Trastuzumab 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 powder for injection and kits for intravenous use. MedsAcross supplies Trastuzumab 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.
Herceptin 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-authorized companion diagnostic for Herceptin.
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. Herceptin has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Herceptin is a mediator of antibody-dependent cellular cytotoxicity (ADCC). In vitro, Herceptin-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. Herceptin has different dosage and administration instructions than subcutaneous trastuzumab products. Do not substitute Herceptin (trastuzumab) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. Perform HER2 testing using FDA-authorized tests by laboratories with demonstrated proficiency. Adjuvant Treatment of HER2-Overexpressing Breast Cancer. Administer at either: Initial dose of 4 mg/kg over 90 minutes IV infusion, then 2 mg/kg over 30 minutes 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: Herceptin 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 Herceptin for cardiomyopathy. Exacerbation of Chemotherapy-Induced Neutropenia. Cardiomyopathy Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. Herceptin can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). There is a 4–6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving Herceptin as a single agent or in combination therapy compared with those not receiving Herceptin.
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 Herceptin may be at increased risk of cardiac dysfunction because of trastuzumab's estimated long washout period. If possible, avoid anthracycline-based therapy for up to 7 months after stopping Herceptin. If anthracyclines are used, closely monitor the patient's cardiac function.
Source: US FDA prescribing information
Store Herceptin vials in the refrigerator at 2°C to 8°C (36°F 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.
14 presentations of Trastuzumab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ogivri kit Cold chain | Mylan Institutional | US FDA | Available on request |
| Ogivri 150 mg/7.4 mL powder for injectionIntravenous Cold chain | Mylan Institutional | US FDA | Available on request |
| Kanjinti 150 mg/7.15 mL powder for injectionIntravenous Cold chain | Amgen | US FDA | Available on request |
| Kanjinti 420 mg/20 mL powder for injectionIntravenous Cold chain | Amgen | US FDA | Available on request |
| Herceptin 150 mg/7.4 mL powder for injectionIntravenous Cold chain | Genentech | US FDA | Available on request |
| Hercessi kit Cold chain | Accord BioPharmaIndia | US FDA | Available on request |
| Hercessi 150 mg/7.4 mL powder for injectionIntravenous Cold chain | Accord BioPharmaIndia | US FDA | Available on request |
| Hercessi 420 mg/20 mL powder for injectionIntravenous Cold chain | Accord BioPharmaIndia | US FDA | Available on request |
| Herzuma kit Cold chain | Cephalon | US FDA | Available on request |
| Herzuma 150 mg/7.15 mL powder for injectionIntravenous Cold chain | Cephalon | US FDA | Available on request |
| Ontruzant 150 mg powder for injectionIntravenous Cold chain | Organon | US FDA | Available on request |
| Trazimera kit Cold chain | Pfizer Laboratories | US FDA | Available on request |
| Trazimera 150 mg/7.15 mL powder for injectionIntravenous Cold chain | Pfizer Laboratories | US FDA | Available on request |
| Ogivri 420 mg/20 mL powder for injectionIntravenous Cold chain | Biocon BiologicsIndia | US FDA | Available on request |
7 brand names across 1 markets.
Indian manufacturers are highlighted.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Trastuzumab in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 14 presentations of Trastuzumab and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Accord BioPharma, Biocon Biologics.
The catalogue lists 7 brand names for Trastuzumab, including Herceptin, Hercessi, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera.
Yes. The US FDA first approved Trastuzumab on 25 September 1998, according to Drugs@FDA.
Yes. Trastuzumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Trastuzumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Trastuzumab is classified under ATC code L01FD01 (Trastuzumab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.