Available Nationwide RAPID REVERSAL min When treating life-threatening or uncontrolled bleeds in patients on apixaban or rivaroxaban Is Within Reach Rapid reversal of anti-FXa activity within 2 minutes following bolus administration in older, healthy volunteers on apixaban or rivaroxaban. 1,2 Expert guidance recommends Andexxa for first-line therapy to reverse apixaban or rivaroxaban in patients with life-threatening or uncontrolled bleeds. 3 2 INDICATION ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with apixaban or rivaroxaban , 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. 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 eff ective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban. Please see additional Important Safety Information on adjacent page and Brief Summary of full Prescribing Information, including Boxed Warning, on following page. SELECT IMPORTANT SAFETY INFORMATION WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS See full prescribing information for complete boxed warning Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: • Arterial and venous thromboembolic events • Ischemic events, including myocardial infarction and ischemic stroke • Cardiac arrest • Sudden deaths Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed. For further information, please visit ANDEXXA.com Coagulation Factor Xa (Recombinant), Inactivated–zhzo
Journal of the American College of Surgeons June 2019: Cover 2
