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These highlights do not include all the information needed to use ANDEXXA safely and effectively. See Full Prescribing Information for ANDEXXA. ANDEXXA® (coagulation factor Xa (recombinant), inactivated-zhzo) Lyophilized powder for solution for intravenous injection Initial U.S. Approval: 2018
Medication labelWhy this: Advisory · dailymed-prescription
ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers [see Clinical Studies (14)]. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients. Limitations of Use ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.
- generic_name
- andexanet alfa
- product_names
- andexanet alfa
- ndc
- 0310-3200, 0310-3200-01, 0310-3200-04, 0310-3200-05
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en