Therapeutic Classification: antithrombocytopenics
Pharmacologic Classification: thrombopoietin receptor agonists
REMS
Promacta or Alvaiz
Promacta
Absorption: 52% absorbed following oral administration.
Distribution: Unknown.
Protein Binding: >99%.
Half-Life: 2135 hr.
Contraindicated in:
Use Cautiously in:
Persistent or Chronic Immune Thrombocytopenia
Hepatic Impairment
Chronic Hepatitis C-Associated Thrombocytopenia
First-Line Treatment of Severe Aplastic Anemia
Hepatic Impairment
Hepatic Impairment
Hepatic Impairment
Refractory Severe Aplastic Anemia
Hepatic Impairment
Lab Test Considerations:
For Chronic Immune Thrombocytopenia (Alvaiz)
Monitor CBC with differential and platelet count weekly until platelet count is stable. Goal is platelet count ≥50 × 109/L. Modify dose based on platelet count. If platelet count <50 × 109/L following ≥2 wk of therapy, ↑ daily dose by 18 mg (max = 54 mg/day). For patients taking 9 mg once daily, ↑ dose to 18 mg once daily before ↑ daily dose by 18 mg. If platelet count is 200 × 109/L400 × 109/L,↓ daily dose by 18 mg. For patients taking 18 mg once daily, ↓ dose to 9 mg once daily. Wait 2 wk to assess effects of dose adjustment. If platelet count >400 × 109/L, stop Alvaiz and ↑ monitoring of platelets to twice weekly. Once platelet count <150 × 109/L, reinitiate therapy at dose ↓ by 18 mg/day. For patients taking 18 mg once daily, reinitiate at dose of 9 mg once daily.If platelet count >400 × 109/L after 2 wk of therapy at lowest dose, permanently discontinue Alvaiz. Discontinue Alvaiz if platelet count does not ↑ to a level sufficient to avoid clinically important bleeding after 4 wk of therapy at max dose of 54 mg/day.Chronic Hepatitis C-Associated Thrombocytopenia (Promacta)
Monitor platelet counts every wk prior to starting antiviral therapy. Goal is to achieve and maintain platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin. Modify dose based on platelet count. Adjust dose in 25-mg increments every 2 wk as necessary for target platelet count required to initiate antiviral therapy. During antiviral therapy, adjust dose to avoid dose reductions of peginterferon. Monitor CBC with differentials, including platelet counts, weekly during antiviral therapy until stable platelet count is achieved. Monitor platelet counts monthly thereafter. If platelet count <50 × 109/L following ≥2 wk of therapy, ↑ daily dose by 25 mg (max = 100 mg/day). If platelet count 200 × 109/L400 × 109/L,↓ daily dose by 25 mg. Wait 2 wk to assess effects of dose adjustment. If platelet count >400 × 109/L, stop Promacta, ↑ monitoring of platelet to twice weekly. Once platelet count <150 × 109/L, reinitiate therapy at dose ↓ by 25 mg/day. For patients taking 25 mg once daily, reinitiate at dose of 12.5 mg once daily.If platelet count >400 × 109/L after 2 wk of therapy at lowest dose, permanently discontinue Promacta. Discontinue Promacta when antiviral therapy is discontinued.Chronic Hepatitis C-Associated Thrombocytopenia (Alvaiz)
Monitor platelet counts every wk prior to starting antiviral therapy. Goal is to achieve and maintain platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin. Modify dose based on platelet count. Adjust dose in 18-mg increments every 2 wk as necessary for target platelet count required to initiate antiviral therapy. During antiviral therapy, adjust dose to avoid dose reductions of peginterferon. Monitor CBC with differentials, including platelet counts, weekly during antiviral therapy until stable platelet count is achieved. Monitor platelet counts monthly thereafter. If platelet count <50 × 109/L following ≥2 wk of therapy, ↑ daily dose by 18 mg (max = 72 mg/day). If platelet count 200 × 109/L400 × 109/L,↓ daily dose by 18 mg. Wait 2 wk to assess effects of dose adjustment. If platelet count >400 × 109/L, stop Alvaiz, ↑ monitoring of platelets to twice weekly. Once platelet count <150 × 109/L, reinitiate therapy at dose ↓ by 18 mg/day. For patients taking 18 mg once daily, reinitiate at dose of 9 mg once daily.If platelet count >400 × 109/L after 2 wk of therapy at lowest dose, permanently discontinue Alvaiz. Discontinue Alvaiz when antiviral therapy is discontinued.Aplastic Anemia (Promacta)
Goal is platelet count >50 × 109/L. Modify dose based on platelet count. If platelet count <50 × 109/L following ≥2 wk of therapy, ↑ daily dose by 50 mg. If patient taking 25 mg once daily, ↑ dose to 50 mg once daily before ↑ daily dose by 50 mg (max = 150 mg/day). If platelet count 200 × 109/L400 × 109/L,↓ daily dose by 50 mg. Wait 2 wk to assess effects of dose adjustment. If platelet count >400 × 109/L, stop Promacta for 1 wk. Once platelet count <150 × 109/L, reinititate therapy at dose ↓ by 50 mg/day. If platelet count >400 × 109/L after 2 wk of therapy at lowest dose, permanently discontinue Promacta. If no hematologic response after 16 wk of therapy, discontinue therapy.Aplastic Anemia (Alvaiz)
Goal is platelet count >50 × 109/L. Modify dose based on platelet count. If platelet count <50 × 109/L following ≥2 wk of therapy, ↑ daily dose by 36 mg. If patient taking 18 mg once daily, ↑ dose to 36 mg once daily before ↑ daily dose by 50 mg (max = 150 mg/day). If platelet count 200 × 109/L400 × 109/L,↓ daily dose by 50 mg. Wait 2 wk to assess effects of dose adjustment. If platelet count >400 × 109/L, stop Alvaiz for 1 wk. Once platelet count <150 × 109/L, reinititate therapy at dose ↓ by 50 mg/day. If platelet count >400 × 109/L after 2 wk of therapy at lowest dose, permanently discontinue Alvaiz. If no hematologic response after 16 wk of therapy, discontinue therapy.First line treatment of aplastic anemia (Promacta)
Measure ALT, AST, and bilirubin before starting therapy, every other day while hospitalized for hATG therapy, and then every 2 wk during therapy. Do not start Promacta if AST or ALT levels ≥6 times ULN. If <5 times ULN, restart at same dose. If AST and ALT >6 times ULN after restarting, discontinue therapy and monitor ALT or AST at least every 3 to 4 days. If ALT or AST < 5 times ULN, restart Promacta at dose reduced from previous dose by 25 mg/day. If AST or ALT >6 times ULN with reduced dose,↓ daily dose by 25 mg until AST or ALT <5 times ULN. In pediatric patients <12 yr,↓ daily dose by ≥15% to nearest dose that can be administered.