Continued approval for this indication may be contingent upon the results of studies to demonstrate an improvement in hemostasis in patients.

An improvement in hemostasis has not been established.Approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers.Rivaroxaban >10 mg or dose unknown (5 mg or dose unknown (Apixaban >5 mg or dose unknown (≥8 hr from last dose).Rivaroxaban >10 mg or dose unknown (≥8 hr from last dose).Apixaban dose ≤5 mg (any timing from last dose).Rivaroxaban dose ≤10 mg (any timing from last dose).Follow-on IV infusion: 8 mg/min IV for up to 120 minĭose based on rivaroxaban or apixaban dose.Initial IV bolus: 800 mg IV target infusion rate of 30 mg/min.Follow-on IV infusion: 4 mg/min IV for up to 120 min.Initial IV bolus: 400 mg IV target infusion rate of 30 mg/min.Safety and efficacy of an additional dose has not been established Low or high dose regimens There are 2 dosage regimens (low dose or high dose) to choose from

Indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding Dosage Forms & Strengths injection, lyophilized powder for reconstitution

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