Xeljanz

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tofacitinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Xeljanz is a medicine to treat:

  • adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints. Xeljanz is used with another medicine, methotrexate, after treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects. Xeljanz can be taken on its own if patients cannot take methotrexate;
  • adults with psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints). Xeljanz is used together with methotrexate after treatment with one or more DMARDs has not worked well enough or has led to troublesome side effects;
  • children from two years of age with active polyarticular juvenile idiopathic arthritis (pJIA) or juvenile psoriatic arthritis, a subtype of juvenile idiopathic arthritis (JIA), which is a long-term disease that causes joint pain and inflammation in children. Xeljanz is used after treatment with one or more DMARDs has not worked well enough. Xeljanz can be taken together with methotrexate or on its own if patients cannot take methotrexate;
  • adults with moderate to severe ulcerative colitis, a disease causing inflammation and ulcers (sores) in the lining of the gut, after treatment with other medicines has not worked well, has stopped working or has led to troublesome side effects;
  • adults with ankylosing spondylitis, a disease that causes inflammation of the joints of the spine, after treatment with other medicines has not worked well enough.

Xeljanz contains the active substance tofacitinib.

This EPAR was last updated on 04/10/2022

Authorisation details

Product details
Name
Xeljanz
Agency product number
EMEA/H/C/004214
Active substance
Tofacitinib
International non-proprietary name (INN) or common name
tofacitinib
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AA29
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
22/03/2017
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

13/09/2022 Xeljanz - EMEA/H/C/004214 - PSUSA/00010588/202111

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis
Tofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) (see section 5.1). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5).

Psoriatic arthritis
Tofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy (see section 5.1).


Ulcerative colitis
Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1).


Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs).

Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Ankylosing spondylitis
Tofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

Assessment history

Changes since initial authorisation of medicine

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