Andexxa availability6/17/2023 ![]() In healthy volunteers who received Andexxa, the most commonly reported adverse events were infusion-related reactions, usually of mild or moderate severity. A clinical study to evaluate the product’s effects on hemostasis in bleeding patients who recently received a factor Xa inhibitor is underway and is described in the labeling. ![]() The labeling for Andexxa states that it is indicated for the treatment of life-threatening or uncontrolled bleeding resulting from the use of rivaroxaban or apixaban.Īndexxa has not been shown to be effective as a reversal agent for any other factor Xa inhibitors and is not indicated for such use, according to the labeling.įDA approved the reversal agent on the basis of data on anti–factor Xa activity in healthy volunteers. Portola referred to the product as andexanet alfa during clinical development. The reversal agent-dubbed coagulation factor Xa (recombinant), inactivated-zhzo-will be marketed as Andexxa. National Pharmacy Preceptors ConferenceįDA on May 3 approved a license from Portola Pharmaceuticals, Inc., of South San Francisco, California, to market the first agency-approved anticoagulation reversal agent for the direct factor Xa inhibitors rivaroxaban and apixaban.Midyear Clinical Meeting and Exhibition.Certified Pharmacy Executive Leader (CPEL).
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