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FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder
Date:11/20/2008

ent.com/prnews?Page=Quote&Ticker=LGND'> LGND). It was developed by GlaxoSmithKline.

The compound is also being studied for thrombocytopenia associated with chronic hepatitis C virus, chronic liver disease and oncology-related thrombocytopenia.

Important Safety Information

BOXED WARNING

PROMACTA may cause hepatotoxicity. Patients receiving therapy with PROMACTA must have regular monitoring of serum liver tests (see Laboratory Monitoring below). Discontinue PROMACTA if ALT levels increase to > / = 3X upper limit of normal (ULN) and are: progressive; or persistent for > / = 4 weeks, or; accompanied by increased direct bilirubin; or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation. Reinitiating treatment with PROMACTA is not recommended and should be considered only with close medical supervision and under exceptional circumstances where the potential benefit outweighs the risk.

Because of the risk for hepatotoxicity and other risks, PROMACTA is available only through a restricted distribution program called PROMACTA Cares. Under the PROMACTA CARES Program, only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive PROMACTA. To enroll in the PROMACTA CARES Program, call 1-877-9-PROMACTA.

Warnings and Precautions:

Additional safety information regarding Risk of Hepatotoxicity: Reinitiating treatment with PROMACTA is not recommended. If the potential benefit for reinitiating PROMACTA treatment is considered to outweigh the risk for hepatotoxicity, then cautiously reintroduce PROMACTA and measure serum liver tests weekly during the dose adjustment phase. If liver test abnormalities p
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SOURCE GlaxoSmithKline
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