WHA

PROMACTA (eltrombopag) 

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

  • Chronic immune (idiopathic) thrombocytopenic purpura (ITP)
  • Chronic Hepatitis C (CHC) Thrombocytopenia
  • Severe aplastic anemia (FDA approved on 8/26/2014)

All of the following must be met:

Chronic immune (idiopathic) thrombocytopenic purpura

  • Patients with immune (idiopathic) thrombocytopenia purpura whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Promacta/Nplate should not be used in an attempt to normalize platelet counts AND
  • Failure or clinically significant adverse effects to corticosteroids, immunoglobulins, or splenectomy AND
  • Baseline platelet count less than or equal to 30,000/mm3 (30 x 109/L or 30,000/ml)

Chronic Hepatitis C-associated Thrombocytopenia

  • Diagnosis of thrombocytopenia in patients with chronic hepatitis C to allow initiation and maintenance of interferon-based therapy with ribavirin AND
  • Baseline platelet count less than 75,000/mm3 (or 75 x 109/L, 7.5 x 108/L, 75,000/ml, 75 K/5L)

Aplastic Anemia

  • Diagnosis of severe aplastic anemia in patients who have had an insufficient response to immunosuppresive therapy

Dosing:

Chronic immune (idiopathic) thrombocytopenic purpura

  • 50 mg orally once daily for most patients
  • For patients of East Asian ancestry or patients with moderate or severe hepatic insufficiency, the starting dose is 25 mg once daily
  • Do not exceed a daily dose of 75 mg

Chronic Hepatitis C-associated Thrombocytopenia

  • 25 mg PO daily
  • Adjust to achieve a target platelet count required to initiate antiviral therapy
  • Do not exceed daily dose of 100 mg

Platelet Count Result

Dose Adjustment or Response

<50 x 109/L following at least 2 weeks of Promacta

Increase daily dose by 25 mg (maximum of 100 mg/day)

≥200 x 109/L to ≤400 x 109/L at any time

Decrease the daily dose by 25 mg

>400 x 109/L

Stop Promacta; increase the frequency of platelet monitoring to twice weekly

Once the platelet count is <150 x 109/L, reinitiate Promacta at a daily dose of reduced by 25 mg

For patients taking the 25 mg PO QD, reinitiate Promacta at a daily dose of 12.5 mg

>400 x 109/L after 2 weeks of therapy at lowest dose of Promacta

Discontinue Promacta

Severe Aplastic Anemia

  • 50 mg orally once daily for most patients
  • Patients of East Asian ancestry or patients with moderate or severe hepatic insufficiency, the starting dose is 25 mg once daily
  • Do not exceed a daily dose of 150 mg

Approval:

  • One month initially
  • Then length of benefit (For AHCS requests: One Year) provided patient maintains a platelet count between 50 x 109/L and 200 x 109/

 

Last review date: July 21, 2016