Posted from: Wednesday, May 16, 2018 - 04:29 PM - Present

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.

 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Friday, September 21, 2018 - 10:20 PM.