Browse Conditions Browse Medicines

Information about Jylamvo

What is it and what is it used for?

Jylamvo is an anti-inflammatory and cancer medicine used to treat the following conditions:
  • active rheumatoid arthritis (a disease causing inflammation in joints) in adults;
  • severe juvenile idiopathic arthritis (inflammation of joints in children) in patients from 3 years of age when NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough;
  • severe disabling psoriasis (a disease causing red, scaly patches on the skin) in adults when other treatments have not worked well enough;
  • severe psoriatic arthritis (inflammation of joints that occurs in patients with psoriasis) in adults;
  • acute lymphoblastic leukaemia (ALL), a cancer of white blood cells, in adults and children over the age of 3 years.
Jylamvo is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ (in this case Methotrexat Lederle) containing the same active substance (methotrexate). The difference between Jylamvo and Methotrexat Lederle is that, whereas the latter is a solution for injection, Jylamvo is available as a solution to be taken by mouth.

How Jylamvo works
The active substance in Jylamvo, methotrexate, stops cells from growing by interfering with the production of DNA. This especially affects fast-growing cells such as cancer cells. The way methotrexate works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.

How Jylamvo is used
Jylamvo can only be obtained with a prescription and should be prescribed by doctors with experience with methotrexate and the way it works.

Jylamvo is available as an oral solution. When used for inflammatory conditions it is taken once a week, on the same day each week. The dose depends on the condition it is being used to treat, how the patient responds to treatment and, in the case of children, on the body surface area. In most cases, Jylamvo is used for long-term treatment.

When used for ALL, the dose of Jylamvo depends on body surface area (calculated using the patient’s height and weight). How often methotrexate is given depends on the other medicines it is used with.

For more information on how to use Jylamvo, see the patient leaflet.

What are the benefits?

The European Medicines Agency decided that Jylamvo has shown to have comparable quality and to be bioequivalent to the methotrexate-containing medicines Methotrexat Lederle and Ebetrexat. Therefore, the CHMP’s view was that the benefit outweighs the identified risk. The Committee recommended that Jylamvo be approved for use in the EU.

What are main side effects?

Contact your doctor immediately if you develop any of the side effects listed below:
  • breathing problems (these include a general feeling of illness, dry, irritating cough, shortness of breath, difficulty in breathing, chest pain or fever)
  • spitting or coughing blood*
  • serious peeling or blistering of the skin
  • unusual bleeding (including vomiting blood), bruising or nose bleeds
  • nausea, vomiting, abdominal discomfort or severe diarrhoea
  • mouth ulcers
  • black or tarry stools
  • blood in the urine or stool
  • small red spots on the skin
  • fever, sore throat, flu-like symptoms
  • yellow colouring of the skin (jaundice) or dark urine
  • pain or difficulties in passing urine
  • thirst and/or frequent urination
  • seizures (convulsions)
  • unconsciousness
  • blurred or restricted vision
  • severe fatigue
*has been reported for methotrexate used in patients with underlying rheumatologic disease.

The following side effects have also been reported:

Very common (may affect more than 1 in 10 people):
  • loss of appetite, feeling sick (nausea), vomiting, abdominal pain, indigestion, inflammation and ulcers of the mouth and throat
  • blood test showing raised liver enzymes.
Common (may affect up to 1 in 10 people):
  • infections
  • reduced blood cell formation with a decrease in white and/or red blood cells and/or platelets (leucocytopenia, anaemia, thrombocytopenia)
  • headache, tiredness, light-headedness
  • inflammation of the lungs (pneumonia) with dry cough, shortness of breath and fever
  • diarrhoea
  • skin rash, skin redness and itching
Uncommon (may affect up to 1 in 100 people):
  • lymphoma (lump in neck, groin or armpits with associated backache, weight loss or night sweats)
  • severe allergic reactions
  • diabetes
  • depression
  • dizziness, confusion, seizures
  • lung damage
  • ulcers and bleeding in the digestive tract
  • liver diseases, reduced content of blood proteins
  • nettle rash, skin reaction in strong light, brown discoloration of the skin, hair loss, increased number of rheumatic nodules, shingles, painful psoriasis, slow wound healing
  • joint or muscle pain, osteoporosis (reduction in bone strength)
  • kidney disease, inflammation or ulcers of the bladder (possibly also with blood in the urine), painful urination
  • inflammation and ulcers of the vagina
Rare (may affect up to 1 in 1,000 people):
  • a blood disorder characterised by the appearance of very large red blood cells (megaloblastic anaemia)
  • mood swings
  • weakness in movements, also only limited to the left or right side of the body
  • severe visual disorders
  • inflammation of the heart sac, accumulation of fluid in the heart sac
  • low blood pressure, blood clots
  • tonsillitis, stopping breathing, asthma
  • inflammation of the pancreas, inflammation of the digestive tract, bloody stools, inflamed gums,
  • indigestion
  • acute hepatitis (inflammation of the liver)
  • discoloration of the nails,acne, red or purple spots due to bleeding from blood vessels
  • worsening of psoriasis during treatment with UV therapy
  • skin lesions resembling sunburn or dermatitis after radiotherapy
  • bone fractures
  • kidney failure, reduction or lack of urine production, abnormal levels of electrolytes in blood
  • impaired sperm formation, menstrual disorders
Very rare (may affect up to 1 in 10,000 people):
  • viral, fungal or bacterial systemic infections,
  • serious disorder of bone marrow (anaemia), swollen glands
  • lymphoproliferative disorders (excessive growth of white blood cells)
  • insomnia
  • pain, muscle weakness, changes in the sense of taste (metallic taste), inflammation of the membrane lining the brain resulting in paralysis or vomiting, pins and needles in arm and legs
  • impaired movement of the muscles used for speech production, difficulty in speaking, impairment of language, feeling sleepy or tired, feeling confused, having unusual sensations in the head, brain swelling, ringing in ears
  • red eyes, damage to the retina of the eye
  • accumulation of fluid in the lung, lung infections
  • vomiting blood, severe complications in the digestive tract
  • liver failure
  • fingernail infections, detachment of the nail from the nail bed, boils, widening of small blood vessels, damage to the blood vessels of the skin, allergic inflammation of blood vessels
  • protein in the urine
  • loss of sex drive, erection problems, vaginal discharge, infertility, enlargement of the breasts in men (gynaecomastia)
  • fever
Not known (frequency cannot be estimated from the available data):
  • pathological change of the white matter of the brain (leukoencephalopathy)
  • haemorrhages
  • bleeding from the lungs*
  • bone damage in the jaw (secondary to excessive growth of white blood cells).
*has been reported for methotrexate used in patients with underlying rheumatologic disease.

Because Jylamvo is a hybrid medicine and is bioequivalent to Methotrexat Lederle and Ebetrexat tablets, its benefits and risks are taken as being the same as the benefits and risks of those medicines.

In addition, there is a risk that patients may make mistakes when measuring the amount of solution they need to take and educational material will be provided to prevent this.

What studies have been done?

The company provided data from the published literature on the benefits and risks of methotrexate in the approved uses.

As for every medicine, the company provided studies on the quality of Jylamvo. The company also carried out studies that showed that it is ‘bioequivalent’ to other methotrexate medicines used to treat inflammatory conditions and ALL (Methotrexat Lederle and Ebetrexat tablets). Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Sources

Jylamvo was first approved for use in the EU in 2017. It is manufactured by Therakind.

European Medicines Agency website page for Jylamvo (accessed 16/07/19)
Links available in External Resources

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.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.


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