Approved for the reversal of the anticoagulant effects of rivaroxaban and apixaban.
A coagulation factor Xa (recombinant), inactivated-zhzo.
Approved for use in patients treated with factor Xa inhibitors would when reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding.
A modified recombinant in active form of human factor Xa designed for binding sequester factor Xa inhibitor molecules, rapidly reducing anti-factor C activity, a measure of the anticoagulation effect of factor Xa inhibitors.
Trade name Andexxa, Portland.
ANNEXA-4 study utilized as a bonus followed by a two hour continuous infusion, with hemostatic efficacy assessed 12 hours after the start of treatment.
Andexxa a coagulation factor Xa (recombinant), inactivated-zhzo
The antidote indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Andexanet alfa for rivaroxaban, edoxaban and apixaban.
The drug’s approval was based on data from two 2 phase 3 studies which evaluated the safety and efficacy in reversing anticoagulant activity of rivaroxaban and apixaban in health volunteers.
The studies showed it rapidly and significantly reversed anti-Factor Xa activity.
In patients with acute major bleeding associated with use of factor Xa inhibitor, treatment results in marked reduced anti-factor Xa activity, and 82% of patients have excellent or good hemostatic efficacy at 12 hours. ( Connally J).
It rapidly and significantly reversed anti-Factor Xa activity when administered as a bolus and sustained reversal when followed by a 120-minute infusion, with a median decrease from baseline of 90% for rivaroxaban and 93% for apixaban.
The most common adverse reactions are urinary tract infections and pneumonia.
Infusion-related reactions were the most commonly reported adverse effects in healthy trial volunteers.
Acts by latching onto the inhibitor molecules and prevents them from interacting with the actual factor Xa.
Has a short half-life and its effect quickly reduces when treatment stops.
Among patients with intracerebral hemorrhage, who were receiving Factor Xa inhibitors , andexanet resulted in better control of the hematoma expansion than usual care but was associated with thrombotic events, including ischemic stroke (ANNEXA-I investigators).
Andexanet administered in patients with intracerebral hemorrhage found it had a better hemostatic efficacy compared with usual care of 67% versus 53.1% but was associated with an increasing ischemic stroke and thrombotic events of 10.3% versus 5.6%;the drug should be administered with caution in patients with prior stroke or thrombosis