Trastuzumab Injection 440 mg/50 mL

🧾 Description:

Trastuzumab is a monoclonal antibody used primarily in the treatment of HER2-positive cancers, especially:

  • Breast cancer
  • Gastric (stomach) cancer

It targets the HER2/neu receptor, which is overexpressed in some cancer cells, helping to inhibit their growth.


⚙️ Mechanism of Action:

Trastuzumab binds to the extracellular domain of the HER2 receptor (human epidermal growth factor receptor 2), inhibiting:

  • Cell proliferation
  • Survival signals
  • DNA repair of cancer cells
    It also mediates antibody-dependent cellular cytotoxicity (ADCC).

💊 Dosage & Administration:

  • Form: Lyophilized powder for injection (to be reconstituted)
  • Strength: 440 mg vial + 50 mL of bacteriostatic water for injection (BWFI) with benzyl alcohol
  • Route: Intravenous infusion (not IV push or bolus)

Typical Dosing:

  • Loading dose: 8 mg/kg IV over 90 minutes
  • Maintenance: 6 mg/kg IV every 3 weeks over 30–90 minutes

Note: Subcutaneous (SC) formulations also exist with fixed doses (e.g., 600 mg).


🤒 Common Side Effects:

  • Fever, chills, nausea
  • Diarrhea
  • Fatigue
  • Infusion-related reactions
  • Headache
  • Rash
  • Cardiotoxicity (especially ↓ LVEF)

🚨 Precautions:

  • Cardiac monitoring (especially LVEF) is required
  • Caution in pregnancy (Category D – known fetal risk)
  • Infusion reactions are common — premedication may be needed
  • Not interchangeable with biosimilars unless specifically approved

🔄 Interactions:

  • Risk of cardiotoxicity increases when combined with anthracyclines (e.g., doxorubicin)
  • May interact with other HER2-targeted therapies (e.g., pertuzumab)

📦 Storage:

  • Store refrigerated at 2°C to 8°C (36°F to 46°F)
  • Do not freeze
  • After reconstitution:
    • Stable for 28 days at 2–8°C
    • Do not shake

🧍‍♂️ Patient Advice:

🧾 Description:

Trastuzumab is a monoclonal antibody used primarily in the treatment of HER2-positive cancers, especially:

  • Breast cancer
  • Gastric (stomach) cancer

It targets the HER2/neu receptor, which is overexpressed in some cancer cells, helping to inhibit their growth.


🚨 Precautions:

  • Cardiac monitoring (especially LVEF) is required
  • Caution in pregnancy (Category D – known fetal risk)
  • Infusion reactions are common — premedication may be needed
  • Not interchangeable with biosimilars unless specifically approved

📦 Storage:

  • Store refrigerated at 2°C to 8°C (36°F to 46°F)
  • Do not freeze
  • After reconstitution:
    • Stable for 28 days at 2–8°C
    • Do not shake

🧍‍♂️ Patient Advice:

  • Report symptoms like shortness of breath, chest pain, dizziness, or swelling
  • Attend all cardiac checkups
  • Women of childbearing potential should use effective contraception during and at least 7 months after therapy
  • Inform your healthcare provider if pregnant or breastfeeding

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