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.

Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological DMARDs (bDMARDs) or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

  • 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.

Limitations of Use: Use of XELJANZ in combination with biological disease-modifying anti-rheumatic drugs (bDMARDs) or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

  • 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: Use of XELJANZ in combination with biological UC therapies or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

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).