Apixaban
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:
SPINAL/EPIDURAL HEMATOMA:
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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[1]
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:
SPINAL/EPIDURAL HEMATOMA:
|
- 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
- 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®[2]
Look-Alike Drug Names
- N/A[3]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Agnelli, Giancarlo (2013-02-21). "Apixaban for extended treatment of venous thromboembolism". The New England Journal of Medicine. 368 (8): 699–708. doi:10.1056/NEJMoa1207541. ISSN 1533-4406. PMID 23216615. Unknown parameter
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