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FDA Grants Full Approval for PROMACTA® (eltrombopag) for Treatment of Rare Blood Disorder
Date:2/25/2011

ation of PROMACTA are to the Initial Dose Regimen and to the Thrombotic/Thromboembolic complications in the Warnings and Precautions section of the PI. The label also now includes efficacy and safety data from RAISE, a 6-month, randomized double-blind, placebo-controlled study in patients with ITP. The RAISE study which was published recently in the medical journal Lancet, showed that patients treated with PROMACTA were significantly more likely to achieve a platelet count between 50,000/microL and 400,000/microL during the entire 6-month treatment period compared to those patients treated with placebo.

The updated PI also incorporates two-year safety data from an open-label, single-arm extension study in patients with chronic ITP. This study showed that adverse reactions occurred in a pattern similar to those reported in the placebo-controlled studies.

Additional changes to the PI include updates on dose adjustments, risk of hepatotoxicity, bone marrow reticulin formation, thrombotic/thromboembolic complications, recurrence of thrombocytopenia, hematologic malignancies, cataracts, adverse event information, drug interactions, use in specific patient populations (hepatic and renal impairment) and to the pharmacokinetic section.   For more information, please review the full Prescribing Information (Available by request: Contact Rob Perry at Robert.P.Perry@gsk.com).  

BOXED WARNING and Important Safety Information

PROMACTA may cause hepatotoxicity.  Increases in serum aminotransferase levels and bilirubin were observed.  Liver chemistries must be measured before the initiation of treatment and regularly during treatment.  See Full Prescribing Information for BOXED WARNING.

Because of the risk of hepatotoxicity, and other risks including bone marrow reticulin and risk for bone marrow fibrosis, thrombotic/thromboembolic complications, recurrenc
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SOURCE GlaxoSmithKline
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