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];

Disclaimer

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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. WARNING: Thromboembolic and ischemic events (including myocardial infarction and ischemic stroke), cardiac arrest, and sudden death have been observed after ANDEXXA administration. Monitor patients and restart anticoagulation as soon as medically appropriate.

Overview

ANDEXXA is an Factor Xa reversal agent that is FDA approved for the {{{indicationType}}} of ANDEXXA (andexanet alfa), 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)

There is limited information regarding ANDEXXA FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding ANDEXXA FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

There is limited information regarding ANDEXXA Contraindications in the drug label.

Warnings

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS See full prescribing information for complete Boxed Warning. WARNING: Thromboembolic and ischemic events (including myocardial infarction and ischemic stroke), cardiac arrest, and sudden death have been observed after ANDEXXA administration. Monitor patients and restart anticoagulation as soon as medically appropriate.

There is limited information regarding ANDEXXA Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding ANDEXXA Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding ANDEXXA Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding ANDEXXA Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of ANDEXXA in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of ANDEXXA in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of ANDEXXA during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of ANDEXXA in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of ANDEXXA in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of ANDEXXA in geriatric settings.

Gender

There is no FDA guidance on the use of ANDEXXA with respect to specific gender populations.

Race

There is no FDA guidance on the use of ANDEXXA with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of ANDEXXA in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of ANDEXXA in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of ANDEXXA in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of ANDEXXA in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding ANDEXXA Administration in the drug label.

Monitoring

There is limited information regarding ANDEXXA Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of ANDEXXA and IV administrations.

Overdosage

There is limited information regarding ANDEXXA overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding ANDEXXA Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding ANDEXXA Mechanism of Action in the drug label.

Structure

There is limited information regarding ANDEXXA Structure in the drug label.

Pharmacodynamics

There is limited information regarding ANDEXXA Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding ANDEXXA Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding ANDEXXA Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding ANDEXXA Clinical Studies in the drug label.

How Supplied

There is limited information regarding ANDEXXA How Supplied in the drug label.

Storage

There is limited information regarding ANDEXXA Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding ANDEXXA Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-ANDEXXA interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding ANDEXXA Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding ANDEXXA Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Identifiers

• Wikidata: Q7120529 (andexanet alfa)
• FDA label (prescribing information): ANDEXXA PI

References

Wikidata::Q7120529 ATC code::V03AB38 CAS number::1262449-58-0 UNII::BI009E452R DrugBank ID::DB14562 KEGG drug ID::D11029 IUPHAR ligand ID::7576

• Wikidata: Q7120529 (andexanet alfa)

Black Box Warning

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

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

Overview

ANDEXXA (andexanet alfa), also known as coagulation factor Xa (recombinant), inactivated-zhzo, is a recombinant modified human factor Xa protein that acts as a decoy receptor for factor Xa inhibitors. It is FDA-approved for the reversal of anticoagulation in patients treated with apixaban or rivaroxaban when reversal is required due to life-threatening or uncontrolled bleeding.

Adult Indications and Dosage

FDA-Labeled Indications

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

Dosing

Two dosing regimens are available:

• Low Dose: 400 mg IV bolus (30 mg/min) followed by 4 mg/min IV infusion for up to 120 minutes
• High Dose: 800 mg IV bolus (30 mg/min) followed by 8 mg/min IV infusion for up to 120 minutes

Dose Selection

• Rivaroxaban ≤10 mg: Low dose
• Rivaroxaban >10 mg or unknown: High dose if <8 hours or unknown; low dose if ≥8 hours
• Apixaban ≤5 mg: Low dose
• Apixaban >5 mg or unknown: High dose if <8 hours or unknown; low dose if ≥8 hours

Pediatric Use

Safety and efficacy in pediatric patients have not been established.

Contraindications

There are no known contraindications to ANDEXXA use.

Warnings

Thromboembolic and Ischemic Risks

In the ANNEXA-4 study, thromboembolic, ischemic, cardiac events, or death occurred in 18% of patients within 30 days of treatment. Median time to first event was 6 days.

Re-elevation of Anti-FXa Activity

Anti-FXa activity decreases rapidly during infusion but may re-elevate following cessation, peaking approximately 4 hours post-infusion.

Adverse Reactions

Clinical Trials

Infusion-related reactions occurred in approximately 18% of treated patients and were more frequent than placebo. No severe adverse reactions were reported in healthy volunteers.

Cardiovascular

Observed events included deep venous thrombosis, ischemic stroke, myocardial infarction, pulmonary embolism, cardiogenic shock, sudden death, cardiac arrest, and non-sustained ventricular tachycardia.

Respiratory

• Pneumonia
• Acute respiratory failure

Miscellaneous

• Urinary tract infection

Drug Interactions

No clinically significant drug–drug interactions have been identified.

Use in Specific Populations

Pregnancy

There are no adequate and well-controlled studies in pregnant women.

Geriatric Use

No overall differences in safety or efficacy were observed in elderly patients compared with younger adults.

Administration and Monitoring

Administration

Intravenous bolus followed by continuous intravenous infusion.

Monitoring

Patients should be monitored for thromboembolic and ischemic events and anticoagulation resumed when clinically appropriate.

Pharmacology

ANDEXXA

Identifiers
IUPAC name Not assigned (biologic)
CAS Number	1262449-58-0
DrugBank	DB14562
UNII	BI009E452R
KEGG	D11029
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}

Mechanism of Action

Andexanet alfa binds and sequesters factor Xa inhibitors and inhibits Tissue Factor Pathway Inhibitor (TFPI), restoring thrombin generation.

Clinical Studies

ANNEXA-4

ANNEXA-4 was a prospective, open-label study demonstrating significant reductions in anti-FXa activity and effective hemostasis in patients with major bleeding.

How Supplied

ANDEXXA is supplied as single-use 100 mg lyophilized vials; cartons contain four vials.

Patient Counseling Information

Patients should be informed that reversal of anticoagulation increases the risk of thromboembolic and ischemic events.

Brand Names

ANDEXXA

Authorship and Editorial Attribution

This page is maintained and medically reviewed by Syed Hassan Abbas Kazmi, MD (Associate Editor-in-Chief, WikiDoc).

Syed Hassan A. Kazmi BSc, MD [2]