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These highlights do not include all the information needed to use HERCESSI safely and effectively. See full prescribing information for HERCESSI. HERCESSI TM(trastuzumab-strf) for injection, for intravenous use Initial U.S. Approval: 2024 HERCESSI (trastuzumab-strf) is biosimilar* to HERCEPTIN (trastuzumab).
Medication labelWhy this: Advisory · dailymed-prescription
HERCESSI TM is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1)]) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2)]. HERCESSI TM is indicated: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1)]. HERCESSI TM is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see D osage and Administration (2.1)] .
- generic_name
- trastuzumab-strf
- product_names
- trastuzumab-strf
- ndc
- 69448-015, 69448-016, 69448-015-05, 69448-016-11
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en