WHAT IS TRODELVY?

TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with:

  • triple-negative breast cancer (negative for estrogen and progesterone hormone receptors and HER2) that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who have received two or more prior treatments, including at least one treatment for metastatic disease.
  • hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body or cannot be removed by surgery, and who previously received endocrine therapy and at least two additional treatments for metastatic disease.

It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.

Important Safety Information

TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:

  • Low white blood cell count (neutropenia) is common and can sometimes 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 and may give a medicine to help prevent neutropenia 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). If your white blood cell count is too low, your healthcare provider may need to delay treatment or lower your dose, give you a medicine to treat low blood cell count, or in some cases may permanently stop TRODELVY. Your healthcare provider may need to give you antibiotic medicines if you develop fever while your white blood cell count is low. Call your healthcare provider right away if you develop any of the following signs of infection: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
  • Severe diarrhea. Diarrhea is common and can be severe. 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 it. 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 your treatment with TRODELVY, your healthcare provider should check to see if it may be caused by an infection. Your healthcare provider may decrease your dose, delay treatment, or permanently stop TRODELVY if your diarrhea is severe and cannot be controlled with anti-diarrheal medicines.
    • Call your healthcare provider right away the first time that you get diarrhea during treatment with TRODELVY; if you have black or bloody stools; if you have symptoms of dehydration, such as lightheadedness, dizziness, or faintness; if you are unable to take fluids by mouth due to nausea or vomiting; or if you are not able to get your diarrhea under control within 24 hours.

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

Allergic and infusion-related reactions which can be serious and life-threatening. Tell your healthcare provider or nurse right away if you get any of the following symptoms during your infusion of TRODELVY or within 24 hours after: 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 pass out; or chills or shaking chills (rigors).

Nausea and vomiting are common with TRODELVY and can sometimes be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting along with medicines to take home with instructions about how to take them. Call your healthcare provider right away if you have nausea or vomiting that is not controlled with the medicines prescribed for you. Your healthcare provider may decide to decrease your dose or stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines.

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 UGT1A1*28, which can increase your risk of getting side effects with TRODELVY, especially low white blood cell counts, with or without a fever, and low red blood cell counts.
  • have 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. 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.
    • 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 breastmilk 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.

The most common side effects of TRODELVY include decreased white blood cell (leukocyte and lymphocyte) and red blood cell counts, feeling tired or weak, hair loss, constipation, increased sugar levels in the blood, decreased protein levels (albumin) in the blood, decreased appetite, changes in kidney function test, increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems), and decreased levels of magnesium, potassium, and sodium in the blood.

These are not all of the possible side effects of TRODELVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please click to see Important Facts about TRODELVY, including Important Warning.

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A new chapter in stage 4 TNBC

A new chapter in stage 4 TNBC

TRODELVY is now approved as a first treatment option for adults with metastatic triple-negative breast cancer (mTNBC)

TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used in adults to treat Triple-Negative Breast Cancer (TNBC), that cannot be removed by surgery (unresectable) and has spread to nearby tissues (locally advanced) or other parts of the body (metastatic).

  • As the first treatment:
    • alone when 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 the tumors test positive for PD-L1.

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

Adults whose breast cancer cannot be removed by surgery and is:

  • Triple-negative: When tests show that a cancer doesn’t express 3 common receptors—estrogen, progesterone, and HER2—it’s considered “triple-negative.” This finding helps guide treatment decisions because this type of cancer behaves differently and is treated with other types of therapies than cancers that do express these receptors

AND

  • Metastatic: Also known as stage 4, “metastatic” refers to cancer that has spread to other parts of the body. Some patients are first diagnosed with metastatic triple-negative breast cancer, which is called a de novo diagnosis. Others are diagnosed with an earlier stage of triple-negative breast cancer, which may later spread or become metastatic
  • “PD-L1” positive or negative: “PD-L1” is a protein that can be found on the surface of some cancer cells, which helps them hide from the immune system. Cancer cells are considered “PD-L1” positive if they have a certain level of this protein, and “PD-L1” negative if they do not. This positive or negative status is among the factors that determine whether TRODELVY is given alone or with a medicine called pembrolizumab (Keytruda®)

Your doctor may prescribe TRODELVY for mTNBC as:

  • First-line monotherapy: TRODELVY may be the first treatment you receive after a metastatic TNBC diagnosis (first-line). It may be the only therapy you receive at the time (monotherapy).
    • This is an option for people who are not a candidate for PD-1 or PD-L1 inhibitor-based therapy
  • First-line combination therapy with an immunotherapy called pembrolizumab (Keytruda): TRODELVY may be the first treatment you receive after a metastatic TNBC diagnosis (first-line). It may be given at the same time with another cancer treatment called pembrolizumab, which is a type of immunotherapy
    • Keytruda works in combination with TRODELVY to treat mTNBC in two different ways
    • This may be an option for people whose tumors test positive for PD-L1

A first-line treatment is the initial therapy for metastatic disease.

Stage 4=metastatic; TNBC=triple-negative breast cancer.

Talk to your doctor to see if TRODELVY may be right for you.

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What is trodelvy?

important safety information

TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:

TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with

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Tap for Important Safety Information. TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:

Expand isi-expand-white-icon Close isi-collapse-white-icon

What is Trodelvy?

TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used in adults to treat Triple-Negative Breast Cancer (TNBC), that cannot be removed by surgery (unresectable) and has spread to nearby tissues (locally advanced) or other parts of the body (metastatic).

  • As the first treatment:
    • alone when 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 the tumors test positive for PD-L1.

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

IMPORTANT SAFETY INFORMATION

TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:

  • Low white blood cell count (neutropenia) 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 and may give a medicine to help prevent neutropenia 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: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
  • 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 it. 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 your treatment with TRODELVY, your healthcare provider should check to see if it 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 dehydration, such as lightheadedness, dizziness, or faintness; if you cannot take fluids by mouth due to nausea or vomiting; or 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.

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

Allergic and infusion-related reactions can be serious or life-threatening. 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 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 can be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting along with medicines to take home with instructions about how to take them. Tell your healthcare provider right away if you develop nausea or vomiting that is not controlled with the medicines prescribed for you.

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 UGT1A1*28, which can increase your risk of getting side effects with TRODELVY, especially low white blood cell counts, with or without a fever, and low red blood cell counts.
  • 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. 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.
    • 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.

The most common side effects of TRODELVY when used alone include decreased white blood cell and 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 in the blood, decreased appetite, stomach pain, decreased creatinine clearance, and decreased magnesium and potassium levels in the blood.

The most common side effects of TRODELVY when used with pembrolizumab include decreased white blood cell and red blood cell counts, diarrhea, nausea, feeling tired or weak, hair loss, increased alkaline phosphatase, sugar (glucose), and 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, and decreased protein levels (albumin) in the blood.

These are not all of the possible side effects of TRODELVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click to see Important Facts about TRODELVY, including Important Warning.