Hertraz 440 mg Injection

Hertraz 440mg Injection (Trastuzumab) – Anti-HER2 Monoclonal Antibody Biosimilar by Mylan | HER2-Positive Breast Cancer and Gastric Cancer

Medically reviewed by a qualified oncologist | Last updated: April 2026 Prescription-only medicine | Administered by a qualified healthcare professional only

What Is Hertraz 440mg?

Hertraz 440mg Injection contains Trastuzumab, manufactured by Mylan Pharmaceuticals Pvt Ltd — a Viatris Company. It is a biosimilar of Herceptin (reference trastuzumab, Roche/Genentech) — a recombinant humanised monoclonal antibody that specifically targets the human epidermal growth factor receptor 2 (HER2) protein overexpressed on the surface of certain cancer cells. Trastuzumab inhibits the proliferation of HER2-overexpressing cancer cells and recruits immune cells to tumour sites to enhance destruction of HER2-positive cells.

Key Facts at a Glance

Active substance: Trastuzumab 440mg per vial. Form: Lyophilised powder for reconstitution, for intravenous infusion. Manufacturer: Mylan Pharmaceuticals Pvt Ltd (A Viatris Company), Bangalore, India. Storage: 2–8°C refrigerated. Do not freeze. Keep in original carton until use. Pack: 1 vial. Prescription: Required. Administered by oncologist or trained healthcare professional only.

Why Hertraz in 2025/2026 — The Clinical and Market Context

The trastuzumab biosimilar market is projected to grow at a 25% CAGR through 2025–2034, driven by rising breast and gastric cancer incidence globally, expanding access to HER2-targeted therapy, and aggressive price competition from approved biosimilar entrants. In the US market, trastuzumab biosimilars now carry an average sales price up to 90% lower than reference Herceptin — with the overall combined trastuzumab market price reduced by 27.7% in the year of biosimilar entry alone.

For oncology centres and patients in the USA, UK, UAE, Canada, Japan, Russia, China, and Thailand, Hertraz 440mg provides access to the same clinically validated HER2-targeted therapy at a substantially more accessible cost — without compromise on efficacy or safety. Population-based real-world studies comparing biosimilar trastuzumab directly to Herceptin for neoadjuvant and adjuvant treatment of HER2-positive breast cancer have confirmed equivalent safety and overall survival outcomes.

What Is Hertraz 440mg Used For?

HER2-Positive Early Breast Cancer — Adjuvant Treatment

Hertraz is indicated for adjuvant (post-surgery) treatment of adults with HER2-positive early breast cancer, used following surgery and chemotherapy to reduce the risk of cancer recurrence. Treatment duration in early breast cancer is 1 year or until disease recurrence — whichever occurs first. Extension beyond 1 year is not recommended.

HER2-Positive Early Breast Cancer — Neoadjuvant Treatment

According to NCCN and ESMO international clinical practice guidelines, neoadjuvant systemic therapy is indicated for HER2-positive early breast cancer when tumours are 2 cm or larger, when the patient is node-positive, or when surgical downstaging is needed for breast conservation. For HER2-overexpressing or amplified tumours, dual anti-HER2 blockade combined with chemotherapy is the endorsed neoadjuvant standard of care. Hertraz is administered as part of this regimen — most commonly combined with pertuzumab and taxane-based chemotherapy.

HER2-Positive Metastatic Breast Cancer

Hertraz is indicated for HER2-positive metastatic breast cancer, including hormone receptor-positive metastatic disease. It may be used as monotherapy or in combination with chemotherapy agents including paclitaxel, docetaxel, cisplatin, capecitabine, and 5-fluorouracil, or with hormonal agents including tamoxifen and anastrozole, to achieve superior outcomes compared to chemotherapy alone.

HER2-Positive Metastatic Gastric Cancer

Hertraz is indicated for use in combination with cisplatin and capecitabine or 5-fluorouracil as first-line treatment of HER2-overexpressing metastatic gastric or gastro-oesophageal junction adenocarcinoma in adults who have not received prior systemic anti-cancer therapy for their metastatic disease.

Important — HER2 Testing Mandatory Before Use: HER2 overexpression or amplification must be confirmed by a validated diagnostic test (IHC 3+ or ISH amplification) before initiating Hertraz therapy. Hertraz is not indicated in patients with HER2-negative tumours.

How Hertraz 440mg Works — Dual Mechanism of Action

Hertraz works through two complementary mechanisms that together make it one of the most clinically effective targeted therapies in oncology:

Mechanism 1 — HER2 Receptor Blockade: Trastuzumab binds with high specificity to the extracellular domain IV of the HER2 receptor on the surface of cancer cells. This binding blocks HER2 from receiving growth signals — halting the downstream cell signalling pathways that drive uncontrolled tumour cell proliferation and survival.

Mechanism 2 — Immune-Mediated Tumour Destruction: Beyond direct receptor blockade, trastuzumab flags HER2-positive tumour cells for destruction by the immune system through antibody-dependent cell-mediated cytotoxicity (ADCC). Immune effector cells recognise the antibody-coated cancer cells and actively destroy them — adding a powerful immunological dimension to the anti-tumour effect.

This dual action — direct growth signal inhibition combined with immune-activated tumour cell killing — explains why trastuzumab-based therapy has transformed outcomes for HER2-positive breast and gastric cancer patients globally.

Why HER2 Status Matters: HER2 is overexpressed in approximately 20–25% of breast cancer cases. HER2 overexpression is associated with more aggressive disease, higher recurrence rates, and significantly poorer disease-free and overall survival compared to HER2-negative cancers — making HER2-targeted therapy with trastuzumab a critical intervention for this patient population.

Hertraz vs Herceptin — Biosimilar Equivalence Explained

Hertraz 440mg is a biosimilar — not a generic — of reference trastuzumab (Herceptin). Biosimilars are highly similar biological medicines to an already approved reference product, with no clinically meaningful differences in quality, safety, or efficacy. They may have minor differences in clinically inactive components as a result of the biological manufacturing process.

Multiple regulatory authorities — including the FDA, EMA, and national health agencies across the UK, Canada, and Australia — have approved trastuzumab biosimilars based on comprehensive comparability exercises demonstrating analytical, functional, pharmacokinetic, and clinical equivalence to Herceptin.

Population-based real-world evidence from over 5,000 HER2-positive breast cancer patients in Canada confirms that trastuzumab biosimilars deliver equivalent overall survival and safety outcomes to reference Herceptin in the adjuvant setting. For patients, oncologists, and healthcare systems across all target markets, Hertraz provides the same proven clinical benefit at dramatically reduced cost.

Dosage and Administration

Hertraz 440mg is administered only by a qualified oncologist or trained healthcare professional in a clinical or hospital setting. Never self-administer.

Reconstitution: The lyophilised powder is reconstituted using bacteriostatic water for injection (BWFI) provided separately, then diluted in 250 mL of 0.9% sodium chloride solution for intravenous infusion. Do not dilute with dextrose (glucose) solutions — this causes protein aggregation. Do not shake the reconstituted solution.

Loading Dose — First Infusion: Administered as a 90-minute intravenous infusion. Must not be given as an IV push or bolus injection. An emergency resuscitation kit and preparations to manage anaphylaxis must be immediately available. Patients must be observed for at least 6 hours after the start of the first infusion for infusion-related symptoms including fever, chills, rigors, and hypotension.

Subsequent Infusions: If the loading dose is well tolerated, subsequent infusions may be administered over 30 minutes. Patients should be observed for at least 2 hours after start of each subsequent infusion.

Weekly Regimen (Metastatic Breast Cancer): Loading dose 4 mg/kg IV over 90 minutes, then 2 mg/kg IV weekly over 30 minutes.

Three-Weekly Regimen (Adjuvant / Neoadjuvant): Loading dose 8 mg/kg IV over 90 minutes, then 6 mg/kg IV every 3 weeks over 30 minutes.

Gastric Cancer: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks, in combination with cisplatin and capecitabine or 5-FU.

Duration: 1 year in early breast cancer adjuvant setting. Until disease progression in metastatic settings. As directed by the treating oncologist in all cases.

Cardiac Monitoring: Cardiac function (LVEF) must be assessed at baseline before starting Hertraz and monitored throughout treatment. Inform your oncologist immediately if you develop shortness of breath, new persistent cough, leg or arm swelling, or palpitations.

Contraception: Effective contraception is required during treatment and for 7 months after the final dose of Hertraz. Inform your oncologist immediately if pregnancy occurs during treatment.

Who Should Not Use Hertraz 440mg

Do not use if: you are pregnant or planning pregnancy; you are breastfeeding; you have severe dyspnoea at rest due to complications of advanced malignancy or require supplemental oxygen therapy; you have known hypersensitivity to trastuzumab, murine proteins, or any excipient; your tumour is confirmed HER2-negative.

Use under close specialist supervision in: patients with pre-existing cardiac disease, recent myocardial infarction, uncontrolled hypertension, or significant cardiac arrhythmia; elderly patients aged 65 years and over (limited clinical data); patients with significant pulmonary compromise or pre-existing lung disease.

Hertraz is not indicated in children or adolescents under 18 years of age.

Important Warnings

Cardiotoxicity — Highest Priority Warning: Trastuzumab can cause asymptomatic decline in left ventricular ejection fraction (LVEF), symptomatic congestive heart failure, and cardiac death. If LVEF drops 10 or more percentage points from baseline AND falls below 50%, treatment must be suspended and LVEF reassessed within approximately 3 weeks. Discontinuation should be strongly considered if LVEF does not recover, declines further, or symptomatic heart failure develops.

Anthracycline Sequence Risk: Patients who receive anthracycline chemotherapy after stopping trastuzumab remain at increased risk of cardiac dysfunction due to trastuzumab's extended biological half-life. This risk should be discussed with all patients before starting therapy.

Infusion-Related Reactions: Serious infusion-related reactions reported include dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria, and angioedema. Emergency resuscitation equipment must be available at all times during infusion.

Pulmonary Toxicity: Pneumonitis has been reported with trastuzumab, particularly in patients receiving concomitant taxane therapy. Monitor for new or worsening respiratory symptoms throughout treatment.

Embryo-Foetal Toxicity: Trastuzumab can cause foetal harm. Cases of oligohydramnios and foetal renal failure have been reported. Effective contraception is mandatory during treatment and for 7 months post-completion.

Drug Interactions

Inform your full oncology team of all medications, supplements, and vaccines before receiving Hertraz.

Anthracyclines (doxorubicin, epirubicin): Concurrent or sequential use significantly increases the risk of cardiac dysfunction. Current clinical guidelines recommend avoiding concurrent anthracycline and trastuzumab administration.

Herpes Zoster / Shingles Vaccine (Recombinant, Adjuvanted): Concurrent use with trastuzumab is classified as a life-threatening interaction. Do not administer this vaccine while on Hertraz therapy.

Paclitaxel and Docetaxel: Trastuzumab does not alter the pharmacokinetics of paclitaxel or docetaxel, and these agents are commonly co-administered. However, trastuzumab may elevate the exposure of certain doxorubicin metabolites — the clinical significance should be monitored.

Capecitabine and Cisplatin: Standard combination partners in HER2-positive gastric cancer protocols. No clinically significant pharmacokinetic interactions reported.

No formal drug interaction studies have been performed specifically for Hertraz. All interaction data are derived from published literature on reference trastuzumab products.

Side Effects

Very common: Fever, chills, and flu-like symptoms during or after infusion — particularly with the first dose. Nausea, headache, fatigue, rash, insomnia, and increased susceptibility to infections due to reduced blood cell counts.

Common: Diarrhoea, abdominal pain, vomiting, muscle and joint pain, hair thinning, increased cough, peripheral neuropathy (tingling or numbness in hands and feet), oedema, mood changes, and weight loss.

Serious — seek immediate medical attention for: Breathlessness, persistent cough, leg or arm swelling, palpitations (signs of cardiac dysfunction or heart failure). Severe infusion reactions including difficulty breathing, chest tightness, or facial swelling. Unexplained fever or signs of serious infection. Signs of pulmonary toxicity including new or worsening breathlessness and oxygen desaturation.

Monitoring throughout therapy: LVEF cardiac assessment before and regularly during treatment. Full blood count monitoring. Liver and renal function as clinically indicated. Immediate reporting of any new cardiovascular, pulmonary, or neurological symptoms to the treating oncologist.

Storage and Handling

Store at 2–8°C in a refrigerator. Do not freeze. Keep in original carton to protect from light. Do not use after the expiry date printed on the label. Reconstituted solution may be stored refrigerated at 2–8°C for up to 28 days when prepared with bacteriostatic water for injection (BWFI). Diluted infusion solution should be used immediately. Dispose of unused medicine in accordance with local regulations for cytotoxic waste.

Frequently Asked Questions

What is Hertraz 440mg used for? Hertraz 440mg is used to treat HER2-positive breast cancer (early, locally advanced, and metastatic) and HER2-positive metastatic gastric or gastro-oesophageal junction cancer in adults. HER2 positivity must be confirmed by validated testing before use.

Is Hertraz the same as Herceptin? Hertraz is a biosimilar of Herceptin — clinically equivalent in efficacy, safety, and mechanism of action, manufactured by Mylan (Viatris) to regulatory biosimilarity standards. Real-world population studies confirm equivalent survival outcomes to Herceptin in adjuvant breast cancer treatment.

How is Hertraz 440mg given? By intravenous infusion only, administered by a qualified oncologist or trained nurse in a hospital or clinical setting. Never self-administer.

How long does a Hertraz infusion take? The loading (first) dose infusion takes 90 minutes. If well tolerated, subsequent doses take 30 minutes.

Can Hertraz cause heart problems? Yes — cardiotoxicity, including reduced left ventricular ejection fraction and heart failure, is a known and serious risk. Cardiac function is assessed before starting treatment and monitored throughout. Report breathlessness, leg swelling, or palpitations to your oncologist immediately.

Is Hertraz safe during pregnancy? No. Hertraz is contraindicated in pregnancy. Effective contraception is required during treatment and for 7 months after the last dose.

How does Hertraz compare to Herceptin in cost? Trastuzumab biosimilars carry an average sales price up to 90% lower than Herceptin in the US market. Hertraz provides identical clinical outcomes at significantly lower cost, improving access to HER2-targeted therapy globally.

Do you ship Hertraz 440mg internationally? Yes — discreet, secure shipping to USA, UK, UAE (Dubai, Abu Dhabi), Canada, Japan, Russia, China, Thailand, India, Saudi Arabia, and Australia.

Is a prescription required? Yes. Hertraz 440mg is a prescription-only oncology medicine. Always consult a qualified oncologist before starting, adjusting, or stopping trastuzumab therapy.

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