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

Xeljanz▼, for Ulcerative colitis from Pfizer Ltd

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.

A European safety review of tofacitinib (Xeljanz▼) has begun following results from an ongoing study in patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular risk factor. The findings show an increased risk of pulmonary embolism and overall mortality, compared with a TNF inhibitor, when patients were treated with 10 mg of tofacitinib twice-daily (twice the recommended dose for rheumatoid arthritis of 5 mg twice-daily).

Information for patients (source EMA)
  • 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.
Xeljanz was first made available in the EU in 2017. It is manufactured by Pfizer.

Sources
The Medicines and Healthcare products Regulatory Agency (MHRA)
European Medicines Agency (EMA)
NHS website for pulmonary embolism
Contains public sector information licensed under the Open Government Licence v3.0.
Accessed 21/05/19
Links available in full article

LINK TO: MHRA guidance on Xeljanz in ulcerative colitis

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.


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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