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Promacta

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Promacta

Promacta

INDICATIONS

Treatment of Thrombocytopenia in Patients with Chronic ITP

PROMACTA® is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Treatment of Thrombocytopenia in Patients with Hepatitis C Infection

PROMACTA is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.

Limitations of use

  • PROMACTA should not be used to normalize platelet counts.
  • PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
  • PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.
  • Safety and efficacy have not been established in combination with direct acting antiviral agents approved for treatment of chronic hepatitis C genotype 1 infection.

DOSAGE AND ADMINISTRATION

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]. In clinical studies, 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].

Initial Dose Regimen

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 ITP patients of East Asian ancestry, initiate PROMACTA at a reduced dose of 25 mg once daily [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

For ITP patients 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 and CLINICAL PHARMACOLOGY].

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

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 Adults 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.
> 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 ITP patients with 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].

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]. In clinical studies, platelet counts generally began to rise within the first week of treatment with PROMACTA.

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 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].

Administration

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

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].

HOW SUPPLIED

Dosage Forms And Strengths

  • 12.5 mg tablets — round, biconvex, white, film-coated tablets debossed with GS MZ1 and 12.5 on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 12.5 mg of eltrombopag free acid.
  • 25 mg tablets — round, biconvex, orange, film-coated tablets debossed with GS NX3 and 25 on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 25 mg of eltrombopag free acid.
  • 50 mg tablets — round, biconvex, blue, film-coated tablets debossed with GS UFU and 50 on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 50 mg of eltrombopag free acid.
  • 75 mg tablets — round, biconvex, pink, film-coated tablets debossed with GS FFS and 75 on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 75 mg of eltrombopag free acid.
  • 100 mg tablets — round, biconvex, green, film-coated tablets debossed with GS 1L5 and 100 on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 100 mg of eltrombopag free acid.

Storage And Handling

  • The 12.5 mg tablets are round, biconvex, white, film-coated tablets debossed with GS MZ1 and 12.5 on one side and are available in bottles of 30: NDC 0007-4643-13.
  • The 25 mg tablets are round, biconvex, orange, film-coated tablets debossed with GS NX3 and 25 on one side and are available in bottles of 30: NDC 0007-4640-13.
  • The 50 mg tablets are round, biconvex, blue, film-coated tablets debossed with GS UFU and 50 on one side and are available in bottles of 30: NDC 0007-4641-13.
  • The 75 mg tablets are round, biconvex, pink, film-coated tablets debossed with GS FFS and 75 on one side and are available in bottles of 30: NDC 0007-4642-13.
  • The 100 mg tablets are round, biconvex, green, film-coated tablets debossed with GS 1L5 and 100 on one side and are available in bottles of 30: NDC 0007-4644-13. This product contains a dessicant.

Store at room temperature between 20°C and 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not remove desiccant if present. Dispense in original bottle.

GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: November 2012

Last reviewed on RxList: 2/20/2014
This monograph has been modified to include the generic and brand name in many instances.

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