Withdrawn from the market (safety)

Andexanet alfa

ANDEXXA

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Pronunciation: an-dex-a-net-AL-fa

Andexanet alfa ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Andexanet alfa ballicule

Andexanet alfa ANDEXXA mascot mnemonic cartoon — Visual mnemonic: Andexanet alfa mascot
**“And’s Xa net”**

What it isCatalytically inactive factor Xa decoy; reversal of apixaban and rivaroxaban in major bleeding.

Why this oneIt sequesters the inhibitor within minutes, where no other agent reliably restores hemostasis.

What limits itThromboembolic events after reversal. Very high cost; it interferes with anti-Xa assays afterwards.

Andexanet alfa molecular structure (skeletal formula) — Molecular structure: Andexanet alfa

FDA label

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BOXED WARNING Associated with thromboembolic and ischemic events (including MI and ischemic stroke), cardiac arrest, and sudden deaths; monitor and resume anticoagulation as soon as medically appropriate.

FDA dosing	Population	Start	Target	Max
Reversal of apixaban/rivaroxaban anticoagulation (life-threatening or uncontrolled bleeding) - Low Dose	Low-dose regimen	400 mg IV bolus at target 30 mg/min, then 4 mg/min x120 min
Reversal of apixaban/rivaroxaban anticoagulation (life-threatening or uncontrolled bleeding) - High Dose	High-dose regimen	800 mg IV bolus at target 30 mg/min, then 8 mg/min x120 min

Renal Undefined

Hepatic Undefined

Safety and effectiveness of more than one dose have not been evaluated.

Instructions

For intravenous use only
Administer as IV bolus at target rate 30 mg/min, followed by continuous infusion for 120 minutes
Select low vs high dose based on the specific FXa inhibitor, its dose, and time since the patient's last dose

Available strengths

powder 200 mg

Cautions

Arterial/venous thromboembolic events, ischemic events, and cardiac events including sudden death
Unresponsiveness to unfractionated heparin reported after administration
Re-elevation or incomplete reversal of anticoagulant activity

Adverse reactions

Urinary tract infections
Pneumonia
Infusion-related reactions

Pregnancy No adequate and well-controlled studies in pregnant women; animal reproductive/developmental studies not conducted.

Lactation No information on presence in human milk, effects on breastfed child, or on milk production.

Cost

Andexanet alfa (ANDEXXA)

Strength		#/mo	generic $/unit	CostPlus
200 mg	powder	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Andexanet alfa is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

⚠ BOXED WARNING

Thromboembolic and ischemic events

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Direct muscarinic antagonism0 / 4

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