BevyxXa Approved for Clot Prevention
June 23, 2017 – The U.S. FDA has approved BevyxXa™ (betrixaban), manufactured by Portola Pharmaceuticals. BevyxXa is an oral, once-daily factor Xa inhibitor indicated to prevent venous thromboembolism (VTE) in hospitalized adults with acute illnesses who are at high risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. Recommended dosing is an initial dose of 160mg on Day 1, followed by 80mg once daily, with food, at the same time each day. Treatment should continue for 35 to 42 days. Portola anticipates that BevyxXa will be available as 40mg and 80mg capsules between August and November of 2017.
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.
- 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
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.