Xeljanz (tofacitinib)

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Xeljanz (tofacitinib)

Xeljanz (tofacitinib) is a medication used for the treatment of severely active rheumatoid arthritis or active psoriatic arthritis, in patients who have had an inadequate response or intolerance to methotrexate. It is also used for moderately to severely active ulcerative colitis.

How to buy Xeljanz (tofacitinib): You can order Xeljanz (tofacitinib) from TheSocialMedwork if the drug has not been approved or is not available in your country.

Rheumatology Rheumatoid Arthritis
Marketing Authorisation Holder Pfizer Limited
Mode of Action Inhibitor of Janus kinases (JAKs)
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 5 milligram
Package 56 Tablets

What is Xeljanz (tofacitinib)?

Xeljanz (tofacitinib) is an inhibitor of Janus kinases (JAKs). It is used to treat moderately to severely active rheumatoid arthritis1,2,3, active psoriatic arthritis1, and moderately to severely active ulcerative colitis1.

Who is it for?

Xeljanz (tofacitinib) is an inhibitor of Janus kinases (JAKs) used to treat adult patients with

  • moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate1,2,3.

  • active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs)2.

moderately to severely active ulcerative colitis2.

How does Xeljanz (tofacitinib) work?

The active substance in Xeljanz, tofacitinib, acts on enzymes known as Janus kinases. These enzymes play an important role in the process of inflammation4 that characterises inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. By blocking their action, tofacitinib helps reduce the inflammation and other symptoms of inflammatory diseases4.

Where has Xeljanz (tofacitinib) been approved?

Xeljanz (tofacitinib) was approved by:

  • Food and Drug Administration (FDA), USA:

    • November 6, 20125, for the treatment of severely active rheumatoid arthritis

    • December 14, 2017, for the treatment of active psoriatic arthritis7

    • May 30, 2018, for the treatment of moderately to severely active ulcerative colitis2

  • European Medical Agency (EMA), European Union, March 22, 20174, for the treatment of severely active rheumatoid arthritis

  • Therapeutic Goods Administration (TGA), Australia, February 5, 20153, for the treatment of severely active rheumatoid arthritis.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Xeljanz (tofacitinib) taken?

The standard dosage is9:

  • 5 mg twice daily.

Tofacitinib is also available as extended-release tablets (Xeljanz XR). Please refer to your doctor for more information about the dosage and administration.

Warning: A patient’s blood count needs to be checked before starting treatment. The doctor should check lymphocytes, neutrophils or hemoglobin carefully before starting treatment.

Complete information about Xeljanz (tofacitinib) dosage and administration can be found in the official prescribing information listed in our resources section1,2,3.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects or adverse reactions of Xeljanz (tofacitinib)?

Rheumatoid and Psoriatic Arthritis

The most common adverse reactions listed in the prescribing information include1,2,3:

  • upper respiratory tract infections

  • headache

  • diarrhea

  • nasopharyngitis (inflammation of the pharynx and nasal cavities).

Ulcerative Colitis

The most common adverse reactions listed in the prescribing information include2:

  • nasopharyngitis (inflammation of the pharynx and nasal cavities)

  • elevated cholesterol levels

  • headache

  • upper respiratory tract infection

  • increased blood creatine phosphokinase

  • rash

  • diarrhea

  • herpes zoster. 

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include: serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections2.

Use in specific populations

There is not sufficient data available for the use of Xeljanz (tofacitinib) in pregnant women. It is advised to avoid breastfeeding if taking this medicine2.


For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,2,3.

More Information
Working ingredient tofacitinib
Shipping method Standard (not temperature controlled)
Package 56
Therapeutic Area Rheumatology
Rheumatology Rheumatoid Arthritis
Indication Moderately to severely active rheumatoid arthritis
Indication Moderately to severely active rheumatoid arthritis
Administration Oral
Mode of Action Inhibitor of Janus kinases (JAKs)
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Pfizer Limited

The Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia approvals of Xeljanz (tofacitinib) for severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate were based on 6 studies. These studies involved a total of over 4,200 patients with rheumatoid arthritis which have shown the effectiveness of tofacitinib at reducing joint pain and swelling, improving joint movement and slowing down joint damage1.

Results

An important measure in patients with rheumatoid arthritis is the ACR 20, 50 or 70 which is a criteria to measure the improvement of patients of 20 %, 50 % or 70 % based on measures as swollen joint count, tender joint count, patient assessment of global status, acute phase reactant (dramatic increase in hepatic synthesis of plasma proteins which accompanies acute phases of tissue injury and inflammation), health professional assessment of global status, physical function, and pain6.

In the clinical studies patients treated with either 5 or 10 mg Xeljanz (tofacitinib) twice daily had ACR20, ACR50, and ACR70 response rates over two times higher than placebo. Higher ACR20 response rates were observed within 2 weeks compared to placebo and were consistent at 6 and 12 months2.

Detailed information about the clinical studies can be found in the official prescribing information listed in our resources section1,2,3.

1. Summary of Product Characteristics [EMA]: Xeljanz (tofacitinib) [PDF]
    Pfizer Ltd., March 2017

2. Summary of Product Characteristics [FDA]: Xeljanz (tofacitinib) [PDF]
    Pfizer Inc., Feb 2016

3. Summary of Product Characteristics [TGA]: Xeljanz (tofacitinib) [PDF]
    Pfizer Australia Pty Ltd, Feb 2017

4. Human Medicines: Xeljanz (tofacitinib)
    EMA, May 2017 

5. Xeljanz (tofacitinib)
    Drugs.com, cited May 2017 

6. Core Data Set and derivative “patient only” indices to assess rheumatoid arthritis
    Pincus T. The American College of Rheumatology 

Shipping Type Standard
Shipping method Standard (not temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.