EMA publishes new measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases
Jylamvo, for Rheumatoid arthritis, Nummular psoriasis, Psoriasis, Crohn's disease, Acute lymphoblastic leukaemia, Juvenile idiopathic arthritis, Psoriatic arthritis, Non-Hodgkin lymphoma, Soft tissue sarcoma, Breast cancer (female), Head and neck cancer, Lung cancer (Non-Small Cell), Bladder cancer, Cervical cancer, Ovarian cancer and Testicular cancer from Therakind
- If you are taking methotrexate for rheumatoid arthritis, psoriasis or Crohn’s disease, you must take it just once a week.
- Take your methotrexate medicine on the same day every week.
- Follow the instructions on the packaging of your methotrexate medicine.
- You will receive a patient card with your methotrexate tablets (or oral liquid). Read it carefully because it tells you how to take your medicine.
- Show your patient card to any new healthcare professional who treats you so that they know that you take your methotrexate medicine once a week.
- See your doctor at once if you get a sore throat, fever, mouth ulcers, diarrhoea, vomiting, skin rashes, bleeding or unusual weakness. These can be signs of taking too much methotrexate.
- Always attend your scheduled clinic visits and blood test appointments. They are important for making sure that your methotrexate medicine is working and that it is not causing any concern.
- If you are not sure about how to take your methotrexate medicine or you have any questions about it, talk to your doctor or pharmacist.
- Methotrexate for inflammatory conditions is intended for use just once a week. Serious side effects including fatalities have occurred when methotrexate is taken more often.
- Only physicians with expertise in using methotrexate medicines should prescribe them.
- Healthcare professionals who prescribe or dispense methotrexate for inflammatory conditions should:
- read the educational materials for oral methotrexate medicines;
- ensure that they are familiar with the latest changes to the summaries of product characteristics for methotrexate medicines used for inflammatory conditions;
- give clear instructions to the patient (or carer) about once-weekly dosing;
- check carefully that the patient (or carer) understands that the medicine must be used once a week, and do this each time a new prescription is issued or the medicine is dispensed;
- decide together with the patient (or carer) on which day of the week the patient uses methotrexate;
- counsel the patient (or carer) about signs of methotrexate overdose and give instructions to promptly seek medical advice in case of suspected overdose.
- treatment of cancer for which the dosing frequency depends on the regimen and can involve daily administration of methotrexate;
- treatment of inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn’s disease, which require once-weekly use of a low dose of methotrexate.
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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