Tofacitinib (Xeljanz, Xeljanz XR)

SELF ADMINISTRATION

Indications for Prior Authorization:

  • Moderate to severe rheumatoid arthritis

Xeljanz/Xeljanz XR are preferred biologic agents for treatment of the following indication(s) when all criteria below are met for specific indication(s):

  • Rheumatoid Arthritis

Patients must meet the following criteria for RA:

  • Diagnosis of moderate to severe active rheumatoid arthritis by rheumatologist (the prescribing MD does not have to be a rheumatologist), AND
  • Inadequate response or intolerance to methotrexate (or if contraindicated, to one or more other Disease Modifying Anti-Rheumatic Drugs (DMARDs): Auranofin (Ridaura), Azathioprine (Imuran), Gold sodium thiomalate (aurolate), Hydroxychloroquine (Plaquenil), D-penicillamine (Cuprimine, Sulfasalazine (Azulfidine)), AND
  • Not used in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine, AND
  • Not used in combination with a strong CYP3A4 inducer

Dosing:

  • Immediate release: 5 mg twice daily
  • Extended release: 11 mg daily
  • When transitioning from immediate release to extended release, begin extended release the day following the last dose of 5 mg immediate release
  • Do not initiate therapy in patients with an absolute lymphocyte count <500 cells/mm3, absolute neutrophil count <1,000 cells/mm3, or hemoglobin <9 g/dL
  • Use with strong CYP3A4 inhibitors: reduce dose to 5 mg (immediate release) once daily (extended release formulation is not recommended)
  • Use with moderate CYP3A4 inhibitors and potent CYP2C19 inhibitors: reduce dose to 5 mg (immediate release) once daily
  • Moderate to severe renal impairment, and/or moderate hepatic impairment: reduce dose to 5 mg (immediate release) once daily
  • Severe hepatic impairment: use not recommended

Approval:

  • One year to assess patient's response

Risk of Tuberculosis:

Patients should be evaluated for latent tuberculosis infection with a TB skin test.  Treatment of later tuberculosis infection should be initiated prior to therapy with Humira.

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