Sarilumab (Kevzara®)

SELF ADMINISTRATION

FDA approved Indication:

For the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs)

Risk of Tuberculosis:

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

Patients must meet the following criteria for RA:

  • Diagnosis of moderate to severe active rheumatoid arthritis confirmed by chart note documentation, AND
  • Diagnosis confirmed by a Rheumatologist (the prescribing MD does not have to be a rheumatologist), AND
  • Inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs): Auranofin, Azathioprine, Gold sodium thiomalate, Hydroxychloroquine, Methotrexate, D-penicillamine, Sulfasalazine  OR has a medical reason why Methotrexate, Hydroxychloroquine, and Sulfasalazine cannot be used, AND
  • Inadequate response or intolerable side effects to at least two preferred biologic agents: Humira®, Cimzia®, Simponi®, Xeljanz/XR®, Rinvoq®AND
  • Inadequate response to BOTH Actemra® and Orencia®AND
  • Kevzara initiation is not recommended in patients with an absolute neutrophil count (ANC) less than 2000 per mm3, platelet count less than 150,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN), AND
  • Not used in conjunction with another biologic DMARD (e.g., TNF antagonist, IL-1R antagonists, anti-CD20 monoclonal antibodies, selective co-stimulation modulators), AND
  • Patient meets one of the following:
    • Initiation of biologic therapy: patient has a negative tuberculosis test result (e.g. TB skin test, Quantiferon TB Gold test, or chest x-ray) prior to therapy initiation as evidenced by a recent TB test result OR
    • Continuation of therapy or switching biologic therapies: patient had a negative TB test result within the past year (as evidenced by a current TB test result)

Dosing:

  • 200 mg once every two weeks given as a subcutaneous injection
  • Reduce dose to 150 mg once every two weeks for management of neutropenia, thrombocytopenia and elevated liver enzymes
  • Kevzara may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs

Approval Period:

  • Initial approval 3 months to assess patient's response
  • Continuation: 1 year with specialist chart notes documenting a clinical response to therapy and current TB (tuberculosis) test results [updated labs required due to monitoring requirement (e.g., risk for neutropenia, thrombocytopenia, elevated liver enzymes)]

 

Last review date: February 18, 2020

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