Tofacitinib (Xeljanz, Xeljanz XR)

SELF ADMINISTRATION

Indications for Prior Authorization:

  • Adults with moderate to severe active rheumatoid arthritis (RA)
  • Adults with active psoriatic arthritis
  • Adults with moderate to severe active ulcerative colitis

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 (RA)
  • Psoriatic Arthritis
  • Ulcerative Colitis

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

Patients must meet the following criteria for psoriatic arthritis:

  • Diagnosis of active psoriatic arthritis made at baseline prior to initiation of DMARD therapy confirmed by rheumatologist or dermatologist (the prescribing physician does not have to be a rheumatologist or dermatologist, AND
  • Patient has failed to respond, or had clinically significant adverse effect to methotrexate unless contraindicated, AND
  • Xeljanz/Xeljanz XR will be used in combination with nonbiologic disease modifying antirheumatic drugs (DMARDs) (the efficacy of Xeljanz/Xeljanz XR as a monotherapy has not been studied in psoriatic arthritis)

Patients must meet the following criteria for ulcerative colitis:

  • Diagnosis of moderate to severe ulcerative colitis by gastroenterologist (the prescribing MD does not have to be a gastroenterologist), AND
  • The extended release product, Xeljanz XR, is not approvable for ulcerative colitis

Dosing:

  • Rheumatoid Arthritis or Psoriatic Arthritis:
    • Immediate release: 5 mg twice daily
    • Extended release: 11 mg daily
  • Ulcerative Colitis:
    • 10 mg twice daily for at least 8 weeks, then 5 or 10 mg twice daily
    • Discontinue after 16 weeks of 10 mg twice daily, if adequate therapeutic benefit is not achieved
    • Use the lowest effective dose to maintain response
  • 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:

  • Rheumatoid Arthritis: 1 year to assess patient's response
  • Psoriatic Arthritis: initial approvals 3 months
  • Ulcerative Colitis: initial approvals 4 months
  • Continuations: 1 year

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 Xeljanz/Xeljanz XR.

Last review date: January 1, 2019