Trastuzumab

Active pharmaceutical substance formulated in Jan Aushadhi generic products for Oncology & Critical Care treatment.

🧴 Clinical Application

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).

⚠️ 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.

🛡️ Safety 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).