Andexxa Generic Name & Formulations
Legal Class
Rx
General Description
Coagulation factor Xa (recombinant), inactivated-zhzo 100mg; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Pharmacological Class
Factor Xa (recombinant).
How Supplied
Single-use vials—4
Manufacturer
Generic Availability
NO
Andexxa Indications
Indications
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.
Andexxa Dosage and Administration
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.
Andexxa Contraindications
Not Applicable
Andexxa Boxed Warnings
Boxed Warning
Thromboembolic risks. Ischemic risks. Cardiac arrests. Sudden deaths.
Andexxa Warnings/Precautions
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.
Andexxa Pharmacokinetics
Elimination
Half-life: 3.3 hours (low-dose), 2.7 hours (high-dose).
Andexxa Interactions
Andexxa Adverse Reactions
Adverse Reactions
Urinary tract infections, pneumonia, infusion-related reactions.
Andexxa Clinical Trials
Andexxa Note
Not Applicable