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Information about Atriance▼

What is it and what is it used for?

Atriance is a solution for infusion. It contains the active substance nelarabine.

Atriance is used to treat patients with T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). These are types of cancer where T-lymphoblasts (a type of immature white blood cell) multiply too quickly. In T-ALL the abnormal cells are mainly in the blood and bone marrow, and in T-LBL they are mainly in the lymphatic system (lymph nodes or thymus gland). Atriance is used when patients have failed to respond to, or have stopped responding to, at least two types of chemotherapy.

Because the number of patients with these diseases is low, the diseases are considered ‘rare’, and Atriance was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 June 2005.

The medicine can only be obtained with a prescription.

How Atriance is used
Atriance is given by intravenous infusion (a drip into a vein) under the supervision of a doctor who has experience in the use of these types of medicine. The dose and frequency of infusion depend on the patient’s age and body surface area. In adults and adolescents aged over 16 years, the recommended starting dose is 1,500 mg per square metre, given over two hours on days one, three and five, repeated every 21 days. Younger patients receive a lower dose (650 mg per square metre) given over one hour on five consecutive days, repeated every 21 days. This schedule can also be used in patients aged 16 to 21 years. Treatment should be stopped if the patient develops serious side effects affecting the brain or nervous system.

Patients receiving Atriance should be monitored regularly for changes in blood counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).

How Atriance works
The active substance in Atriance, nelabarine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells. It belongs to the group of anticancer medicines called ‘antimetabolites’.

Nelarabine is converted within cells into an analogue of guanine, one of the fundamental chemicals that make up DNA. In the body, this analogue takes the place of guanine and interferes with the enzymes involved in making new DNA, DNA polymerases. This stops the production of DNA and thus slows down the growth and multiplication of cells. As the guanine analogue accumulates in T-cells and lasts longer in these cells, Atriance slows down the growth and multiplication of the cells involved in T-ALL and T-LBL.

What are the benefits?

The CHMP noted that, due to the small number of patients with these diseases, the information to support the approval of Atriance is limited, but it agreed that the medicine could allow some patients to go on to receive a bone-marrow transplant, increasing their chances of survival. Therefore, the Committee decided that Atriance’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Atriance has been authorised under ‘exceptional circumstances’. This means that because the diseases are rare, it has not been possible to obtain complete information about Atriance. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What are main side effects?

The most common side effects with Atriance in adults (seen in more than 1 patient in 10) are infection, febrile neutropenia (low white-blood-cell counts with fever), neutropenia (low white-blood-cell counts), thrombocytopenia (low platelet counts), anaemia (low red-blood-cell counts), somnolence (sleepiness), peripheral neuropathy (damage to the nerves in the extremities), hypoesthesia (a reduced sense of touch), paresthesia (abnormal sensations), dizziness, headache, dyspnoea (breathlessness), cough, diarrhoea, vomiting, constipation, nausea (feeling sick), myalgia (muscle pain), peripheral oedema (swelling in ankles and feet), pyrexia (fever), pain, fatigue (tiredness) and asthenia (weakness). Most of these side effects were also seen very commonly in children. For the full list of all side effects reported with Atriance, see the package leaflet.

Severe side effects affecting the brain and nervous system have been reported in patients taking Atriance, including somnolence, convulsions, and peripheral neuropathy causing numbness, unusual sensations, weakness and even paralysis. Patients should be monitored closely for these side effects and treatment stopped if necessary.

Atriance must not be used in people who are hypersensitive (allergic) to nelarabine or any of the other ingredients.

What studies have been done?

Atriance was shown to be effective in a proportion of the patients in both studies. In the first study, among the 39 children and young adults who had failed two or more previous treatments, five (13%) had a complete response to treatment after a month, with no evidence of disease and normal blood counts. In the second study, among the 28 adults and adolescents who had failed two or more previous treatments, five (18%) had a complete response to treatment. In both studies, more patients had a partial response to Atriance treatment, with blood counts returning towards normal levels.

Sources

Atriance was first approved for use in the EU in 2007. It is manufactured by Novartis.

European Medicines Agency website page for Atriance (accessed 19/07/18)

Links available in External Resources

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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For the full list of side effects and restrictions, see the package leaflet (link to package leaflet available in External Resources).