ELIQUIS® (Apixaban)

Apixaban (brand name Eliquis) is a direct oral anticoagulant (DOAC) commonly used for preventing and treating thromboembolic disorders. It inhibits factor Xa, a key enzyme in the coagulation cascade. Below is an overview of European Union (EU) guidelines and recommendations for its use:

Indications

Apixaban is approved in the EU for:

1. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) and one or more risk factors, such as:
   • Previous stroke or transient ischemic attack (TIA)
   • Age ≥75 years
   • Hypertension
   • Diabetes mellitus
   • Symptomatic heart failure (NYHA class ≥II)
2. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE):
   • Initial treatment and prevention of recurrent DVT/PE.
3. Prevention of venous thromboembolism (VTE):
   • In adults undergoing elective hip or knee replacement surgery.

Dosage Recommendations

For Stroke Prevention in NVAF

• Standard dose: 5 mg twice daily.
• Dose reduction to 2.5 mg twice daily if at least two of the following criteria are met:
  • Age ≥80 years
  • Body weight ≤60 kg
  • Serum creatinine ≥1.5 mg/dL (133 μmol/L).

For Treatment of DVT/PE

• Initial phase: 10 mg twice daily for the first 7 days.
• Maintenance phase: 5 mg twice daily thereafter.

For Prevention of Recurrent DVT/PE

• Prophylactic dose: 2.5 mg twice daily after at least 6 months of initial treatment.

For VTE Prophylaxis (Hip or Knee Replacement)

• Recommended dose: 2.5 mg twice daily starting 12–24 hours post-surgery.
• Duration:
  • Hip replacement: 32–38 days
  • Knee replacement: 10–14 days

Contraindications

• Active bleeding
• Severe hepatic impairment associated with coagulopathy
• Lesions or conditions at significant risk of bleeding
• Use of other anticoagulants (except during transition)
• Pregnancy and breastfeeding (safety not established)

Renal Impairment

• ELIQUIS® (Apixaban) is primarily metabolized by the liver, but renal clearance accounts for approximately 27% of elimination.
• Mild or moderate renal impairment (CrCl ≥30 mL/min): No dose adjustment needed unless dose reduction criteria are met.
• Severe renal impairment (CrCl <30 mL/min): Use with caution; limited data are available.

Hepatic Impairment

• Mild to moderate impairment (Child-Pugh A or B): No dose adjustment, but use with caution.
• Severe impairment (Child-Pugh C): Contraindicated.

Drug Interactions

• Strong inhibitors of CYP3A4 and P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir): Reduce apixaban dose by 50%.
• Strong inducers of CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin): Avoid use, as they may reduce efficacy.

Monitoring

• Routine coagulation monitoring is not required, but clinicians may assess anti-Xa activity or specific tests if necessary.
• Monitor renal and hepatic function periodically, especially in patients with known impairment or on long-term therapy.

Reversal of Anticoagulation

• Andexanet alfa (Ondexxya) is approved for reversing apixaban’s effects in cases of life-threatening bleeding.
• Activated charcoal can be used if the last dose was within 2–6 hours.

For more detailed or patient-specific advice, always consult the latest EU prescribing information or local clinical guidelines