These highlights do not include all the information needed to use XELJANZ safely and effectively. See full prescribing information for XELJANZ.
XELJANZ ® (tofacitinib) tablets for oral administration
Initial U.S. Approval: 2012
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
See full prescribing information for complete Boxed Warning.
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Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving XELJANZ. (5.1)
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If a serious infection develops, interrupt XELJANZ until the infection is controlled. (5.1)
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Prior to starting XELJANZ, perform a test for latent tuberculosis; if it is positive, start treatment for tuberculosis prior to starting XELJANZ. (5.1)
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Monitor all patients for active tuberculosis during treatment, even if the initial latent tuberculosis test is negative. (5.1)
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Lymphoma and other malignancies have been observed in patients treated with XELJANZ. Epstein Barr Virus- associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications. (5.2)
INDICATIONS AND USAGE
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XELJANZ, an inhibitor of Janus kinases (JAKs), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
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XELJANZ should not be used in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine. (1.1)
DOSAGE AND ADMINISTRATION
Rheumatoid Arthritis (2)
The recommended dose of XELJANZ is 5 mg twice daily. (2)
DOSAGE FORMS AND STRENGTHS
None (4)
WARNINGS AND PRECAUTIONS
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Serious Infections – Do not administer XELJANZ during an active infection, including localized infections. If a serious infection develops, interrupt XELJANZ until the infection is controlled. (5.1)
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Lymphomas and other malignancies have been reported in patients treated with XELJANZ. (5.2)
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Gastrointestinal Perforations – Use with caution in patients that may be at increased risk. (5.3)
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Laboratory monitoring –Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids. (5.4)
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Immunizations –Live vaccines should not be given concurrently with XELJANZ. (5. 5)
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Severe hepatic impairment–Not recommended (5.6)
ADVERSE REACTIONS
The most commonly reported adverse reactions during the first 3 months in controlled clinical trials (occurring in greater than or equal to 2% of patients treated with XELJANZ monotherapy or in combination with DMARDs) were upper respiratory tract infections, headache, diarrhea and nasopharyngitis. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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Potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole): Reduce dose to 5 mg once daily. (2.1)
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One or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole): Reduce dose to 5 mg once daily. (2.1)
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Potent CYP inducers (e.g., rifampin): May result in loss of or reduced clinical response. (2.2)
USE IN SPECIFIC POPULATIONS
Moderate and severe renal impairment and moderate hepatic impairment: Reduce dose to 5 mg once daily. (8.6, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2012
