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]; Associate Editor(s)-in-Chief: Syed Hassan A. Kazmi BSc, MD [2]

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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. Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: Arterial and venous thromboembolic events Ischemic events, including myocardial infarction and ischemic stroke Cardiac arrest Sudden deaths Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

Overview

ANDEXXA is a Recombinant Factor Xa that is FDA approved for the Reversal agent 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. Continued approval for this indication may be contingent upon the results of studies to demonstrate an improvement in hemostasis in patients.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include urinary tract infection, pneumonia, and [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. Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: Arterial and venous thromboembolic events Ischemic events, including myocardial infarction and ischemic stroke Cardiac arrest Sudden deaths Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

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.

INDICATIONS AND USAGE

• ANDEXXA is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
• This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers.
• An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies to demonstrate an improvement in hemostasis in patients.

Limitation of Use

• ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban and rivaroxaban.

DOSAGE AND ADMINISTRATION

For intravenous use only.

Dose

• There are two dosing regimens
• The safety and efficacy of an additional dose has not been established
  • Low Dose: 400 mg at a target rate of 30 mg/min; Follow-On infusion: 4 mg/min for up to 120 minutes
  • High Dose: 800 mg at a target rate of 30 mg/min; Follow-On infusion: 8 mg/min for up to 120 minutes