patients of 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, 8.7)
•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)
•Severe Aplastic Anemia: Initiate PROMACTA at 50 mg once daily for most patients. Reduce initial dose in patients with hepatic impairment or patients of 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, 8.7)
DOSAGE FORMS AND STRENGTHS
•Tablets: 12.5 mg, 25 mg, 50 mg, and 75 mg ( 3.1)
•For oral suspension: 12.5 mg, 25 mg ( 3.2)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•Hepatotoxicity: Monitor liver function before and during therapy. ( 5.2)
•Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia. ( 5.3)
•Thrombotic/Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving PROMACTA. Monitor platelet counts regularly. ( 5.4)
ADVERSE REACTIONS
•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, urinary tract infection, increased ALT, and myalgia. ( 6.1)
•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)
•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, insomnia, asthenia, cough, pruritus, chills, myalgia, alopecia, and peripheral edema. ( 6.1)
•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 Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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)
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding not recommended during treatment. (8.2)
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7714a0ed-34bb-46e6-a0a5-b363908b22c2 |
