Andexanet alfa
ANDEXXA
What it isCatalytically inactive factor Xa decoy; reversal of apixaban and rivaroxaban in major bleeding.
Why this oneIt sequesters the inhibitor within minutes, where no other agent reliably restores hemostasis.
What limits itThromboembolic events after reversal. Very high cost; it interferes with anti-Xa assays afterwards.
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Reversal of apixaban/rivaroxaban anticoagulation (life-threatening or uncontrolled bleeding) - Low Dose | Low-dose regimen | 400 mg IV bolus at target 30 mg/min, then 4 mg/min x120 min | ||
| Reversal of apixaban/rivaroxaban anticoagulation (life-threatening or uncontrolled bleeding) - High Dose | High-dose regimen | 800 mg IV bolus at target 30 mg/min, then 8 mg/min x120 min |
Renal Undefined
Hepatic Undefined
Safety and effectiveness of more than one dose have not been evaluated.
Instructions
- For intravenous use only
- Administer as IV bolus at target rate 30 mg/min, followed by continuous infusion for 120 minutes
- Select low vs high dose based on the specific FXa inhibitor, its dose, and time since the patient's last dose
Cautions
- Arterial/venous thromboembolic events, ischemic events, and cardiac events including sudden death
- Unresponsiveness to unfractionated heparin reported after administration
- Re-elevation or incomplete reversal of anticoagulant activity
Adverse reactions
- Urinary tract infections
- Pneumonia
- Infusion-related reactions
Pregnancy No adequate and well-controlled studies in pregnant women; animal reproductive/developmental studies not conducted.
Lactation No information on presence in human milk, effects on breastfed child, or on milk production.
⚠ BOXED WARNING
- Thromboembolic and ischemic events
Classes and tags
Clinical profile
Mechanism of action: Andexanet alfa ballicule
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