Prescription medicine
Sacituzumab govitecan Brand names: Trodelvy
Sacituzumab govitecan (Trodelvy) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the sacituzumab govitecan FDA label on DailyMed (effective June 24, 2026); every sacituzumab govitecan label on DailyMed.
Highlights of the record
FDA label of June 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
NEUTROPENIA AND DIARRHEA.
TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia [see Dosage and Administration (2.4) ]. Initiate anti-infective treatment in patients with febrile neutropenia without delay [see Warnings and Precautions (5.1) ]. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide [see Warnings and Precautions (5.2) ]. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses [see Dosage and Administration (2.4) ]. WARNING: NEUTROPENIA AND DIARRHEA See full prescribing information for complete boxed warning. TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. […]
Used for
From the label: indications and usageTRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated: Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line As a single agent for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy.
Forms and strengths
- 180 mg
Powder for 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
- FAERS reports
- 4,518 through July 30, 2026
What is sacituzumab govitecan used for?
From the label: indications and usageTRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated: Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line As a single agent for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. ( 1.1 , 14.1 ) In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥ 10) as determined by an FDA-authorized test. […]
Conditions named in the indications of sacituzumab govitecan's FDA labels, with every medicine labeled for each:
Source: FDA drug label (TRODELVY), Gilead Sciences, Inc., effective June 24, 2026 (SPL set 57a597d2-03f0-472e-b148-016d7169169d), via openFDA; the full label on DailyMed
What does the patient leaflet for sacituzumab govitecan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TRODELVY?TRODELVY can cause serious side effects, including: Low white blood cell count (neutropenia). Low white blood cell counts can be severe and lead to infections that can be life-threatening or cause death as early as the first cycle of treatment. Your healthcare provider should check your blood cell counts during treatment with TRODELVY and may give a medicine to help prevent low white blood cell count starting in the first cycle of treatment if you have an increased risk for developing low white blood cell count with a fever (febrile neutropenia). Tell your healthcare provider right away if you develop any of the following signs of infection during treatment with TRODELVY : fever chills cough shortness of breath burning or pain when you urinate Severe diarrhea. Severe diarrhea can lead to loss of too much body fluid (dehydration) and kidney problems. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control your diarrhea. If you lose too much body fluid, your healthcare provider may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during treatment with TRODELVY, your healthcare provider should check to see if diarrhea may be caused by an infection. […]
Source: FDA drug label (TRODELVY), Gilead Sciences, Inc., effective June 24, 2026 (SPL set 57a597d2-03f0-472e-b148-016d7169169d), via openFDA; the full label on DailyMed
Is there a generic for sacituzumab govitecan (Trodelvy)?
No generic sacituzumab govitecan 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 sacituzumab govitecan label say about other medicines?
The sacituzumab govitecan label names 3 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 |
|---|---|---|
| Atropine | warnings and precautions | Patients who exhibit an excessive cholinergic response to treatment with TRODELVY (e.g., abdominal cramping, diarrhea, salivation, etc.) can receive appropriate premedication (e.g., atropine) for subsequent treatments. |
| Dexamethasone | warnings and precautions | Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK 1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV) [ see Dosage and Administration (2.1) ]. |
| Loperamide | boxed warning | At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide [see Warnings and Precautions (5.2) ]. |
Source: FDA drug label (TRODELVY), Gilead Sciences, Inc., effective June 24, 2026 (SPL set 57a597d2-03f0-472e-b148-016d7169169d), via openFDA; the full label on DailyMed
What do FAERS reports show for sacituzumab govitecan?
The FDA Adverse Event Reporting System holds 4,518 reports that list sacituzumab govitecan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 929 are coded as a death and 1,231 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. Reports rose sharply in 2022 (1,248, against a median of 112 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
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 sacituzumab govitecan?
12 other medicines are given the same way (intravenous) and in the same FDA class as sacituzumab govitecan 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 |
|---|---|---|---|---|
| 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 | Breast cancer | none listed | n/a | No current entry |
| Margetuximab | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab emtansine | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab-strf | Breast cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as sacituzumab govitecan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sacituzumab govitecan
- 12 medicines for the same use
- Sacituzumab govitecan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other