Trumab (150mg / 440mg) - Reliance Trastuzumab for Injection

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1. HER2-positive metastatic breast cancer
2. Early-stage HER2-positive breast cancer, as adjuvant therapy following surgery and chemotherapy
3. HER2-positive gastric or gastroesophageal junction adenocarcinoma in combination with chemotherapy
4. Neoadjuvant therapy in HER2-positive locally advanced breast cancer
5. Recurrent HER2-positive breast cancer (both locoregional and distant metastases)
6. Off-label in some HER2-amplified solid tumors (under clinical evaluation)

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1. Store the lyophilized vial at 2°C to 8°C (refrigerator)
2. Do not freeze the vials
3. Protect from light and moisture
4. Once reconstituted, the solution should be used immediately or stored at 2–8°C for up to 28 days (for 440 mg multidose)
5. Discard unused solution beyond the recommended storage duration

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1. Binds specifically to the HER2 receptor, overexpressed in ~20-25% of breast cancers
2. Inhibits receptor dimerization and downstream signaling (PI3K/Akt and MAPK pathways)
3. Promotes antibody-dependent cellular cytotoxicity (ADCC), directing immune cells to destroy tumor cells
4. Leads to cell cycle arrest, decreased proliferation, and apoptosis of HER2-positive cancer cells

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1. Fever, chills during infusion
2. Nausea, vomiting
3. Fatigue
4. Headache
5. Rash
6. Diarrhea

1. Cardiotoxicity – including congestive heart failure (especially when combined with anthracyclines)
2. Infusion-related reactions – fever, hypotension, bronchospasm, angioedema
3. Pulmonary toxicity – interstitial pneumonitis, acute respiratory distress
4. Hepatotoxicity – elevated liver enzymes
5. Anaphylaxis or hypersensitivity reactions
6. Myelosuppression – rare but may occur in combination regimens

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Dosage (Typical Recommended Dose):

1. Loading dose:
   1. 4 mg/kg IV over 90 minutes
2. Maintenance dose:
   1. 2 mg/kg IV weekly (or 6 mg/kg every 3 weeks depending on the regimen)
3. Duration: Usually continued for 1 year in early breast cancer

1. Loading dose: 8 mg/kg IV over 90 minutes
2. Maintenance dose: 6 mg/kg IV every 3 weeks
3. Continue until disease progression or unacceptable toxicity

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1. Administered intravenously after reconstitution with sterile water
2. Initial loading dose over 90 minutes under medical supervision
3. If well tolerated, subsequent doses may be infused over 30 minutes
4. Must not be administered as an IV push or bolus
5. Observe the patient closely during and after the first infusion for infusion-related reactions

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1. Baseline and periodic cardiac function monitoring (e.g., echocardiogram or MUGA scan) is essential
2. Avoid concurrent use with anthracyclines due to enhanced cardiotoxicity risk
3. Use caution in elderly patients or those with prior heart conditions
4. Discontinue temporarily or permanently if left ventricular ejection fraction (LVEF) declines significantly
5. Not recommended during pregnancy or lactation
6. Ensure HER2-positive status is confirmed by validated testing before starting treatment

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1. Anthracyclines (e.g., Doxorubicin): High risk of cardiotoxicity
2. Cyclophosphamide, Paclitaxel: Commonly used together but require close cardiac monitoring
3. No significant CYP450-mediated interactions, but concurrent cytotoxic chemotherapies may amplify side effects
4. Live vaccines should be avoided during and shortly after therapy

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1. Contraindicated in patients with known hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins, or any excipients
2. Watch for signs of anaphylaxis, angioedema, urticaria, or bronchospasm during infusion
3. Premedication with antipyretics and antihistamines may be considered in patients with prior mild infusion reactions

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1. No specific antidote for trastuzumab overdose
2. In cases of overdose, monitor for signs of toxicity, especially cardiac function
3. Supportive and symptomatic care is essential
4. Infusion should be stopped immediately if any severe adverse event occurs

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1. If a scheduled dose is missed, it should be administered as soon as possible
2. The interval between subsequent doses should be maintained as originally scheduled
3. If a delay exceeds one week, reloading may be required depending on treatment protocol
4. Always consult an oncologist for dose re-initiation planning

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1. HER2 testing (IHC or FISH) is mandatory prior to initiating Trumab
2. Cardiotoxicity may be reversible upon discontinuation in most cases
3. Treatment is often combined with chemotherapy, endocrine therapy, or radiation depending on the stage
4. Patients should be monitored long-term for delayed cardiotoxicity, even after discontinuation
5. Trumab is a biosimilar – proven comparable to Herceptin in terms of safety, efficacy, and quality
6. Should only be administered under the supervision of an experienced oncologist