigduo
  • empagliflozin - Jardiance, Glyxambi▼ and Synjardy▼
  • ertugliflozin - Steglatro▼, Segluromet▼ and Steglujan▼
The new warning relates to 6 reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum).

Necrotising fasciitis is a rare but serious bacterial infection that affects the tissue beneath the skin and surrounding muscles and organs (fascia).

It's sometimes called the "flesh-eating disease", although the bacteria that cause it do not "eat" flesh, but release toxins that damage nearby tissue.

Necrotising fasciitis can start from a relatively minor injury, such as a small cut, but gets worse very quickly and can be life threatening if it's not recognised and treated early on.

The symptoms of necrotising fasciitis develop quickly over hours or days.

They may not be obvious at first and can be similar to less serious conditions, such as flu, gastroenteritis or cellulitis.

Early symptoms can include:
  • a small but painful cut or scratch on the skin
  • intense pain that's out of proportion to any damage to the skin
  • a high temperature (fever) and other flu-like symptoms
After a few hours to days, you may develop:
  • swelling and redness in the painful area – the swelling will usually feel firm to the touch
  • diarrhoea and vomiting
  • dark blotches on the skin that turn into fluid-filled blisters
If left untreated, the infection can spread quickly through the body and cause symptoms such as dizziness, weakness and confusion.

When to get medical help
Necrotising fasciitis is a medical emergency that requires immediate treatment.

Go to your nearest A&E department as soon as possible if you think you have it.

Call 999 for an ambulance if you're too unwell to get yourself to A&E.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.



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MMR vaccination

We have added the 'procedure' of MMR vaccination to the Conditions section of Keep Me Informed. This includes links to the NHS and Merck Manual resources on the subject.

The incidence of measles throughout the world is increasing to epidemic levels.

A significant factor in eliminating this worrying trend is to ensure that information is not just created, but disseminated to those who are concerned about vaccination.

The effect of disinformation needs to be countered, but it is clear that factual evidence of the safety of vaccinations is being overwhelmed by those who use cynical emotional tactics to trick people into disbelieving the medical realities.

Keep Me Informed will explore the many ways in which we can promote scientific evidence.

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NICE recommend brentuximab vedotin (Adcetris▼) for the treatment of CD30-positive cutaneous T-cell lymphoma

The National Institute for Health and Care Excellence (NICE) has approved Takeda's CD30-positive cutaneous T-cell lymphoma treatment brentuximab vedotin, brand name Adcetris▼ for use by the NHS in England and Wales.

The full recommendation states that:

Brentuximab vedotin (Adcetris) is available on the NHS. It is a possible treatment for CD30-positive cutaneous T-cell lymphoma in adults if:
  • they have already had 1 systemic therapy
  • they have mycosis fungoides stage IIB or over, primary cutaneous anaplastic large cell lymphoma or Sézary syndrome.
If you are not eligible for brentuximab vedotin but are already taking it, you should be able to continue until you and your doctor decide when best to stop.

There are more than 50 different diseases that involve B cells or T cells (lymphocytes), which are types of white blood cell. Each of these lymphomas has a distinct appearance under the microscope, a different cell pattern, and a different pattern of symptoms and progression. Most non-Hodgkin lymphomas (85%) are from B cells. Less than 15% develop from T cells.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.



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NICE recommend tildrakizumab (Ilumetri▼) for the treatment of moderate to severe plaque psoriasis

The National Institute for Health and Care Excellence (NICE) has approved Almirall's psoriasis treatment tildrakizumab, brand name Ilumetri ▼ for use by the NHS in England and Wales.

The full recommendation states that:

Tildrakizumab (Ilumetri) is available on the NHS as a possible treatment for plaque psoriasis in adults if:
  • the psoriasis is severe and affects quality of life and
  • the psoriasis has not improved with other treatments, for example, ciclosporin, methotrexate and phototherapy, or these can’t be taken.
Tildrakizumab may be stopped between 12 and 28 weeks of starting treatment, but should be stopped at 28 weeks if the psoriasis does not improve enough.

When assessing how psoriasis affects your quality of life, healthcare professionals should take into account any disabilities or difficulties in communicating you might have.

If you are not eligible for tildrakizumab but are already taking it, you should be able to continue until you and your doctor decide when best to stop.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.



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Welsh patients with acute lymphoblastic leukaemia (ALL) can now receive treatment with Blincyto▼ on NHS

The All Wales Medicines Strategy Group have recommended Amgen's blinatumomab, brand name Blincyto as an option for use within NHS Wales.

Blincyto is approved as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL).

The condition should be refractory (difficult to treat) or in relapse (has come back) after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation.

This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.



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Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir)- pregnancy warning update

Pregnancy warning update

The product information for Stribild has been updated to advise that the treatment should not be initiated during pregnancy. An alternative regimen for pregnant women should be undertaken. This is based on data from a study which showed that there was lower elvitegravir and cobicistat levels during 2nd and 3rd trimesters compared to after birth. This means that the treatment may be less effective.

Gilead, the manufacturers of HIV infection treatment, a combination of four medicines - emtricitabine, elvitegravir, cobicistat and tenofovir alafenamide fumarate - brand name Stribild, have updated the pregnancy information.

The product information has been updated to advise not to initiate this product during pregnancy, and to switch to alternative regimen for pregnant women. This is based on data from a study which showed that there was lower elvitegravir and cobicistat levels during 2nd and 3rd trimesters compared to after birth. This means that the treatment may be less effective.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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NICE recommend use of certolizumab pegol (Cimzia) in treating plaque psoriasis

The National Institute for Health and Care Excellence (NICE) has approved UCB's psoriasis treatment certolizumab pegol, brand name Cimzia for use by the NHS in England and Wales.

The full recommendation states that:

Certolizumab pegol (Cimzia) is available on the NHS as a possible treatment for plaque psoriasis in adults if:
  • the psoriasis is severe and affects quality of life and
  • the psoriasis has not improved with other treatments, for example, ciclosporin, methotrexate or phototherapy, or these can’t be taken
  • a maintenance dose of 200 mg every 2 weeks is used.
Treatment with certolizumab pegol should be stopped after 16 weeks if the psoriasis does not improve enough.

When assessing how psoriasis affects your quality of life, healthcare professionals should take into account any disabilities or difficulties in communicating you might have.

Patients not eligible for certolizumab pegol but are already taking it, you should be able to continue until you and your doctor decide when best to stop.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.



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MHRA update valproate Pregnancy Prevention information

The Medicines and Healthcare products Regulatory Agency (MHRA) have published updates for valproate medicines and serious harms in pregnancy. The updates include a new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme.

Ongoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme and meet the goal to rapidly reduce and eventually eliminate the harms of valproate in pregnancy in view of its serious effect in causing birth defects.

The MHRA have updated the Annual Risk Acknowledgement Form, which should be used during annual specialist review of all women and girls of childbearing potential on valproate medicines (irrespective of indication). Specialists should comply with guidance given on the form if they consider the patient is not at risk of pregnancy, including the need for regular review in case her risk status changes.

You can follow developments with valproate by using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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EMA restrict use of multiple sclerosis medicine Lemtrada

The European Medicines Agency (EMA) has started a review of Genzyme's multiple sclerosis medicine alemtuzumab, brand name Lemtrada, following new reports of immune-mediated conditions (caused by the body’s defence system not working properly) and problems with the heart and blood vessels with the medicine, including fatal cases.

As a temporary measure while the review is ongoing, Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease modifying therapies (a type of multiple sclerosis medicine) or where other disease-modifying therapies cannot be used. Patients being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their doctor.

Information for Patients
New cases of side effects have been reported with Lemtrada, including some affecting the heart, blood vessels, lungs and liver.

You should get medical help immediately if you experience symptoms of:
  • acute (sudden) heart problems (usually within 1–3 days of receiving the medicine): such as trouble breathing and chest pain
  • bleeding in lungs: such as trouble breathing and coughing up blood
  • stroke and tears in blood vessels supplying the brain: such as drooping of the face, sudden severe headache, weakness on one side, difficulty with speech or neck pain
  • liver problems: such as yellow skin or eyes, dark urine, and bleeding or bruising more easily than normal
  • an inflammatory condition known as haemophagocytic lymphohistiocytosis: with symptoms of fever, swollen glands, bruising and skin rash

If you have any of these symptoms, contact your doctor who will examine you and may consider stopping Lemtrada and switching you to an alternative treatment.

An in-depth review of Lemtrada is ongoing and further information will be provided as soon as it is available.

While the review is ongoing, Lemtrada will only be prescribed to new patients if other medicines have not worked or are not suitable.

Speak with your doctor if you have questions or concerns about your treatment.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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Xeljanz▼ (tofacitinib) in treating rheumatoid arthritis - safety update

The European Medicines Agency (EMA) is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz (tofacitinib) when treating rheumatoid arthritis. The advice follows early results from an ongoing study in patients with rheumatoid arthritis which showed an increased risk of blood clots in the lungs and death when the normal dose of 5 mg twice daily was doubled.

In the EU, 5 mg twice daily is the authorised dose for rheumatoid arthritis and psoriatic arthritis. The higher dose of 10 mg twice daily is approved for the initial treatment of patients with ulcerative colitis.

The EMA is assessing the early results and will consider if any regulatory action is needed. In the meantime, patients with rheumatoid arthritis who are receiving Xeljanz at 10 mg twice daily in the study will have their dose reduced to 5 mg twice daily for the remaining duration of the study.

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Keep Me Informed - Conditions and medicines added in March 2019

The following conditions have been added to Keep Me Informed since March 1st 2019.
  • Cholecystitis
  • Liver disease
  • Vaccination
  • Polyneuropathy
  • Amyloidosis
  • Smith-Magenis syndrome
  • Autism
For information about medicines added, NICE guidelines, and patient safety information, please see the full article.

You can follow any of these conditions using Keep Me Informed, which provides users with updates about the conditions they are interested in, including updates to NICE guidelines, patient leaflets, risk management materials, information from medicine regulators and clinical trial information. To track information about these conditions please use the 'Select conditions' button.


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NICE encourages use of greener asthma inhalers

The National Institute for Health and Care Excellence (NICE) is encouraging asthma patients on using greener asthma inhalers.

NICE highlight a new patient decision aid indicating which inhalers have a higher carbon footprint than others.

The aid will help people with asthma, alongside health professionals, to identify which inhalers could meet their needs and control their symptoms.

Where several inhalers could be viable options, patients can opt for the more environmentally friendly option, which may help to cut the health service’s carbon footprint.

The new aid, partially funded by the Sustainable Development Unit, also says that all used inhalers should be returned to local pharmacies for environmentally safe disposal or recycling.

Feature
The National Institute for Health and Care Excellence (NICE) says everyone should be able to choose the inhaler they find easiest to use. NICE also says that everyone should have the way they use their inhaler checked regularly. If needed, people should be given advice on how to improve their technique

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NICE publish updated medicines safety priorities for Asthma

The National Institute for Health and Care Excellence (NICE) have updated the medicines safety priorities for asthma.

The update covers:
  • National review of asthma deaths
  • Self-management and reviews
  • Decreasing maintenance therapy
  • Practice examples and shared learning
Whilst not specific guidance, the therapeutic topic of asthma summarises the evidence base on asthma: medicines safety priorities.


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Lokelma - new product for treating hyperkalaemia

AstraZeneca have launched their treatment for hyperkalaemia (high levels of potassium in the blood). The medicine contains the ingredient sodium zirconium cyclosilicate (brand name Lokelma).

Lokelma captures potassium in the blood in exchange for hydrogen and sodium atoms. The exchange with potassium ions occurs throughout the gastrointestinal tract with onset in the upper part of the gastrointestinal tract. The trapped potassium ions are excreted from the body via the faeces, thereby reducing any excess and resolving hyperkalaemia.

Lokelma is licensed for the treatment of hyperkalaemia in adult patients.


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Listening to the myeloma patient voice is difficult – but it still needs to be done

In an article published by Pharmaphorum written by Amanda Burrell, she speaks to Simon Ridley, director of research at Myeloma UK, on the role of the patient in influencing the healthcare community.

The shift towards including the 'patient voice' is evident in many conditions and by many organisations such as the NHS, NICE and the pharmaceutical industry.

Engaging with patients provides these groups with a view that can be factored into many facets of care, including the identification of important issues that affect patients' lives over and above the standard care models.

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NICE guidance - Lung cancer: diagnosis and management

The National Institute for Health and Care Excellence (NICE) have published an updated their guideline on the diagnosis and management of lung cancer.

The guideline aims to improve outcomes for patients by ensuring that the most effective tests and treatments are used, and that people have access to suitable palliative care and follow-up.

The guidelines are intended to inform:
  • People with lung cancer and their families and carers
  • Healthcare professionals
  • Commissioners and providers
NICE have reviewed the evidence and made new recommendations on:
  • intrathoracic lymph node assessment
  • brain imaging for people with non-small-cell lung cancer
  • radical radiotherapy (including stereotactic ablative radiotherapy [SABR]) for people with non-small-cell lung cancer
  • chemoradiotherapy and surgery for people with stage IIIA-N2 non-small-cell lung cancer
  • thoracic radiotherapy and prophylactic cranial irradiation for people with small-cell lung cancer
This guideline (NG122) updates and replaces NICE guideline CG121 (April 2011).

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NHS online tool for predicting breast cancer

The NHS have published a 'Predict' tool that helps show how breast cancer treatments after surgery might improve survival rates.

Once details about the patient and their cancer have been entered, the tool will show how different treatments would be expected to improve survival rates up to 15 years after diagnosis. This is based on data from similar women in the past. It is important to note that these treatments have side effects which should also be considered when deciding on a treatment.

The tool is designed to be used by the patient and their doctor.

For more information see full article.

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Keep Me Informed - inclusion of rare disease classification

We have introduced the category of 'Rare diseases and conditions' to Keep Me Informed.

Please go to the full article to read an introduction from Cystic Fibrosis patient and European Health Parliament Member, Thomas Smith.

We have classified over 100 rare conditions in addition, where appropriate, to their collective description (such as cancer, respiratory disease).

According to Rare Diseases UK a rare disease is defined by the European Union as one that affects fewer than 1 in 2,000 of the general population. There are between 6,000 and 8,000 known rare diseases and around five new rare diseases are described in medical literature each week. Some 6% of the population are affected by a rare disease.

In the USA a condition that affects under 200,000 people, is considered a rare condition.

We have introduced links to the National Organization for Rare Disease (NORD) database that provides information on over 1200 rare conditions.

Our future plans include working with patient organisations to provide resources for patients, not only for their condition, but also for other conditions they may experience.

For further information on rare conditions, see the main article.

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NHS publish online tool that helps men choose best prostate cancer treatment

The NHS have published an online tool to help men with prostate cancer

The researchers who developed the tool were from the University of Cambridge, the National Cancer Registration and Analysis Service in the UK, and from the Singapore General Hospital in Singapore.

The tool can show the potential effects of treatments such as surgery or radiotherapy, compared with "wait and see" approaches.

The tool is specifically for use in men with prostate cancer that's localised and not spread outside of the prostate gland.

For more information see full article (click on this email).

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Addition to medicines database - Kuvan for phenylketonuria

We are currently updating our medicines database to support the Medicines Tracker function.

We have updated the medicine containing the ingredient sapropterin, brand name Kuvan.

Kuvan is a medicine that is used to treat high blood levels of phenylalanine in adults and children of all ages with the genetic disorders phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.

Patients with these disorders cannot process the amino acid phenylalanine from dietary protein, and as a result the amino acid builds up in the blood to abnormally high levels, causing problems in the nervous system.

Because the number of patients with conditions leading to high phenylalanine levels is low, the conditions are considered ‘rare’, and Kuvan was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 June 2004.

Kuvan contains the active substance sapropterin dihydrochloride.

Because the number of patients with conditions leading to high phenylalanine levels is low, the conditions are considered ‘rare’, and Kuvan was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 June 2004.

This medicine can only be obtained with a prescription.

For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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Keep Me Informed - Medicines Tracker update

Following the release of the latest version of the Keep Me Informed browser, including our new Medicine Tracker, we are pleased to advise you that medicines can now be searched for using the ingredient name(s).

This will present the brand name and the ingredient names.

We are working on the following improvements:
  • finalising our clinical coding efforts to ensure that Keep Me Informed can be integrated into into other applications such as GP and pharmacy systems, organisations and NHS information services
  • provide personal health record functionality such as interaction checking and side effect reporting
  • launch our Patient Safety Programme to ensure all patients can access important new information about their medicines
  • create a patient reported outcome process
  • expand our content sources (including clinical trial information)
  • make Keep Me Informed available in other countries
We want to thank all our users for their support and wish you seasons greetings and a happy New Year.

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Hypertension in adults: diagnosis and management

NICE has published its draft updated guideline on the diagnosis and treatment of high blood pressure (hypertension) for public consultation.

In the biggest change to NICE’s previous guidance published in 2011, the level of a person’s cardiovascular disease risk at which treatment for high blood pressure can be started has been reduced.

The draft guideline recommends that blood pressure lowering drugs should be offered to people aged under 80 with a diagnosis of stage 1 hypertension who have a 10% or greater risk of developing cardiovascular disease within the next 10 years.

It is estimated that around 450,000 men and 270,000 women would fall into this category. However, it is likely that the impact of the new recommendations will in fact be lower as some estimates suggest half of people in this category are already receiving treatment.

The draft guideline also considered new studies suggesting people with blood pressure below the level at which high blood pressure is usually diagnosed (140/90mmHg) might also benefit from medication. It also looked at what the effect would be of lowering the blood pressure target for people on treatment. However, some of these studies, which formed a key part of the evidence reviewed in other recent international hypertension guidelines, were difficult to interpret because they included people who had other conditions that would also raise their cardiovascular disease risk, such as chronic kidney disease. Therefore, these studies could not be directly used to inform the recommendations in this draft guidance.

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NICE approve tisagenlecleucel (Kymriah▼) for use in treating lymphoma under Cancer Drug Fund

The National Institute for Health and Care Excellence (NICE) has approved the use of Novartis' lymphoma treatment tisagenlecleucel, brand name Kymriah.

Kymriah is recommended for use within the Cancer Drugs Fund as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more systemic therapies and only if the conditions in the managed access agreement are followed.

Managed access schemes are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

NICE state that:

'More evidence on tisagenlecleucel is being collected, until June 2023. After this NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.

If you are not eligible for tisagenlecleucel therapy but are already having it, you should be able to continue until you and your doctor decide when best to stop.'

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Update on the substitution of medicines in the event of shortages

Following the governments January publication of a policy paper on obtaining medications in the event of no deal Brexit, we would like to alert Keep Me Informed users to the conditions and medicines where substitution of medicines should be approached with caution.

The government stated that around three-quarters of the medicines and over half the devices and one-use medical products (such as syringes) that the NHS uses, come into the UK via the EU.

'The government has analysed the supply chain, made plans to reduce the risk of disruption, and given instructions to pharmaceutical companies to ensure that they have adequate stocks to cope with any potential delays at the border.'

Anti epileptic treatments are one group where consistent use of the same prescribed medicine is required.

Other considerations are where medicines should be prescribed by brand name. For example, all biologicals should be prescribed by brand name.

This is due to a variety of factors such as:
  • bioavailability differences
  • modified-release characteristics
  • formulation difference of effect
  • patient familiarity
  • different licensed indications
The UK Medicines Information group published guidance in 2017. A link to this document is available in the main article (click on this headline to access).

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Public Health England launches 'Cervical Screening Saves Lives' campaign

Public Health England have launched on a new drive to encourage women to ensure they undertake cervical screening.

The PHE campaign is designed to boost the number of women taking screening tests after attendance levels reached a 20-year low.

PHE state that 1 in 4 women are not undertaking screening even though they are entitled to. The campaign will encourage women to respond to their cervical screening invitation letter, and if they missed their last screening, to book an appointment at their GP practice.

Around 2,600 women are diagnosed with cervical cancer in England each year, and around 690 women die from the disease, which is 2 deaths every day. It is estimated that if everyone attended screening regularly, 83% of cervical cancer cases could be prevented.

New research from PHE shows that nearly all women eligible for screening (90%) would be likely to take a test that could help prevent cancer - and of those who have attended screening, 9 in 10 (94%) would encourage others who are worried to attend their cervical screening. Despite this, screening is at a 20-year low, with 1 in 4 eligible women (those aged 25 to 64) in the UK not attending their test.

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Keep Me Informed - Conditions and medicines added in January and February 2019

The following conditions have been added to Keep Me Informed since January 1st 2019.
  • Measles
  • Mumps
  • Rubella
  • Primary immunodeficiency disorders (PID)
  • Batten's disease (Neuronal ceroid lipofuscinosis)
  • Chronic myelomonocytic leukemia (CMML)
  • Chronic fatigue syndrome (ME)
  • Pruritis
  • Priapism
  • Liposarcoma
  • Pre-eclampsia
  • Photosensitivity reactions including solar urticaria, chemical photosensitization and polymorphous light eruption
For information about medicines added, NICE guidelines, and patient safety warnings, please see the full article.

You can follow any of these conditions using Keep Me Informed, which provides users with updates about the conditions they are interested in, including updates to NICE guidelines, patient leaflets, risk management materials, information from medicine regulators and clinical trial information. To track information about these conditions please use the 'Select conditions' button.

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NICE guidance recommending abemaciclib (Verzenios▼, Lilly) in treating breast cancer

The National Institute for Health and Care Excellence (NICE) has published guidance for Lilly's breast cancer treatment abemaciclib (brand name Verzenios) with another medicine, an aromatase inhibitor, for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.

NICE state that 'Abemaciclib with an aromatase inhibitor is recommended as an option for treating breast cancer that is:
  • locally advanced or metastatic - the cancer is 'advanced' at the original site or has spread to other parts of the body
  • hormone receptor-positive - the cancer cells grow in response to the hormone oestrogen or progesterone
  • human epidermal growth factor receptor 2 (HER2)-negative - where the cancer cells lack the HER2 protein on their surface. HER2 helps control cell growth.
NICE have approved abemaciclib for treating breast cancer as first line endocrine-based therapy in adults.

Abemaciclib is recommended only if the manufacturer provides it according to the commercial arrangement.

Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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NICE publish draft guidelines recommending use of pertuzumab (Perjeta, Roche) in the early treatment breast cancer

The National Institute for Health and Care Excellence (NICE) has published final draft guidance for Roche's breast cancer treatment pertuzumab (brand name Perjeta) for treating early HER2-positive breast cancer in people whose disease has spread to their lymph nodes. .

NICE state that 'this positive recommendation is for people who have had surgery for their breast cancer and whose cancer has already spread to their lymph nodes. The estimated 2700 people in this subgroup have a higher risk of their cancer returning.

The evidence shows that adding pertuzumab to trastuzumab and chemotherapy after surgery increased the proportion of people whose disease didn’t spread. However, there is a lack of evidence on how long, if at all, adding pertuzumab might increase the overall length of time people live.'

Pertuzumab, with intravenous trastuzumab and chemotherapy, is recommended for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults, only if:
  • they have lymph-node-positive disease
  • the company provides it according to the commercial arrangement
Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

A final decision is expected to be published on 20th March 2019.

For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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MHRA drug safety update for carbimazole

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a drug safety update for the hyperthyroidism treatment carbimazole. The update states that cases of acute pancreatitis have been reported very infrequently during treatment with carbimazole

Acute pancreatitis is a condition where the pancreas becomes inflamed (swollen) over a short period of time.

The pancreas is a small organ, located behind the stomach, that helps with digestion.

Symptoms of acute pancreatitis include:
  • suddenly getting severe pain in the centre of your tummy (abdomen)
  • feeling or being sick
  • diarrhoea
  • a high temperature of 38C or more (fever)
The MHRA advice is:
  • if acute pancreatitis occurs, stop carbimazole treatment immediately
  • do not use carbimazole in patients with a history of acute pancreatitis in association with previous treatment
  • re-exposure may result in life-threatening acute pancreatitis with a decreased time to onset
  • report suspected adverse drug reactions to the Yellow Card Scheme immediately
For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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NICE publish draft guidance recommending use of brigatinib (brand name Alunbrig▼) for the treatment of lung cancer

The National Institute for Health and Care Excellence (NICE) has published final draft guidance for Takeda's lung cancer treatment brigatinib (brand name Alunbrig) for treating liver cancer.

NICE state that 'brigatinib is recommended, within its marketing authorisation, for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib. It is recommended only if the company provides it according to the commercial arrangement.'

Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

This means that Alunbrig will be available for use by NHS England and Wales when the determination is published in March 2019.

For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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