PROMACTA is a thrombopoietin receptor agonist indicated for the treatment of:

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thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1)

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thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ( 1.2)

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patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3)

Limitations of Use:

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PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.4)

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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. ( 1.4)

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Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. ( 1.4)

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Take on an empty stomach (1 hour before or 2 hours after a meal). ( 2.4)

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Chronic ITP: Initiate PROMACTA at 50 mg once daily for most adult and pediatric patients 6 years and older and at 25 mg once daily for pediatric patients aged 1 to 5 years. Dose reductions are needed for patients with hepatic impairment and some patients of East Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 10 9/L. Do not exceed 75 mg per day. ( 2.1, 8.6, 8.8)

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Chronic Hepatitis C-associated Thrombocytopenia: Initiate PROMACTA at 25 mg once daily for all patients. Adjust to achieve target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 100 mg. ( 2.2)

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Severe Aplastic Anemia: Initiate PROMACTA at 50 mg once daily for most patients. Reduce initial dose in patients with hepatic impairment or patients of East Asian ancestry. Adjust to maintain platelet count greater than 50 x 10 9/L. Do not exceed 150 mg per day. ( 2.3, 8.6, 8.8)

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Tablets: 12.5 mg, 25 mg, 50 mg, 75 mg, and 100 mg ( 3)

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For oral suspension: 25 mg ( 3)

CONTRAINDICATIONS

None. (4)
WARNINGS AND PRECAUTIONS

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Hepatotoxicity: Monitor liver function before and during therapy. ( 5.2)

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Thrombotic/Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving PROMACTA. Monitor platelet counts regularly. ( 5.3)

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In adult patients with ITP, the most common adverse reactions (greater than or equal to 5% and greater than placebo) were: nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia, and urinary tract infection. ( 6.1)

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In pediatric patients age 1 year and older with ITP, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were upper respiratory tract infection, and nasopharyngitis. ( 6.1)

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In patients with chronic hepatitis C-associated thrombocytopenia, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were: anemia, pyrexia, fatigue, headache, nausea, diarrhea, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, myalgia, alopecia, and peripheral edema. ( 6.1)

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In patients with severe aplastic anemia, the most common adverse reactions (greater than or equal to 20%) were: nausea, fatigue, cough, diarrhea, and headache. ( 6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Take PROMACTA at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids, calcium-rich foods, and mineral supplements. (2.4, 7.1)

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Pregnancy: Based on animal data, PROMACTA may cause fetal harm. ( 8.1)

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Nursing Mothers: A decision should be made to discontinue PROMACTA or nursing, taking into account the importance of PROMACTA to the mother. ( 8.3)