Product image of Ontruzant (Trastuzumab) supplied by GNH India

Ontruzant

Active Ingredient:
Trastuzumab
Origin:
EU

Ontruzant (Trastuzumab)

Trastuzumab, the active ingredient in Ontruzant, is a monoclonal antibody presented as an intravenous formulation for intravenous use. It targets HER2‑positive malignancies, primarily breast and gastric cancers, in adult patients.
GNH India supplies Ontruzant as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.

Manufacturer / TM Owner

Samsung Bioepis Nl B.V.

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Indications & Clinical Uses

Ontruzant is a monoclonal antibody that acts on the HER2 signaling pathway in several solid tumours.

  • HER2‑positive metastatic breast cancer: improves overall survival when combined with chemotherapy.
  • HER2‑positive early‑stage breast cancer (adjuvant setting): reduces risk of disease recurrence after surgery.
  • HER2‑positive gastric or gastro‑esophageal adenocarcinoma: enhances response rates when used with chemotherapy.

How It Works

  • Trastuzumab binds with high affinity to the extracellular domain of the HER2 receptor, blocking ligand‑independent dimerisation and downstream signalling through the PI3K/AKT and MAPK pathways. This inhibition reduces tumour cell proliferation and survival, and also mediates antibody‑dependent cellular cytotoxicity against HER2‑overexpressing cells.

Side Effects

Adverse reactions may occur with trastuzumab therapy and are monitored closely.

Common Side Effects

  • Fever or chills during infusion
  • Nausea or vomiting
  • Diarrhoea
  • Fatigue
  • Headache
  • Rash or mild skin reactions

Serious or Rare Side Effects

  • Cardiac dysfunction or heart failure
  • Severe infusion‑related reactions (anaphylaxis, bronchospasm)
  • Pulmonary toxicity (interstitial lung disease)
  • Hepatotoxicity (elevated liver enzymes)
  • Thrombocytopenia or neutropenia
  • Severe skin reactions (Stevens‑Johnson syndrome).

Precautions & Warnings

Trastuzumab requires careful clinical monitoring to minimise risks.

  • Cardiac assessment: baseline and periodic ejection fraction evaluation is recommended.
  • Infusion monitoring: observe patients for signs of hypersensitivity during and after administration.
  • Pregnancy: avoid use; potential fetal harm has been reported.
  • Breastfeeding: discontinue therapy; drug may be present in milk.
  • Concomitant cardiotoxic agents: use with caution and monitor cardiac function closely.

Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Trastuzumab may interact with other agents, influencing safety or efficacy.

Major Interactions (Avoid)

  • Anthracycline chemotherapy (e.g., doxorubicin): increased risk of cardiotoxicity.
  • Concurrent use with other HER2‑targeted antibodies without clinical justification.

Moderate Interactions (Monitor Closely)

  • Paclitaxel or other taxanes: may enhance infusion‑related reactions.
  • CYP450 inducers or inhibitors: generally minimal effect but monitor for unexpected toxicity.
  • Vaccines: live attenuated vaccines should be avoided during treatment.

Frequently Asked Questions

Ontruzant, containing trastuzumab, is used for HER2‑positive breast cancer in both early and metastatic settings, as well as for HER2‑positive gastric or gastro‑esophageal adenocarcinoma. It is prescribed as part of combination regimens to improve survival and disease control.

Trastuzumab binds to the extracellular domain of the HER2 receptor, blocking its activation and downstream signalling pathways that drive tumour growth. It also flags HER2‑overexpressing cells for destruction by immune cells through antibody‑dependent cellular cytotoxicity.

The dosing regimen for Ontruzant is determined by the treating oncologist based on the specific indication, patient weight, and clinical response. Prescribers follow established guidelines and adjust the infusion schedule as needed.

Ontruzant is not recommended for use during pregnancy because it may cause fetal harm. Women of child‑bearing potential should use effective contraception. Breastfeeding is also discouraged, as trastuzumab can be excreted in milk and affect the infant.

To place an order, submit an enquiry on the Ontruzant product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain logistics) and necessary import documentation.

Ontruzant (trastuzumab) is a well‑established HER2‑directed monoclonal antibody with a long safety record. Compared with newer agents such as pertuzumab or trastuzumab‑deruxtecan, it has a similar mechanism but may differ in efficacy, toxicity profile, and approved combination regimens. Choice of therapy depends on disease stage, prior treatments, and physician judgment.

Ontruzant must be stored refrigerated at 2‑8 °C. It should be kept in its original container, protected from light, and must not be frozen or shaken. If temperature excursions occur, the product should be inspected for visual changes before use.

Ontruzant is given as an intravenous infusion under the supervision of qualified healthcare professionals. The infusion rate and duration are determined by the prescribing physician and may be adjusted based on patient tolerance and clinical response.

The most serious risks include cardiac dysfunction or heart failure, severe infusion‑related reactions such as anaphylaxis, and rare pulmonary toxicity. Patients are monitored regularly for cardiac function and signs of hypersensitivity throughout treatment.

Ontruzant should not be used in patients with known hypersensitivity to trastuzumab or any of its excipients, and it is contraindicated in individuals with uncontrolled cardiac disease or recent significant declines in left ventricular ejection fraction. Clinicians must assess each patient’s medical history before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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