Apixaban

Apixaban
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: Gerald Chi

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Black Box Warning

WARNING: See full prescribing information for complete Boxed Warning. DISCONTINUING ELIQUIS IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE: Discontinuing ELIQUIS places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered. SPINAL/EPIDURAL HEMATOMA: When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins, heparinoids, or Factor Xa inhibitors for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. The risk of these events may be increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture. Monitor patients for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary. Consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

Overview

Apixaban is an anticoagulant that is FDA approved for the {{{indicationType}}} of stroke and systemic embolism in nonvalvular atrial fibrillation and prophylaxis of deep vein thrombosis following hip or knee replacement surgery. There is a Black Box Warning for this drug as shown here. Common adverse reactions include bleeding.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation

• Dosing Information

• The recommended dose of ELIQUIS is 5 mg taken orally twice daily.

Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery

• Dosing Information

• The recommended dose of ELIQUIS is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.
• In patients undergoing hip replacement surgery, the recommended duration of treatment is 35 days.
• In patients undergoing knee replacement surgery, the recommended duration of treatment is 12 days.

Dosage Adjustments

• In patients with nonvalvular atrial fibrillation: The recommended dose of ELIQUIS is 2.5 mg twice daily in patients with any 2 of the following characteristics:

• Age ≥80 years
• Body weight ≤60 kg
• Serum creatinine ≥1.5 mg/dL

• Coadministration with CYP3A4 and P-gp inhibitors: For patients receiving ELIQUIS 5 mg twice daily when ELIQUIS is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin), the recommended dose is 2.5 mg twice daily [see Clinical Pharmacology (12.3)].
• In patients already taking 2.5 mg twice daily, coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp should be avoided.

Missed Dose

• If a dose of ELIQUIS is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

Temporary Interruption for Surgery and Other Interventions

• ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.

Converting from or to ELIQUIS

• Switching from warfarin to ELIQUIS: Warfarin should be discontinued and ELIQUIS started when the international normalized ratio (INR) is below 2.0.
• Switching from ELIQUIS to warfarin: ELIQUIS affects INR, so that initial INR measurements during the transition to warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue ELIQUIS and begin both a parenteral anticoagulant and warfarin at the time the next dose of ELIQUIS would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.
• Switching between ELIQUIS and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.

Hepatic Impairment

• No dose adjustment is required in patients with mild hepatic impairment.
• Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with ELIQUIS in these patients, dosing recommendations cannot be provided.
• ELIQUIS is not recommended in patients with severe hepatic impairment.

Renal Impairment

• The dosing adjustment for moderate renal impairment is described above [see Dosage and Administration (2.2)]. The recommended dose for nonvalvular atrial fibrillation patients with end-stage renal disease (ESRD) maintained on hemodialysis is 5 mg twice daily. Reduce dose to 2.5 mg twice daily if one of the following patient characteristics (age ≥80 years or body weight ≤60 kg) is present.

Administration Options

• For patients who are unable to swallow whole tablets, 5 mg and 2.5 mg ELIQUIS tablets may be crushed and suspended in 60 mL D5W and immediately delivered through a nasogastric tube (NGT) [see Clinical Pharmacology (12.3)]. Information regarding the administration of crushed and suspended ELIQUIS tablets swallowed by mouth is not available.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Prophylaxis of Venous Thromboembolism

• Dosing Information

• 2.5 mg or 5 mg PO twice daily

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Safety and effectiveness in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• Condition1

Warnings

WARNING: See full prescribing information for complete Boxed Warning. DISCONTINUING ELIQUIS IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE: Discontinuing ELIQUIS places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered. SPINAL/EPIDURAL HEMATOMA: When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins, heparinoids, or Factor Xa inhibitors for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. The risk of these events may be increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture. Monitor patients for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary. Consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Apixaban in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Apixaban in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Apixaban with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Apixaban with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Apixaban with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Apixaban in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Apixaban in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Apixaban in the drug label.

Pharmacology

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

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Apixaban in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Apixaban in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Precautions with Alcohol

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

Brand Names

• Eliquis®

Look-Alike Drug Names

• N/A

Drug Shortage Status

Price

References

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

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