Trastuzumab and hyaluronidase-oysk
Trastuzumab and hyaluronidase-oysk is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Herceptin Hylecta. Available dosage form: injection, solution.
Drug Details
- Generic Name
- Trastuzumab and hyaluronidase-oysk
- Brand Names
- Herceptin Hylecta
- Application Number
- BLA761106
- Sponsor
- Genentech, Inc.
- NDC Codes
- 1
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- SUBCUTANEOUS
- Active Ingredients
- TRASTUZUMAB, HYALURONIDASE (HUMAN RECOMBINANT)
Indications and Usage
1 INDICATIONS AND USAGE HERCEPTIN HYLECTA is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) Select patients for therapy based on an FDA-authorized companion diagnostic for trastuzumab. ( 1 , 2.2 ) 1.1 Adjuvant Breast Cancer 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) ] . 1.2 Metastatic Breast Cancer 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) ] .