Xeljanz
New Arthritis Drug Xeljanz Gets FDA Approval »
"Nov. 6, 2012 -- The FDA has approved Pfizer's Xeljanz (tofacitinib), a first-of-its-kind treatment for rheumatoid arthritis.
Xeljanz is approved for use by patients not helped by methotrexate, the usual first treatment for RA. It's a "...
Read the New Arthritis Drug Xeljanz Gets FDA Approval article »
Xeljanz
INDICATIONS
Rheumatoid Arthritis
- XELJANZ (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).
- XELJANZ should not be used in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine.
DOSAGE AND ADMINISTRATION
XELJANZ is given orally with or without food.
Rheumatoid Arthritis
XELJANZ 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.
- Dose interruption is recommended for management of lymphopenia, neutropenia and anemia [see WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS].
- XELJANZ dosage should be reduced to 5 mg once daily in patients:
- with moderate or severe renal insufficiency
- with moderate hepatic impairment
- receiving potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole)
- receiving one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole).
General Considerations for Administration
- XELJANZ should not be used in patients with severe hepatic impairment.
- It is recommended that XELJANZ not be initiated in patients with a 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.
- Coadministration of XELJANZ with potent inducers of CYP3A4 (e.g., rifampin) may result in loss of or reduced clinical response to XELJANZ.
Dosage Modifications
XELJANZ treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
Table 1: Dose Adjustments for Lymphopenia
| Low Lymphocyte Count [see WARNINGS AND PRECAUTIONS] | |
| Lab Value (cells/mm³) | Recommendation |
| Lymphocyte count greater than or equal to 500 | Maintain dose |
| Lymphocyte count less than 500 (Confirmed by repeat testing) | Discontinue XELJANZ |
Table 2: Dose Adjustments for Neutropenia
| Low ANC [see WARNINGS AND PRECAUTIONS] | |
| Lab Value (cells/mm³) | Recommendation |
| ANC greater than 1000 | Maintain dose |
| ANC 500-1000 | For persistent decreases in this range, interrupt dosing until ANC is greater than 1000 |
| When ANC is greater than 1000, resume XELJANZ 5 mg twice daily | |
| ANC less than 500 (Confirmed by repeat testing) | Discontinue XELJANZ |
Table 3: Dose Adjustments for Anemia
| Low Hemoglobin Value [see WARNINGS AND PRECAUTIONS] | |
| Lab Value (g/dL) | Recommendation |
| Less than or equal to 2 g/dL decrease and greater than or equal to 9.0 g/dL | Maintain dose |
| Greater than 2 g/dL decrease or less than 8.0 g/dL (Confirmed by repeat testing) | Interrupt the administration of XELJANZ until hemoglobin values have normalized |
HOW SUPPLIED
Dosage Forms And Strengths
XELJANZ is provided as 5 mg tofacitinib (equivalent to 8 mg tofacitinib citrate) tablets: White, round, immediate-release film-coated tablets, debossed with “Pfizer” on one side, and “JKI 5” on the other side.
Storage And Handling
XELJANZ is provided as 5 mg tofacitinib (equivalent to 8 mg tofacitinib citrate) tablets: White, round, immediate-release film-coated tablets, debossed with “Pfizer” on one side, and “JKI 5” on the other side, and available in:
Bottles of 60: NDC 0069-1001-01
Bottles of 180: NDC 0069-1001-02
Storage
Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].
Do not repackage.
Distributed by : Pfizer Labs Division of Pfizer Inc, NY, NY 10017. Issued: November 2012
Last reviewed on RxList: 11/15/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Xeljanz Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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