What are the FDA-approved indications for Eliquis (apixaban)?

FDA-Approved Indications for Eliquis (Apixaban)

Eliquis (apixaban) is FDA-approved for five specific indications: reduction of stroke and systemic embolism risk in nonvalvular atrial fibrillation, prophylaxis of deep vein thrombosis following hip or knee replacement surgery, treatment of deep vein thrombosis, treatment of pulmonary embolism, and reduction in the risk of recurrent DVT and PE following initial therapy. 1

Detailed Indications

1. Nonvalvular Atrial Fibrillation

• Indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
• Demonstrated superior efficacy compared to warfarin in the ARISTOTLE trial with:
  • 21% reduction in stroke or systemic embolism
  • 31% reduction in major bleeding
  • 11% reduction in all-cause mortality 2
• Standard dosing: 5 mg twice daily
• Reduced dosing (2.5 mg twice daily) for patients with at least two of:
  • Age ≥80 years
  • Body weight ≤60 kg
  • Serum creatinine ≥1.5 mg/dL (133 μmol/L) 3

2. DVT Prophylaxis After Orthopedic Surgery

• Indicated for prophylaxis of deep vein thrombosis (DVT) following hip or knee replacement surgery
• Helps prevent DVT that may lead to pulmonary embolism (PE) 1

3. Treatment of DVT

• Indicated for the treatment of acute deep vein thrombosis 1
• Initial treatment dosing: 10 mg twice daily for 7 days, followed by 5 mg twice daily 3

4. Treatment of PE

• Indicated for the treatment of acute pulmonary embolism 1
• Same dosing regimen as DVT treatment

5. Secondary Prevention of Recurrent DVT/PE

• Indicated to reduce the risk of recurrent DVT and PE following initial therapy 1
• Maintenance dosing: 5 mg twice daily or 2.5 mg twice daily for extended treatment 3

Important Considerations

Dosing Adjustments

• Dose reduction to 2.5 mg twice daily is required for patients with at least two of the following:
  • Age ≥80 years
  • Body weight ≤60 kg
  • Serum creatinine ≥1.5 mg/dL 2, 3
• Careful consideration required in patients with severe renal impairment (CrCl <30 mL/min) 3
• Contraindicated in patients with severe renal impairment (CrCl <15 mL/min) and significant hepatic impairment 3

Clinical Advantages

• No routine coagulation monitoring required 4, 5
• Predictable pharmacokinetics with multiple elimination pathways 5
• Lower risk of intracranial hemorrhage compared to warfarin 2
• Rapid onset of action with maximum concentration occurring 3-4 hours after oral administration 5
• Half-life of approximately 12 hours 5

Contraindications and Precautions

• Active pathological bleeding
• Severe hypersensitivity to apixaban
• Concurrent use with strong dual inhibitors of CYP3A4 and P-glycoprotein 3
• Increased bleeding risk with concomitant use of antiplatelet agents, NSAIDs, SSRIs, or SNRIs 3

Clinical Evidence

Apixaban's approval for nonvalvular AF was based on the ARISTOTLE trial, which demonstrated superiority over warfarin for stroke prevention with better safety outcomes 2. For VTE treatment and prevention, the AMPLIFY and AMPLIFY-EXT trials showed non-inferiority to standard therapy with improved bleeding profiles 6, 7.