XELJANZ(tofacitinib)tablets/XELJANZ XR(tofacitinib)extended release tablets
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ.
XELJANZ ® (tofacitinib) tablets, for oral use
XELJANZ ® XR (tofacitinib) extended release tablets, for oral use
Initial U.S. Approval: 2012
WARNING: SERIOUS INFECTIONS AND MALIGNANCY SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
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)
If a serious infection develops, interrupt XELJANZ/XELJANZ XR until the infection is controlled. (5.1)
Prior to starting XELJANZ/XELJANZ XR, perform a test for latent tuberculosis; if it is positive, start treatment for tuberculosis prior to starting XELJANZ/XELJANZ XR. (5.1)
Monitor all patients for active tuberculosis during treatment, even if the initial latent tuberculosis test is negative. (5.1)
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)
RECENT MAJOR CHANGES
Indications and Usage, Psoriatic Arthritis (1.2) 12/2017
Dosage and Administration, Dosage in Psoriatic Arthritis (2.2) 12/2017
Warnings and Precautions, Serious Infections (5.1) 12/2017
Warnings and Precautions, Malignancy and Lymphoproliferative Disorders (5.2) 12/2017
Warnings and Precautions, Gastrointestinal Perforations (5.3) 12/2017
Warnings and Precautions, Vaccinations (5.5) 8/2017
INDICATIONS AND USAGE
XELJANZ/XELJANZ XR is an inhibitor of Janus kinases (JAKs) 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). (1.1)
XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). (1.2)
Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.1, 1.2)
DOSAGE AND ADMINISTRATION
Rheumatoid Arthritis
Recommended dose of XELJANZ is 5 mg twice daily. (2.1)
Recommended dose of XELJANZ XR is 11 mg once daily. (2.1)
Recommended dose in patients with moderate and severe renal impairment and moderate hepatic impairment is XELJANZ 5 mg once daily. (2.5, 8.7, 8.8)
Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment is not recommended. (2.5, 8.7)
Psoriatic Arthritis
Recommended dose of XELJANZ is 5 mg twice daily, used in combination with nonbiologic DMARDs. (2.2)
Recommended dose of XELJANZ XR is 11 mg once daily, used in combination with nonbiologic DMARDs. (2.2)
Recommended dose in patients with moderate and severe renal impairment a |
