Repatha (Evolocumab) | ASCVD | HongKong DengYue Medicine

Evolocumab Application Scope

• Adults with primary hypercholesterolemia (heterozygous familial or non‑familial) or mixed dyslipidemia adjunct to diet, as monotherapy or with statins/eze­timibe when LDL‑C goals are not achieved

• Adults and children ≥10 years with homozygous familial hypercholesterolemia (HoFH)

• Secondary prevention in adults with established atherosclerotic cardiovascular disease to reduce major adverse CV events

 

Evolocumab Characteristics

• Ingredients:

  • Active: Evolocumab (human monoclonal IgG2 antibody inhibiting PCSK9)

  • Inactive: Acetate, polysorbate 80, proline, water for injection, sodium hydroxide (pH adjuster)

• Properties: Binds PCSK9 → prevents LDL receptor degradation → lowers LDL‑C (≈ 50–60%) and reduces CV events (~15–20% risk reduction)

• Packaging Specification:

  • Prefilled SureClick® autoinjector or syringe: 140 mg/mL in 1 mL

  • Pushtronex® on‑body infusor: 420 mg/3.5 mL cartridge

• Storage: Refrigerate at 2–8 °C (36–46 °F). May be kept at room temp (20–25 °C) up to 30 days .

• Expiry Date: Typically 24 months from manufacture for pens and syringes; cartridges similar .

• Executive Standard: FDA-approved biologic (BLA 125522); complies with EMA, TGA, USP standards.

• Approval Number: FDA BLA 125522 (approved Aug 27, 2015).

• Date of Revision: Label last updated in 2022–23; information current as of latest prescribing info

• Manufacturer: Amgen Inc., Thousand Oaks, CA, USA

Guidelines for the Use of Evolocumab

• Dosage and Administration:

  • 140 mg subcutaneously every 2 weeks or 420 mg once monthly

  • In HoFH: start with 420 mg monthly; can uptitrate to 420 mg biweekly if needed .

  • Standard SC injection sites (thigh, abdomen, upper arm); rotate sites

• Adverse Reactions:
  Common (>3%): nasopharyngitis, URIs, influenza, back pain, injection site reactions, cough, UTI, sinusitis, headache, myalgia, dizziness, hypertension, diarrhea
  Hypersensitivity events (rash, urticaria, angioedema) seen; more in evolocumab (5.1%) vs placebo (4.7%)

• Contraindications:
  Known serious hypersensitivity to evolocumab or its excipients (e.g., latex in needle covers)

• Precautions:
  Monitor for hypersensitivity reactions. Avoid in latex allergy due to device components

Evolocumab Interactions

• Drug Interactions:​ No major CYP interactions. Compatible with statins, ezetimibe. No dose adjustments for renal/hepatic impairment.

 

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.