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Canmab (150mg / 440mg) - Trastuzumab for Injection

Canmab (150mg / 440mg) - Trastuzumab for Injection

Canmab contains Trastuzumab, a monoclonal antibody used primarily in the treatment of HER2-positive breast and gastric cancers. It targets the HER2 receptor to stop the growth of cancer cells and is administered intravenously under medical supervision.

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Description Product Details
General Information:
Generic Name: Trastuzumab
Brand Name: Canmab
Packing: Single-use vial
Strengths Available: 150mg and 440mg
Manufacturer: Biocon Ltd
Form: Lyophilized powder for intravenous injection
Category: Monoclonal Antibody, Antineoplastic Agent
Route: Intravenous infusion
Prescription: Rx-only
Product Introduction:
Canmab is a biosimilar version of the innovator drug Herceptin, developed to treat cancers that overexpress the HER2 protein. It is manufactured by Biocon and is available in lyophilized powder form for reconstitution. Canmab offers a cost-effective treatment option for eligible patients, maintaining comparable efficacy and safety.
Uses:
Canmab is indicated for the treatment of HER2-positive cancers, including:
  1. Early-stage HER2-positive breast cancer (adjuvant setting)
  2. Metastatic HER2-positive breast cancer
  3. HER2-positive gastric or gastroesophageal junction cancer
  4. Neoadjuvant therapy in breast cancer
  5. Maintenance therapy post-chemotherapy
  6. HER2-overexpressing tumors under clinical guidance
Storage Instructions:
  1. Store at 2°C to 8°C (refrigerated conditions)
  2. Do not freeze
  3. After reconstitution, use within the recommended time frame as per label
  4. Protect from light; keep in original carton
  5. Keep out of reach of children
How It Works (Mechanism of Action):
Trastuzumab binds specifically to the HER2/neu receptor (a tyrosine kinase receptor) overexpressed in certain cancer cells. By inhibiting HER2 signaling and triggering antibody-dependent cellular cytotoxicity (ADCC), it stops cell proliferation and induces immune-mediated tumor destruction.
Side Effects:
Common side effects:
  1. Fever or chills (especially during the first infusion)
  2. Nausea, vomiting
  3. Diarrhea
  4. Headache
  5. Fatigue
  6. Infusion-related reactions
  7. Rash
Severe side effects:
  1. Cardiotoxicity (heart failure or reduced ejection fraction)
  2. Pulmonary toxicity (breathing difficulties)
  3. Anaphylaxis or hypersensitivity
  4. Severe infusion reactions
  5. Neutropenia or infections
  6. Liver enzyme elevation
Dosage (Typical Recommended Dose):
  1. Loading dose: 4 mg/kg IV over 90 minutes
  2. Maintenance dose: 2 mg/kg IV over 30 minutes weekly (or 6 mg/kg every 3 weeks depending on regimen)
    Dosing is weight-based and may vary depending on whether it’s adjuvant, metastatic, or in combination therapy.
Method of Administration:
  1. Administered via IV infusion only
  2. Do not administer as IV push or bolus
  3. Must be reconstituted with bacteriostatic water for injection (for 440mg vial)
  4. Infusion should be given in a hospital or clinic under medical supervision
  5. Premedication may be required to reduce infusion-related reactions
Precautions:
  1. Monitor cardiac function (LVEF) before and during treatment
  2. Avoid use in pregnant or breastfeeding women
  3. Discontinue if severe hypersensitivity or lung toxicity occurs
  4. Do not use with anthracyclines simultaneously (increases heart risk)
  5. Use caution in patients with a history of heart disease or lung disorders
Drug Interactions:
  1. May interact with anthracyclines (e.g., doxorubicin) increasing heart toxicity
  2. Monitor when used with taxanes (e.g., paclitaxel)
  3. No major CYP450 metabolism; minimal systemic drug-drug interactions
  4. Inform doctor about all chemotherapy agents, biologics, or immune modulators used
Allergies:
  1. Contraindicated in patients with known hypersensitivity to Trastuzumab or any excipients
  2. Signs of an allergic reaction include: swelling, rash, shortness of breath, anaphylaxis
Overdose Information:
  1. Limited human data on overdose
  2. Possible symptoms: severe infusion reaction, heart complications, or lung issues
  3. Requires immediate medical attention and supportive care
Missed Dose Instructions:
  1. If a scheduled dose is missed, consult your oncologist immediately
  2. Rescheduling depends on time since the last dose and current cardiac status
  3. Do not self-adjust or skip future doses
Additional Notes:
  1. Requires HER2 testing before initiation (immunohistochemistry or FISH)
  2. Regular cardiac monitoring (ECHO/MUGA scan) is mandatory during therapy
  3. Continue for 1 year in adjuvant breast cancer therapy unless discontinued due to side effects
  4. Patients should report any symptoms of breathlessness, fatigue, or palpitations promptly

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