ANDEXXA

ANDEXXA
	Black Box Warning
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS

See full prescribing information for complete Boxed Warning.

Arterial and venous thromboembolic events
Ischemic events, including myocardial infarction and ischemic stroke
Cardiac arrest
Sudden death

Overview

ANDEXXA is a Factor Xa reversal agent that is FDA approved for the {{{indicationType}}} of ANDEXXA, coagulation factor Xa (recombinant), inactivated-zhzo is a recombinant modified human Factor Xa (FXa) protein indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. There is a Black Box Warning for this drug as shown here. Common adverse reactions include urinary tract infections, pneumonia, infusion-related reactions.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

ANDEXXA is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Dosing Information

There are two dosing regimens:

Low Dose: 400 mg at a target rate of 30 mg/min; Follow-On IV infusion: 4 mg/min for up to 120 minutes
High Dose: 800 mg at a target rate of 30 mg/min; Follow-On IV infusion: 8 mg/min for up to 120 minutes

ANDEXXA Dose Based on Rivaroxaban or Apixaban Dose

Dosing Information

For Rivaroxaban ≤ 10 mg, give low dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours, unknown or ≥ 8 hours
For Rivaroxaban > 10 mg / Unknown high dose, give high dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours or unknown and give low dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is ≥ 8 Hours
For Apixaban ≤ 5 mg, give low dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours, unknown or ≥ 8 hours
For Apixaban > 5 mg / Unknown high dose, give high dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is < 8 hours or unknown and give low dose ANDEXXA if the timing of FXa inhibitor last dose before ANDEXXA initiation is ≥ 8 Hours

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1

Dosing Information

The safety and efficacy of ANDEXXA in the pediatric population have not been studied.

Off-Label Use and Dosage (Pediatric)

Contraindications

There are no contraindications to the use of ANDEXXA.

Warnings

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS

See full prescribing information for complete Boxed Warning.

Arterial and venous thromboembolic events
Ischemic events, including myocardial infarction and ischemic stroke
Cardiac arrest
Sudden death

Thromboembolic and Ischemic Risks

Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, were observed within 30 days post-ANDEXXA administration in 33 of the 185 patients (18%) evaluable for safety in the ongoing ANNEXA-4 study. The median time to first event was 6 days. Of the 86 patients who were re-anticoagulated prior to a thrombotic event, 11 (12.7%) patients experienced a thromboembolic, ischemic event, cardiac event or death.
Monitor patients treated with ANDEXXA for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA.
The safety of ANDEXXA has not been evaluated in patients who experienced thromboembolic events or disseminated intravascular coagulation within two weeks prior to the life-threatening bleeding event requiring treatment with ANDEXXA. Safety of ANDEXXA also has not been evaluated in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood products within seven days prior to the bleeding event.

Re-elevation or Incomplete Reversal of Anti-FXa Activity

The time course of anti-FXa activity following ANDEXXA administration was consistent among the healthy volunteer studies and the ANNEXA-4 study in bleeding patients.
Compared to baseline, there was a rapid and substantial decrease in anti-FXa activity corresponding to the ANDEXXA bolus. This decrease was sustained through the end of the ANDEXXA continuous infusion.
Following the infusion, there was an increase in anti-FXa activity, which peaked 4 hours after infusion in ANNEXA-4 subjects. After this peak, the antiFXa activity decreased at a rate similar to the clearance of the FXa inhibitors.
Thirty-eight patients who were anticoagulated with apixiban had baseline levels of anti-FXa activity >150 ng/mL. Nineteen of these 38 (50%) patients experienced a > 93% decrease from baseline anti-FXa activity after administration of ANDEXXA. Eleven patients who were anticoagulated with rivaroxaban had baseline anti-FXa activity levels > 300 ng/mL. Five of the 11 patients experienced a >90% decrease from baseline anti-FXa activity after administration of ANDEXXA.