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 Period

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


Western Health Advantage Pharmacy and Therapeutics Committee

Approved:  September 2014 | Revised: July 2015 | Reviewed:  July 2016

Last review date: July 20, 2016