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Eltrombopag Olamine

Risk for Hepatic Decompensation in Patients with Chronic Hepatitis C

  • In patients with chronic hepatitis C, PROMACTA® in combination with interferon and ribavirin may increase the risk of hepatic decompensation.
  • May increase the risk of severe and potentially lifethreatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended. One patient (<1>

Increased Risk of Death and Progression of Myelodysplastic Syndromes (MDS) to Acute Myeloid Leukemia (AML)

  • A randomized, double-blind, placebo-controlled, multicenter trial in patients with International Prognostic Scoring System (IPSS) intermediate-1, intermediate-2 or high risk MDS with thrombocytopenia, receiving azacitidine in combination with either PROMACTA (n=179) or placebo (n=177) was terminated due to lack of efficacy and safety reasons, including increased progression to AML. Patients received PROMACTA or placebo at a starting dose of 200 mg once daily, up to a maximum of 300 mg once daily, in combination with azacitidine for at least six cycles. The incidence of death (overall survival) was 32% (57/179) in the PROMACTA arm versus 29% (51/177) in the placebo arm (HR [95% CI] = 1.42 [0.97, 2.08], showing an increased relative risk of death in this trial by 42% in the PROMACTA arm). The incidence of progression to AML was 12% (21/179) in the PROMACTA arm versus 6% (10/177) in the placebo arm (HR [95% CI] = 2.66 [1.31, 5.41], showing an increased relative risk of progression to AML in this trial by 166% in the PROMACTA arm.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

First-Line Treatment of Severe Aplastic Anemia

  • Measure ALT, AST, and bilirubin prior to initiation of PROMACTA, every other day while hospitalized for h- ATG therapy, and then every 2 weeks during treatment. During treatment, manage increases in ALT or AST levels as recommended.

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Eltrombopag Olamine

Additional Information

Updated December 2018