Frequently Asked Questions

TREATMENT OVERVIEW

What is TRODELVY?

TRODELVY 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.

How is TRODELVY thought to work?

TRODELVY is a type of drug called an antibody-drug conjugate, or ADC for short. ADCs join 3 parts into 1 drug: an antibody, an anti-cancer drug, and a linker. The antibody looks for a specific protein, in this case Trop-2, which is found to be overexpressed in many cancers, including bladder cancer. The anti-cancer drug kills cancer cells once they’re found. The linker connects the anti-cancer drug to the antibody.

Scientists discovered that patients with metastatic bladder cancer have tumor cells that more often contain the Trop-2 protein. TRODELVY binds to cells with Trop-2.

Information from laboratory studies suggest that this is how TRODELVY works. The clinical benefit of these observations is unknown.

How is TRODELVY given?

You will receive TRODELVY from your healthcare provider as an infusion into your vein. Each treatment cycle is 21 days. Doses are given once a week for 2 weeks, of 21-day treatment cycles.

  • You will receive the first dose of TRODELVY over 3 hours. If you tolerate the first dose well, future doses may be given over 1 to 2 hours
  • Before each dose of TRODELVY, you will receive medicines to help prevent infusion reactions, and nausea and vomiting
  • You will be monitored for side effects during and for at least 30 minutes after you receive each infusion of TRODELVY
  • Your healthcare provider may slow down, interrupt, or stop your infusion of TRODELVY if you have a life-threatening infusion-related reaction. Your healthcare provider may temporarily reduce the dose of TRODELVY to help manage side effects. In certain instances, permanent discontinuation may be recommended
  • Your healthcare provider will decide how long you will continue to receive TRODELVY

What are some of the things that need to be done before I am given TRODELVY?

Before your first infusion, you may be given medicines such as antihistamines, corticosteroids, or H1 or H2 blockers. You may also receive a fever reducer. These medicines can help prevent reactions to the infusion. You may also be given medicine to help prevent nausea and vomiting.

On the day of your first infusion, you may have a short physical exam to check your blood pressure, pulse, breathing, and temperature. Your weight will also be measured to find the right dosage of TRODELVY. An intravenous (IV) tube will be put into your vein and a blood sample may be taken.

How often will I receive TRODELVY?

TRODELVY is an IV infusion. It is given once a week for 2 weeks, followed by 1 week off. Each treatment cycle is 3 weeks, which means treatment cycles repeat every 21 days.

How long will I be on TRODELVY?

You and your healthcare provider will decide how many treatment cycles you receive. This may be based on factors such as whether your tumor has responded to treatment or your body’s ability to tolerate treatment.

Will TRODELVY affect other medical conditions I may have?

TRODELVY may affect your body in different ways.

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 uridine diphosphate-glucuronosyl transferase A1 (UGT1A1)*28. People who carry this gene have an increased risk of getting side effects with TRODELVY, especially low white blood cell counts, a fever while your white blood cell count is low, 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

SIDE EFFECTS

What is the most important information I should know about TRODELVY?

TRODELVY can cause serious side effects, including:

  • Low white blood cell count (neutropenia): Low white blood cell counts are common with TRODELVY 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 with TRODELVY. If your white blood cell count is too low, your healthcare provider 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 healthcare provider may need to give you antibiotic medicines if you develop fever while your white blood cell count is low. Contact your healthcare provider immediately if you experience fever, chills, cough, shortness of breath, or burning or pain when you urinate.
  • Severe diarrhea: Diarrhea is common with TRODELVY and can also be severe. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control your diarrhea. 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 the diarrhea 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 antidiarrheal 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 losing too much body fluid (dehydration) 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

What are the possible side effects of TRODELVY?

TRODELVY can cause serious side effects, including:

  • See “What is the most important information I should know about TRODELVY?”
  • Allergic and infusion-related reactions: Serious allergic reactions can happen during treatment with TRODELVY, including life-threatening allergic reactions, and infusion-related reactions. Tell your healthcare provider right away if you get any of the following symptoms of an allergic reaction during an infusion of TRODELVY or within 24 hours after you receive a dose of TRODELVY:
    • 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. You should be given medicines to take home with you, along with instructions about how to take them to help prevent and treat any nausea and vomiting after you receive TRODELVY. 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.

    The most common side effects in all patients treated with TRODELVY include:

    • Feeling tired or weak
    • Hair loss
    • Decreased red blood cell count
    • Constipation
    • Decreased appetite
    • Rash (see "allergic and infusion-related reactions" above)
    • Stomach-area (abdominal) pain or discomfort

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.

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.

What side effects should I call my healthcare provider about?

Tell your healthcare provider about any side effects that occur while receiving TRODELVY. Call your doctor for medical advice about side effects.

TRODELVY can cause serious side effects, including:

  • Low white blood cell count (neutropenia). Low white blood cell counts are common with TRODELVY 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 with TRODELVY. If your white blood cell count is too low, your healthcare provider 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 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 during treatment with TRODELVY: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
  • Severe diarrhea. Diarrhea is common with TRODELVY and can also be severe. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control your diarrhea. 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 the diarrhea 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 antidiarrheal 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 losing too much body fluid (dehydration) and body salts, 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.
  • Allergic and infusion-related reactions. Serious allergic reactions can happen during treatment with TRODELVY, including life-threatening allergic reactions, and infusion-related reactions. Tell your healthcare provider right away if you get any of the following symptoms of an allergic reaction during an infusion of TRODELVY or within 24 hours after you receive a dose of TRODELVY: 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, and 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. You should be given medicines to take home with you to help prevent and treat any nausea and vomiting after you receive TRODELVY. Call your healthcare provider 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.

These are not all the possible side effects of TRODELVY. Tell your healthcare provider 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.

Can I take a break during the infusion if I start feeling unwell?

If you start to feel unwell, alert the nurse or other healthcare team member immediately. They will discuss your options with you.

Will I experience hair loss?

Hair loss is common with TRODELVY.

Are there things I can do to help with certain side effects?

Yes, your healthcare provider will discuss medications you may take before, during, or after treatment to help manage certain side effects. These may include medication to help prevent nausea and vomiting and antidiarrheal medication. Your healthcare provider may recommend treatments for other side effects as well. Granulocyte colony-stimulating factor (G-CSF) was used in 47% of patients who received TRODELVY. Your healthcare provider may also reduce the dose or modify the dosing schedule. Some side effects may require you to reduce your dose and some side effects may require you to interrupt your treatment or permanently discontinue TRODELVY.

There may also be some lifestyle changes you can make to help manage some side effects. Be sure to discuss any side effects that you may have with your healthcare provider.

NAUSEA AND VOMITING

Your healthcare provider may provide medications to help prevent nausea and vomiting. Follow the directions from your healthcare provider. 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

DIARRHEA

Antidiarrheal medications may be given to you by your healthcare provider. Contact your healthcare provider immediately if you are unable to get your diarrhea under control within 24 hours after infusion. The following tips may help control diarrhea:

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

FEELING TIRED (fatigue) OR WEAK

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 healthcare provider before starting a new exercise routine
  • Drink plenty of water and eat well
  • Reduce stress by trying meditation, yoga, reading, or keeping a diary

LOW RED BLOOD CELL COUNT (anemia)

A low red blood cell count can be common with treatment. This can leave you feeling weak and tired. Following these tips may help:

  • Limit activities and get plenty of rest
  • Take short naps and try to get 7 to 8 hours of sleep each night
  • Eat a well-balanced diet that includes proteins (such as meat, fish, eggs, dairy, and nuts) and drink plenty of water

LOW WHITE BLOOD CELL COUNT (neutropenia)

TRODELVY may lower your neutrophils, a type of white blood cell. This can put you at higher risk of infection. The following tips may help reduce the risk of infection:

  • Contact your healthcare provider immediately if you experience fever, chills, or other signs 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

HAIR LOSS (alopecia)

Hair loss is common with treatment. These tips may help:

  • If you are considering a wig, buying it before treatment begins may help you match it to the color and style of your hair
  • Check to see if your insurance company will cover the cost for a wig (cranial prosthesis)
  • Wear a hair net at night or sleep on a satin pillowcase to keep hair from coming out in clumps
  • Protect your scalp from the sun by using sunscreen and wear a hat or scarf outside
  • The effectiveness and safety of cooling caps is still being researched. If you are curious about this option, talk to your healthcare provider. Also, ask if the treatment center has experience in using cooling caps and how successful they have been

TREATMENT DAYS

How long does a TRODELVY infusion take?

Your first infusion will take approximately 3 hours. After that, if prior treatment was well tolerated, your infusions will take 1 to 2 hours.

What would be helpful for me to know on my treatment days?

Treatment days can be exhausting. Here are a few tips to consider:

  • If you think you will feel too tired to drive, arrange for transportation to and from the infusion center
  • Bring things to pass the time. Books, audio books, and magazines are great choices. Headphones and a tablet or phone for music, shows, movies, or podcasts can be helpful
  • Consider downloading a meditation app
  • Wear comfortable clothing and bring a blanket in case you start to feel cold
  • Until you know how TRODELVY will affect you, consider asking someone to be home to help you on treatment days. Once you have had a few treatments, you can have a better sense of how you will feel and what kind of help you may or may not need on treatment days

Will I need to have a port for my infusion?

You do not need to have a port inserted to receive treatment with TRODELVY. However, if you already have a port, it can be used for the infusion.

A port can help reduce the number of times a nurse needs to insert a needle into your vein. This can be helpful if your veins are small or damaged.

What should I expect on treatment days?

Your healthcare provider may recommend the following on treatment days:

Pre-infusion: You may be given medicines before your infusion to help prevent infusion reactions, including a fever reducer, antihistamines, or corticosteroids. Your healthcare provider may also give you medicine to help reduce or prevent nausea or vomiting.

Infusion: Your first infusion will take approximately 3 hours. Your healthcare provider will observe you during the infusion. After that, if prior treatment was well tolerated, your infusions with TRODELVY will take 1 to 2 hours.

Observation: After each infusion, your healthcare provider will watch for reactions for at least 30 minutes. If you experience any side effects while taking TRODELVY, tell your healthcare provider right away. Please read the Important Safety Information at the bottom of this website.

How can my healthcare provider and I tell if the treatment is working?

Your healthcare provider will tell how well your treatment is working by doing different exams or tests. Ask your healthcare provider to explain the results to you and if your treatment is working.

Keep in mind that side effects do not tell you if the treatment is, or is not, working.

ACCESS AND SUPPORT

What if I need help paying for TRODELVY?

TRODELVY ACCESS SUPPORT can help you determine your benefits and coverage for TRODELVY and provide support throughout your treatment journey.

Reimbursement support is available. You can speak to a representative about:

  • Benefits and coverage
  • Out-of-pocket cost assessment
  • Patient support programs
  • Alternate assistance options

Call 1-844-TRODELVY (1-844-876-3358), Monday through Friday, 9 AM-7 PM ET.

What support groups are available for patients with advanced bladder cancer?

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

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

American Cancer Society: Find local cancer support programs and resources.

Cancer Support Community: Access information, support, and other resources.