Edoxaban

Edoxaban
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: Martin Nino [2]

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Black Box Warning

(A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CREATININE CLEARANCE (CRCL) > 95 ML/MIN (B) PREMATURE DISCONTINUATION OF EDOXABAN TOSYLATE INCREASES THE RISK OF ISCHEMIC EVENTS (C) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete Boxed Warning. A. REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CRCL > 95 ML/MIN SAVAYSA should not be used in patients with CrCL > 95 mL/min. In the ENGAGE AF-TIMI 48 study, nonvalvular atrial fibrillation patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg once daily compared to patients treated with warfarin. In these patients another anticoagulant should be used. B. PREMATURE DISCONTINUATION OF EDOXABAN TOSYLATE INCREASES THE RISK OF ISCHEMIC EVENTS Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If SAVAYSA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guidance. C. SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with SAVAYSA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants a history of traumatic or repeated epidural or spinal punctures a history of spinal deformity or spinal surgery optimal timing between the administration of SAVAYSA and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.

Overview

Edoxaban is a factor Xa inhibitor that is FDA approved for the prevention of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). Is also indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant. There is a Black Box Warning for this drug as shown here. Common adverse reactions include bleeding and anemia in the treatment of NVAF (≥ 5%) and bleeding, rash, abnormal liver function tests and anemia in the treatment of DVT and PE (≥ 1%).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pimavanserin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pimavanserin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness have not been established in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pimavanserin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pimavanserin in pediatric patients.

Contraindications

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

Warnings

(A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CREATININE CLEARANCE (CRCL) > 95 ML/MIN (B) PREMATURE DISCONTINUATION OF EDOXABAN TOSYLATE INCREASES THE RISK OF ISCHEMIC EVENTS (C) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete Boxed Warning. A. REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CRCL > 95 ML/MIN SAVAYSA should not be used in patients with CrCL > 95 mL/min. In the ENGAGE AF-TIMI 48 study, nonvalvular atrial fibrillation patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg once daily compared to patients treated with warfarin. In these patients another anticoagulant should be used. B. PREMATURE DISCONTINUATION OF EDOXABAN TOSYLATE INCREASES THE RISK OF ISCHEMIC EVENTS Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If SAVAYSA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guidance. C. SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with SAVAYSA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants a history of traumatic or repeated epidural or spinal punctures a history of spinal deformity or spinal surgery optimal timing between the administration of SAVAYSA and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

Edoxaban
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Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Clinical Studies

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

How Supplied

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

Storage

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

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

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Patient Counseling Information

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

Precautions with Alcohol

Alcohol-Edoxaban 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 Edoxaban Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Edoxaban 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.