What is Xeljanz - Tofacitinib used for?
Xeljanz is a medicine used to treat adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints.
Xeljanz is used together with methotrexate after treatment with one or more medicines known as disease-modifying antirheumatic drugs (DMARDs) has not worked enough or has caused annoying side effects. It can also be used on its own in patients who cannot or who are intolerant to methotrexate.
Xeljanz contains the active substance tofacitinib.
How is Xeljanz - Tofacitinib used?
Xeljanz is available as a 5 mg tablet taken by mouth twice a day. Treatment may be interrupted in patients who develop an infection, this being a known side effect of the medicine, or in patients with abnormal blood test results. The dose may also be decreased in some patients with reduced kidney or liver function. For more information, see the package leaflet.
Xeljanz can only be obtained with a prescription. Treatment should be started and supervised by a doctor experienced in the treatment of rheumatoid arthritis.
How does Xeljanz - Tofacitinib work?
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 and joint damage that occurs in rheumatoid arthritis. By blocking its action, tofacitinib helps reduce inflammation and other symptoms of the disease.
What benefit has Xeljanz - Tofacitinib shown during the studies?
Six studies conducted on more than 4 200 patients with rheumatoid arthritis have shown that Xeljanz is effective in reducing joint pain and swelling, improving joint movement and slowing joint damage. Most of the patients involved in these studies had previously tried other treatments and most took Xeljanz with methotrexate.
In one of the studies, in which Xeljanz was taken on its own (monotherapy), it was more effective than methotrexate in slowing joint damage and reducing symptoms. In another study, Xeljanz taken alone was more effective than placebo in reducing symptoms such as pain and swelling.
What are the risks associated with Xeljanz - Tofacitinib?
The most common side effects of Xeljanz are headache, infection and inflammation of the nose and throat, diarrhea, nausea and high blood pressure (high blood pressure).
The most common serious side effects observed with Xeljanz are serious infections such as pneumonia (lung infection), cellulitis (infection of the deep skin tissue), herpes zoster (S. Antonio fire), urinary tract infection, diverticulitis (infection of the 'intestine) and appendicitis (infection of the appendix), in addition to opportunistic infections that can occur in patients with weakened immune systems.
Xeljanz should not be used in patients with active tuberculosis, severe infections or any opportunistic infection. Xeljanz should not be used in patients with severe hepatic impairment and in women who are pregnant or breast-feeding.
For the full list of side effects and limitations, see the package leaflet.
Why has Xeljanz - Tofacitinib been approved?
Several studies have shown that Xeljanz taken with methotrexate is effective in the treatment of rheumatoid arthritis in patients who have previously tried other treatments. Xeljanz is effective even if taken alone.
The most important side effect with the medicine is infection and health professionals are given specific recommendations to reduce this risk. In general, the risks associated with Xeljanz were similar to those associated with other medicines in its class.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Xeljanz's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Xeljanz - Tofacitinib?
The company that markets Xeljanz will provide information material to healthcare professionals and patients to improve awareness of the risks associated with the medicine, in particular the risk of serious infections, and how to treat them.
Recommendations and precautions to be followed by healthcare professionals and patients for Xeljanz to be used safely and effectively have also been included in the summary of product characteristics and the package leaflet.
More information on Xeljanz - Tofacitinib
For the full EPAR by Xeljanz, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Xeljanz therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
