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Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo)
coagulation factor Xa (recombinant), inactivated
Black Box Warnings .
Thromboembolic and Ischemic Events, Cardiac Arrest, and Sudden Deaths
serious and life-threatening arterial and venous thromboembolic events, ischemic events, including MI and ischemic stroke, cardiac arrest, and sudden deaths have occurred; monitor for thromboembolic events and initiate anticoagulation when medically appropriate; monitor for signs/symptoms preceding cardiac arrest and tx as needed
Adult Dosing .
Dosage forms: INJ
Withdrawn from US Market
- [December 22, 2025]
- Info: voluntarily withdrawn due to reported serious and fatal thromboembolic events and risk/benefit ratio
Peds Dosing .
- Dosage forms: --
Withdrawn from US Market
- [December 22, 2025]
- Info: voluntarily withdrawn due to reported serious and fatal thromboembolic events and risk/benefit ratio
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: thromboembolism risk
- caution: stroke risk
- caution: MI risk
Drug Interactions .
Overview
coagulation factor Xa (recombinant), inactivated
coagulation factor/cofactor
-
None
- Withdrawn from US Market
Avoid/Use Alternative
- heparin
Adverse Reactions .
Serious Reactions
- thrombosis
- thromboembolism
- ischemic stroke
- MI
Common Reactions
- UTI
- pneumonia
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available
Lactation
Clinical Summary
may use while breastfeeding; no human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for factor Xa: unknown; CYP450: unknown
Excretion: for factor Xa: unknown; Half-life: 1.9-4h
Subclass: Anticoagulant Reversal Agents ; Hemostasis: Coagulation Factors/Cofactors ; Toxicity: Drugs
Mechanism of Action
for factor Xa: binds and sequesters factor Xa inhibitor and inhibits tissue factor pathway inhibitor (TFPI), reversing anti-factor Xa activity and restoring thrombin generation
Formulary .
No Formulary Selected
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