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.

Advanced Bladder Cancer
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A WELL-ESTABLISHED SAFETY PROFILE,
A WELL-DOCUMENTED SIDE EFFECT PLAN

Having open discussions with your healthcare team can help you develop a plan to proactively manage potential side effects. When discussing side effect management with your healthcare team, be sure to:

  • Ask about other treatments or medicines you may be able to take before, during, or after treatment
  • Share any side effects you may have experienced with previous therapies
  • Provide a list of all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the way TRODELVY works

Be sure to tell your healthcare team about any side effects you have while on TRODELVY.

Treatment modification

Your healthcare provider (HCP) may modify your dose to help you manage certain side effects and continue treatment. If adverse events are serious, your treatment may need to be stopped or discontinued by your HCP.

Side effect management

There may also be some lifestyle changes you can make to help manage some of the most common side effects. Be sure to discuss any side effects you may have with your HCP.

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.

Be sure to tell your HCP about any side effects you have while on TRODELVY and refer to the Important Facts for a list of possible side effects. Some side effects may require you to interrupt your treatment or permanently discontinue TRODELVY. Do not make any changes to your treatment plan or medicine usage prescribed to you without being instructed to do so by your HCP.

Neutropenia (Low White Blood Cell Count)

TRODELVY may lower your neutrophils, a type of white blood cell. This is common and can sometimes be severe and lead to infections which can be life-threatening or cause death.

Your HCP should check your blood cell counts during treatment with TRODELVY. If your white blood cell count is too low, your HCP may need to lower your dose of TRODELVY, give you a medicine to help prevent low blood cell count with future doses of TRODELVY, or in some cases may stop TRODELVY. Your HCP may need to give you antibiotic medicines if you develop fever while your white blood cell count is low.

Contact your HCP immediately if you experience fever, chills, cough, shortness of breath, burning or pain when you urinate, or other signs of infection.

The following tips may also help reduce the risk of infection:

  • Wash your hands often with soap and warm water
  • Avoid large crowds and stay away from people who are sick
  • Thoroughly wash raw fruits and vegetables before eating them
Diarrhea

Diarrhea is common and can be severe. Severe diarrhea can lead to loss of too much body fluid (dehydration) and kidney problems. Your HCP should monitor you for diarrhea and give you medicine as needed to help control it. If you lose too much body fluid, your HCP may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during your treatment with TRODELVY, your HCP should check to see if it may be caused by an infection. Your HCP may decrease your dose or stop TRODELVY if your diarrhea is severe and cannot be controlled with anti-diarrheal medicines.

Call your HCP 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 losing too much body fluid and body salts, such as lightheadedness, dizziness, or faintness
  • If you are unable to take fluids by mouth due to nausea or vomiting
  • If you are not able to get your diarrhea under control within 24 hours

The following tips may also help control diarrhea:

  • Slowly sip cool, clear liquids throughout the day to stay hydrated
  • Eat frequent, small meals that are bland and low in fiber such as bananas, white rice, and toast
  • Avoid alcohol, caffeine, greasy or spicy foods, and limit dairy products and raw vegetables
Allergic and Infusion-Related Reactions

TRODELVY can cause serious and life-threatening allergic and infusion-related reactions during infusion.

Tell your HCP right away if you get any of the following symptoms during your infusion of TRODELVY or within 24 hours: 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; chills or shaking chills (rigors).

Nausea and Vomiting

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 HCP right away if you have nausea or vomiting that is not controlled with the medicines prescribed for you. Your HCP may decide to decrease your dose or stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines. These tips may also help:

  • Eat 5 to 6 small meals or snacks a day rather than 3 large meals
  • Eat bland foods, such as toast and crackers
  • Try eating small amounts of foods that are high in calories
  • Slowly sip cool, clear liquids such as ginger ale, apple juice, broth, or tea throughout the day to stay hydrated
  • Try to take deep, slow breaths or get fresh air when you begin to feel sick
  • If you are vomiting, ice chips or frozen juice chips may help you take in fluids more easily
Fatigue

It’s common for treatment to leave you feeling weak and tired. Help manage your fatigue using the following tips:

  • Plan time to relax and rest, and create a schedule that works for you
  • Take short naps and try to get 7 to 8 hours of sleep each night
  • Try to stay active but talk with your HCP before starting a new exercise routine
  • Drink plenty of water and eat well
  • Reduce stress by trying meditation, yoga, reading, or keeping a diary
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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:

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.