Factor Xa (recombinant), Inactivated-zhzo
Class: Antihemorrhagic Agents, Miscellaneous
Chemical Name: Recombinant inactivated Factor Xa containing Gla-domain deletion and S290A mutation
Molecular Formula: C1750H2727N489O539S27
CAS Number: 1262449-58-0
Brands: Andexxa
Warning
- Thromboembolic Risks, Ischemic Risks, Cardiac Arrest, and Sudden Death
Treatment with factor Xa (recombinant), inactivated-zhzo has been associated with serious and life-threatening adverse effects (e.g., arterial and venous thromboembolic events, ischemic events [MI and ischemic stroke], cardiac arrest, sudden death).
Monitor for manifestations of thromboembolic events and initiate anticoagulation when medically appropriate.
Monitor for signs and symptoms that precede cardiac arrest and provide appropriate medical treatment. (See Thromboembolic Risks, Ischemic Risks, Cardiac Arrest, and Sudden Death under Cautions.)
Introduction
Specific reversal agent for anticoagulant effects of apixaban or rivaroxaban; a recombinant modified human factor Xa protein. Also known as andexanet alfa.
Uses for Factor Xa (recombinant), Inactivated-zhzo
Reversal of Apixaban or Rivaroxaban Anticoagulation
Used for the reversal of apixaban or rivaroxaban anticoagulation in patients with life-threatening or uncontrolled bleeding; designated an orphan drug by FDA for this use.
Accelerated approval is based on the change from baseline in anti-factor Xa activity following administration in healthy individuals; improvement in hemostasis not established. Continued FDA approval for this indication may be contingent on results of studies demonstrating improvement in hemostasis.
Rapidly reverses the anticoagulant effects of apixaban or rivaroxaban (as measured by anti-factor Xa activity, unbound anticoagulant concentration, and thrombin generation).
Not indicated for treatment of bleeding related to other factor Xa inhibitors; safety and efficacy not established.
Management of bleeding complications in patients receiving direct oral anticoagulants (DOACs) should be individualized according to severity and location of hemorrhage. Reversal agents should generally be reserved for patients with severe and life-threatening bleeding. Experts state that reversal agents should only be administered when clinically relevant DOAC concentrations are documented or expected. If a reversal agent is warranted in patients with rivaroxaban- or apixaban-associated major bleeding, factor Xa (recombinant), inactivated-zhzo may be used.
Factor Xa (recombinant), Inactivated-zhzo Dosage and Administration
Administration
IV Administration
Administer as a direct IV (“bolus”) injection followed by a continuous infusion.
Initiate continuous infusion within 2 minutes after the direct IV injection of the drug.
Reconstitution
Reconstitute vials containing 200 mg of factor Xa (recombinant), inactivated-zhzo with 20 mL of s..
