Side effects

What you may expect

It’s important to understand what side effects may be expected with TRODELVY, including serious side effects. Contact your doctor immediately if you have any side effects. Some side effects may require medical attention and, for some side effects, your doctor may have tips to help you manage or cope with them.

Some side effects of TRODELVY are similar to those you may have had while taking chemotherapy for mTNBC, and the severity is different for everyone. TRODELVY is likely to cause hair loss, even for patients who have not lost hair before. This may happen soon after starting treatment.

The most common side effects seen in ≥25% of patients were:

Decreased white blood cell count (neutropenia)

Nausea

Diarrhea

Feeling tired

Hair loss

Decreased red blood cell count (anemia)

Vomiting

Constipation

Decreased appetite

Rash

Stomach-area (abdominal) pain or discomfort

TRODELVY also caused serious side effects, including neutropenia, severe diarrhea, serious infusion-related reactions and allergic reactions that can be life-threatening, and nausea and vomiting in the phase 3 trial.

  • Serious adverse reactions occurred in 27% of patients receiving TRODELVY. Serious adverse reactions in >1% of patients receiving TRODELVY included neutropenia (7%), diarrhea (4%), and pneumonia (3%)
  • 5% of patients stopped treatment due to side effects
  • Side effects leading to a treatment interruption of TRODELVY occurred in 63% of patients
  • Doses were reduced for 22% of patients to help manage side effects

Be sure to tell your doctor about any side effects you have while on TRODELVY. They may be able to help by:

  • Recommending medications that support your treatment
    • Granulocyte colony-stimulating factor (G-CSF) was used in 44% of patients who received TRODELVY
  • Reducing/interrupting your dose
  • Discontinuing your treatment with TRODELVY

These are not all of the possible side effects of TRODELVY. Tell your doctor about any side effects that bother you or do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.

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) 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. 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 (dehydration), your healthcare provider may need to give you fluids and electrolytes to replace body salts. If diarrhea happens later in your treatment, your healthcare provider may check you 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.
    • 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.
    • Tell your healthcare provider right away if you or your partner become pregnant during treatment with 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 feeling tired or weak, hair loss, decreased red blood cell count, constipation, decreased appetite, rash, and stomach-area (abdominal) pain or discomfort.

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.

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