The safety and efficacy of an additional dose have not been established. There are two dosing regimens (see Table 1). The safety and effectiveness of more than one dose have not been evaluated. Administer as an IV bolus, with a target rate of 30 mg/min, followed by continuous infusion for up to 120 minutes.Dose ANDEXXA based on the specific FXa inhibitor, dose of FXa inhibitor, and time since the patient's last dose of FXa inhibitor.(1)ĪNDEXXA 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. (1, 14)ĪNDEXXA 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. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients. An improvement in hemostasis has not been established. This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.ĪNDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. ![]() See full prescribing information for complete boxed warningĪNDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed. Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Ischemic events, including myocardial infarction and ischemic stroke Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: (5.1)Īrterial and venous thromboembolic events ![]() WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS
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