Generic Name and Formulations:
Coagulation factor Xa (recombinant), inactivated-zhzo 100mg; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Indications for ANDEXXA:
Reversal of anticoagulation with rivaroxaban or apixaban due to life-threatening or uncontrolled bleeding.
Limitations Of use:
Not effective for, and not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban and rivaroxaban.
For IV use only. Low-dose regimen: initially 400mg (target rate: 30mg/min) as IV bolus, followed by 4mg/min IV infusion for up to 120mins. High-dose regimen: initially 800mg (target rate: 30mg/min) as IV bolus, followed by 8mg/min IV infusion for up to 120mins. If last rivaroxaban dose ≤10mg or apixaban dose ≤5mg given <8hrs (or unknown): use low-dose regimen. If last rivaroxaban dose >10mg/unknown or apixaban dose >5mg/unknown given <8hrs (or unknown): use high-dose regimen. If rivaroxaban or apixaban dose given ≥8hrs: use high-dose regimen.
Thromboembolic risks. Ischemic risks. Cardiac arrests. Sudden deaths.
Risk of serious events (eg, thromboembolism, ischemia, cardiac arrest, sudden deaths); monitor for signs/symptoms; resume anticoagulant therapy as soon as medically appropriate after Andexxa. Re-elevation or incomplete reversal of anti-FXa activity can occur. Labor & delivery: not evaluated. Pregnancy. Nursing mothers.
Factor Xa (recombinant).
Urinary tract infections, pneumonia, infusion-related reactions.
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