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

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

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.