Xeljanz (tofacitinib)

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What is Xeljanz (tofacitinib)?

Xeljanz (tofacitinib) is an inhibitor of Janus kinases (JAKs). It is used to treat moderately to severely active rheumatoid arthritis^[1,2,3] active psoriatic arthritis^[1], and moderately to severely active ulcerative colitis^[1].

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 methotrexate^[1,2,3]

• active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs)^[1,2,3].
• moderately to severely active ulcerative colitis^[1,2].

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 diseases^[4].

Where has Xeljanz (tofacitinib) been approved?

Xeljanz (tofacitinib) was approved by:

• Food and Drug Administration (FDA), USA:
  • November 6, 2012 for the treatment of severely active rheumatoid arthritis^[5]
  • December 14, 2017 for the treatment of active psoriatic arthritis^[7]
  • May 30, 2018, for the treatment of moderately to severely active ulcerative colitis^[2].

• European Medical Agency (EMA), European Union:
  • March 22, 2017 for the treatment of severely active rheumatoid arthritis^[4]
  • April 26, 2018 for the treatment of active psoriatic arthritis^[9].
  • May 31, 2018 for the treatment of moderately to severely active ulcerative colitis^[10].

• Therapeutic Goods Administration (TGA), Australia:
  • February 5, 2015 for the treatment of severely active rheumatoid arthritis^[3]
  • November 13, 2018 for the treatment of active psoriatic arthritis^[11].
• Health Canada on June 3, 2014^[12]:
  • for the treatment of moderate to severely active rheumatoid arthritis
  • for the treatment of psoriatic arthritis
  • for the treatment of moderate to severely active ulcerative colitis.

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 is^[9]:

• 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 section^[1,2,3].

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 include^[1,2,3]:

• 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 include^[2]:

• 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 infections^[2].

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 medicine^[2].

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information^[1,2,3].

References

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 arthritisPincus T. The American College of Rheumatology
7. Pfizer announces FDA approval of Xeljanz (tofacitinib) and Xeljanz XR for the treatment of active psoriatic arthritis
8. The Health Assessment Questionnaire (HAQ) Disability Index (DI) of the clinical health assessment questionnaire[PDF] www.niehs.nih.gov, cited on 12/06/2018.
9. Committee for Medicinal Products for Human Use [EMA], New indication approval:  Xeljanz (tofacitinib[PDF]

10. Committee for Medicinal Products for Human Use [EMA], New indication approval:  Xeljanz (tofacitinib) [PDF]

11. Australian Register of Therapeutic Goods (ARTG): Prescription medicines: new or extended uses, or new combinations of registered medicines: Xeljanz (tofacitinib)[PDF]
12. Summary of Product Characteristics [Health Canada]: Xeljanz (tofacitinib)[PDF] Pfizer Canada, June 2014

This content has been reviewed by a Medical Doctor.