Pertuzumab Application Scope

For treatment of HER2-positive metastatic breast cancer, in combination with trastuzumab and docetaxel
As neoadjuvant or adjuvant therapy for early HER2-positive breast cancer, when given with trastuzumab and chemotherapy

Pertuzumab Characteristics

Ingredients: Pertuzumab, a humanized monoclonal antibody targeting HER2 dimerization
Properties: Acts as a HER dimerization inhibitor, binding the HER2 extracellular domain to block HER2/HER3 signaling and tumor growth
Packaging Specification:
- Supplied in 420 mg/14 mL single-use vials for IV infusion
- Subcutaneous form (PHESGO) is packaged in vials for single use
Storage:
- IV vials: store at 2–8 °C (36–46 °F) in original carton; do not freeze
- Subcutaneous PHESGO: similar refrigeration guidelines
- Drug substance stability: 24 months at 2–8 °C; drug substance at −20 °C
Expiry Date: Typically expires 24 months post-manufacture; labeled as month/year on packaging
Executive Standard: Meets U.S. FDA biologics license requirements (BLA 125409) with complete prescribing information
Approval Number: FDA BLA 125409 — approved June 2012 for metastatic use; September 2013 for neoadjuvant setting
Date of Revision: Label updates through 2024 (with safety updates); subcutaneous approval in June 2020
Manufacturer:Developed and marketed by Genentech/Roche (manufacturing in U.S. and EU)

Dosage and Administration:
- Metastatic breast cancer:
  - Loading dose: 840 mg IV over 60 min on Day 1 of cycle 1
  - Maintenance dose: 420 mg IV over 30–60 min every 3 weeks
  - Administer before trastuzumab/docetaxel infusion if loading
- Neoadjuvant/adjuvant setting: Similar dosing – often given with subcutaneous trastuzumab/chemo
Adverse Reactions:
- Common (≥30%): diarrhea, alopecia, neutropenia, nausea, fatigue, rash, peripheral neuropathy
- Grade 3–4 (≥2%): neutropenia, febrile neutropenia, leukopenia, diarrhea, anemia, fatigue
- Other notable reactions: infusion/injection-related reactions (~13–21%), hypersensitivity/anaphylaxis (~8–11%), left ventricular dysfunction (~4%), embryo-fetal toxicity, pulmonary toxicity
Contraindications: Known hypersensitivity to pertuzumab or any component
Precautions:
- Monitor cardiac function (LVEF) before/during treatment; avoid use in baseline LVEF ≤50% or CHF history
- Be prepared for infusion reactions (monitor during and post-infusion) and manage with supportive meds or slowing infusion
- Avoid during pregnancy (fetal harm risk); require contraception during and post-treatment
- Counsel on risk of pulmonary toxicity and manage new respiratory symptoms

Drug Interactions:
No major metabolic drug–drug interactions; monoclonal antibody not CYP-metabolized
Moderate interactions with efgartigimod alfa, idelalisib, nipocalimab, rozanolixizumab
Disease-state interactions: existing CHF, pulmonary disease, neuropathy, thrombocytopenia, renal 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.