Andexxa Approved to Reverse Effects of Factor Xa Inhibitors
May 3, 2018 – The U.S. FDA has approved Andexxa® (coagulation factor Xa [recombinant] inactivated-zhzo), manufactured by Portola Pharmaceuticals. Indicated for use in cases of life-threatening or uncontrolled bleeding to reverse the effects of the factor Xa inhibitors apixaban and rivaroxaban, Andexxa is the first FDA-approved antidote for this class of drugs.
Marketed under the brand names Eliquis® and Xarelto® respectively, apixaban and rivaroxaban are used to reduce the risk of stroke and thrombotic events caused by blood clots. Due to their anticoagulant properties, these drugs can contribute to severe bleeding. Approximately 117,000 U.S. hospital admissions in 2016 were attributed to bleeding related to factor Xa inhibitor use. An estimated four million Americans take drugs in this class.
Andexxa has two dosing recommendations. For high dose administration, an initial intravenous bolus of 800mg should be administered at a rate of 30mg/min. This is then followed by an infusion of 8mg/min for up to two hours. Low dose administration requires an initial bolus of 400mg at a rate of 30mg/min, with a follow-up infusion of 4mg/min for up to two hours. A black box warning indicates that Andexxa’s use may be associated with cardiac arrest, thromboembolic events, ischemic events, and sudden death.
Portola Pharmaceuticals plans an initial, limited launch in early June, with wider distribution expected by 2019. The average wholesale price (AWP) for Andexxa will be $27,500 per gram.
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
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