Prescription medicine
Margetuximab Brand names: Margenza
Margetuximab (Margenza) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the margetuximab FDA label on DailyMed (effective February 11, 2025); every margetuximab label on DailyMed.
Highlights of the record
FDA label of February 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY.
See full prescribing information for complete boxed warning. Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function. ( 2.2 , 5.1 , 6.1 ) Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception. ( 5.2 , 8.1 , 8.3 ) Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function [see Dosage and Administration (2.2), Warnings and Precautions (5.1), and Adverse Reactions (6.1) ]. Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions (5.2), Use in Specific Populations (8.1 , 8.3) ].
Used for
From the label: indications and usageMARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ].
Forms and strengths
- 25 mg/ml
Injection (solution) (concentrate).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 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
- FAERS reports
- 26 through July 30, 2026
What is margetuximab used for?
From the label: indications and usageMARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ]. MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
Conditions named in the indications of margetuximab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: HER2/neu Receptor Antagonist.
Source: FDA drug label (MARGENZA), TerSera Therapeutics LLC, effective February 11, 2025 (SPL set 6a6d50c7-06ea-479c-83cc-f197a9e428c9), via openFDA; the full label on DailyMed
Is there a generic for margetuximab (Margenza)?
No generic margetuximab 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 margetuximab label say about other medicines?
The margetuximab label names 2 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 |
|---|---|---|
| Diphenhydramine | warnings and precautions | Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with medical therapy which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators and oxygen. |
| Epinephrine | warnings and precautions | Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with medical therapy which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators and oxygen. |
Source: FDA drug label (MARGENZA), TerSera Therapeutics LLC, effective February 11, 2025 (SPL set 6a6d50c7-06ea-479c-83cc-f197a9e428c9), via openFDA; the full label on DailyMed
What do FAERS reports show for margetuximab?
The FDA Adverse Event Reporting System holds 26 reports that list margetuximab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 3 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as margetuximab?
12 other medicines are given the same way (intravenous) and in the same FDA class as margetuximab 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 |
| Trastuzumab-strf | 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 margetuximab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to margetuximab
- 12 medicines for the same use
- Other her2/neu receptor antagonists
- the pharmacologic class, with prices and generics
- Margetuximab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other