What is the recommended dose of Praluent (alirocumab) for lowering Low-Density Lipoprotein (LDL) cholesterol?

Recommended Dosage of Praluent (Alirocumab) for Lowering LDL Cholesterol

The recommended starting dosage of Praluent (alirocumab) is 75 mg subcutaneously every 2 weeks or 300 mg every 4 weeks, with possible dose increase to 150 mg every 2 weeks if LDL-C response is inadequate. 1

Dosing Algorithm

Initial Dosing

• Standard starting dose: 75 mg subcutaneously every 2 weeks or 300 mg every 4 weeks 2, 1
• For patients receiving the 300 mg every 4 weeks regimen, measure LDL-C just prior to the next scheduled dose, as LDL-C levels can vary between doses 1
• Alirocumab can be administered without regard to timing of meals 1

Dose Adjustment

• If LDL-C response is inadequate at the starting dose, increase to 150 mg subcutaneously every 2 weeks 1
• The LDL-lowering effect may be measured as early as 4 weeks after initiation 1
• In clinical trials, 73.7% of patients achieved LDL-C goals with the initial 75 mg every 2 weeks dose when added to statin therapy 3
• For the 26.3% of patients requiring dose increase to 150 mg every 2 weeks, an additional 14.2% reduction in LDL-C was observed, with 60.9% of these patients achieving their LDL-C goals 3

Efficacy

• Alirocumab 75 mg every 2 weeks reduces LDL-C by approximately 45% when added to maximally tolerated statin therapy 2
• Alirocumab 150 mg every 2 weeks reduces LDL-C by approximately 58% when added to maximally tolerated statin therapy 2
• As monotherapy, alirocumab 75 mg every 2 weeks reduces LDL-C by approximately 47-53% 4, 5
• The ODYSSEY OUTCOMES trial demonstrated that alirocumab reduced major adverse cardiovascular events by 15% over a median follow-up of 2.8 years 2

Special Populations

• For patients with heterozygous familial hypercholesterolemia (HeFH) undergoing LDL apheresis: The recommended dose is 150 mg every 2 weeks 1
• For pediatric patients aged 8 years and older with HeFH:
  • Body weight <50 kg: 150 mg every 4 weeks (may adjust to 75 mg every 2 weeks if response inadequate) 1
  • Body weight ≥50 kg: 300 mg every 4 weeks (may adjust to 150 mg every 2 weeks if response inadequate) 1

Administration

• Administer subcutaneously into areas of the thigh, abdomen, or upper arm that are not tender, bruised, red, or indurated 1
• Rotate injection sites for each administration 1
• Allow Praluent to warm to room temperature for 30-40 minutes if refrigerated before use 1
• To administer the 300 mg dose, give two 150 mg injections consecutively at two different injection sites 1

Missed Doses

• If missed dose is within 7 days: Administer the dose and resume original schedule 1
• If missed dose is more than 7 days:
  • For every 2-week dosing: Wait until the next dose on the original schedule 1
  • For every 4-week dosing: Administer the dose and start a new schedule based on this date 1

Safety Profile

• Generally well-tolerated with adverse effects including nasopharyngitis, injection site reactions, and influenza 2, 6
• No significant increase in muscle-related adverse events compared to placebo 7
• Adverse event rates were comparable in patients with versus without dose increase (approximately 72% in placebo-controlled trials and 67% in ezetimibe-controlled trials) 3

Additional Benefits

• Beyond LDL-C reduction, alirocumab provides significant reductions in lipoprotein(a) [Lp(a)] by 23-29%, which is sustained over 78-104 weeks 8
• These reductions are independent of race, gender, presence of familial hypercholesterolemia, baseline Lp(a) and LDL-C concentrations, or use of statins 8

Treatment Goals

• For patients with established atherosclerotic cardiovascular disease (ASCVD), the target LDL-C is <1.4 mmol/L (55 mg/dL) with a reduction of at least 50% from baseline 2
• For patients who experience a second vascular event within 2 years while on maximum tolerated statin-based therapy, an even lower LDL-C goal of <1.0 mmol/L (40 mg/dL) may be considered 2