Xeljanz

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots

EMA has concluded that Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk.

As a result, the Agency is recommending that Xeljanz should be used with caution in all patients at high risk of blood clots. In addition, the maintenance doses of 10 mg twice daily should not be used in patients with ulcerative colitis who are at high risk of blood clots unless there is no suitable alternative treatment. Further, EMA is recommending that, due to an increased risk of infections, patients older than 65 years of age should be treated with Xeljanz only when there is no alternative treatment.

These recommendations follow the Agency’s review of an ongoing study (study A3921133) in patients with rheumatoid arthritis and an increased risk of cardiovascular disease, plus data from earlier studies and consultation with experts in the field. All data combined showed that the risk of blood clots in deep veins and lungs was higher in patients taking Xeljanz, especially the 10 mg twice daily dose, and in those being treated for an extended period. Results also showed a further increased risk of serious and fatal infections in patients older than 65 years of age.

The recommendations were issued by the EMA’s safety committee (PRAC) and have now been endorsed by the Agency’s human medicines committee (CHMP). They will replace the measures put in place at the start of the review in May 2019. The changes come into force when the European Commission issues its decision.

Key facts

About this medicine
Approved name
Xeljanz
International non-proprietary name (INN) or common name

tofacitinib

Associated names
Xeljanz
About this procedure
Current status
Opinion provided by Committee for Medicinal Products for Human Use
Reference number
EMEA/H/A-20/1485
Type
Article 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally authorised product(s)
Key dates and outcomes
Procedure start date
16/05/2019
PRAC recommendation date
31/10/2019
CHMP opinion/CMDh position date
14/11/2019
Outcome
Risk minimisation measures

All documents

Procedure started

Under evaluation

  • List item

    Xeljanz Article-20 procedure - PRAC assessment report on provisional measures (PDF/84.79 KB)


    First published: 05/07/2019
    EMA/309456/2019

  • List item

    Xeljanz Article-20 procedure - Annex I, II and III (PDF/521.23 KB)


    First published: 05/07/2019

  • Recommendation provided by Pharmacovigilance Risk Assessment Committee

    Opinion provided by Committee for Medicinal Products for Human Use

    Document description

    • Annex I - List of the medicines affected by the referral
    • Annex II - Scientific conclusions of the CHMP or CMDh
    • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
    • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
    • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
    • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
    • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
    • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
    • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

    News

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