Praluent (Alirocumab) | ASCVD | HongKong DengYue Medicine

Alirocumab Application Scope

• Adults with primary hypercholesterolemia (heterozygous familial or non‑familial) and mixed dyslipidemia as adjunct to diet, alone or additive to statins/other lipid therapies

• Reduction of cardiovascular events (MI, stroke, unstable angina) in adults with established ASCVD

• Homozygous familial hypercholesterolemia (HoFH)

• Pediatric HeFH (aged ≥8 years) in some regions

 

Alirocumab Characteristics

• Ingredients:

  • Active: Alirocumab, a fully human IgG1 monoclonal antibody targeting PCSK9

  • Inactive: Formulation-specific excipients per regulatory label

• Properties:
  Binds circulating PCSK9 → prevents LDL receptor degradation → reduces LDL‑C by ~50–60% and lowers CV events risk

• Packaging Specification:

  • Single‑use, prefilled pens or syringes: 75 mg/mL and 150 mg/mL

• Storage: Refrigerate at 2–8 °C; may keep at room temperature (≤25 °C) up to 30 days .

• Expiry Date: Typically 24 months from manufacture; room-temp shelf limited to 30 days after removal from fridge .

• Executive Standard: Approved under FDA BLA 125559; meets EMA/Health Canada standards

• Approval Number: FDA BLA 125559 (July 24, 2015) .

• Date of Revision: Label revisions to reflect ODYSSEY outcomes trials (latest ~2023)

• Manufacturer: Regeneron Pharmaceuticals & Sanofi (U.S.), plus Sanofi globally

Guidelines for the Use of Alirocumab

• Dosage and Administration:

  • Start at 75 mg SC every 2 weeks; or 300 mg once monthly.

  • Titrate to 150 mg Q2W if LDL‑C goals not met after at least 12 weeks

• Adverse Reactions:

  • ≥5%: nasopharyngitis (~11%), injection-site reactions (~7%), influenza (~6%), back pain, UTIs, cough, musculoskeletal pain, diarrhea

  • Allergic/hypersensitivity (rash, urticaria, vasculitis) ~8–9% .

  • Low LDL‑C and immunogenicity (4–6%) reported; neurocognitive events <1%

• Contraindications: Known hypersensitivity to alirocumab or formulation components (e.g. latex in pen)

• Precautions: Monitor for allergic reactions; caution with latex allergy

Alirocumab Interactions

• Drug Interactions:​ No clinically significant CYP450 interactions; safe to use with statins and other lipid-lowering therapies.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.