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These highlights do not include all the information needed to use HERCEPTIN HYLECTA safely and effectively. See full prescribing information for HERCEPTIN HYLECTA. HERCEPTIN HYLECTA® (trastuzumab and hyaluronidase-oysk) injection, for subcutaneous use Initial U.S. Approval: 2019
Medication labelWhy this: Advisory · dailymed-prescription
HERCEPTIN HYLECTA is indicated for adjuvant treatment of adults with 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-authorized companion diagnostic for trastuzumab [see Dosage and Administration (2.2)]. HERCEPTIN HYLECTA is indicated in adults: 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-authorized companion diagnostic for trastuzumab [see Dosage and Administration (2.2)].
- generic_name
- trastuzumab and hyaluronidase-oysk
- product_names
- Trastuzumab and hyaluronidase-oysk
- ndc
- 50242-077, 50242-077-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en