Tavalisse Approved for Chronic Immune Thrombocytopenia
April 17, 2018 – The U.S. FDA has approved Tavalisse™ (fostamatinib disodium hexahydrate), manufactured by Rigel. The drug is indicated to treat adults who have chronic immune thrombocytopenia (ITP) and for whom a previous treatment has not worked.
Chronic ITP is a rare condition in which the immune system begins to attack blood platelets in the body. The condition leads to bruising, bleeding, and fatigue, and can cause severe and potentially fatal bleeding events. Chronic ITP can be difficult to treat, as patient response to available therapies can vary widely.
Tavalisse is a spleen tyrosine kinase (SYK) inhibitor that works by preventing the body from destroying platelets. Recommended dosing is 100mg twice daily for the first four weeks. The dosage can then be increased if needed to 150mg twice daily. If Tavalisse has not increased platelet levels a sufficient amount after 12 weeks, its use should be discontinued.
Pricing should be available early in May 2018. Tavalisse is expected to launch in the same month.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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