Ontruzant is an HER2/neu receptor antagonist indicated in adults for the treatment of HER2-overexpressing breast cancer, among other approved uses. It is available as kits for intravenous use. MedsAcross supplies Ontruzant for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Ontruzant is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
Source: US FDA prescribing information
The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab products have been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab products are mediators of antibody-dependent cellular cytotoxicity (ADCC). In vitro, trastuzumab product-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
Source: US FDA prescribing information
For intravenous (IV) infusion only. Do not administer as an IV push or bolus. Ontruzant has different dosage and administration instructions than subcutaneous trastuzumab products. Do not substitute Ontruzant (trastuzumab-dttb) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. Adjuvant Treatment of HER2-Overexpressing Breast Cancer. Administer at either: Initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel and carboplatin).
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning: Cardiomyopathy: trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue Ontruzant for cardiomyopathy. Exacerbation of Chemotherapy-Induced Neutropenia. Cardiomyopathy Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. Trastuzumab products can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). There is a 4 to 6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving trastuzumab products as a single agent or in combination therapy compared with those not receiving trastuzumab products.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the label: Cardiomyopathy Infusion Reactions Embryo-Fetal Toxicity Pulmonary Toxicity Exacerbation of Chemotherapy-induced Neutropenia Adjuvant Breast Cancer Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills. Metastatic Breast Cancer Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. Metastatic Gastric Cancer Most common adverse reactions (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.
Source: US FDA prescribing information
Anthracyclines Patients who receive anthracycline after stopping trastuzumab products may be at increased risk of cardiac dysfunction because of trastuzumab products' estimated long washout period. If possible, avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab products. If anthracyclines are used, closely monitor the patient's cardiac function.
Source: US FDA prescribing information
Store Ontruzant vials in the refrigerator at 2° to 8°C (36° to 46°F) until time of reconstitution.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Ontruzant, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ontruzant kitIntravenous Cold chainGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | Not recorded | — |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Ontruzant in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Ontruzant and sources them for licensed hospitals, importers and physicians against valid import documents.
At least one listed presentation of Ontruzant must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Ontruzant is classified under ATC code L01XC03 (Ontruzant).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.