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)

Patients must meet the following criteria for RA:

  • Diagnosis of moderate to severe active rheumatoid arthritis 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 (Ridaura), Azathioprine (Imuran), Gold sodium thiomalate (Aurolate), Hydroxychloroquine (Plaquenil), Methotrexate (Rheumatrix), D-penicillamine (Cuprimine), Sulfasalazine (Azulfidine) OR has a medical reason why Methotrexate, Hydorxychloroquine and Sulfasalazine cannot be used, AND
  • Inadequate response or intolerable side effects to two of the following: Humira, Enbrel, Actemra or Xeljanz/XR
  • 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)
  • Not used in conjunction with another biologic DMARD (e.g., TNF antagonist, IL-1R antagonists, anti-CD20 monoclonal antibodies, selective co-stimulation modulators)

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
  • Renewal for one year if patient has clinical response (updated lab and chart note documentation required due to monitoring requirement (e.g., risk for neutropenia, thrombocytopenia, elevated liver enzymes)

Risk of Tuberculosis:

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