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.
• hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body or cannot be removed by surgery, and who previously received endocrine therapy and at least two additional treatments for metastatic disease.

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

TRODELVY is a type of treatment called an antibody-drug conjugate (ADC) that is designed to work differently than traditional chemotherapy. It is designed to deliver anticancer medicine directly to cells with Trop-2 proteins.

An ADC is a substance that binds to a specific protein or receptor found on certain types of cells, including cancer cells. It has 3 parts: an antibody that looks for the proteins, an anticancer drug, and a linker that connects the antibody to the drug.

In certain types of cancers, tumor cells have a higher amount of a protein called Trop-2. TRODELVY seeks out and attaches to Trop-2.

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

• You will receive TRODELVY from your HCP as an infusion into your vein. Each treatment cycle is 21 days. Doses are given once a week on Days 1 and 8, followed by 1 week off during a 21-day treatment cycle
• 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, your HCP will give you medicines that can help to prevent infusion-related 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 HCP may slow down, interrupt, or stop your infusion of TRODELVY if you have a life-threatening infusion-related reaction. Your HCP may reduce the dose of TRODELVY to help manage side effects. In certain instances, permanent discontinuation may be recommended
• Your HCP will decide how long you will continue to receive TRODELVY

Before your infusion, you may be given medicines to help prevent infusion reactions, including a fever reducer, antihistamines, and corticosteroids. You may also be given medicine to help prevent nausea and vomiting.

On the day of your infusion, you may have a short physical exam to check your blood pressure, pulse, breathing, and temperature. Your height and weight will also be measured to find the right dosage of TRODELVY. An intravenous (IV) tube will be put into your arm, unless you already have a port which can be used for the infusion, and a blood sample may be taken.

Doses are given once a week on Days 1 and 8, followed by 1 week off during a 21-day treatment cycle. Refer to the dosing schedule for more information.

You and your HCP 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.

TRODELVY may affect your body in different ways.

Before receiving TRODELVY, tell your HCP about all of your medical conditions, including if you:

• Have been told that you carry a gene for uridine diphosphate-glucuronosyl transferase 1A1 (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 HCP 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 HCP 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 HCP 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.

TRODELVY can cause serious side effects, including:

• 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 HCP should check your blood cell counts during treatment. If your white blood cell count is too low, your HCP 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 HCP may need to give you antibiotic medicines if you develop fever while your white blood cell count is low. Call your HCP right away if you develop any of the following signs of infection:
  • Fever
  • Chills
  • Cough
  • Shortness of breath
  • 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 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

TRODELVY can cause serious side effects, including:

• See “What is the most important information I should know about TRODELVY?”
• Allergic and infusion-related reactions which can be serious and life-threatening. Tell your HCP or nurse right away if you get any of the following symptoms during an infusion 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
  • 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 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.

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.

TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your HCP if fertility is a concern for you.

Before and during treatment with TRODELVY, your HCP will need to do tests to monitor your health. Tell your HCP right away if you have any new symptoms while taking TRODELVY.

These are not all of the possible side effects of TRODELVY. Call your HCP for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

TRODELVY can cause serious side effects, including:

• 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 HCP should check your blood cell counts during treatment. If your white blood cell count is too low, your HCP 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 HCP may need to give you antibiotic medicines if you develop fever while your white blood cell count is low. Call your HCP right away if you develop any of the following signs of infection:
  • Fever
  • Chills
  • Cough
  • Shortness of breath
  • 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 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

• Allergic and infusion-related reactions which can be serious and life-threatening. Tell your HCP or nurse right away if you get any of the following symptoms during an infusion 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
  • 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 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.

TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your HCP if fertility is a concern for you.

Before and during treatment with TRODELVY, your HCP will need to do tests to monitor your health. Tell your HCP right away if you have any new symptoms while taking TRODELVY.

These are not all of the possible side effects of TRODELVY. Call your HCP for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Hair loss is common with TRODELVY.

Yes, your HCP will discuss medicines you may take before, during, or after treatment to help manage certain side effects. These may include medicine to help prevent nausea and vomiting and antidiarrheal medicine. Your HCP may recommend treatments for other side effects as well. Granulocyte colony-stimulating factor (G-CSF) was used in patients who received TRODELVY. Your HCP may also reduce or temporarily suspend your treatment with TRODELVY if certain side effects occur. Some side effects may require your HCP to permanently discontinue TRODELVY.

Do not make any changes to your treatment schedule unless instructed to by your doctor/healthcare team.

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

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 HCP 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

DIARRHEA Antidiarrheal medicines may be given to you by your HCP. Contact your HCP 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 in fiber such as bananas, white rice, and toast
• Avoid alcohol, caffeine, greasy or spicy foods, and limit dairy products and raw vegetables

NAUSEA AND VOMITING Your HCP may provide medicines to help prevent nausea and vomiting. Follow the directions from your HCP. 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

FEELING TIRED OR WEAK (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

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

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 wearing 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 HCP. Also, ask if the treatment center has experience in using cooling caps and how successful they have been

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

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

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.

Your HCP may recommend the following on treatment days:

Pretreatment medicine: Before your infusion, you may be given medicines to help prevent infusion reactions, including a fever reducer, antihistamines, and corticosteroids. You may also be given medicine to help prevent nausea and vomiting.

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

Postinfusion observation: After each infusion, your HCP will watch for reactions for at least 30 minutes. If you experience any side effects while taking TRODELVY, tell your HCP right away. Please see the Important Safety Information for more information.

Your HCP will tell how well your treatment is working by doing different exams or tests. Ask your HCP 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.

Gilead Oncology Support can help you determine your benefits and coverage for TRODELVY and provide support throughout your treatment.

For additional information, contact a Gilead Oncology Support program specialist Monday through Friday, 9 AM to 7 PM ET at 1-844-TRODELVY (1-844-876-3358).

Visit Gilead Oncology Support to enroll online and get more information about support offerings.