Clinical Overview
Trastuzumab Injection (440mg with WFI) is a recombinant humanized IgG1 monoclonal antibody on the WHO Model List of Essential Medicines that specifically targets the extracellular domain IV of the Human Epidermal Growth Factor Receptor 2 (HER2 / ErbB2) protein. It blocks ligand-independent HER2 homodimerization and downstream PI3K/Akt survival signaling, prevents shedding of the HER2 extracellular domain, and flags HER2-overexpressing tumor cells for Antibody-Dependent Cellular Cytotoxicity (ADCC) mediated by natural killer (NK) cells. Indicated for adjuvant and metastatic HER2-overexpressing (IHC 3+ or FISH-amplified) breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
Administer intravenously only. NEVER administer as an IV push or bolus. Initial loading dose (8 mg/kg for 3-weekly regimen, or 4 mg/kg for weekly regimen) is infused over 90 minutes; subsequent maintenance doses (6 mg/kg 3-weekly, or 2 mg/kg weekly) are infused over 30 minutes if tolerated. Reconstitute with provided Sterile Water for Injection (or Bacteriostatic Water for Injection).
General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.
Possible Side Effects
Common: Mild-to-moderate infusion reactions (chills, fever, nausea within 2 hours of infusion), fatigue, diarrhea, headache, arthralgia. Rare/Severe: Subclinical or clinical cardiotoxicity (asymptomatic decline in LVEF, congestive heart failure), severe pulmonary toxicity / ARDS, and anaphylaxis.
*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.
Precautions & Warnings
Black Box Warning: Cardiomyopathy (congestive heart failure and severe decrease in LVEF); baseline and every 3-month echocardiogram or MUGA scan is mandatory. Withhold if LVEF drops >= 16% from baseline or >= 10% below lower limit of normal. Black Box Warning: Infusion-related reactions and pulmonary toxicity. Black Box Warning: Embryofetal toxicity (oligohydramnios).
Schedule H (Prescription Required)
This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.
Medical Disclaimer: Statutory Clinical Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice, oncological diagnosis, or chemotherapy protocol guidance. Cancer therapies require specialized administration under the direct supervision of a registered medical oncologist in an accredited healthcare facility.