February 28, 2011
Promacta receives full approval for chronic ITP
The labeling for Promacta has been updated to include changes to the initial dose regimen, dose adjustments, and to the Warnings and Precautions section (eg, thrombotic/thromboembolic complications, hepatotoxicity risk, bone marrow reticulin formation). The labeling also now includes efficacy and safety data from RAISE, a 6-month, randomized, double-blind, placebo-controlled study in patients with ITP which showed that patients treated with Promacta were significantly more likely to achieve a platelet count between 50,000/μL and 400,000/μL during the entire 6-month treatment period compared to those treated with placebo. The updated labeling also incorporates two-year safety data from an open-label, single-arm extension study in patients with chronic ITP, which showed that adverse reactions occurred in a pattern similar to those reported in the placebo-controlled studies.
For more information call (888) 825-5249 or visit www.promactacares.com.