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HOW TRODELVY IS DESIGNED TO WORK

TRODELVY^®

Sacituzumab govitecan-hziy

180 mg for injection

WHAT IS TRODELVY?

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.
• bladder cancer and cancers of the urinary tract that have spread 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.

Please continue watching for Important Safety Information at the end of this video and please see link provided for Important Facts, including Important Warning.

The actors portrayed in this video are not actual TRODELVY patients. They are here for your education and entertainment. Enjoy.

Crystal:

I’m an info nerd. UFO sightings, beekeeping, or Barry Manilow’s greatest hits, you name it, I know it. So when I got my metastatic cancer diagnosis, I wanted to know everything I could about treatment options.

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TRODELVY^®

Sacituzumab govitecan-hziy

180 mg for injection

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Right now, I’m looking at some firsthand experience with TRODELVY sacituzumab govitecan-hziy?

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Sacituzumab govitican hziy

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Is that a word? Has anyone here tried it?

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CRYSTAL

Curious about TRODELVY

Self-proclaimed Info Nerd

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TRODELVY? I haven’t tried that yet.

I’ll have to talk to my doctor about that one.

My doctor mentioned TRODELVY, but I haven’t looked into it.

I’ve been taking TRODELVY for three months now. What’s on your mind?

I’ve heard about TRODELVY but need to find more info too. Let me know what you learn.

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Amanda:

I’ve been taking TRODELVY for 3 months now. What’s on your mind?

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AMANDA

TRODELVY Patient and Champion

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Crystal:

I’ve probably got 100 questions, but how exactly does it work?

Amanda:

My doctor told me it delivers anticancer medicine into cells... But how it does that… I’m lousy at explaining things. Hold on one moment.

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My doctor told me it delivers anticancer medicine into cells…

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DR. ESPOSITO

Oncologist

(Has no idea she’s on mute)

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Amanda:

You’re on mute.

Dr. Esposito:

Sorry. Anyway, hey. I’m an oncologist. It is so good to see you again. Do more people want to learn about TRODELVY? That’s 4 just this week!

Crystal:

Wait, did you two plan this?

Dr. Esposito:

First, let’s look at cancer cells. They’re notoriously hard to destroy, smart, and may become resistant or may not respond at all to treatments.

TRODELVY takes a different approach when it comes to cancer cells.

Crystal:

Okay. I’m with you so far.

Dr. Esposito:

TRODELVY is known as an antibody-drug conjugate or ADC for short.

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Antibody-drug conjugate

ADC

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Amanda:

Uh, anti-what now?

Dr. Esposito:

Think of TRODELVY like a cargo ship. The TRODELVY ship is an antibody, and it’s carrying anticancer medicine.

Jim:

Woah, woah—not to knock the wind out of your sails, but I know a thing or two about ships. They need some type of navigation to see where they’re going. See, there was this one time I was lost at sea, and I had to navigate by sense of smell. We had nothing to eat but sea sponges and…

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JIM

TRODELVY patient

Lost at sea

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Dr. Esposito:

I can’t speak to the nutritional benefit of a sea sponge-based diet. Our SS TRODELVY is an antibody designed to seek out a specific protein called Trop-2. Compared with healthy cells, some cancer cells may have a higher amount of Trop-2.

Jim:

Trop-2... Do I need to see the first Trop to understand the sequel?

Amanda:

Good one. So these Trop-2 things enable TRODELVY to target cells?

Dr. Esposito:

The Trop-2 acts like a beacon, telling the TRODELVY ship to enter the docking area of that specific cell.

Jim:

What kind of cargo is this TRODELVY ship carrying anyway?

Dr. Esposito:

The cancer-fighting kind. Each TRODELVY ship can on average carry about 7 to 8 molecules of the anticancer medicine.

Crystal:

Holy ship!

Dr. Esposito:

Now, once TRODELVY docks in the cell, it delivers and releases the anticancer medicine, destroying the cell.

Crystal:

Wow! So TRODELVY is targeted at those cells with Trop-2? That sounds like a treatment option I’d like to try. I’ll discuss it with my doctor.

Dr. Esposito:

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

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

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Crystal:

Thanks for talking me through how TRODELVY is designed to work. Is there any important safety information I should know about?

[Voiceover with text on-screen]:

I’m glad you asked. Here’s what you should know.

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.

WHAT IS TRODELVY?

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.
• bladder cancer and cancers of the urinary tract that have spread 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.

Please see Important Facts, including Important Warning on TRODELVY.com.

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Crystal:

I just learned this for the first time, so I recommend you follow up with your doctor to see if TRODELVY is right for you.

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TRODELVY^®

sacituzumab govitecan-hziy

180 mg for injection

GILEAD

This information does not constitute the provision of medical advice and should not substitute for clinical decision making.

TRODELVY, the TRODELVY logo, GILEAD, and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.

© 2023 Gilead Sciences, Inc. All rights reserved. US-TROC-0123 02/23

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