andexanet alfa

REMS

To reverse the anticoagulant effect of rivaroxaban or apixaban in patients experiencing life-threatening or uncontrolled bleeding.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None reported.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: DEEP VENOUS THROMBOSIS, MI

Metab: infusion reactions

Neuro: STROKE, transient ischemic attack

Resp: PULMONARY EMBOLISM

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Lyophilized powder for injection: 200 mg/vial

Route/Dosage ⬆ ⬇

Low Dose (should be administered if last dose of rivaroxaban 10 mg, last dose of apixaban 5 mg, or time since patient's last dose (any dose) of rivaroxaban or apixaban 8 hr)

IV (Adults ): 400 mg IV bolus, followed by 4 mg/min continuous infusion administered for up to 120 min (2 hr).

High Dose (should be administered if last dose of rivaroxaban >10 mg, apixaban >5 mg, or unknown dose AND dose given 8 hr or at unknown time

IV (Adults ): 800 mg IV bolus, followed by 8 mg/min continuous infusion administered for up to 120 min (2 hr).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to and sequesters rivaroxaban or apixaban, thereby negating their anticoagulant effects. Also inhibits the activity of tissue factor pathway inhibitor, increasing tissue factor-initiated thrombin generation.

Therapeutic effects:

Reversal of the anticoagulant effect of rivaroxaban or apixaban.

Classifications ⬆ ⬇

Therapeutic Classification: antidotes

Pharmacologic Classification: clotting factors replacements

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: Low dose: 3.3 hr; high dose: 2.7 hr.

Time/Action Profile ⬆ ⬇

(reduction in anti-Factor Xa activity)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	minutes	2 hr‡

‡Following completion of bolus and continuous infusion.

Patient/Family Teaching ⬆ ⬇

Explain purpose of andexanet alfa to patient.
Instruct patient to notify health care professional immediately if signs and symptoms of thromboembolism or cardiac arrest occur.
Advise female patients of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇