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FDA Approves New Treatment For Thrombocytopenia In Adults With ITP

By The U.S. Food and Drug Administration | April 20, 2018

The FDA approved fostamatinib disodium hexahydrate tablets (Tavalisse, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

The most common adverse reactions in at least five percent of patients treated with fostamatinib were diarrhea, hypertension, nausea, dizziness, alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia. In the ITP double-blind studies, serious adverse drug reactions were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which each occurred in one percent of patients receiving fostamatinib. 

For more information, please visit: Tavalisse.

(Source: The U.S. Food and Drug Administration) 


Filed Under: Drug Discovery

 

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