Xeljanz 5 mg Film-Coated Tablets

XELJANZ 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. XELJANZ 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).

XELJANZ 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).

XELJANZ 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 medicine (see section 5.1).

Contraindications

• Hypersensitivity to the tofacitinib or to any of the excipients listed in section 6.1
• Untreated pulmonary tuberculosis (active and latent) or untreated extra pulmonary tuberculosis, serious infections such as sepsis, or opportunistic infections (see section 4.4)
• Severe hepatic impairment (see section 4.2)
• Pregnancy and lactation (see section 4.6)
• Patients with treatment naïve / experienced HIV infections

Special warnings and precautions for use

XELJANZ has not been studied and its use should be avoided in combination with biologics such as TNF antagonists, interleukin (IL)-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL-12/IL-23 antagonists, anti-integrins, selective co-stimulation modulators and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporin and tacrolimus because of the possibility of increased immunosuppression and increased risk of infection.

Treatment should be initiated and supervised by medical practitioners experienced in the diagnosis and treatment of conditions for which XELJANZ is indicated.

The recommended dose is 5 mg administered twice daily.

For ulcerative colitis, the recommended dose is 10 mg given orally twice daily for induction for 8 weeks and 5 mg given twice daily for maintenance.

The most common serious adverse reactions were serious infections (see section 4.4). The most common serious infections reported with XELJANZ were pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis. Among opportunistic infections, TB and other mycobacterial infections, cryptococcus, histoplasmosis, oesophageal candidiasis, multidermatomal herpes zoster, cytomegalovirus, BK virus infections and listeriosis were reported with XELJANZ.

The most commonly reported adverse reactions during the first 3 months in controlled clinical trials were headache, upper respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension.

XELJANZ does not require any special temperature storage conditions. Store in the original, bottle and/or blister, in order to protect from moisture.