R (tofacitinib) 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).
Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
1.2 Psoriatic Arthritis
XELJANZ/XELJANZ XR (tofacitinib) 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).
Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
2 DOSAGE AND ADMINISTRATION
The recommended dose of XELJANZ is 5 mg twice daily and the recommended dose of XELJANZ XR is 11 mg once daily.
XELJANZ/XELJANZ XR is given orally with or without food.
Swallow XELJANZ XR tablets whole and intact. Do not crush, split, or chew.
Switching from XELJANZ Tablets to XELJANZ XR Tablets
Patients treated with XELJANZ 5 mg twice daily may be switched to XELJANZ XR 11 mg once daily the day following the last dose of XELJANZ 5 mg.
2.1 Dosage in Rheumatoid Arthritis
XELJANZ/XELJANZ XR may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). The recommended dose of XELJANZ is 5 mg twice daily and the recommended dose of XELJANZ XR is 11 mg once daily.
2.2 Dosage in Psoriatic Arthritis
The recommended dose of XELJANZ is 5 mg twice daily, used in combination with nonbiologic DMARDs.
The recommended dose of XELJANZ XR is 11 mg once daily used in combination with nonbiologic DMARDs.
The efficacy of XELJANZ/XELJANZ XR as a monotherapy has not been studied in psoriatic arthritis.
2.3 Dosage Modifications due to Serious Infections and Cytopenias
(see TABLES 1, 2, and 3 below)
It is recommended that XELJANZ/XELJANZ XR not be initiated in patients with an absolute lymphocyte count less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1000 cells/mm3 or who have hemoglobin levels less than 9 g/dL.
Dose interruption is recommended for management of lymphopenia, neutropenia and anemia [see WARNINGS AND PRECAUTIONS (5.4) and ADVERSE REACTIONS (6.1)].
Avoid use of XELJANZ/XELJANZ XR if a patient develops a serious infection until the infection is controlled.
2.4 Dosage Modifications due to Drug Interactions
In patients receiving:
potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole), or
one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole),
the recommended dose is XELJANZ 5 mg once daily.
Coadministration of potent inducers of CYP3A4 (e.g., rifampin) with XELJANZ/XELJANZ XR may result in loss of or reduced clinical response to XELJANZ/XELJANZ XR.
Coadministration of potent inducers of CYP3A4 with XELJANZ/XELJANZ XR is not recommended.
2.5 Dosage Modifications in Patients with Renal or Hepatic Impairment
In patients with:
moderate or severe renal insufficiency, or
moderate hepatic impairment,
the recommended dose is XELJANZ 5 mg once daily.
Use of XELJANZ/XELJANZ XR in p |
