Tocilizumab (Actemra)

OFFICE ADMINISTRATION / SELF-INJECTION

Indications for Prior Authorization:

  • Moderate to severe rheumatoid arthritis
  • Polyarticular Juvenile Idiopathic Arthritis (PJIA)
  • Systemic Juvenile Idiopathic Arthritis (SJIA)

Patients must meet the following criteria for the indications above:

Rheumatoid Arthritis (moderate to severe)

  • Diagnosed by rheumatologist (prescriber does not have to be rheumatologist)
  • ONE of the following:
    • Inadequate response or intolerance to at least one Disease Modifying Anti-Rheumatic Drug (DMARDs):
      • auranofin (Ridaura®)
      • azathioprine (Imuran®)
      • cyclosporine (Neoral®)
      • hydroxychloroquine (Plaquenil®)
      • methotrexate (Rheumatrex®)
      • D-penicillamine (Cuprimine®)
      • sulfasalazine (Azulfidine®)
      • leflunomide (Arava®)
    • Has medical justification why methotrexate, hydroxychloroquine, and sulfasalazine cannot be used
    • Inadequate response or intolerable side effects to two of the following: adalimumab (Humira), etanercept (Enbrel) or infliximab (Remicade)

Polyarticular Juvenile Idiopathic Arthritis

  • Diagnosis of polyarticular juvenile idiopathic arthritis (PJIA), AND
  • Diagnosed by a Rheumatologist (the prescribing physician does not have to be a Rheumatologist), AND
  • Patient is 2 years of age or older, AND
  • Inadequate response, intolerance , or contraindication to methotrexate, AND
  • Inadequate response or intolerable side effect to Enbrel and Humira

Systemic Juvenile Idiopathic Arthritis (SJIA)/Still’s Disease

  • Diagnosis of systemic juvenile idiopathic arthritis (SJIA)/Still’s disease, AND
  • Diagnosed by a Rheumatologist (the prescribing physician does not have to be a Rheumatologist), AND
  • Patient is 2 years of age or older

Dosing:

Rheumatoid Arthritis

  • Intravenous Infusion: 4 mg/Kg is given by IV infusion over 60 minutes every four weeks
  • The dose may be increased to 8 mg/Kg based on clinical response.  Actemra doses exceeding 800 mg per infusion are not recommended in RA patients

Subcutaneous self-administration

  • For patients <100kg: Initial to 162 mg SubQ every other week. May increase to 162 mg SubQ based on clinical response
  • For patients ≥100kg: up to 162 mg SubQ weekly

Polyarticular Juvenile Idiopathic Arthritis

  • Up to 10mg/kg IV infusion as often as every 4 weeks at the following dose:
Patient Wt Maximum Dose
< 30kg  10mg/kg
> 30kg 8mg/kg

 

Systemic Juvenile Idiopathic Arthritis (SJIA)/Still’s Disease

  • Up to 12mg/kg IV infusion as often as every 2 weeks at the following dose:
Patient Wt Maximum Dose
< 30kg  12mg/kg
> 30kg  8mg/kg

 

Tocilizumab should not be initiated in patients with an absolute neutrophil count (ANC)

  • Below 2000/mm3, platelet count below 100,000/mm3, OR
  • Who have ALT or AST above 1.5 times the normal range

Tocilizumab may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs)

Approval:

  • Initial: six months to assess patient’s response
  • Renewal: one year if patient has clinical response
  • Risk of Tuberculosis and Serious Infection
  • 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 golimumab
  • Do not administer live vaccines or attenuated vaccines concurrently with golimumab
  • Patients should be routinely monitored for elevated liver enzymes, elevated low-density lipoprotein (LDL), hypertension, and gastrointestinal perforations

 

Last review date: July 20, 2016