XELJANZ / XELJANZ XR (tofacitinib) 1 Indications

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Rheumatoid Arthritis

XELJANZ/XELJANZ XR (tofacitinib), in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms of rheumatoid arthritis (RA) in adult patients with moderately to severely active RA who have had an inadequate response to MTX and to one or more disease-modifying anti-rheumatic drugs (DMARDs).

In cases of intolerance to MTX and other DMARDs, physicians may consider the use of XELJANZ/XELJANZ XR (tofacitinib) as monotherapy.

Psoriatic Arthritis

XELJANZ (tofacitinib), in combination with methotrexate (MTX) or another conventional synthetic disease-modifying antirheumatic drug (DMARD), is indicated for reducing the signs and symptoms of psoriatic arthritis (PsA) in adult patients with active PsA when the response to previous DMARD therapy has been inadequate.

Ankylosing Spondylitis

XELJANZ (tofacitinib) is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to a biologic DMARD or when use of those therapies is inadvisable.

Ulcerative Colitis

XELJANZ (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) with an inadequate response, loss of response or intolerance to either conventional UC therapy or a TNFα inhibitor.

Limitations of Use

XELJANZ should not be used in combination other Janus kinase (JAK) inhibitors, immunomodulating biologics (e.g., biologic DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

1.1 Pediatrics

Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

1.2 Geriatrics

Geriatrics (>65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. The frequency of adverse events including serious infections, all-cause mortality, cardiovascular events, malignancies, non-melanoma skin cancer, gastrointestinal perforations, interstitial lung disease, venous thromboembolism, and arterial thromboembolism in XELJANZ-treated subjects 65 years of age and older was higher than among those under the age of 65. Therefore, caution should be used when treating geriatric patients with XELJANZ/XELJANZ XR (see 7 WARNINGS AND PRECAUTIONS, 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY).