Promacta

Promacta Manufacturers

• Glaxosmithkline Llc
  

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  Promacta | Glaxosmithkline Llc

  

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  2.1 Chronic Immune (Idiopathic) Thrombocytopenia

  Use the lowest dose of PROMACTA to achieve and maintain a platelet count greater than or equal to 50 x 109/L as necessary to reduce the risk for bleeding. Dose adjustments are based upon the platelet count response. Do not use PROMACTA to normalize platelet counts [see Warnings and Precautions (5.3)]. In clinical trials, platelet counts generally increased within 1 to 2 weeks after starting PROMACTA and decreased within 1 to 2 weeks after discontinuing PROMACTA [see Clinical Studies (14.1)].

  Initial Dose Regimen:Adult and Pediatric Patients 6 Years and Older with ITP: Initiate PROMACTA at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A, B, C).

  For patients of East Asian ancestry with ITP, initiate PROMACTA at a reduced dose of 25 mg once daily [see Use in Specific Populations (8.8), Clinical Pharmacology (12.3)].

  For patients with ITP and mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, C), initiate PROMACTA at a reduced dose of 25 mg once daily [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

  For patients of East Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A, B, C), consider initiating PROMACTA at a reduced dose of 12.5 mg once daily [see Clinical Pharmacology (12.3)].

  Monitoring and Dose Adjustment: After initiating PROMACTA, adjust the dose to achieve and maintain a platelet count greater than or equal to 50 x 109/L as necessary to reduce the risk for bleeding. Do not exceed a dose of 75 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with PROMACTA and modify the dosage regimen of PROMACTA based on platelet counts as outlined in Table 1. During therapy with PROMACTA, assess CBCs with differentials, including platelet counts, weekly until a stable platelet count has been achieved. Obtain CBCs with differentials, including platelet counts, monthly thereafter.

  Table 1. Dose Adjustments of PROMACTA in Patients with Chronic Immune (Idiopathic) Thrombocytopenia

  Platelet Count Result

  Dose Adjustment or Response

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

  Increase daily dose by 25 mg to a maximum of 75 mg/day.

  For patients taking 12.5 mg once daily, increase the dose to 25 mg daily before increasing the dose amount by 25 mg.

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

  Decrease the daily dose by 25 mg. Wait 2 weeks to assess the effects of this and any subsequent dose adjustments.

  For patients taking 25 mg once daily, decrease the dose to 12.5 mg once daily.

  >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 therapy at a daily dose reduced by 25 mg.

  For patients taking 25 mg once daily, reinitiate therapy at a daily dose of 12.5 mg.

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

  Discontinue PROMACTA.

  In patients with ITP and hepatic impairment (Child-Pugh Class A, B, C), after initiating PROMACTA or after any subsequent dosing increase, wait 3 weeks before increasing the dose.

  Modify the dosage regimen of concomitant ITP medications, as medically appropriate, to avoid excessive increases in platelet counts during therapy with PROMACTA. Do not administer more than one dose of PROMACTA within any 24-hour period.

  Discontinuation: Discontinue PROMACTA if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of therapy with PROMACTA at the maximum daily dose of 75 mg. Excessive platelet count responses, as outlined in Table 1, or important liver test abnormalities also necessitate discontinuation of PROMACTA [see Warnings and Precautions (5.2)]. Obtain CBCs with differentials, including platelet counts, weekly for at least 4 weeks following discontinuation of PROMACTA.

  2.2 Chronic Hepatitis C-associated Thrombocytopenia

  Use the lowest dose of PROMACTA to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin. Dose adjustments are based upon the platelet count response. Do not use PROMACTA to normalize platelet counts [see Warnings and Precautions (5.3)]. In clinical trials, platelet counts generally began to rise within the first week of treatment with PROMACTA [see Clinical Studies (14.2)].

  Initial Dose Regimen: Initiate PROMACTA at a dose of 25 mg once daily.

  Monitoring and Dose Adjustment: Adjust the dose of PROMACTA in 25-mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Monitor platelet counts every week prior to starting antiviral therapy.

  During antiviral therapy, adjust the dose of PROMACTA to avoid dose reductions of peginterferon. Monitor CBCs with differentials, including platelet counts, weekly during antiviral therapy until a stable platelet count is achieved. Monitor platelet counts monthly thereafter. Do not exceed a dose of 100 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with PROMACTA.

  For specific dosage instructions for peginterferon or ribavirin, refer to their respective prescribing information.

  Table 2. Dose Adjustments of PROMACTA in Adults with Thrombocytopenia due to Chronic Hepatitis C

  Platelet Count Result

  Dose Adjustment or Response

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

  Increase daily dose by 25 mg to a maximum of 100 mg/day.

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

  Decrease the daily dose by 25 mg.

  Wait 2 weeks to assess the effects of this and any subsequent dose adjustments.

  >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 therapy at a daily dose reduced by 25 mg.

  For patients taking 25 mg once daily, reinitiate therapy at a daily dose of 12.5 mg.

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

  Discontinue PROMACTA.

  Discontinuation: The prescribing information for pegylated interferon and ribavirin include recommendations for antiviral treatment discontinuation for treatment futility. Refer to pegylated interferon and ribavirin prescribing information for discontinuation recommendations for antiviral treatment futility.

  PROMACTA should be discontinued when antiviral therapy is discontinued. Excessive platelet count responses, as outlined in Table 2, or important liver test abnormalities also necessitate discontinuation of PROMACTA [see Warnings and Precautions (5.2)].

  2.3 Severe Aplastic Anemia

  Use the lowest dose of PROMACTA to achieve and maintain a hematologic response. Dose adjustments are based upon the platelet count. Hematologic response requires dose titration, generally up to 150 mg, and may take up to 16 weeks after starting PROMACTA [see Clinical Studies (14.3)].

  Initial Dose Regimen: Initiate PROMACTA at a dose of 50 mg once daily.

  For patients with severe aplastic anemia of East Asian ancestry or those with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, C), initiate PROMACTA at a reduced dose of 25 mg once daily [see Use in Specific Populations (8.6, 8.8), Clinical Pharmacology (12.3)].

  Monitoring and Dose Adjustment: Adjust the dose of PROMACTA in 50-mg increments every 2 weeks as necessary to achieve the target platelet count greater than or equal to 50 x 109/L as necessary. Do not exceed a dose of 150 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with PROMACTA and modify the dosage regimen of PROMACTA based on platelet counts as outlined in Table 3.

  Table 3. Dose Adjustments of PROMACTA in Patients with Severe Aplastic Anemia

  Platelet Count Result

  Dose Adjustment or Response

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

  Increase daily dose by 50 mg to a maximum of 150 mg/day.

  For patients taking 25 mg once daily, increase the dose to 50 mg daily before increasing the dose amount by 50 mg.

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

  Decrease the daily dose by 50 mg. Wait 2 weeks to assess the effects of this and any subsequent dose adjustments.

  >400 x 109/L

  Stop PROMACTA for 1 week.

  Once the platelet count is <150 x 109/L, reinitiate therapy at a dose reduced by 50 mg.

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

  Discontinue PROMACTA.

  For patients who achieve tri-lineage response, including transfusion independence, lasting at least 8 weeks: the dose of PROMACTA may be reduced by 50% [see Clinical Studies (14.3)]. If counts remain stable after 8 weeks at the reduced dose, then discontinue PROMACTA and monitor blood counts. If platelet counts drop to less than 30 x 109/L, hemoglobin to less than 9 g/dL, or ANC to less than 0.5 x 109/L, PROMACTA may be reinitiated at the previous effective dose.

  Discontinuation: If no hematologic response has occurred after 16 weeks of therapy with PROMACTA, discontinue therapy. If new cytogenetic abnormalities are observed, consider discontinuation of PROMACTA [see Adverse Reactions (6.1)]. Excessive platelet count responses (as outlined in Table 3) or important liver test abnormalities also necessitate discontinuation of PROMACTA [see Warnings and Precautions (5.2)].

  2.4 Administration

  Take PROMACTA on an empty stomach (1 hour before or 2 hours after a meal) [see Clinical Pharmacology (12.3)].

  Allow at least a 4-hour interval between PROMACTA and other medications (e.g., antacids), calcium-rich foods (e.g., dairy products and calcium-fortified juices), or supplements containing polyvalent cations such as iron, calcium, aluminum, magnesium, selenium, and zinc [see Drug Interactions (7.1)].

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