Xeljanz

tofacitinib

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Patient safety

Patient safety information

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.

: Xeljanz is available as tablets and as a liquid to be taken by mouth.
For the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, the recommended dose is 5 mg taken twice a day.
For the treatment of ulcerative colitis, the recommended dose is 10 mg twice a day for the first eight weeks and then 5 mg twice a day.
For the treatment of juvenile idiopathic arthritis, Xeljanz is taken twice a day, and the recommended dose depends on the patient’s bodyweight. Patients with a bodyweight of at least 40 kg can take the tablets (5 mg twice a day) or the liquid form (5 ml twice a day), while patients who weigh below 40 kg are given the liquid form of the medicine (3.2 to 5 mg based on the patient’s bodyweight).
Treatment may be stopped in patients who develop an infection, which is a known side effect of the medicine, or in those with abnormal levels of red blood cells or certain white blood cells. The dose may also be lowered in some patients with reduced kidney or liver function.
Xeljanz can only be obtained with a prescription, and treatment should be started and supervised by a specialist doctor experienced in treating the relevant condition.
For more information about using Xeljanz, see the package leaflet or contact your doctor or pharmacist.

: The active substance in Xeljanz, tofacitinib, works by blocking the action of enzymes known as Janus kinases. These enzymes play an important role in the process of inflammation that occurs in rheumatoid, psoriatic or juvenile idiopathic arthritis, and ulcerative colitis. By blocking the enzymes’ action, tofacitinib helps reduce the inflammation and other symptoms of these diseases.

: Rheumatoid arthritis
Six studies in over 4,200 patients with rheumatoid arthritis have shown that Xeljanz is effective at reducing joint pain and swelling, improving joint movement and slowing down joint damage. Most patients in these studies had tried other treatments before, and most took Xeljanz with methotrexate.
In one of the studies, where Xeljanz was taken alone, Xeljanz was more effective than methotrexate at slowing down joint damage and reducing symptoms. In another study, Xeljanz taken alone was more effective than placebo (a dummy treatment) at reducing symptoms, such as pain and swelling.
Psoriatic arthritis
Xeljanz, in combination with methotrexate, was shown to be effective at improving symptoms of psoriatic arthritis in two main studies.
The first study compared Xeljanz with adalimumab (an injected medicine for psoriatic arthritis) and placebo in 422 patients. The second study compared Xeljanz with placebo in 395 patients. In both studies, patients’ disease had not responded satisfactorily to other treatments.
In the first study, symptoms improved substantially in 50 and 52% of patients taking Xeljanz and adalimumab, respectively, for three months, compared with 33% of those receiving placebo; patients taking Xeljanz or adalimumab also showed a greater improvement in their ability to perform everyday activities. Similarly, in the second study, Xeljanz was more effective than placebo at improving symptoms (50% of Xeljanz-treated patients versus 24% of those given placebo) and ability to perform everyday activities.
Juvenile idiopathic arthritis
Xeljanz was more effective than placebo at reducing symptoms of juvenile idiopathic arthritis both in combination with methotrexate and alone. The study compared disease flare-ups (worsening of symptoms) between patients treated with Xeljanz or placebo.
In the study involving 173 patients between 2 and 17 years old with juvenile idiopathic arthritis, 28% of the patients who received Xeljanz experienced flare-ups after 26 weeks compared with 53% of those who received placebo.
Ulcerative colitis
Xeljanz was more effective than placebo at reducing the symptoms of ulcerative colitis in three main studies.
In the first study in 614 patients with ulcerative colitis, 18% of patients treated with Xeljanz 10 mg twice a day had mild or no symptoms after eight weeks of treatment compared with 8% of patients who received placebo. Similarly, in the second study involving 547 patients, 17% of patients treated with Xeljanz had mild or no symptoms after eight weeks of treatment compared with 4% of patients receiving placebo.
In the third study involving 593 patients, 34% of patients treated with Xeljanz 5 mg twice a day had mild or no symptoms after a year of treatment compared with 11% of patients receiving placebo. Additionally, more patients treated with Xeljanz were able to reduce their use of corticosteroid medicines.
Ankylosing spondylitis
Xeljanz was more effective than placebo at reducing symptoms of ankylosing spondylitis in one study involving patients that had not responded well enough to previous treatment. The main measure of effectiveness was a 20% reduction in ASAS scores (back pain, morning stiffness and other symptoms) after 16 weeks of treatment.
In this study, involving 269 patients, ASAS scores were satisfactorily reduced in around 56% of patients who received Xeljanz, compared with some 29% of those who received placebo. Additionally, around 41% of patients treated with Xeljanz had a 40% reduction in ASAS scores, versus about 13% of patients on placebo.

: The most common side effects with Xeljanz (which may affect up to 1 in 10 people) are headache, infection and inflammation of the nose and throat, diarrhoea, nausea (feeling sick) and hypertension (high blood pressure).
The most common serious side effects seen with Xeljanz are serious infections such as pneumonia (infection of the lungs), cellulitis (infection of the deep skin tissue), herpes zoster (shingles), urinary tract infection, diverticulitis (infection affecting the intestines) and appendicitis (infection of the appendix) as well as opportunistic infections that can occur in patients with weakened immune systems.
Xeljanz must not be used in patients with active tuberculosis, serious infections or any opportunistic infection. Xeljanz must also not be used in patients with severely reduced liver function or pregnant and breastfeeding women.
For the full list of side effects and restrictions, see the package leaflet.

: Several studies have shown that Xeljanz is effective at treating rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, specific subtypes of juvenile idiopathic arthritis and ankylosing spondylitis in patients who had previously tried other treatments. The fact that Xeljanz is taken by mouth may be an advantage compared with existing medicines taken as an injection under the skin.
The most important side effect seen with the medicine is infection, and there are specific recommendations to help healthcare professionals reduce this risk. In general, the risks with Xeljanz were similar to those of other medicines of its class.
The European Medicines Agency, therefore, decided that Xeljanz’s benefits are greater than its risks and it can be authorised for use in the EU.

: The company that markets Xeljanz will provide educational materials to healthcare professionals and patients with information about the risks with the medicine, particularly the risk of serious infections and the risk of blood clots in certain patients.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xeljanz have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Xeljanz are continuously monitored. Side effects reported with Xeljanz are carefully evaluated and any necessary action taken to protect patients.

: Xeljanz received a marketing authorisation valid throughout the EU on 22 March 2017.

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Xeljanz : EPAR - Medicine overview (PDF/142.78 KB)

First published: 31/03/2017
Last updated: 14/12/2021
EMA/687021/2019
- Bulgarian
  (PDF/174.84 KB)
- Croatian
  (PDF/171.1 KB)
- Czech
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- Danish
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- Estonian
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- German
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- Hungarian
  (PDF/168.57 KB)
- Italian
  (PDF/143.24 KB)
- Latvian
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- Lithuanian
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- Maltese
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- Polish
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- Portuguese
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- Romanian
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- Slovenian
  (PDF/168.94 KB)
- Spanish
  (PDF/145.52 KB)
- Swedish
  (PDF/143.82 KB)
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Xeljanz : EPAR - Risk-management-plan summary (PDF/232.35 KB)

First published: 19/12/2019
Last updated: 04/10/2022

This EPAR was last updated on 30/03/2023

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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Xeljanz : EPAR - Product Information (PDF/1.73 MB)

First published: 31/03/2017
Last updated: 28/09/2022
- Bulgarian
  (PDF/1.29 MB)
- Croatian
  (PDF/1.19 MB)
- Czech
  (PDF/3.2 MB)
- Danish
  (PDF/1.31 MB)
- Dutch
  (PDF/1.87 MB)
- Estonian
  (PDF/1.41 MB)
- Finnish
  (PDF/1.15 MB)
- French
  (PDF/1.4 MB)
- German
  (PDF/1.86 MB)
- Greek
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- Hungarian
  (PDF/1.25 MB)
- Icelandic
  (PDF/1.38 MB)
- Italian
  (PDF/1.49 MB)
- Latvian
  (PDF/1.14 MB)
- Lithuanian
  (PDF/1.31 MB)
- Maltese
  (PDF/1.51 MB)
- Norwegian
  (PDF/1.35 MB)
- Polish
  (PDF/1.46 MB)
- Portuguese
  (PDF/1.11 MB)
- Romanian
  (PDF/1.44 MB)
- Slovak
  (PDF/1.6 MB)
- Slovenian
  (PDF/1.31 MB)
- Spanish
  (PDF/1.13 MB)
- Swedish
  (PDF/1.32 MB)

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

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.

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Xeljanz : EPAR - All Authorised presentations (PDF/48.53 KB)

First published: 31/03/2017
Last updated: 14/09/2021
- Bulgarian
  (PDF/36.9 KB)
- Croatian
  (PDF/33.28 KB)
- Czech
  (PDF/33.97 KB)
- Danish
  (PDF/32.89 KB)
- Dutch
  (PDF/32.03 KB)
- Estonian
  (PDF/32.03 KB)
- Finnish
  (PDF/30.7 KB)
- French
  (PDF/32.12 KB)
- German
  (PDF/33.38 KB)
- Greek
  (PDF/43.49 KB)
- Hungarian
  (PDF/33.09 KB)
- Icelandic
  (PDF/32.81 KB)
- Italian
  (PDF/30.83 KB)
- Latvian
  (PDF/31.12 KB)
- Lithuanian
  (PDF/35.33 KB)
- Maltese
  (PDF/32.54 KB)
- Norwegian
  (PDF/33.41 KB)
- Polish
  (PDF/32.77 KB)
- Portuguese
  (PDF/32.97 KB)
- Romanian
  (PDF/32.21 KB)
- Slovak
  (PDF/33.72 KB)
- Slovenian
  (PDF/31.1 KB)
- Spanish
  (PDF/32.24 KB)
- Swedish
  (PDF/31.13 KB)

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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Xeljanz : EPAR - Procedural steps taken and scientific information after authorisation (PDF/198.42 KB)

First published: 19/07/2017
Last updated: 28/09/2022
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Xeljanz-H-C-PSUSA-00010588-202111 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/101.87 KB)

First published: 28/09/2022
EMA/780791/2022
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Xeljanz-H-C-004214-II-0039 : EPAR - Assessment Report - Variation (PDF/9.73 MB)

Adopted

First published: 08/07/2022
EMA/CHMP/623552/2022
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CHMP post-authorisation summary of opinion for Xeljanz (PDF/104.14 KB)

Adopted

First published: 20/05/2022
EMA/CHMP/262700/2022
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Xeljanz-H-C-004214-II-0035 : EPAR - Assessment Report - Variation (PDF/13.86 MB)

Adopted

First published: 14/12/2021
EMA/CHMP/743175/2021
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CHMP post-authorisation summary of positive opinion for Xeljanz (II-35) (PDF/141.62 KB)

Adopted

First published: 15/10/2021
EMA/CHMP/561838/2021
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Xeljanz-H-C-4214-X-0024-G: EPAR - Assessment Report - Variation (PDF/2.24 MB)

Adopted

First published: 14/09/2021
EMA/CHMP/389275/2021
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CHMP post-authorisation summary of positive opinion for Xeljanz (X-24-G) (PDF/143.8 KB)

Adopted

First published: 25/06/2021
EMA/CHMP/337119/2021
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Xeljanz-H-C-4214-P46-012 : EPAR - Assessment Report - Variation (PDF/4.29 MB)

Adopted

First published: 20/04/2020
EMA/113484/2020
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Xeljanz-H-A-20-1485 : EPAR - Scientific conclusions (PASS) - Article-20 (PDF/51.82 KB)

Adopted

First published: 06/03/2020
- Bulgarian
  (PDF/114.73 KB)
- Croatian
  (PDF/107.43 KB)
- Czech
  (PDF/245.03 KB)
- Danish
  (PDF/77.07 KB)
- Dutch
  (PDF/177.59 KB)
- Estonian
  (PDF/167.61 KB)
- Finnish
  (PDF/167.33 KB)
- French
  (PDF/166.59 KB)
- German
  (PDF/73.75 KB)
- Greek
  (PDF/122.91 KB)
- Hungarian
  (PDF/93.04 KB)
- Italian
  (PDF/66.49 KB)
- Latvian
  (PDF/109.35 KB)
- Lithuanian
  (PDF/106.7 KB)
- Maltese
  (PDF/287.57 KB)
- Polish
  (PDF/104.27 KB)
- Portuguese
  (PDF/92.47 KB)
- Romanian
  (PDF/111.17 KB)
- Slovak
  (PDF/102.16 KB)
- Slovenian
  (PDF/106.98 KB)
- Spanish
  (PDF/172.32 KB)
- Swedish
  (PDF/139.61 KB)
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Xeljanz-H-A-20-1485 : EPAR - Scientific conclusions - Article-20 (PDF/29.44 KB)

Adopted

First published: 21/08/2019
- Bulgarian
  (PDF/82.52 KB)
- Croatian
  (PDF/68.92 KB)
- Czech
  (PDF/72.6 KB)
- Danish
  (PDF/52.19 KB)
- Dutch
  (PDF/30.64 KB)
- Estonian
  (PDF/32.4 KB)
- Finnish
  (PDF/32.73 KB)
- French
  (PDF/31.48 KB)
- German
  (PDF/31.28 KB)
- Greek
  (PDF/88.44 KB)
- Hungarian
  (PDF/53.47 KB)
- Italian
  (PDF/32.36 KB)
- Latvian
  (PDF/73.73 KB)
- Lithuanian
  (PDF/83.85 KB)
- Maltese
  (PDF/72.46 KB)
- Polish
  (PDF/60.36 KB)
- Portuguese
  (PDF/29.52 KB)
- Romanian
  (PDF/73.37 KB)
- Slovak
  (PDF/68.95 KB)
- Slovenian
  (PDF/67.07 KB)
- Spanish
  (PDF/31.26 KB)
- Swedish
  (PDF/29.1 KB)
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Xeljanz-H-A-20-1485-C-4214-0017: Assessment report on provisional measures - Article 20 (PDF/84.79 KB)

Adopted

First published: 05/07/2019
EMA/309456/2019
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Xeljanz-H-C-4214-X-0005 : EPAR - Assessment Report - Variation (PDF/10.78 MB)

First published: 16/08/2018
Last updated: 20/08/2018
EMA/414633/2018
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Xeljanz-H-C-4214-II-0006: EPAR - Assessment Report - Variation (PDF/9.34 MB)

First published: 16/08/2018
Last updated: 16/08/2018
EMA/CHMP/197115/2018
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CHMP post-authorisation summary of positive opinion for Xeljanz (PDF/71.5 KB)

Adopted

First published: 27/04/2018
Last updated: 27/04/2018
EMA/CHMP/244920/2018

Initial marketing-authorisation documents

Patient Safety

EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders

28/10/2022

Xeljanz

Table of contents

Overview

Xeljanz : EPAR - Medicine overview (PDF/142.78 KB)

Xeljanz : EPAR - Risk-management-plan summary (PDF/232.35 KB)

Authorisation details

Product information

Xeljanz : EPAR - Product Information (PDF/1.73 MB)

Xeljanz : EPAR - All Authorised presentations (PDF/48.53 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Xeljanz : EPAR - Procedural steps taken and scientific information after authorisation (PDF/198.42 KB)

Xeljanz-H-C-PSUSA-00010588-202111 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/101.87 KB)

Xeljanz-H-C-004214-II-0039 : EPAR - Assessment Report - Variation (PDF/9.73 MB)

CHMP post-authorisation summary of opinion for Xeljanz (PDF/104.14 KB)

Xeljanz-H-C-004214-II-0035 : EPAR - Assessment Report - Variation (PDF/13.86 MB)

CHMP post-authorisation summary of positive opinion for Xeljanz (II-35) (PDF/141.62 KB)

Xeljanz-H-C-4214-X-0024-G: EPAR - Assessment Report - Variation (PDF/2.24 MB)

CHMP post-authorisation summary of positive opinion for Xeljanz (X-24-G) (PDF/143.8 KB)

Xeljanz-H-C-4214-P46-012 : EPAR - Assessment Report - Variation (PDF/4.29 MB)

Xeljanz-H-A-20-1485 : EPAR - Scientific conclusions (PASS) - Article-20 (PDF/51.82 KB)

Xeljanz-H-A-20-1485 : EPAR - Scientific conclusions - Article-20 (PDF/29.44 KB)

Xeljanz-H-A-20-1485-C-4214-0017: Assessment report on provisional measures - Article 20 (PDF/84.79 KB)

Xeljanz-H-C-4214-X-0005 : EPAR - Assessment Report - Variation (PDF/10.78 MB)

Xeljanz-H-C-4214-II-0006: EPAR - Assessment Report - Variation (PDF/9.34 MB)

CHMP post-authorisation summary of positive opinion for Xeljanz (PDF/71.5 KB)

Initial marketing-authorisation documents

Xeljanz : EPAR - Public assessment report (PDF/4.12 MB)

CHMP summary of positive opinion for Xeljanz (PDF/68.9 KB)

Patient Safety

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