Herclon 440 mg Injection

Herclon 440 mg Injection – Trastuzumab 440mg | Roche Originator-Brand HER2-Targeted Therapy for Breast and Gastric Cancer

Herclon 440 mg Injection is a prescription-only, intravenously administered recombinant humanized IgG1 monoclonal antibody containing Trastuzumab 440mg, marketed in India by Roche Products India Pvt. Ltd. — the Indian subsidiary of F. Hoffmann-La Roche Ltd., Basel, Switzerland — and manufactured by F. Hoffmann-La Roche Ltd. in collaboration with Cipla Ltd., India.

Roche is the global originator of Trastuzumab therapy. When the FDA approved Herceptin in 1998 — making Trastuzumab the world's first anti-HER2 monoclonal antibody therapy for breast cancer — it was Roche and Genentech who brought that landmark therapy to patients. Herclon 440 mg represents that same originator scientific heritage and manufacturing standard, available through the Indian market and its global distribution network.

Herclon carries the full clinical authority of over 25 years of Trastuzumab use across millions of patients worldwide, backed by the most extensive body of HER2 clinical trial data in oncology history — including the pivotal HERA trial in early breast cancer, the landmark ToGA trial in gastric cancer, and over two decades of real-world post-marketing safety surveillance across more than 100 countries.

Herclon 440 mg is supplied as a lyophilised powder for concentrate for solution for infusion in a single-use glass vial containing Trastuzumab 440mg, administered exclusively by qualified oncologists or trained clinical professionals in a hospital or oncology infusion centre. It is an NPPA-regulated product in India, reinforcing its compliance with stringent national pricing and quality standards.

What is Herclon 440 mg Used For?

HER2-Positive Early Breast Cancer — Adjuvant Therapy

Herclon 440 mg is indicated as part of a complete treatment programme for patients with HER2-positive early breast cancer following surgery and chemotherapy. HER2 positivity — defined as IHC 3+ staining or FISH/ISH amplification — is confirmed by validated pathological testing before initiating Trastuzumab therapy. In the landmark HERA trial, adjuvant Trastuzumab administered for 12 months reduced the relative risk of breast cancer recurrence by 46% and achieved a 37% relative improvement in 10-year overall survival compared to chemotherapy alone — with 10-year survival increasing from 75.2% to 84%. Disease-free survival over 10 years improved from 62.2% to 73.7%. These results, generated from nearly 4,000 patients, represent the most robust adjuvant HER2 data in oncology and form the clinical foundation for Herclon's use in early breast cancer. Herclon may be used as monotherapy following completion of multimodality chemotherapy, or in combination with paclitaxel, docetaxel, or carboplatin-containing regimens.

HER2-Positive Locally Advanced and Metastatic Breast Cancer

Herclon 440 mg is indicated as first-line therapy for HER2-positive metastatic breast cancer (MBC) — either as monotherapy in patients who have received at least two prior chemotherapy regimens for metastatic disease, or in combination with paclitaxel for patients without prior chemotherapy for metastatic disease. It is also indicated in combination with aromatase inhibitors for hormone receptor-positive metastatic breast cancer with HER2 overexpression. Herclon is additionally suitable for HER2-positive metastatic breast cancer in patients with hormone receptor positive disease, used in combination with hormonal therapies including anastrozole and tamoxifen.

HER2-Positive Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

Herclon 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 previously received treatment for metastatic disease. The pivotal ToGA trial — the first successful targeted therapy trial in gastric cancer, conducted across 24 countries — demonstrated that adding Trastuzumab to standard chemotherapy increased median overall survival from 11.1 to 13.8 months, with overall survival reaching 16 months in the highest HER2-expressing subgroup. Herclon, as the Roche originator Trastuzumab, carries the full clinical authority of the ToGA trial data.

HER2 positivity for gastric cancer must be confirmed as IHC 3+ or IHC 2+/FISH-amplified by a validated laboratory test before initiating Herclon therapy.

How Does Herclon 440 mg (Trastuzumab) Work?

Trastuzumab in Herclon 440 mg is a recombinant humanized monoclonal antibody — constructed by engineering the complementarity-determining regions (CDRs) of a murine anti-HER2 antibody into a human IgG1 framework — that exerts its comprehensive anti-tumour activity through four distinct and clinically established mechanisms:

Mechanism 1 – HER2 Extracellular Domain IV Binding and Signalling Pathway Blockade Herclon's Trastuzumab binds with high selectivity and affinity to subdomain IV of the HER2 receptor extracellular domain on HER2-overexpressing tumour cell surfaces. This binding prevents HER2 homo- and heterodimerisation and sterically blocks activation of the juxtamembrane tyrosine kinase domain, shutting down the PI3K/AKT (cell survival) and MAPK/ERK (cell proliferation) downstream signalling cascades that drive HER2-amplified tumour growth, invasion, and distant metastasis.

Mechanism 2 – Inhibition of Proteolytic HER2 Ectodomain Shedding In HER2-overexpressing cancer cells, the ADAM10 and ADAM17 metalloprotease enzymes cleave and shed the extracellular domain of HER2 — producing a constitutively active truncated fragment p95-HER2 associated with Trastuzumab resistance. Herclon's Trastuzumab binds subdomain IV and physically blocks this proteolytic cleavage, maintaining intact full-length HER2 receptor expression and preserving ongoing therapeutic susceptibility throughout the course of treatment.

Mechanism 3 – Fc-Mediated Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) The human IgG1 Fc region of Trastuzumab in Herclon engages Fc-gamma receptors on immune effector cells — particularly natural killer (NK) cells, macrophages, and dendritic cells — recruiting them to HER2-overexpressing tumour cells and triggering direct immune-mediated cytolysis of cancer cells through ADCC. This immunological mechanism is a primary and clinically essential component of Trastuzumab's in vivo anti-tumour efficacy and distinguishes monoclonal antibody-based HER2 therapy from small molecule tyrosine kinase inhibitors such as lapatinib, which lack an Fc region.

Mechanism 4 – Suppression of Tumour Angiogenesis Trastuzumab reduces the expression and secretion of pro-angiogenic factors — including VEGF, Ang-1, and TGF-beta — within the tumour microenvironment, limiting the formation of new tumour vasculature, restricting oxygen and nutrient delivery to cancer cells, and contributing to tumour regression.

Dosage and Administration

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

Reconstitution

Using strict aseptic technique, reconstitute each 440 mg vial with 20 mL of Bacteriostatic Water for Injection (BWFI) containing 1.1% benzyl alcohol to yield a multi-dose solution with a Trastuzumab concentration of 21 mg/mL. Gently swirl the vial for approximately 5 minutes — do not shake as shaking causes protein aggregation and foaming. The reconstituted solution should appear clear to slightly opalescent, colourless to pale yellow, and free of visible particulate matter. Inspect each vial visually before use and discard if discoloured, turbid, or if visible particles are present.

When BWFI is unavailable, reconstitute with preservative-free Sterile Water for Injection — however the resulting solution must be used immediately as a single-use preparation and any unused volume discarded without refrigeration.

Dilution

Withdraw the calculated dose volume from the reconstituted vial and transfer 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 5% Dextrose (glucose) solutions for dilution as they cause Trastuzumab protein aggregation and are incompatible.

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

Loading dose: 8 mg/kg body weight as a 90-minute intravenous infusion on Day 1, Cycle 1. Maintenance dose: 6 mg/kg every 3 weeks administered as a 30-minute intravenous infusion if the loading dose was well tolerated. Adjuvant treatment duration: 52 weeks (12 months). Metastatic treatment: continue until disease progression or unacceptable toxicity.

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

Loading dose: 8 mg/kg as a 90-minute intravenous infusion on Day 1 of Cycle 1, in combination with cisplatin and capecitabine or 5-fluorouracil. Maintenance dose: 6 mg/kg every 3 weeks as a 30-minute infusion. Continue until disease progression.

Step 1 – Pre-Medication Administer antihistamine and paracetamol or antipyretic pre-medication as prescribed prior to each infusion to minimise the risk and severity of infusion-related reactions, particularly with the first dose.

Step 2 – First Infusion Monitoring Administer the loading dose over a minimum of 90 minutes. Monitor the patient closely throughout the infusion and for a minimum of 6 hours following the start of the first infusion and 2 hours following each subsequent infusion for fever, chills, dyspnoea, hypotension, bronchospasm, urticaria, or anaphylaxis.

Step 3 – Infusion Reaction Response Interrupt the infusion immediately if the patient develops dyspnoea, clinically significant hypotension, angioedema, or severe bronchospasm. Initiate appropriate medical management — antihistamines, corticosteroids, bronchodilators, epinephrine as clinically indicated. Restart the infusion at a reduced rate once symptoms have fully resolved.

Step 4 – Cardiac Monitoring Throughout Therapy Assess left ventricular ejection fraction (LVEF) at baseline before initiating Herclon and at regular intervals every 3 months throughout treatment. Continue monitoring for up to 24 months following completion of adjuvant therapy. Withhold Herclon if LVEF drops 16 or more percentage points from baseline or falls below 50% with a 10 or more percentage point absolute decline from baseline. Permanently discontinue if LVEF does not recover within 8 weeks of withholding treatment, or if three consecutive withholding decisions are required.

Step 5 – Missed Infusion If an infusion is missed by more than 1 week, re-administer the 8 mg/kg loading dose followed by resumption of the regular 6 mg/kg three-weekly maintenance schedule. If an infusion is missed by one week or less, administer the usual maintenance dose at the next scheduled visit without re-loading.

Herclon 440 mg vs Trastuzumab Biosimilars — Why the Originator Matters

Herclon is not a biosimilar. It is the originator-brand Trastuzumab product marketed by Roche — the company that developed, clinically validated, and has continuously manufactured Trastuzumab since its original FDA approval in 1998. This distinction is clinically and commercially significant for the following reasons:

• Originator heritage: Every major Trastuzumab clinical trial — HERA, ToGA, BCIRG 006, FinHer, PACS-04, PHARE, PERSEPHONE — was conducted using Roche's originator Trastuzumab. All clinical outcome data cited in oncology guidelines globally are derived from originator product studies
• Manufacturing consistency: Roche's originator manufacturing process has been continuously refined over 25+ years, with the most extensive post-marketing safety database of any anti-HER2 agent in clinical use
• Regulatory standing: Herclon as the originator product is the reference listed drug (RLD) against which all biosimilars must demonstrate comparability — it is the gold standard by definition
• Institutional preference: Major cancer centres, academic medical institutions, and national oncology procurement programmes in the USA, UK, UAE, and globally continue to specify originator Trastuzumab for clinical trials, compassionate use programmes, and as the reference product for biosimilar switching decisions
• Patient support programmes: Roche provides structured patient assistance programmes through its Indian market operations to support eligible patients in accessing Herclon at subsidised cost

Contraindications

Herclon 440 mg Injection is contraindicated in:

• Patients with known hypersensitivity to Trastuzumab, murine proteins, benzyl alcohol (BWFI excipient), or any other excipient in the formulation
• Patients with severe dyspnoea at rest due to the complications of advanced malignancy, or patients who require supplemental oxygen therapy at rest — the risk of serious and potentially fatal infusion-related pulmonary events is substantially elevated in this population
• Pregnant women — Trastuzumab causes oligohydramnios, foetal renal dysfunction and hypoplasia, skeletal malformations, and potentially fatal embryo-foetal toxicity when administered during pregnancy. Effective contraception must be maintained throughout treatment and for 7 months following the last dose
• Breastfeeding mothers — Trastuzumab is present in breast milk and poses a risk of serious harm to the nursing infant. Breastfeeding must be discontinued during therapy and for 7 months following the last dose
• Patients below 18 years of age — safety and efficacy in paediatric patients have not been established

Clinically Important Warnings

Cardiotoxicity and LVEF Decline Trastuzumab is associated with left ventricular dysfunction, symptomatic congestive heart failure, and clinically significant LVEF reduction — particularly in patients who have received or are receiving anthracycline-based chemotherapy (doxorubicin, epirubicin). Concurrent administration of Herclon with anthracyclines is not recommended. Risk is elevated in patients with pre-existing cardiac conditions including prior myocardial infarction, treated angina, clinically significant valvular heart disease, uncontrolled hypertension, and documented heart failure. Baseline LVEF assessment and regular monitoring throughout therapy are mandatory.

Infusion-Related Reactions and Pulmonary Events Serious and potentially fatal infusion-related reactions — including anaphylaxis, angioedema, urticaria, severe bronchospasm, hypotension, and cardiovascular collapse — have been reported, predominantly during or within 24 hours of the first infusion. Fatal outcomes have occurred in post-marketing surveillance. Emergency resuscitation facilities, trained personnel, and epinephrine must always be immediately available at the infusion site during and following administration.

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. Patients with pre-existing pulmonary compromise are at the highest risk.

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

Drug Interactions

Anthracyclines (doxorubicin, epirubicin): Concomitant administration significantly increases the risk of cardiotoxicity. Not recommended. Administer Herclon sequentially following completion of anthracycline-based chemotherapy.

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

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

Warfarin and anticoagulants: Multiple concurrent factors in the clinical management of oncology patients may alter INR. Monitor closely when Herclon is initiated or discontinued in patients on anticoagulant therapy.

Clarithromycin and atazanavir: Concurrent use should be approached with caution and close monitoring for signs of taste disturbance, nausea, diarrhoea, vomiting, and fatigue.

Live vaccines (including Herpes Zoster / Shingles vaccine — Recombinant, Adjuvanted, and Cholera vaccine): Do not administer live vaccines during Herclon therapy. Concurrent use significantly increases the risk of serious and potentially life-threatening infection. Ensure all vaccinations are up to date before initiating treatment.

Avoid alcohol: Alcohol consumption during Herclon therapy may increase dizziness and worsen any hepatic side effects. Patients should be advised to avoid or strictly limit alcohol intake throughout treatment.

Possible Side Effects

Herclon 440 mg Injection is generally well tolerated in the oncology setting when used at the prescribed dose under appropriate monitoring. 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, nausea, vomiting, headache, dizziness, dyspnoea, and muscle tension — typically mild to moderate and resolving within hours
• Increased susceptibility to infections — upper respiratory tract infections, urinary tract infections, sepsis
• Anaemia, neutropenia, leukopenia, and thrombocytopenia
• Left ventricular dysfunction and LVEF reduction
• Peripheral neuropathy — tingling and numbness of hands and feet
• Nausea, diarrhoea, vomiting, and mucosal inflammation
• Fatigue and weakness
• Musculoskeletal pain — joint pain, bone pain, and back pain
• Insomnia and sleep disturbance
• Alopecia — typically associated with concurrent chemotherapy rather than Trastuzumab alone
• Rash and skin reactions
• Weight loss

Serious side effects requiring immediate medical attention:

• Symptomatic congestive heart failure — significant breathlessness, leg or arm swelling, palpitations, and markedly reduced exercise tolerance
• Severe anaphylaxis — rapid-onset angioedema, severe bronchospasm, cardiovascular collapse
• Severe pulmonary toxicity — acute interstitial pneumonitis, respiratory distress, pulmonary fibrosis
• Oligohydramnios — immediately discontinue if pregnancy is detected during treatment

Storage Instructions

Store at 2 to 8 degrees Celsius in a refrigerator. Do not freeze. Store in the original carton to protect from light and moisture. Avoid extreme heat or cold during transport — cold chain integrity must be maintained throughout storage and shipping. Following reconstitution with Bacteriostatic Water for Injection, the multi-dose solution is stable for up to 28 days when stored at 2 to 8 degrees Celsius — label the vial with the date and time of reconstitution. Do not freeze the reconstituted solution. Following dilution in 0.9% Sodium Chloride Injection, use the infusion preparation immediately or store at 2 to 8 degrees Celsius for no longer than 24 hours before administration. Discard any unused volume in accordance with local pharmaceutical waste disposal regulations. Keep out of reach of children.

Frequently Asked Questions

What is Herclon 440 mg used for? Herclon 440 mg Injection 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 the originator-brand Trastuzumab product marketed by Roche Products India.

Who manufactures Herclon 440 mg? Herclon 440 mg is marketed by Roche Products India Pvt. Ltd. — the Indian subsidiary of F. Hoffmann-La Roche Ltd., Basel, Switzerland — and manufactured by F. Hoffmann-La Roche Ltd. in collaboration with Cipla Ltd., India. Roche is the global originator of Trastuzumab therapy.

Is Herclon the same as Herceptin? Herclon and Herceptin both contain the originator Roche Trastuzumab and share the same manufacturing heritage. Herceptin is the globally marketed brand name for originator Trastuzumab. Herclon is the Indian market brand name for the same originator product marketed by Roche Products India.

How is Herclon different from Trastuzumab biosimilars like Vivitra or Trumab? Herclon is the originator Roche Trastuzumab — the reference product against which all biosimilars must demonstrate comparability. All pivotal clinical trial data underpinning Trastuzumab therapy globally was generated using the originator product. Biosimilars have demonstrated comparable efficacy and safety but carry shorter post-marketing safety histories and different manufacturing processes.

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

What cardiac monitoring is required during Herclon therapy? LVEF must be assessed at baseline before initiating Herclon and monitored every 3 months throughout treatment. Monitoring must continue for up to 24 months following completion of adjuvant therapy. Herclon must be withheld if LVEF declines significantly as defined in the prescribing information.

Is there a patient support programme available for Herclon? Yes. Roche Products India provides a structured patient support and patient assistance programme for Herclon in India for eligible patients. Contact your prescribing oncologist or call the Roche India patient support line for details.

Do you supply Herclon 440 mg to hospitals and oncology centres in USA, UK, and UAE? Yes. We supply Herclon 440 mg Injection to hospitals, oncology infusion centres, and licensed pharmaceutical importers in the United States, United Kingdom, UAE (Dubai, Abu Dhabi), Saudi Arabia, the Philippines, Brazil, Russia, Australia with full cold chain integrity throughout.

Is a prescription required? Yes. Herclon 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/Roche), EMA Herceptin Summary of Product Characteristics (Roche Registration GmbH), DailyMed NIH Trastuzumab prescribing information, 1mg and Netmeds Herclon product monographs, GNH India Herclon supply documentation, NCBI PubMed HERA and ToGA trial publications, ASCO HER2-targeted therapy clinical practice guidelines, and Roche Products India product data. This product is for professional and institutional use only and must be administered by a qualified oncologist in a supervised clinical setting.