Vivitra 440 mg Injection

Vivitra 440 mg Injection – Trastuzumab 440mg | HER2-Targeted Monoclonal Antibody Biosimilar by Zydus Lifesciences

Vivitra 440 mg Injection is a prescription-only, intravenously administered humanized IgG1 monoclonal antibody containing Trastuzumab 440mg, manufactured by Zydus Lifesciences Ltd. (formerly Zydus Cadila) — one of India's largest globally operating pharmaceutical and biopharmaceutical companies, headquartered in Ahmedabad, Gujarat. Vivitra is a clinically validated biosimilar of Herceptin, the reference Trastuzumab product developed by Roche and Genentech and approved by the FDA in 1998 as the first monoclonal antibody therapy for breast cancer.

Trastuzumab is the global gold standard in HER2-targeted oncology therapy and remains one of the most clinically impactful cancer medicines ever developed. Vivitra 440 mg delivers the same mechanism, efficacy, and safety profile as the originator Herceptin at a significantly more accessible price point — making it the preferred Trastuzumab biosimilar for oncology institutions, hospitals, and cancer treatment centres across India, the Middle East, Africa, and internationally.

Vivitra 440 mg is supplied as a lyophilised powder for concentrate for solution for infusion in a single-use multi-dose glass vial, reconstituted with Bacteriostatic Water for Injection (BWFI) and administered intravenously by a qualified oncologist or trained clinical professional in a hospital or infusion centre setting.

What is Vivitra 440 mg Used For?

HER2-Positive Early Breast Cancer (EBC)

Vivitra 440 mg is indicated as part of a complete treatment regimen for HER2-positive early breast cancer — used as adjuvant therapy following surgery, chemotherapy, and radiation in eligible patients. In the landmark HERA clinical trial, adjuvant Trastuzumab reduced the risk of breast cancer recurrence by 46% and significantly improved disease-free and overall survival. Treatment duration in the adjuvant setting is typically 12 months or until disease recurrence, administered every 3 weeks. Vivitra may be used alone or in combination with chemotherapy agents including paclitaxel, docetaxel, or carboplatin in HER2-positive early breast cancer patients.

HER2-Positive Locally Advanced and Metastatic Breast Cancer (MBC)

Vivitra 440 mg is indicated as first-line therapy for HER2-positive metastatic breast cancer — either as monotherapy in patients who have previously received at least two chemotherapy regimens for metastatic disease, or in combination with paclitaxel for patients who have not received chemotherapy for metastatic disease. HER2-positive tumours — defined by IHC 3+ staining or FISH amplification — represent approximately 15 to 20% of all breast cancers and are associated with a more aggressive disease course and poorer prognosis when untreated with targeted therapy. Trastuzumab has transformed the prognosis of HER2-positive MBC, with response rates of 26 to 50% in combination regimens.

HER2-Positive Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

Vivitra 440 mg is indicated in combination with cisplatin and capecitabine or 5-fluorouracil for the first-line treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma who have not previously received anti-cancer treatment for metastatic disease. The pivotal ToGA trial demonstrated that adding Trastuzumab to chemotherapy significantly extended overall survival in HER2-positive gastric cancer patients, establishing Trastuzumab as the standard of care in this indication.

HER2-Positive Metastatic Gastric Cancer — HER2 Overexpression Requirement

HER2 positivity for gastric cancer is defined as IHC 3+ or IHC 2+/FISH amplified tumour status, as determined by a validated and approved test. Trastuzumab therapy must only be initiated in patients confirmed HER2-positive by pathology. Patients whose tumours do not overexpress HER2 have not demonstrated clinical benefit from Trastuzumab therapy.

How Does Vivitra 440 mg (Trastuzumab) Work?

Trastuzumab is a recombinant humanized monoclonal antibody that exerts its anti-tumour activity through multiple complementary mechanisms, all dependent on the presence of HER2 overexpression on the surface of cancer cells:

Mechanism 1 – HER2 Receptor Binding and Signalling Blockade Trastuzumab binds with high specificity and affinity to subdomain IV of the HER2 extracellular domain on the surface of HER2-overexpressing tumour cells. This binding prevents HER2 from activating its tyrosine kinase intracellular domain, blocking downstream signalling pathways — including the PI3K/AKT and MAPK/ERK pathways — that drive tumour cell proliferation, survival, and angiogenesis. By cutting off these growth signals, Trastuzumab arrests cell cycle progression and suppresses tumour growth.

Mechanism 2 – HER2 Receptor Shedding Inhibition HER2 overexpressing cancer cells cleave and shed the extracellular domain of HER2 — a process that generates a constitutively active truncated membrane fragment (p95-HER2) associated with Trastuzumab resistance and aggressive disease. Trastuzumab inhibits this shedding process, preserving full-length HER2 receptor and maintaining therapeutic sensitivity.

Mechanism 3 – Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) The Fc region of Trastuzumab recruits immune effector cells — primarily natural killer (NK) cells — to HER2-overexpressing tumour cells. This recruitment activates ADCC, in which the immune system directly destroys the flagged cancer cells. This immunological mechanism of action is a key contributor to Trastuzumab's clinical efficacy and distinguishes it from small molecule HER2 inhibitors.

Mechanism 4 – Inhibition of Tumour Angiogenesis Trastuzumab reduces tumour vascularity by decreasing the expression of angiogenic factors including VEGF and other pro-angiogenic mediators, thereby limiting the blood supply that supports tumour growth and metastasis.

Dosage and Administration

This product must be administered exclusively by a qualified oncologist or trained healthcare professional in a hospital or oncology infusion centre. It must not be self-administered.

Reconstitution

Using aseptic technique, reconstitute the 440 mg vial with 20 mL of Bacteriostatic Water for Injection (BWFI) supplied with the product to yield a multi-dose solution of 21 mg/mL. Gently swirl the vial — do not shake. Allow approximately 5 minutes for complete dissolution. The reconstituted solution should appear clear to slightly opalescent and colourless to pale yellow. Inspect visually — do not use if the solution is discoloured, cloudy, or contains visible particles. If BWFI is unavailable, the vial may be reconstituted with Sterile Water for Injection USP without benzyl alcohol — however, this yields a single-use solution that must be used immediately and any unused portion discarded.

Dilution Withdraw the calculated volume from the reconstituted vial and add to an infusion bag containing 250 mL of 0.9% Sodium Chloride Injection. Gently invert the bag to mix — do not shake. Do not use dextrose (5% glucose) solutions for dilution as they cause protein aggregation.

Adult Dosing — Breast Cancer (Intravenous)

Initial loading dose: 8 mg/kg administered as a 90-minute intravenous infusion. If the loading dose was well tolerated, subsequent maintenance doses of 6 mg/kg may be administered as 30-minute infusions every 3 weeks. Treatment continues for 52 weeks (1 year) in the adjuvant setting, or until disease progression in the metastatic setting.

Adult Dosing — Metastatic Gastric Cancer (Intravenous)

Initial loading dose: 8 mg/kg as a 90-minute infusion on Day 1 of Cycle 1. Maintenance doses: 6 mg/kg every 3 weeks as a 30-minute infusion. Treatment is continued until disease progression.

Infusion Monitoring

Step 1 – Pre-medicate with antihistamine and paracetamol/antipyretic as prescribed to reduce infusion-related reactions. Step 2 – Administer the initial dose over 90 minutes. Monitor the patient closely throughout and for at least 6 hours following the start of the first infusion and for 2 hours following subsequent infusions for signs of infusion-related reactions. Step 3 – Interrupt the infusion immediately if the patient develops dyspnoea, clinically significant hypotension, or other serious infusion reactions. Restart at a slower rate once symptoms resolve. Step 4 – Assess left ventricular ejection fraction (LVEF) before initiation and at regular intervals during treatment — every 3 months during therapy and for up to 24 months following completion of adjuvant treatment.

Vivitra (Trastuzumab Biosimilar) vs Herceptin – What is the Difference?

Both Vivitra 440 mg and Herceptin contain Trastuzumab as the active substance and work through identical mechanisms of action. As an approved Trastuzumab biosimilar, Vivitra has undergone rigorous comparability studies to demonstrate equivalent quality, safety, and efficacy to the reference product.

The key differences are:

• Cost: Vivitra 440 mg is significantly more cost-effective than branded Herceptin — making life-saving HER2-targeted therapy accessible to a far broader patient population
• Manufacturer: Vivitra is manufactured by Zydus Lifesciences, India; Herceptin is manufactured by Roche/Genentech, Switzerland
• Clinical equivalence: Biosimilar comparability studies confirm no clinically meaningful differences in pharmacokinetics, pharmacodynamics, efficacy, or safety
• Regulatory status: Vivitra is approved by the Central Drugs Standard Control Organisation (CDSCO) in India and is available for export to international markets

Contraindications

Vivitra 440 mg Injection is contraindicated in:

• Patients with known hypersensitivity to Trastuzumab, murine proteins, or any excipient in the formulation
• Patients with severe dyspnoea at rest due to advanced malignancy or requiring supplemental oxygen therapy — the risk of serious and fatal pulmonary events is significantly elevated in this population
• Pregnant women — Trastuzumab can cause oligohydramnios, foetal renal dysfunction, and potentially fatal foetal harm. Women of childbearing potential must use effective contraception during treatment and for 7 months after the last dose
• Breastfeeding mothers — Trastuzumab is excreted in breast milk and must not be used during breastfeeding or for 7 months following the last dose

Clinically Important Warnings

Cardiotoxicity and Left Ventricular Dysfunction Trastuzumab is associated with a risk of left ventricular dysfunction, symptomatic heart failure, and reduced left ventricular ejection fraction (LVEF). Risk is highest when used concurrently or sequentially with anthracycline-based chemotherapy (doxorubicin, epirubicin). LVEF must be assessed at baseline and monitored every 3 months during therapy. Withhold Trastuzumab if LVEF drops 16 or more percentage points from baseline or below 50% with a 10 or more percentage point drop from baseline. Permanently discontinue if LVEF does not recover within 8 weeks.

Infusion-Related Reactions and Pulmonary Events Serious and potentially fatal infusion-related reactions — including anaphylaxis, bronchospasm, hypotension, and acute respiratory distress — have been reported. Most reactions occur during or within 24 hours of the initial infusion. A resuscitation team and emergency equipment must always be immediately available during and following infusion.

Embryo-Fetal Toxicity Trastuzumab causes oligohydramnios and associated complications including pulmonary hypoplasia, skeletal abnormalities, and neonatal death when administered during pregnancy. Women must avoid pregnancy during treatment and for 7 months after the last dose.

Drug Interactions

Anthracyclines (doxorubicin, epirubicin): Concurrent administration with anthracyclines significantly increases the risk of cardiac dysfunction and is not recommended. Trastuzumab may be used after completion of anthracycline-based chemotherapy.

Paclitaxel: Paclitaxel plasma concentrations are increased by approximately 1.5-fold when co-administered with Trastuzumab. Monitor for enhanced paclitaxel-related toxicity including peripheral neuropathy and myelosuppression.

Warfarin and anticoagulants: Cancer patients on concurrent anticoagulation therapy should be monitored closely as multiple factors in their clinical management may alter INR.

Capecitabine and cisplatin: Used in combination in the gastric cancer indication; no clinically significant pharmacokinetic interactions have been identified. Monitor closely for additive toxicities.

Possible Side Effects

Vivitra 440 mg Injection is generally well tolerated in the oncology setting. Side effects reported in clinical trials include:

Very common — affecting more than 1 in 10 patients:

• Infusion-related reactions during or after the first infusion — fever, chills, rigors, headache, nausea, vomiting, dizziness, dyspnoea, hypotension, rash, and fatigue
• Increased susceptibility to infections — upper respiratory tract infections, urinary tract infections
• Anaemia, neutropenia, and thrombocytopenia
• Left ventricular dysfunction and reduced LVEF
• Peripheral neuropathy — tingling and numbness of hands and feet
• Alopecia (hair loss)
• Nausea, diarrhoea, and mucositis
• Musculoskeletal pain — joint pain, muscle pain, and back pain
• Fatigue and asthenia

Serious side effects requiring immediate medical attention:

• Symptomatic congestive heart failure — shortness of breath, leg oedema, palpitations
• Severe infusion-related anaphylaxis — facial swelling, severe bronchospasm, cardiovascular collapse
• Severe pulmonary events — interstitial pneumonitis, pulmonary fibrosis, acute respiratory distress syndrome
• Oligohydramnios in pregnant patients — immediately discontinue if pregnancy is detected

Storage Instructions

Store at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) in a refrigerator. Do not freeze. Store in the original carton to protect from light. Following reconstitution with BWFI, the multi-dose solution is stable for up to 28 days at 2 to 8 degrees Celsius — do not freeze the reconstituted solution. If reconstituted with Sterile Water for Injection (preservative-free), discard any unused portion immediately after single use. Following dilution in 0.9% Sodium Chloride for infusion, use immediately or store at 2 to 8 degrees Celsius for up to 24 hours — do not freeze. Keep out of reach of children.

Frequently Asked Questions

What is Vivitra 440 mg used for? Vivitra 440 mg Injection (Trastuzumab) is used for the treatment of HER2-positive early breast cancer as adjuvant therapy, HER2-positive locally advanced and metastatic breast cancer, and HER2-positive metastatic gastric and gastroesophageal junction adenocarcinoma. It is a targeted monoclonal antibody therapy that inhibits HER2-driven tumour growth.

Is Vivitra the same as Herceptin? Vivitra is a biosimilar of Herceptin. Both contain Trastuzumab as the active substance and work through the same mechanism. Biosimilar comparability studies confirm no clinically meaningful differences in quality, safety, or efficacy. Vivitra is significantly more cost-effective than branded Herceptin.

How is Vivitra 440 mg administered? Vivitra 440 mg is administered intravenously by a qualified oncologist or trained healthcare professional in a hospital or infusion centre. It is not suitable for self-administration. The vial is reconstituted with Bacteriostatic Water for Injection and diluted in 0.9% Sodium Chloride before infusion.

How long does each Trastuzumab infusion take? The initial loading dose infusion is administered over 90 minutes. If well tolerated, subsequent maintenance doses may be given as 30-minute infusions every 3 weeks.

How long is Trastuzumab treatment continued? In the adjuvant early breast cancer setting, treatment is continued for 52 weeks (12 months). In the metastatic breast cancer and metastatic gastric cancer settings, treatment is continued until disease progression or unacceptable toxicity.

What cardiac monitoring is required during Vivitra therapy? Left ventricular ejection fraction (LVEF) must be assessed before starting treatment and monitored every 3 months throughout therapy. LVEF should continue to be monitored for up to 24 months following completion of adjuvant treatment.

Do you supply Vivitra 440 mg to hospitals and oncology centres in USA, UK, and UAE? Yes. We supply Vivitra 440 mg Injection to hospitals, oncology infusion centres, and licensed pharmaceutical importers in the United States, United Kingdom, UAE (Dubai, Abu Dhabi), Saudi Arabia, Australia, and India.

Is a prescription required? Yes. Vivitra 440 mg is a prescription-only oncology medicine. It must only be prescribed by a qualified oncologist and administered under oncological supervision in an appropriate clinical setting.

Medically Reviewed Content This product description has been written in accordance with clinical oncology guidelines and publicly available pharmaceutical references including the FDA-approved Herceptin (Trastuzumab) prescribing information (Genentech), EMA Herceptin Summary of Product Characteristics, DailyMed NIH Trastuzumab monograph, NCBI PubMed HERA and ToGA trial data, Vivitra product information (Zydus Lifesciences), Apollo Pharmacy and Netmeds clinical monographs, and American Society of Clinical Oncology (ASCO) Trastuzumab clinical practice guidelines. This product is for professional and institutional use only and must be administered by a qualified oncologist in a supervised clinical setting.