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Trodelvy (Sacituzumab govitecan): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
180 mg
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Trodelvy

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.

    Tell your healthcare provider right away:

    • the first time that you get diarrhea during treatment with TRODELVY
    • if you develop black or bloody stools
    • if you develop symptoms of losing too much body fluid and body salts, such as lightheadedness, dizziness or faintness
    • if you cannot take fluids by mouth due to nausea or vomiting
    • if you cannot get your diarrhea under control within 24 hours

If you develop serious side effects, your healthcare provider may treat you with certain medicines, delay treatment, lower your dose, or permanently stop treatment with TRODELVY.

See “What are the possible side effects of TRODELVY?” for more information about side effects.

What is TRODELVY?

TRODELVY is a prescription medicine used in adults to treat:

  • Triple-Negative Breast Cancer (TNBC) that has spread to nearby tissues (locally advanced) or other parts of the body (metastatic)

    As the first treatment:

    • alone when your TNBC cannot be removed by surgery and you are not a candidate for PD-1 or PD-L1 inhibitor-based therapy.
    • with the medicine pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph when your TNBC cannot be removed by surgery and the tumors test positive for PD-L1.

    As the second or later treatment:

    • after you have received 2 or more prior therapies throughout the body (systemic) for TNBC that cannot be removed by surgery and at least 1 of the therapies was for metastatic TNBC.

  • Hormone Receptor (HR) positive, Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer that has spread to nearby tissues (locally advanced) or other parts of the body (metastatic)

    • when your HR-positive, HER2-negative breast cancer cannot be removed by surgery and you have received hormonal-based therapy and at least 2 more therapies throughout the body (systemic) for metastatic breast cancer.

It is not known if TRODELVY is safe and effective in children.

Who should not receive TRODELVY?

Do not receive TRODELVY if you have had a severe allergic reaction to TRODELVY. Ask your healthcare provider if you are not sure.

Before receiving TRODELVY, tell your healthcare provider about all of your medical conditions, including if you:

  • have been told that you carry a gene for uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28. People who carry this gene have an increased risk of getting side effects with TRODELVY, especially low white blood cell counts, a fever while your white blood cell count is low, and low red blood cell counts. See “What is the most important information I should know about TRODELVY?”
  • have liver problems. It is not known if TRODELVY is safe in people with moderate or severe liver problems.

  • are pregnant or plan to become pregnant. TRODELVY can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start receiving TRODELVY.

    • Females who can become pregnant should use effective birth control during treatment and for 6 months after your last dose of TRODELVY. Talk to your healthcare provider about birth control choices that may be right for you during this time. Tell your healthcare provider right away if you become pregnant during treatment with TRODELVY.
    • Males with a female partner who can become pregnant should use effective birth control during treatment and for 3 months after your last dose of TRODELVY.
  • are breastfeeding or plan to breastfeed. It is not known if TRODELVY passes into your breast milk and can harm your baby. Do not breastfeed during treatment and for 1 month after your last dose of TRODELVY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the way TRODELVY works and may increase your risk of side effects.

How will I receive TRODELVY?

  • Your healthcare provider will give you TRODELVY into your vein through an intravenous (IV) line.
  • TRODELVY is usually given 1 time each week, on Day 1 and on Day 8 of a 21-day treatment cycle.
  • You will receive the first dose of TRODELVY over 3 hours. If you tolerate the first dose well, future doses may be given over 1 to 2 hours.
  • Before each dose of TRODELVY, you will receive medicines to help prevent infusion-related reactions, and nausea and vomiting.
  • You will be monitored for side effects during and for at least 30 minutes after you receive each infusion of TRODELVY.
  • Your healthcare provider may slow down or temporarily stop your infusion of TRODELVY if you have an infusion-related reaction or permanently stop TRODELVY if you have a life-threatening infusion-related reaction.
  • Your healthcare provider will decide how long you will continue to receive TRODELVY.

What are the possible side effects of TRODELVY?

TRODELVY can cause serious side effects, including:

  • See “What is the most important information I should know about TRODELVY?”
  • Allergic and infusion-related reactions. TRODELVY can cause serious or life-threatening allergic and infusion-related reactions. These reactions are more common within 24 hours of receiving TRODELVY. Tell your healthcare provider right away if you get any of the following symptoms of an allergic or infusion-related reaction during or at any time after your TRODELVY infusion:
  • swelling of your face, lips, tongue, or throat
  • hives
  • skin rash, itching, or flushing of your skin
  • fever
  • difficulty breathing or wheezing
  • lightheadedness, dizziness, feeling faint or passing out
  • chills or shaking chills (rigors)
  • chest pain
  • Nausea and vomiting. Nausea and vomiting can be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting. You should be given medicines to take home with you, along with instructions about how to take them to help prevent and treat any nausea and vomiting after you receive TRODELVY. Tell your healthcare provider right away if you develop nausea or vomiting that is not controlled with the medicines prescribed for you.

The most common side effects of TRODELVY when used alone include:

  • decreased white blood cell counts
  • decreased red blood cell counts
  • nausea
  • diarrhea
  • feeling tired or weak
  • hair loss
  • increased sugar levels (glucose) in the blood
  • constipation
  • vomiting
  • decreased protein levels (albumin) in the blood
  • increased alkaline phosphatase levels in the blood
  • decreased appetite
  • stomach pain
  • decreased creatinine clearance
  • decreased magnesium and potassium levels in the blood

The most common side effects of TRODELVY when used with pembrolizumab include:

  • decreased white blood cell counts
  • decreased red blood cell counts
  • diarrhea
  • nausea
  • feeling tired or weak
  • hair loss
  • increased alkaline phosphatase levels in the blood
  • increased sugar levels (glucose) in the blood
  • increased liver enzyme levels in the blood
  • constipation
  • rash
  • decreased potassium levels in the blood
  • increased lactate dehydrogenase levels in the blood
  • vomiting
  • stomach pain
  • headache
  • increased eosinophil levels in the blood
  • decreased protein levels (albumin) in the blood

TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your healthcare provider if fertility is a concern for you.

These are not all of the possible side effects of TRODELVY.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of TRODELVY.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about TRODELVY that is written for health professionals.

What are the ingredients in TRODELVY?

Active ingredient: sacituzumab govitecan-hziy

Inactive ingredients: 2-(N-morpholino) ethane sulfonic acid (MES), polysorbate 80 and trehalose

Manufactured by: Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404, USA

U.S. License No. 2258

761115-GS-011

For more information about TRODELVY, go to www.TRODELVY.com or call 1-888-983-4668.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 761115 · View the label on DailyMed

Revision date stated in the text: June 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Trodelvy

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Active ingredient Sacituzumab govitecan 180 mg
Dosage form Powder, for solution
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) IMMUNOMEDICS INC
FDA approval BLA 761115Biologics License Application (BLA) Approved April 22, 2020
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
180 mg – 1 in 1 vial / 1 in 1 box

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.