What is the recommended dosage and usage of Alirocumab (Praluent) for treating high cholesterol?

Alirocumab (Praluent) Dosage and Administration for High Cholesterol

For adults with high cholesterol, alirocumab (Praluent) should be initiated at 75 mg subcutaneously every 2 weeks or 300 mg every 4 weeks, with dose adjustment to 150 mg every 2 weeks if LDL-C reduction is inadequate. 1, 2

Recommended Dosing by Patient Population

Adults with Primary Hyperlipidemia or Established Cardiovascular Disease

• Initial dose: 75 mg subcutaneously every 2 weeks OR 300 mg every 4 weeks
• Administration site: Thigh, abdomen, or upper arm
• Dose adjustment: If LDL-C response is inadequate, increase to 150 mg every 2 weeks
• Monitoring: LDL-C can be measured as early as 4 weeks after initiation
• For 300 mg dose: Administer two 150 mg injections consecutively at different injection sites 1, 2

Adults with HeFH Undergoing LDL Apheresis or Adults with HoFH

• Recommended dose: 150 mg subcutaneously every 2 weeks
• Timing: Can be administered without regard to apheresis schedule 1, 2

Pediatric Patients with HeFH (8 years and older)

• For patients <50 kg: 150 mg every 4 weeks (can adjust to 75 mg every 2 weeks if needed)
• For patients ≥50 kg: 300 mg every 4 weeks (can adjust to 150 mg every 2 weeks if needed) 2

Administration Instructions

1. Allow Praluent to warm to room temperature for 30-40 minutes if refrigerated
2. Visually inspect solution (should be clear, colorless to pale yellow)
3. Administer subcutaneously into areas not tender, bruised, red, or indurated
4. Rotate injection sites for each administration
5. For 300 mg dose, give two 150 mg injections at different sites 2

Efficacy and Expected Outcomes

• Alirocumab 75 mg every 2 weeks reduces LDL-C by approximately 45% when added to maximally tolerated statin therapy
• Alirocumab 150 mg every 2 weeks reduces LDL-C by approximately 58% when added to maximally tolerated statin therapy 1
• The ODYSSEY Outcomes trial demonstrated reduction in cardiovascular events (CHD death, MI, ischemic stroke, or hospitalization for unstable angina) in post-ACS patients 1

Missed Dose Management

• If missed dose is within 7 days: Administer and resume original schedule
• If missed dose is more than 7 days:
  • For every 2-week dosage: Wait until next scheduled dose
  • For every 4-week dosage: Administer and start a new schedule based on this date 2

Safety Considerations

• Contraindication: History of serious hypersensitivity to alirocumab or excipients
• Warnings: Hypersensitivity reactions including vasculitis and angioedema have been reported
• Common adverse effects:
  • Primary hyperlipidemia: Injection site reactions, influenza, nasopharyngitis
  • Established CVD: Myalgia, noncardiac chest pain, nasopharyngitis 1, 2

Practical Considerations

• Real-world evidence shows alirocumab achieves target LDL-C levels in approximately 78% of patients 3
• Long-term safety profile is favorable with no significant increase in adverse events compared to placebo 4
• Prior authorization may be required due to cost considerations 1

Monitoring Recommendations

• Measure LDL-C when clinically appropriate, typically at 4 weeks after initiation
• For patients receiving 300 mg every 4 weeks, measure LDL-C just prior to the next scheduled dose, as LDL-C can vary between doses 2

Alirocumab represents an effective option for patients with inadequately controlled LDL-C despite maximally tolerated statin therapy or for those with statin intolerance, with demonstrated cardiovascular outcome benefits.