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