Prescription medicine
Hyaluronidase and trastuzumab Brand names: Herceptin
Hyaluronidase and trastuzumab (Herceptin) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the hyaluronidase and trastuzumab FDA label on DailyMed (effective May 29, 2026); every hyaluronidase and trastuzumab label on DailyMed.
Highlights of the record
FDA label of May 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY,.
and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: HERCEPTIN HYLECTA 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 HYLECTA for cardiomyopathy. ( 2.4 , 5.1 ) Pulmonary Toxicity: Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome. ( 5.3 ) Embryo-Fetal Toxicity: Exposure to HERCEPTIN HYLECTA during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. ( 5.2 , 8.1 , 8.3 ) Cardiomyopathy HERCEPTIN HYLECTA administration can result in sub - clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving HERCEPTIN HYLECTA with anthracycline - containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with HERCEPTIN HYLECTA. […]
Used for
From the label: indications and usageHERCEPTIN 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.
Forms and strengths
- 600 mg/5ml / 5ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is hyaluronidase and trastuzumab used for?
From the label: indications and usageHERCEPTIN 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. […]
Conditions named in the indications of hyaluronidase and trastuzumab's FDA labels, with every medicine labeled for each:
From other hyaluronidase and trastuzumab labelsBreast cancer: 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 …
FDA pharmacologic class: Endoglycosidase and HER2/neu Receptor Antagonist.
Source: FDA drug label (Herceptin Hylecta), Genentech, Inc., effective May 29, 2026 (SPL set ebf30894-41cf-480c-8bc3-56f592a13813), via openFDA; the full label on DailyMed
Is there a generic for hyaluronidase and trastuzumab (Herceptin)?
No generic hyaluronidase and trastuzumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the hyaluronidase and trastuzumab label say about other medicines?
The hyaluronidase and trastuzumab label names 6 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carboplatin | warnings and precautions | BCIRG006; Docetaxel + carboplatin + intravenous trastuzumab; 0.4% (4/1056); 0.3% (3/1050) |
| Cyclophosphamide | warnings and precautions | NSABP B31 & NCCTG N9831 Median follow-up duration for studies NSABP B31 and NCCTG N9831 combined was 8.3 years in the AC→ paclitaxel+Herceptin arm.; AC Anthracycline (doxorubicin) and cyclophosphamide. →paclitaxel + intravenous trastuzumab; … |
| Docetaxel | warnings and precautions | BCIRG006; AC →docetaxel + intravenous trastuzumab; 2% (20/1068); 0.3% (3/1050) |
| Doxorubicin | warnings and precautions | NSABP B31 & NCCTG N9831 Median follow-up duration for studies NSABP B31 and NCCTG N9831 combined was 8.3 years in the AC→ paclitaxel+Herceptin arm.; AC Anthracycline (doxorubicin) and cyclophosphamide. →paclitaxel + intravenous trastuzumab; … |
| Epirubicin | warnings and precautions | H0648g (AC) Anthracycline (doxorubicin or epirubicin) and cyclophosphamide.; Cardiac Dysfunction; 28%; 7%; 19%; 3% |
| Paclitaxel | warnings and precautions | NSABP B31 & NCCTG N9831 Median follow-up duration for studies NSABP B31 and NCCTG N9831 combined was 8.3 years in the AC→ paclitaxel+Herceptin arm.; AC Anthracycline (doxorubicin) and cyclophosphamide. →paclitaxel + intravenous trastuzumab; … |
Source: FDA drug label (Herceptin Hylecta), Genentech, Inc., effective May 29, 2026 (SPL set ebf30894-41cf-480c-8bc3-56f592a13813), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as hyaluronidase and trastuzumab?
2 other medicines are given the same way (subcutaneous) and in the same FDA class as hyaluronidase and trastuzumab or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Berahyaluronidase alfa and pembrolizumab | Breast cancer | none listed | n/a | No current entry |
| Goserelin | Breast cancer | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other endoglycosidases
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other