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)1,2,3.
moderately to severely active ulcerative colitis1,2.
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 diseases4.
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 arthritis5
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, 2017 for the treatment of severely active rheumatoid arthritis4
April 26, 2018 for the treatment of active psoriatic arthritis9.
May 31, 2018 for the treatment of moderately to severely active ulcerative colitis10.
Therapeutic Goods Administration (TGA), Australia,
February 5, 2015 for the treatment of severely active rheumatoid arthritis3
November 13, 2018 for the treatment of active psoriatic arthritis11.
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.
