XELJANZ / XELJANZ XR (tofacitinib) Indications And Clinical Use

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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.

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

Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological disease-modifying anti-rheumatic drugs (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.

Pediatrics (<18 years of age)

The safety and effectiveness of XELJANZ/XELJANZ XR in pediatric patients have not been established. Therefore XELJANZ/XELJANZ XR should not be used in this patient population (see DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY ).

Geriatrics (>65 years of age)

The frequency of serious infection among 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 the elderly with XELJANZ/XELJANZ XR (see WARNINGS AND PRECAUTIONS, DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY ).