July 29, 2016
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Xeljanz

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Xeljanz




Indications
Dosage
How Supplied

INDICATIONS

Rheumatoid Arthritis

  • XELJANZ/XELJANZ XR (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.

DOSAGE AND ADMINISTRATION

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.
  • 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.

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

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.

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 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/XELJANZ XR

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/XELJANZ XR 11 mg once daily
ANC less than 500 (Confirmed by repeat testing) Discontinue XELJANZ/XELJANZ XR

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/XELJANZ XR 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 XR is provided as 11 mg tofacitinib (equivalent to 17.77 mg tofacitinib citrate) tablets: Pink, oval, extended release film-coated tablets with a drilled hole at one end of the tablet band and “JKI 11” printed on one side of the tablet.

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:

XELJANZ

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

XELJANZ XR is provided as 11 mg tofacitinib (equivalent to 17.77 mg tofacitinib citrate) tablets: Pink, oval, extended release tablet with a drilled hole at one end of the tablet band and “JKI 11” printed on one side of the tablet:

XELJANZ XR

Bottles of 14: NDC 0069-0501-14
Bottles of 30: NDC 0069-0501-30

Storage And Handling

Store XELJANZ/XELJANZ XR 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. Revised: February 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/7/2016

Indications
Dosage
How Supplied

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