Bleeding disorders:
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.
Adult:
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.
Children:
Not studied.
Boxed Warning:
Thromboembolic risks. Ischemic risks. Cardiac arrests. Sudden deaths.
Warnings/Precautions:
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.
Pharmacologic Class:
Factor Xa (recombinant).
Adverse Reactions:
Urinary tract infections, pneumonia, infusion-related reactions.
Generic Availability:
NO
How Supplied:
Single-use vials—4
