Xeljanz▼ (tofacitinib) in treating ulcerative colitis - safety update
Xeljanz▼, for Ulcerative colitis from Pfizer Ltd
- difficulty breathing
- chest pain or pain in your upper back
- coughing up blood
- excessive sweating
- bluish skin
- 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.
- This dose is higher than the approved dose of 5 mg twice daily for rheumatoid arthritis. However, this dose is used for the initial treatment of patients with ulcerative colitis (for up to 16 weeks) and may also be used in some patients when continuing treatment.
- While an in-depth review of Xeljanz is ongoing, if you are being treated with Xeljanz 10 mg twice daily and you are at high risk of blood clots in the lungs, your doctor may switch you to an alternative treatment.
- You may be at high risk of blood clots in the lungs if you:
− have heart failure (when the heart does not work as well as it should)
− have inherited blood clotting disorders
− have had blood clots in the veins
− are taking combined hormonal contraceptives or hormone replacement therapy
− have cancer
− will have or have recently had major surgery.
- Your doctor will also take into account your age, whether you are obese (your body mass index is above 30), smoke or are immobilised when evaluating your risk of blood clots.
- If you are being treated with Xeljanz, you should not change the dose or stop taking the medicine without discussing it with your doctor.
- 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 and bluish skin.
- If you have any concerns about your medicine, you should discuss them with a healthcare professional.
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.
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