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Xeljanz

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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).
  • Limitations of Use: Use of XELJANZ in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

DOSAGE AND ADMINISTRATION

Dosage In 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.
  • XELJANZ is given orally with or without food.

Dosage Modifications Due To Serious Infections And Cytopenias (See Tables 1, 2, and 3 below.)

  • It is recommended that XELJANZ 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 and ADVERSE REACTIONS].
  • Avoid use of XELJANZ if a patient develops a serious infection until the infection is controlled.

Dosage Modifications Due To Drug Interactions

  • XELJANZ dosage should be reduced to 5 mg once daily in patients:
    • 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).
  • Coadministration of potent inducers of CYP3A4 (e.g., rifampin) with XELJANZ may result in loss of or reduced clinical response to XELJANZ. Coadministration of potent inducers of CYP3A4 with XELJANZ is not recommended.

Dosage Modifications In Patients With Renal Or Hepatic Impairment

  • XELJANZ dosage should be reduced to 5 mg once daily in patients:
    • with moderate or severe renal insufficiency.
    • with moderate hepatic impairment.
  • Use of XELJANZ in patients with severe hepatic impairment is not recommended.

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 Discontinue XELJANZ
(Confirmed by repeat testing)  

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.

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:

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Bottles of 28: NDC 0069-1001-03
Bottles of 60: NDC 0069-1001-01
Bottles of 180: NDC 0069-1001-02

Storage And Handling

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: March 2014

Last reviewed on RxList: 5/27/2014
This monograph has been modified to include the generic and brand name in many instances.

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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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