Trumab 440 mg Injection

Trumab 440 mg Injection – Trastuzumab 440mg | Glenmark Pharmaceuticals HER2-Targeted Biosimilar for Breast and Gastric Cancer

Trumab 440 mg Injection is a prescription-only, intravenously administered recombinant humanized IgG1 monoclonal antibody containing Trastuzumab 440mg, manufactured by Glenmark Pharmaceuticals Ltd. — a globally operating Indian pharmaceutical company headquartered in Mumbai, Maharashtra, with a presence across more than 80 countries and a strong portfolio of oncology biosimilars.

Trumab is a biosimilar of Herceptin, the reference Trastuzumab product developed by Roche/Genentech and approved by the FDA in 1998 as the first anti-HER2 monoclonal antibody therapy for breast cancer — one of the most transformative developments in the history of oncology. As a Trastuzumab biosimilar developed and manufactured by Glenmark Pharmaceuticals, Trumab delivers the same proven HER2-targeted mechanism, equivalent clinical efficacy, and comparable safety profile as the originator product — at a more accessible and cost-effective price point.

Trumab 440 mg is supplied as a lyophilised powder for concentrate for solution for infusion in a single-use glass vial, administered exclusively by qualified oncologists or trained clinical professionals in a hospital or oncology infusion centre setting. Each vial contains Trastuzumab 440mg alongside excipients including L-Histidine (6.4 mg), L-Histidine HCl Monohydrate (9.9 mg), Polysorbate 20 (1.8 mg), and Trehalose (400 mg).

What is Trumab 440 mg Used For?

HER2-Positive Early Breast Cancer — Adjuvant Therapy

Trumab 440 mg is indicated as part of a multimodal treatment regimen for patients with HER2-positive early breast cancer following surgery, chemotherapy, and radiation. In the adjuvant setting, Trastuzumab is administered for 52 weeks (12 months) and has been shown in the landmark HERA clinical trial to reduce the risk of breast cancer recurrence by 46% and significantly improve disease-free and overall survival compared to chemotherapy alone. Trumab may be used as monotherapy or in combination with paclitaxel, docetaxel, or carboplatin-based chemotherapy regimens in confirmed HER2-positive early breast cancer patients.

HER2-Positive Locally Advanced and Metastatic Breast Cancer

Trumab 440 mg is indicated as first-line therapy for HER2-positive metastatic breast cancer (MBC) either as monotherapy for patients previously treated with at least two prior chemotherapy regimens, or in combination with paclitaxel for patients without prior chemotherapy for metastatic disease. HER2-positive tumours account for approximately 15 to 20% of all breast cancers and are characterised by overexpression of the HER2 protein — defined as IHC 3+ staining or FISH/ISH amplification confirmed by pathology — and are associated with more aggressive disease behaviour when untreated. Trastuzumab-based regimens have demonstrated response rates of 26 to 50% in the metastatic setting, establishing Trastuzumab as the cornerstone of HER2-positive MBC management.

HER2-Positive Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

Trumab 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 (GEJ) adenocarcinoma who have not received prior systemic therapy for metastatic disease. The pivotal ToGA (Trastuzumab for Gastric Cancer) trial — the first successful targeted therapy trial in gastric cancer — demonstrated that adding Trastuzumab to standard platinum-fluoropyrimidine chemotherapy significantly extended median overall survival from 11.1 months to 13.8 months, with the benefit most pronounced in patients with IHC 3+ or IHC 2+/FISH-positive tumours.

HER2 positivity in gastric cancer must be confirmed by IHC 3+ or IHC 2+/FISH amplified results from a validated laboratory test before initiating Trumab therapy.

How Does Trumab 440 mg (Trastuzumab) Work?

Trastuzumab in Trumab 440 mg is a recombinant humanized monoclonal antibody — engineered from murine anti-HER2 antibody with human IgG1 framework regions — that exerts its anti-tumour activity through four complementary mechanisms, all entirely dependent on the tumour overexpressing HER2:

Mechanism 1 – Selective HER2 Receptor Binding and Downstream Signalling Blockade Trastuzumab contains two antigen-specific binding sites that bind selectively and with high affinity to subdomain IV of the HER2 receptor extracellular domain — the juxtamembrane region — on HER2-overexpressing tumour cell surfaces. This binding sterically prevents HER2 receptor dimerisation and blocks activation of the intracellular tyrosine kinase domain, shutting down the PI3K/AKT and MAPK/ERK downstream proliferation and survival signalling pathways that drive HER2-amplified tumour growth, invasion, and metastasis.

Mechanism 2 – Inhibition of HER2 Ectodomain Shedding In HER2-overexpressing tumours, the HER2 receptor undergoes proteolytic cleavage and shedding of its extracellular domain — generating a constitutively active truncated membrane fragment called p95-HER2 that is associated with resistance to anti-HER2 therapy and aggressive disease. Trastuzumab inhibits this shedding process, preserving full-length receptor expression and maintaining Trastuzumab sensitivity throughout the course of treatment.

Mechanism 3 – Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) The conserved human IgG1 Fc region of Trastuzumab recruits immune effector cells — principally natural killer (NK) cells and macrophages — to HER2-overexpressing tumour cells through Fc receptor engagement. This triggers ADCC, wherein the activated immune cells directly lyse and destroy the opsonised cancer cells. ADCC is considered a primary mechanism of Trastuzumab's in vivo antitumour activity and is a key differentiator from small molecule tyrosine kinase inhibitors.

Mechanism 4 – Anti-Angiogenic Activity Trastuzumab reduces the expression of pro-angiogenic factors including VEGF within the tumour microenvironment, thereby limiting the formation of new blood vessels supplying the tumour and restricting oxygen and nutrient delivery to cancer cells.

Dosage and Administration

This product must be administered exclusively by a qualified oncologist or experienced clinical professional in a hospital or oncology infusion centre equipped with resuscitation facilities. Trumab 440 mg Injection is not for self-administration.

Reconstitution

Using strict aseptic technique, reconstitute each 440 mg vial with 20 mL of Bacteriostatic Water for Injection (BWFI) containing 1.1% benzyl alcohol — supplied with the product — to yield a multi-dose solution with a concentration of 21 mg/mL. Gently swirl the vial for approximately 5 minutes — do not shake. The reconstituted solution should appear clear to slightly opalescent and colourless to pale yellow without visible particles. Do not use the solution if it appears discoloured, cloudy, or contains particulate matter. When BWFI is unavailable, reconstitute with Sterile Water for Injection without benzyl alcohol — use the resultant solution as a single-use preparation and discard any unused portion immediately.

Dilution

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

Adult Dosing — Breast Cancer (Intravenous Three-Weekly Schedule)

Loading dose: 8 mg/kg administered as a 90-minute intravenous infusion on Day 1 of Cycle 1. If the loading dose was well tolerated without infusion-related reactions, subsequent maintenance doses of 6 mg/kg every 3 weeks may be administered as 30-minute infusions. Continue treatment for 52 weeks in the adjuvant setting, or until disease progression or unacceptable toxicity in the metastatic setting.

Adult Dosing — Metastatic Gastric Cancer (Intravenous Three-Weekly Schedule)

Loading dose: 8 mg/kg intravenous infusion over 90 minutes on Day 1 of the first treatment cycle. Maintenance doses: 6 mg/kg every 3 weeks as a 30-minute infusion. Administer in combination with cisplatin and capecitabine or 5-fluorouracil. Continue until disease progression.

Step 1 – Pre-Medication Administer antihistamine and antipyretic pre-medication as prescribed to reduce the incidence and severity of infusion-related reactions before the first and subsequent infusions.

Step 2 – Initial Infusion Monitoring Administer the first dose over 90 minutes. Monitor the patient closely throughout the infusion and for a minimum of 6 hours following initiation of the first dose and for 2 hours following subsequent infusions for signs of infusion-related reactions, anaphylaxis, bronchospasm, hypotension, or respiratory distress.

Step 3 – Infusion Reaction Management Interrupt the infusion immediately if the patient develops dyspnoea, severe bronchospasm, hypotension, urticaria, or angioedema. Administer appropriate supportive treatment. Restart the infusion at a reduced rate once symptoms fully resolve.

Step 4 – Cardiac Monitoring Assess left ventricular ejection fraction (LVEF) at baseline before initiating Trumab therapy and monitor at regular intervals every 3 months throughout treatment. Continue LVEF monitoring for up to 24 months following completion of adjuvant treatment. Withhold Trumab if LVEF drops 16 or more percentage points from baseline or falls below 50% with a 10 or more percentage point drop from baseline.

Step 5 – Missed Infusion If a scheduled Trumab infusion is missed by more than one week, re-administer the loading dose of 8 mg/kg as soon as possible, followed by resumption of the regular maintenance dose schedule. Contact the oncology team immediately if a scheduled infusion is missed.

Trumab (Glenmark) vs Herceptin — What is the Difference?

Both Trumab and Herceptin contain Trastuzumab as the active substance and deliver identical HER2-targeted clinical activity. As a biosimilar developed through rigorous analytical, functional, and clinical comparability studies, Trumab has demonstrated no clinically meaningful differences in pharmacokinetics, pharmacodynamics, efficacy, or safety profile compared to the originator Herceptin.

The key distinctions are:

• Manufacturer: Trumab is manufactured by Glenmark Pharmaceuticals Ltd., Mumbai, India — a globally recognised pharmaceutical company present in 80+ countries. Herceptin is manufactured by Roche/Genentech, Switzerland
• Cost advantage: Trumab is significantly more cost-effective than branded Herceptin, making HER2-targeted therapy accessible to a broader patient and institutional population
• Clinical equivalence: Biosimilar comparability data confirm equivalent quality, safety, and efficacy
• Glenmark's oncology expertise: Glenmark has established a dedicated oncology biosimilar portfolio and global distribution infrastructure, ensuring supply reliability and cold chain integrity for international institutional buyers
• Pack presentation: Single vial of 1, containing Trastuzumab 440mg powder for concentrate for solution for infusion, with BWFI diluent

Contraindications

Trumab 440 mg Injection is contraindicated in:

• Patients with known hypersensitivity to Trastuzumab, murine proteins, benzyl alcohol (BWFI excipient), or any other component of the formulation
• Patients with severe dyspnoea at rest due to advanced malignancy or complications of disease, or patients requiring supplemental oxygen therapy — the risk of fatal pulmonary events is substantially elevated in this population
• Pregnant women — Trastuzumab causes oligohydramnios, foetal renal dysfunction, and potentially fatal embryo-foetal harm. Effective contraception must be used during treatment and for 7 months following the last dose
• Breastfeeding mothers — Trastuzumab is detectable in breast milk. Breastfeeding must be discontinued during therapy and for 7 months after the last dose
• Patients below 18 years of age — safety and efficacy in paediatric patients have not been established

Clinically Important Warnings

Cardiotoxicity Trastuzumab is associated with left ventricular dysfunction, symptomatic congestive heart failure, and reduction in LVEF — particularly when used concurrently or sequentially with anthracycline chemotherapy. Concurrent administration with anthracyclines (doxorubicin, epirubicin) is not recommended. A history of myocardial infarction, angina, clinically significant valvular disease, or hypertension requiring treatment increases cardiac risk and requires closer monitoring.

Infusion-Related Reactions Serious and potentially life-threatening infusion-related reactions including anaphylaxis, angioedema, urticaria, bronchospasm, and cardiovascular collapse have been reported — predominantly during or within 24 hours of the first infusion. Emergency resuscitation facilities and personnel must always be immediately available. Patients with pre-existing pulmonary compromise are at highest risk.

Pulmonary Toxicity Severe pulmonary events including interstitial pneumonitis, pulmonary fibrosis, pleural effusion, non-cardiogenic pulmonary oedema, and acute respiratory distress syndrome have been reported in post-marketing experience. Discontinue Trumab in patients who develop pulmonary infiltrates or acute respiratory distress syndrome.

Embryo-Foetal Toxicity Trastuzumab exposure during pregnancy has been associated with oligohydramnios and associated complications — pulmonary hypoplasia, skeletal malformations, and neonatal death. All women of childbearing potential must use effective contraception during treatment and for 7 months following the last dose. Report any suspected pregnancy during treatment immediately.

Drug Interactions

Anthracyclines (doxorubicin, epirubicin): Concomitant use with anthracyclines significantly increases the risk of cardiotoxicity and is not recommended. Administer Trumab sequentially following completion of anthracycline-based regimens.

Paclitaxel: Co-administration increases paclitaxel plasma exposure by approximately 1.5-fold. Monitor closely for enhanced paclitaxel toxicity including peripheral neuropathy and neutropenia.

Capecitabine and cisplatin: Used in combination in the gastric cancer indication. No clinically significant pharmacokinetic interactions identified. Monitor for additive gastrointestinal and haematological toxicities.

Warfarin and oral anticoagulants: Multiple factors in the clinical management of oncology patients may affect INR. Monitor closely in patients receiving concurrent anticoagulant therapy.

Live vaccines: Do not administer live vaccines during Trumab therapy. Ensure all vaccinations are up to date prior to initiating treatment. Inactivated vaccines may be administered but immune responses may be attenuated.

Possible Side Effects

Trumab 440 mg Injection is generally well tolerated in the oncology setting. Side effects reported in clinical trial data for Trastuzumab include:

Very common — affecting more than 1 in 10 patients:

• Infusion-related reactions — fever, chills, nausea, vomiting, headache, dizziness, and dyspnoea — most common during the first infusion and typically resolving within hours
• Increased susceptibility to infections — upper respiratory tract infections, urinary tract infections, sepsis
• Left ventricular dysfunction and reduced LVEF
• Anaemia, neutropenia, leukopenia, and thrombocytopenia
• Peripheral neuropathy — numbness and tingling in hands and feet
• Nausea, diarrhoea, vomiting, and mucositis
• Fatigue and asthenia
• Musculoskeletal pain including joint pain, bone pain, and back pain
• Insomnia
• Rash and skin reactions

Serious side effects requiring immediate medical attention:

• Symptomatic congestive heart failure — shortness of breath, leg oedema, palpitations, and reduced exercise tolerance
• Severe anaphylaxis — facial swelling, severe bronchospasm, hypotension, and cardiovascular collapse
• Severe pulmonary events — interstitial pneumonitis, acute respiratory distress
• Oligohydramnios — if pregnancy is suspected, discontinue immediately and investigate

Storage Instructions

Store at 2 to 8 degrees Celsius in a refrigerator. Do not freeze. Store in the original carton to protect from light. Following reconstitution with Bacteriostatic Water for Injection, the multi-dose reconstituted solution is stable for up to 28 days at 2 to 8 degrees Celsius — label the vial with the date of reconstitution and discard after 28 days. Do not freeze the reconstituted solution. If reconstituted with preservative-free Sterile Water for Injection, use immediately and discard any unused volume. Following dilution in 0.9% Sodium Chloride Injection, use immediately or store at 2 to 8 degrees Celsius for no longer than 24 hours before administration. Keep out of reach of children.

Frequently Asked Questions

What is Trumab 440 mg used for? Trumab 440 mg Injection contains Trastuzumab 440mg and 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 HER2-targeted monoclonal antibody biosimilar of Herceptin.

Who manufactures Trumab 440 mg? Trumab 440 mg is manufactured by Glenmark Pharmaceuticals Ltd., headquartered in Mumbai, Maharashtra, India — a globally operating pharmaceutical company with presence in over 80 countries and a dedicated oncology biosimilar portfolio.

Is Trumab the same as Herceptin? Trumab is a biosimilar of Herceptin. Both contain Trastuzumab 440mg as the active substance and work through identical mechanisms of action. Biosimilar comparability studies confirm no clinically meaningful differences in quality, safety, or efficacy. Trumab offers a significantly more cost-effective alternative to branded Herceptin.

How is Trumab 440 mg administered? Trumab 440 mg is reconstituted with Bacteriostatic Water for Injection, diluted in 250 mL of 0.9% Sodium Chloride, and administered as an intravenous infusion by a qualified oncologist or trained healthcare professional. It must not be self-administered.

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

What cardiac monitoring is required? LVEF must be assessed at baseline and monitored every 3 months throughout therapy. Monitoring should continue for up to 24 months after completing adjuvant treatment. Trumab must be withheld if LVEF declines significantly below the threshold defined in the prescribing information.

Do you supply Trumab 440 mg to hospitals and oncology centres in USA, UK, and UAE? Yes. We supply Trumab 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 with full cold chain integrity maintained throughout shipping.

Is a prescription required? Yes. Trumab 440 mg is a prescription-only oncology medicine that must be prescribed by a qualified oncologist and administered under supervised clinical conditions.

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, Truemeds and Oddway International Trumab product information, Glenmark Pharmaceuticals product data, NCBI PubMed HERA and ToGA trial publications, and ASCO HER2-targeted therapy 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.