Promacta or Alvaiz:
Promacta:
Absorption: 52% absorbed following oral administration.
Distribution: Unknown.
Protein Binding: >99%.
Metabolism/Excretion: Extensively metabolized; 59% eliminated in feces, 20% as unchanged drug; 31% excreted in urine as metabolites.
Half-life: 21–35 hr.
Contraindicated in:
Use Cautiously in:
Drug-Drug:
2 hr before or 4 hr after medications containing these and other polyvalent cations.Drug-Food:
Persistent or Chronic Immune Thrombocytopenia
6 yr): Promacta: 50 mg once daily; may ↑ dose to achieve a platelet count of 50 × 109/L (not to exceed 75 mg/day); Alvaiz: 36 mg once daily; may ↑ dose to achieve a platelet count of 50 × 109/L (not to exceed 54 mg/day). Patients of East/Southeast Asian ancestry: Promacta: 25 mg once daily initially; may ↑ dose to achieve a platelet count of 50 × 109/L (not to exceed 75 mg/day); Alvaiz: 18 mg once daily initially; may ↑ dose to achieve a platelet count of 50 × 109/L (not to exceed 54 mg/day).50 × 109/L (not to exceed 75 mg/day).Hepatic Impairment
50 × 109/L (not to exceed 75 mg/day); Alvaiz: 18 mg once daily initially; may ↑ dose to achieve a platelet count of 50 × 109/L (not to exceed 54 mg/day). Patients of East/Southeast Asian ancestry with mild, moderate, or severe hepatic impairment:Promacta: 12.5 mg once daily initially; may ↑ dose to achieve a platelet count of 50 × 109/L (not to exceed 75 mg/day); Alvaiz: 9 mg once daily initially; may ↑ dose to achieve a platelet count of 50 × 109/L (not to exceed 54 mg/day).Chronic Hepatitis C-Associated Thrombocytopenia
First-Line Treatment of Severe Aplastic Anemia
12 yr): Promacta: 150 mg once daily for 6 mo. Patients of East/Southeast Asian ancestry: Promacta: 75 mg once daily for 6 mo.Hepatic Impairment
12 yr): Mild, moderate, or severe hepatic impairment: Promacta: 75 mg once daily for 6 mo.Hepatic Impairment
Hepatic Impairment
Refractory Severe Aplastic Anemia
50 × 109/L (not to exceed 150 mg/day); Alvaiz: 36 mg once daily; may ↑ by 36 mg every 2 wk to achieve a platelet count of 50 × 109/L (not to exceed 108 mg/day). Patients of East/Southeast Asian ancestry: Promacta: 25 mg once daily; may ↑ by 50 mg every 2 wk to achieve a platelet count of 50 × 109/L (not to exceed 150 mg/day); Alvaiz: 18 mg once daily; may ↑ by 36 mg every 2 wk to achieve a platelet count of 50 × 109/L (not to exceed 108 mg/day).Hepatic Impairment
50 × 109/L (not to exceed 150 mg/day); Alvaiz: 18 mg once daily; may ↑ by 36 mg every 2 wk to achieve a platelet count of 50 × 109/L (not to exceed 108 mg/day).(Generic available)
50 × 109/L. Modify dose based on platelet count. If platelet count <50 × 109/L following 2 wk of therapy, ↑ daily dose by 25 mg (max = 75 mg/day). For patients taking 12.5 mg once daily, ↑ dose to 25 mg once daily before ↑ daily dose by 25 mg. If platelet count is 200 × 109/L–400 × 109/L,↓ daily dose by 25 mg. For patients taking 25 mg once daily, ↓ dose to 12.5 once daily. Wait 2 wk to assess effects of dose adjustment. If platelet count >400 × 109/L, stop Promacta and ↑ monitoring of platelets 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 dailyIf platelet count >400 × 109/L after 2 wk of therapy at lowest dose, permanently discontinue Promacta. Discontinue Promacta if platelet count does not ↑ to a level sufficient to avoid clinically important bleeding after 4 wk of therapy at max dose of 75 mg/day.
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/L–400 × 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.2 wk of therapy, ↑ daily dose by 25 mg (max = 100 mg/day). If platelet count 200 × 109/L–400 × 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.2 wk of therapy, ↑ daily dose by 18 mg (max = 72 mg/day). If platelet count 200 × 109/L–400 × 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.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/L–400 × 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.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/L–400 × 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.3 times upper limit of normal (ULN) in patients with normal liver function or 3 times baseline or >5 times ULN and progressively increasing, or persistent for 4 wk, or accompanied by ↑ direct bilirubin, or accompanied by symptoms of liver injury or hepatic decompensation. 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.
50 mg). DNC: Swallow tablets whole; do not crush, break, chew, or mix with food/liquids.
4 hr between Promacta or Alvaizand other medications (antacids), calcium-rich foods (containing > 50 mg calcium [dairy products, calcium-fortified juices, certain fruits and vegetables]), and supplements containing polyvalent cations (iron, calcium, aluminum, magnesium, zinc, selenium).7 days after therapy ended and to notify health care professional promptly if pregnancy is planned or suspected and to avoid breastfeeding.