Prescription medicine
Trastuzumab-strf Brand names: Hercessi
Trastuzumab-strf (Hercessi) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the trastuzumab-strf FDA label on DailyMed (effective March 21, 2025); the BLA 761346 record on Drugs@FDA; every trastuzumab-strf label on DailyMed.
Highlights of the record
FDA label of March 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY,.
and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY Cardiomyopathy Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with HERCESSI TM . Discontinue HERCESSI TM treatment in patients receiving adjuvant therapy and withhold HERCESSI TM in patients with metastatic disease for clinically significant decrease in left ventricular function [see Dosage and Administration (2.5) and Warnings and Precautions (5.1)]. Infusion Reactions; Pulmonary Toxicity Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration of trastuzumab products. Interrupt HERCESSI TM infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue HERCESSI TM for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome [see Warnings and Precautions (5.2, 5.4)]. […]
Used for
From the label: indications and usageHercessi is a HER2/neu receptor antagonist indicated for: The treatment of HER2-overexpressing breast cancer.
Forms and strengths
- 150 mg/7.4ml
- 420 mg/20ml
Injection (powder) (lyophilized) for solution; kit.
On the market
- Earliest approval on file
- April 25, 2024 Hercessi, Accord Biopharma Inc.; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- 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 trastuzumab-strf used for?
From the label: indications and usageHercessi is a HER2/neu receptor antagonist indicated for: The treatment of HER2-overexpressing breast cancer. (1.1, 1.2) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. […]
Conditions named in the indications of trastuzumab-strf's FDA labels, with every medicine labeled for each:
From other trastuzumab-strf 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: HER2/neu Receptor Antagonist.
Source: FDA drug label (HERCESSI), Accord BioPharma Inc., effective March 21, 2025 (SPL set 285d2142-5bfa-401c-9246-7de21c4451af), via openFDA; the full label on DailyMed
Is there a generic for trastuzumab-strf (Hercessi)?
No generic trastuzumab-strf is approved (Drugs@FDA, October 8, 2026).
- 2024 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the trastuzumab-strf label say about other medicines?
The trastuzumab-strf label names 9 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 | In BCIRG006, a total of 2.9% (31/1056) of patients in the TCH (docetaxel, carboplatin, trastuzumab) arm (1.5% during the chemotherapy phase and 1.4% during the monotherapy phase) and 5.7% (61/1068) of patients in the AC TH arm (1.5% during the chemotherapy phase and 4.2% during the monotherapy phase) discontinued … |
| Cyclophosphamide | warnings and precautions | … or significant decline in LVEF after a median follow-up duration of 8.7 years in the AC-TH (anthracycline, cyclophosphamide, paclitaxel, and trastuzumab) arm. |
| Diphenhydramine | warnings and precautions | Interrupt HERCESSI TM infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen). |
| Docetaxel | warnings and precautions | BCIRG006; AC b → Docetaxel+Trastuzumab; 2% (20/1068); 0.3% (3/1050) |
| Doxorubicin | warnings and precautions | … for NSABP B31 and NCCTG N9831 combined was 8.3 years in the AC→paclitaxel+trastuzumab arm. b Anthracycline (doxorubicin) and cyclophosphamide. c Includes 1 patient with fatal cardiomyopathy and 1 patient with sudden death without documented etiology. … |
| Epinephrine | warnings and precautions | Interrupt HERCESSI TM infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen). |
| Epirubicin | warnings and precautions | … N/A a Congestive heart failure or significant asymptomatic decrease in LVEF. b Anthracycline (doxorubicin or epirubicin) and cyclophosphamide. c Includes 1 patient with fatal cardiomyopathy. |
| Paclitaxel | warnings and precautions | NSABP B31 & NCCTG N9831 a; AC b → Paclitaxel+Trastuzumab; 3.2% (64/2000) c; 1.3% (21/1655) |
| Trastuzumab | boxed warning | CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY Cardiomyopathy Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. |
Source: FDA drug label (HERCESSI), Accord BioPharma Inc., effective March 21, 2025 (SPL set 285d2142-5bfa-401c-9246-7de21c4451af), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as trastuzumab-strf?
12 other medicines are given the same way (intravenous) and in the same FDA class as trastuzumab-strf 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. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Trastuzumab | Breast cancer | none listed | n/a | No current entry |
| Margetuximab | Breast cancer | none listed | n/a | No current entry |
| Pertuzumab | Breast cancer | none listed | n/a | No current entry |
| Docetaxel | Breast cancer | 14 labelers | n/a | A presentation being discontinued |
| Paclitaxel | Breast cancer | 20 labelers | n/a | No current entry |
| Gemcitabine | Breast cancer | 10 labelers | n/a | No current entry |
| Eribulin | Breast cancer | 14 labelers | n/a | No current entry |
| Trastuzumab emtansine | Breast cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as trastuzumab-strf
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to trastuzumab-strf
- 12 medicines for the same use
- Other her2/neu receptor antagonists
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other