TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract that have spread (metastatic) or cannot be removed by surgery, and who have received a platinum-containing chemotherapy medicine and also received an immunotherapy medicine. This indication is approved based on medical studies that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in additional medical studies. 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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FINDING YOUR NEXT TREATMENT OPTION

TRODELVY was studied in a phase 2 clinical trial. The trial included 112 adults with bladder cancer and cancers of the urinary tract that spread or could not be removed by surgery. Patients in the trial had previously received a platinum-containing chemotherapy and an immunotherapy medicine. Patients were given 10 mg/kg of TRODELVY as an intravenous infusion on days 1 and 8 of a 21-day treatment cycle.

TRODELVY may help your tumors shrink or disappear

Of the 27.7% of patients (31 out of 112) receiving TRODELVY who responded to treatment in the clinical trial:

22.3% saw their tumors DECREASE IN SIZE by at least by 30%
5.4% saw their tumors DISAPPEAR
The median length of response to treatment with TRODELVY lasted for 7.2 MONTHS.*

* The range of response was 1.4+ months to 13.7.

+ indicates that the response is ongoing.

TRODELVY may not work for everyone. Individual results may vary.

SIDE EFFECTS: WHAT YOU MAY EXPECT

It’s important to understand what side effects may be expected with TRODELVY, including serious side effects. It’s also important to know that your healthcare provider may be able to help you proactively plan for some side effects with pretreatment medicine and guidance to help you manage side effects if they do occur.

If you experience any side effects, contact your healthcare provider immediately. Some side effects may require medical attention.

In the clinical trial, the most common side effects seen in at least 25% of patients were:

  • Decreased white blood cell (leukocyte, lymphocyte, and neutrophil) and red blood cell counts
  • Diarrhea
  • Feeling tired or weak (fatigue)
  • Nausea
  • Increased sugar levels in the blood
  • Decreased protein levels (albumin) in the blood
  • Hair loss (alopecia)
  • Any infection
  • Decreased levels of calcium, sodium, phosphate, magnesium, and potassium in the blood
  • Decreased appetite
  • Increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems)
  • Constipation
  • Vomiting
  • Changes in the ability of blood to clot
  • Rash
  • Changes in kidney function
  • Abdominal pain
  • Increased liver enzyme tests (for liver problems)
  • Increased levels of enzyme called lactate dehydrogenase
  • Decreased platelet counts in blood

TRODELVY can also cause serious side effects, including neutropenia, severe diarrhea, serious infusion-related reactions and severe allergic reactions, which could be life-threatening, as well as nausea and vomiting.

For those taking TRODELVY in the clinical trial:

  • Serious side effects occurred in 44% of patients receiving TRODELVY. The most common serious side effects in ≥5% of patients in the TRODELVY group were infection (18%), low white blood cell counts called neutrophils (12%), acute kidney injury (6%), urinary tract infections (6%), and blood infections (5%)
  • 10% of patients stopped treatment due to side effects
  • Side effects leading to a treatment interruption of TRODELVY occurred in 52% of patients
  • Doses were reduced for 42% of patients to help manage side effects

These are not all of the possible side effects of TRODELVY. Tell your healthcare provider about any side effects that bother you or do not go away. Call your healthcare provider 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 bladder cancer and cancers of the urinary tract that have spread (metastatic) or cannot be removed by surgery, and who have received a platinum-containing chemotherapy medicine and also received an immunotherapy medicine.

This indication is approved based on medical studies that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in additional medical studies.

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. 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 may report side effects to FDA at 1-800-FDA-1088.

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