TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) 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.

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About HR+/HER2- mBC treatment

Breast cancer is classified by whether or not the cancer cells have certain proteins called receptors. Cancer cells may have receptors for 2 types of hormones (estrogen or progesterone) or another receptor called human epidermal growth factor receptor 2 (HER2).

Treatment depends on your HR and HER2 status

HR+

If estrogen or progesterone hormone receptors are detected in at least 1 out of every 100 cancer cells, the breast cancer is hormone receptor-positive (HR+).

Hormone therapy (also called endocrine therapy) works by interfering with the activity of estrogen and/or progesterone hormones, which cancer cells can use to grow. This is why hormone therapy is a common initial treatment for HR+ breast cancer.

HER2-

If tests detect low or no HER2 receptors, the breast cancer is considered HER2-negative (HER2-).

TRODELVY was designed for certain patients with previously-treated HER2- breast cancer.

70% of all breast cancers are HR+/HER2-

70% of all breast cancers are HR+/HER2-

Eventually, hormone therapy can stop working, so your healthcare provider may prescribe systemic treatments that more widely affect your cancer cells.

Beyond hormone therapy

After many treatments, it’s normal to feel like you’re running out of options. TRODELVY can be used in certain adults who have received endocrine therapy and 2 or more treatments for metastatic breast cancer that is HR+ and HER2-negative, which includes cancer that is HER2-low.

Why TRODELVY may be an option

Unlike some other treatments, TRODELVY does not need cancer cells to have estrogen receptors, progesterone receptors, or HER2 in order to work, which is why it is an option for people with HR+/HER2- metastatic breast cancer. TRODELVY is designed to seek out a different protein that may be present on breast cancer cells.

What is TRODELVY?

TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) 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:

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

  • Low white blood cell count (neutropenia) which is common and can sometimes be severe and lead to infections that can be life-threatening or cause death. Your healthcare provider should check your blood cell counts during treatment. If your white blood cell count is too low, your healthcare provider may need to lower your dose, give you a medicine to help prevent low blood cell count with future doses of TRODELVY, or in some cases may 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 or 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.