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. TRODELVY 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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UNDERSTANDING ADVANCED BLADDER CANCER

Types of bladder cancer

Locally Advanced Bladder Cancer

Locally advanced cancer refers to when the cancer cells have spread from where they started to nearby tissues or to lymph nodes. With bladder cancer, this means that the cancer has spread to the walls of the bladder or to the lymph node, but it has not spread to any other parts of the body.

Metastatic Bladder Cancer

Bladder cancer is referred to as “metastatic” when it spreads outside of the bladder to other parts of the body.

Treatment plan considerations

These are some things to consider when discussing your treatment plan for advanced bladder cancer with your healthcare provider. Sharing this information can help you and your healthcare team decide what your next treatment option could be.

Other Conditions You May Have

You’ll want to bring up any current conditions you have been diagnosed with. About 1 out of every 4 patients with advanced bladder cancer also has diabetes. Other common conditions include kidney disease, chronic obstructive pulmonary disease (COPD), heart disease, and stroke. Knowing about your overall health will help your healthcare provider develop the best treatment plan for you.

Treatments You’ve Tried

Your treatment considerations may change over time. It is important to talk to your healthcare provider about any new signs or symptoms you have experienced during your treatment journey for advanced bladder cancer. Discuss any treatments you may have tried in the past and any side effects you may have experienced.

A different type of treatment

Together with your healthcare provider, take control of your treatment plan with TRODELVY.

TRODELVY is designed to carry anticancer medicine to cells that have the Trop-2 protein, which is more often present on certain types of cancer cells in comparison to normal cells, including those found in advanced bladder cancer. See how TRODELVY is designed to work.

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 or cannot be removed by surgery. TRODELVY may be used if you have received a platinum-containing chemotherapy medicine and also received an immunotherapy medicine.*

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

*TRODELVY 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.

Advanced Bladder Cancer Community Support

Here are some additional resources that may be helpful to patients, families, and care partners dealing with advanced bladder cancer. The following resources are not controlled or owned by Gilead, and Gilead is not responsible for their content.

American Cancer Society: Find local cancer support.

Bladder Cancer Advocacy Network (BCAN): Connect with a community of patients, care partners, survivors, advocates, and medical and research professionals dedicated to helping people with bladder cancer.

Bladder Cancer Matters Podcast: Listen to a podcast created for the bladder cancer community that discusses bladder cancer research, treatment, caregiving, and more.

Cancer Support Community: The largest professionally led nonprofit network of cancer support worldwide, providing access to information, support, and other resources.

Inspire Online Community: Ask questions and connect with other people with bladder cancer and care partners.

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.

TRODELVY 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. 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.