Addressing side effects

Addressing diarrhea

Overall, the key information to know about diarrhea: it can be managed with the appropriate steps, so EXPECT, PLAN, and ACT.

EXPECT

DIARRHEA IS A COMMON SIDE EFFECT

Diarrhea is a common side effect with Verzenio and may sometimes be severe, but you and your doctor can take steps to manage it. If diarrhea occurs, it will most likely happen in the first month. You should be on the lookout for cramping or frequent, loose, or watery stools.

PLAN

PLAN AHEAD OF TIME

It is important to plan ahead of time with your doctor. Make sure you have an over-the-counter antidiarrheal medicine, such as loperamide (also known as Imodium^®) available at home before you start taking Verzenio.

ACT

IMMEDIATE 24-HOUR ACTION PLAN

If you begin experiencing diarrhea, it is very important that you take action immediately at the first signs of symptoms. The best way to manage diarrhea is to start an anti-diarrheal at the first sign and call your doctor, who may make a dose change.

STEP 1: Start an anti-diarrheal and call your doctor
- If you are experiencing diarrhea, you need to start taking an anti-diarrheal as directed on the packaging and call your doctor or nurse immediately so they are aware and can help you manage the diarrhea.
STEP 2: Stay hydrated and drink clear fluids
- Drink at least 8-10 glasses of clear fluids in the first 24 hours you experience symptoms (and continue any day you experience diarrhea) to avoid dehydration.
STEP 3: Watch for improvement and follow up with your doctor
- Ideally, the anti-diarrheal will be able to help resolve your symptoms, but if symptoms continue after the first 24 hours, you need to talk to your doctor or nurse that day. He or she may consider adjusting your dose, with the ultimate goal of finding which dose is right for you. Verzenio is effective at different doses, so it is important to find what dose is right for your body.

See how Tan and Laura navigated Verzenio treatment with the help of their care teams.

TODO — **0:00**
[Verzenio logo and indication over faded shot of Tan sitting at table with her computer]

**Caption:** Verzenio logo, Verzenio is a prescription medicine used in combination with endocrine (hormone) therapy (tamoxifen or an aromatase inhibitor) to treat adults with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2–), node-positive early breast cancer with a high risk of coming back as determined by your healthcare provider.
The recommended dose of Verzenio in combination with hormone therapy is 150 mg by mouth twice a day, taken once in the morning and once at night.
It is not known if it's safe and effective in children.
Individual results may vary. Talk to your doctor to see if Verzenio is right for you.
Please see Indication and Safety Summary at the end of this video.
Participants were compensated for their time.

0:19
Title Card: Deciding To Take Verzenio
[Tan sitting on her couch]

**VO:** My name is Tan. I was diagnosed with HR+, HER2–, node positive early breast cancer.

**0:27**
[Tan sitting at a table typing on her computer]

**VO:** Saying OK to Verzenio and hormone therapy was easy...

**Caption:** Verzenio + hormone therapy showed a 35% reduction in the risk of cancer returning, compared with hormone therapy alone. In a study, 85.5% of people taking Verzenio+ hormone therapy were alive without their cancer returning vs 78.6% taking hormone therapy alone. Data was assessed at 48 months; the study is ongoing to see if there is a survival benefit.

**0:37**
[Tan sitting on her couch]

**VO:** ...because it was mentioned it might lower the chances of recurrence and I wanted to go ahead and do whatever I could to limit that as much as possible.

**Caption:** Warnings - Verzenio may cause serious side effects, including: Diarrhea is common with Verzenio, may sometimes be severe and may cause dehydration or infection. The most common time to develop diarrhea is during the first month of Verzenio treatment.

0:46
VO: Knowing that Verzenio is specifically for my disease made me feel more willing to try.

**Caption:** If you develop diarrhea during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, stop your treatment, or decrease your dose.

**0:56**
[Tan sitting at table typing on her computer]

**Title Card:** Managing Treatment Expectations

**VO:** When my doctor did have that separate meeting with me in regards to the side effects of Verzenio,...

1:03
VO: ...and if I had any type of questions, they answered all those questions for me. They were like, OK, we're we're here with you through this.

**Caption:** If you have any loose stools, start taking an antidiarrheal medicine (such as loperamide), drink more fluids, and tell your healthcare provider right away.

1:10
Title Card: Managing Side Effects with Dose Reduction

**VO:** So my doctor brought up the dose reduction after I told her I didn't like how it made me feel.

**Caption:** Tan started on the recommended dose of Verzenio in combination with hormone therapy which is 150 mg by mouth twice a day, taken once in the morning and once at night.

1:21
VO: I was like, OK, I'll give it a try as long as it reduces some of those side effects for me.

**Caption:** The most common side effects of taking Verzenio + hormone therapy: Diarrhea, Low white blood cell counts (neutropenia, leukopenia), Nausea, Infections, Low red blood cell counts (anemia), Decreased appetite, Headache, Hair thinning or hair loss (alopecia), Abdominal pain, Tiredness, Vomiting, Low platelet count (thrombocytopenia).

**VO:** So my doctor decided that it would be best to lower the dosage in increments.

**1:30**
[Tan kicking a soccer ball with her son in the park]

**VO:** I had to decrease twice, lowering it to 50 milligrams.

**Caption:** You should tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Verzenio. For more information, you should ask your doctor or pharmacist.

**1:36**
[Tan sitting on her couch]

**VO:** So we were able to actually find that sweet spot and get it lowered to the best dosage for me and that was the one that I can maintain...

**Caption:** Take Verzenio exactly as your doctor tells you. Your doctor may change your dose if needed. Do not stop taking Verzenio or change the dose without talking to your doctor.

**1:50**
[Tan walking in park, holding hands with her kids]

**VO:** ...and still be able to be active in my kids life.

**Caption:** Most common side effects can be managed with a reduced dose, and the benefit of a reduced dose of Verzenio plus hormone therapy is similar to that of adults receiving the recommended dose.

**1:54**
[Tan in orchard picking a sunflower with her kids, then placing a sunflower behind her daughter's ear]

**VO:** Before finishing Verzenio, my doctor did tell me that there is new data on lower dosage...

**2:08**
[Tan sitting on her couch]

**VO:** ...and how it still is a decreased chance of of having a recurrence, which made me happy...because you know, I lowered my dosage so it was always that chance still in the back of my head. But now that it we have data that shows that it still works, that's a good thing.

**Caption:** Data from the clinical trial was further analyzed to assess the results when dose reduction was needed. These analyses were not pre-planned. Individual results may vary.

**2:27**
[Tan and her kids in the kitchen making pizza and sprinkling cheese]

**VO:** ...because again it was that possibility... of recurrence and that's my biggest fear.

**2:34**
[Tan sitting on her couch]

**VO:** I think me ringing my Verzenio bell and completing it, that was a a big huge accomplishment for me.

2:45
Indication & Safety Summary:
VO + Caption: Verzenio is used to treat certain types of breast cancer known as HR+, HER2-negative, hormone receptor positive human epidermal growth factor receptor two negative breast cancer. It is a medicine you can take if you have no positive early breast cancer that has a high risk of coming back as determined by your healthcare provider. Verzenio is given along with hormonal therapy to women and men. It is not known if Verzenio is safe and effective in children.

3:12
VO + Caption: Warnings. Verzenio may cause serious side effects, including diarrhea is common with Verzenio, may sometimes be severe, and may cause dehydration or infection. The most common time to develop diarrhea is during the first month of Verzenio treatment. If you develop diarrhea during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, stop your treatment or decrease your dose. If you have any loose stools, start taking an anti-diarrheal medicine such as loperamide, drink more fluids, and tell your healthcare provider right away.

3:45
VO + Caption: Low white blood cell counts, neutropenia are common with Verzenio and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment. If you develop low white blood cell counts during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, decrease your dose or wait before starting your next month of treatment. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills.

4:16
VO + Caption: Verzenio may cause severe or life-threatening inflammation, swelling of the lungs during treatment that can lead to death. If you develop lung problems during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, decrease your dose, or stop your treatment. Tell your healthcare provider right away if you have any new or worsening symptoms, including trouble breathing or shortness of breath, cough with or without mucus, chest pain.

4:41
VO + Caption: Verzenio can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment. If you develop liver problems during treatment with Verzenio, your healthcare provider may reduce your dose or stop your treatment. Tell your healthcare provider right away if you have any of the following signs and symptoms of liver problems: Feeling very tired, loss of appetite, pain in the upper right side of your stomach area, abdomen, bleeding or bruising more easily than normal. Verzenio may cause blood clots in your veins or in the arteries of your lungs. Verzenio may cause serious blood clots that have led to death. If you develop blood clots during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it. Tell your healthcare provider right away if you have any of the following signs and symptoms of a blood clot: Pain or swelling in your arms or legs, fast breathing, shortness of breath, fast heart rate, chest pain.

5:36
VO + Caption: Verzenio can harm your unborn baby. Use effective birth control contraception during treatment and for three weeks after the last dose of Verzenio, and do not breastfeed during treatment with Verzenio and for at least three weeks after your last dose. Verzenio may affect the ability of males to father a child. Common side effects. The most common side effects of Verzenio include nausea, abdominal pain, infections, low red blood cell counts, anemia, decreased appetite, headache, hair thinning or hair loss, alopecia, tiredness, low white blood cell counts, leukopenia, vomiting, low platelet counts, thrombocytopenia. These are not all the possible side effects of Verzenio. Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088, or www.fda.gov/medwatch.

6:34
VO + Caption: Before using. Before you use Verzenio, tell your healthcare provider about all your medical conditions, including if you have fever, chills, or other signs of infection, if you have a history of blood clots in your veins, have lung or breathing problems, have liver or kidney problems, if you are pregnant, plan to become pregnant or are breastfeeding, about all the medications you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take a medicine that contains ketoconazole.

7:07
VO + Caption: How to take. Take Verzenio exactly as your healthcare provider tells you. Your healthcare provider may change your dose if needed. Do not stop taking Verzenio or change the dose without talking to your healthcare provider. Verzenio may be taken with or without food. Swallow Verzenio tablets whole. Do not chew, crush, or split the tablets before swallowing. Do not take Verzenio tablets if they're broken, cracked, or damaged. Take your doses of Verzenio at about the same time every day. If you vomit or miss a dose of Verzenio, take your next dose at your regular time. Do not take two doses at the same time to make up for the missed dose.

7:47
VO + Caption: What to avoid during treatment. Avoid taking ketoconazole during treatment with Verzenio. Tell your healthcare provider if you take a medicine that contains ketoconazole. Avoid grapefruit and products that contain grapefruit during treatment with Verzenio. Grapefruit may increase the amount of Verzenio in your blood.

8:06
VO + Caption: Learn more. Verzenio is a prescription medicine. For more information call 1-800-545-5979, or go to www.verzenio.com.This summary provides basic information about Verzenio but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Verzenio and how to take it. Your healthcare provider is the best person to help you decide if Verzenio is right for you. Verzenio is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

PP-AL-US-4150 02/2024 ©Lilly USA, LLC 2024. All rights reserved.

“Advocate for yourself. Talk to your doctor. That's the most important thing that you can do.”

“If you can see the goal at the end of the road—that's what you need to think about.”

Dietary suggestions

Diet may have an impact on your experience with diarrhea, but it doesn't mean you have to completely change how or what you eat. Before you make any changes to your diet, be sure to talk to your healthcare team. Also note that these tips are not specific to Verzenio.

Choose foods that are easy to digest
Eat smaller meals more frequently. It is better to eat 5 or 6 small meals a day instead of 3 big meals
Look for soft, bland foods: bananas, applesauce, crackers, eggs, white rice, white toast, plain pasta, chicken or turkey (without the skin)
Eat foods that are high in sodium and potassium: canned fruits (apricots, peaches, pears), potatoes (baked, boiled, or mashed)
When you have diarrhea, your body may lose some of these important minerals, so it's important to make sure you get enough in your diet

There are many other dietary options to help with diarrhea. This list is just a guide you can refer to when choosing what to eat and drink.

Suggestions for what to avoid:

Dairy products—milk, cheese, or sour cream
High-fiber foods and foods that cause gas—whole wheat bread, granola, bran cereals, raw fruits and vegetables, nuts, seeds, popcorn, lentils, peas, corn, broccoli, cabbage
Fatty or greasy foods—fried foods, bacon, sausage, hamburgers, pizza, salad dressings, pastries
Spicy foods—pepper, hot sauce, salsa, chili
Sugar-free candy or gum made with sugar alcohol (sorbitol)
Food or drinks that have caffeine—regular coffee or tea, some sodas, chocolate
Alcoholic drinks—beer, wine, and other types of alcohol
Food or drinks that are too hot or too cold—have food or drinks at room temperature

Monitoring blood counts and liver function

Some patients experienced low white blood cell counts (neutropenia) and/or liver problems.

Your doctor will do blood tests to monitor your blood cell counts and to check for liver problems before and during treatment.

Side effects with Verzenio

The most common side effects of Verzenio include:

Nausea
Infections
Low red blood cell counts (anemia)
Decreased appetite
Headache
Hair thinning or hair loss (alopecia)
Abdominal pain
Tiredness
Low white blood cell counts (leukopenia)
Vomiting
Low platelet counts (thrombocytopenia)

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Verzenio. For more information, ask your doctor or pharmacist.

Dose Reductions/Modifications

Most common side effects of Verzenio can be managed with a reduced dose. The benefit of a reduced dose of Verzenio + hormone therapy is similar to that seen in adults receiving the recommended dose.

Data from the clinical trial was further analyzed to assess the results when dose reduction was needed. These analyses were not pre-planned. Individual results may vary.

Take Verzenio exactly as your doctor tells you. Your doctor may change your dose if needed. Do not stop taking Verzenio or change the dose without talking to your doctor.

The recommended dose of Verzenio (in combination with hormone therapy) is 150 mg by mouth twice a day, taken once in the morning and once at night.

MyRightDose Exchange Program^*

If your doctor recommends a change to your medication dosing, they can sign you up for a dose exchange program, at no cost to you.

For educational purposes only.

Consult with your healthcare provider for further details about the program. When used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor, the recommended dose of Verzenio is 150 mg taken orally twice daily.

When used as monotherapy, the recommended dose of Verzenio is 200 mg taken orally twice daily.

^*Additional terms and conditions apply. Please talk with your doctor about program enrollment

Learn about Savings & Support, including how to enroll in the Lilly Support Services^™ for Verzenio^® Program

Learn more

Diarrhea Incidence

Diarrhea is the most common side effect, and severity and duration may vary from person to person. It's important to talk to your doctor and have a plan in place.

Across all studies (3691 adults), diarrhea occurred in up to 90% of patients taking Verzenio. Diarrhea was temporary and had a predictable timeline for onset and resolution. Severe diarrhea (Grade 3, or an increase of ≥7 stools per day from the study start) was reported in up to 20% of patients. Median time to onset for all cases of diarrhea was 6 to 8 days. Most cases of moderate (Grade 2, or an increase of 4 to 6 stools per day from the study start) and severe diarrhea resolved within 5 to 11 days. No patients experienced life-threatening (Grade 4) diarrhea.

Diarrhea occurrence for HR+, HER2–, node-positive EBC with a high chance of returning as determined by your healthcare provider (Verzenio + hormone therapy)

Severe: 8%

All cases: 84%

Diarrhea occurrence for HR+, HER2– MBC (Verzenio + AI)

Severe: 9%

All cases: 81%

Diarrhea occurrence for HR+, HER2– MBC (Verzenio + fulvestrant)

Severe: 13%

All cases: 86%

Diarrhea occurrence for HR+, HER2– MBC (Verzenio alone)

Severe: 20%

All cases: 90%

There was 1 death associated with diarrhea in a study of Verzenio.

AI=aromatase inhibitor.

Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

You may also report side effects to Eli Lilly and Company at 1-800-545-5979.

SAFETY SUMMARY

Warnings - Verzenio may cause serious side effects, including: Diarrhea is common with Verzenio, may sometimes be severe and may cause dehydration or infection. The most common time to develop diarrhea is during the first month of Verzenio treatment. If you develop diarrhea during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, stop your treatment, or decrease your dose.
If you have any loose stools, start taking an antidiarrheal medicine (such as loperamide), drink more fluids, and tell your healthcare provider right away.

Low white blood cell counts (neutropenia) are common with Verzenio and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment. If you develop low white blood cell counts during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, decrease your dose, or wait before starting your next month of treatment. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills.

Verzenio may cause severe or life-threatening inflammation (swelling) of the lungs during treatment that can lead to death. If you develop lung problems during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, decrease your dose, or stop your treatment. Tell your healthcare provider right away if you have any new or worsening symptoms, including:

Trouble breathing or shortness of breath
Cough with or without mucus
Chest pain

Verzenio can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment. If you develop liver problems during treatment with Verzenio, your health care provider may reduce your dose or stop your treatment. Tell your healthcare provider right away if you have any of the following signs or symptoms of liver problems:

Feeling very tired
Pain on the upper right side of your stomach area (abdomen)

Loss of appetite
Bleeding or bruising more easily than normal

Verzenio may cause blood clots in your veins, or in the arteries of your lungs. Verzenio may cause serious blood clots that have led to death. If you develop blood clots during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it. Tell your healthcare provider right away if you have any of the following signs and symptoms of a blood clot:

Pain or swelling in your arms or legs
Shortness of breath
Chest pain

Fast breathing
Fast heart rate

Verzenio can harm your unborn baby. Use effective birth control (contraception) during treatment and for 3 weeks after the last dose of Verzenio and do not breastfeed during treatment with Verzenio and for at least 3 weeks after your last dose. Verzenio may affect the ability of males to father a child.

Common side effects

The most common side effects of Verzenio include:

Nausea
Infections
Low red blood cell counts (anemia)
Decreased appetite
Headache
Hair thinning or hair loss (alopecia)

Abdominal pain
Tiredness
Low white blood cell counts (leukopenia)
Vomiting
Low platelet counts (thrombocytopenia)

These are not all the possible side effects of Verzenio.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Before you use Verzenio, tell your healthcare provider about all your medical conditions, including:

If you have fever, chills, or other signs of infection.
If you have a history of blood clots in your veins.
Have lung or breathing problems.
Have liver or kidney problems.
If you are pregnant, plan to become pregnant, or are breastfeeding.
About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take a medicine that contains ketoconazole.

How to take

Take Verzenio exactly as your healthcare provider tells you.
Your healthcare provider may change your dose if needed. Do not stop taking Verzenio or change the dose without talking to your healthcare provider.
Verzenio may be taken with or without food.
Swallow Verzenio tablets whole. Do not chew, crush, or split the tablets before swallowing. Do not take Verzenio tablets if they are broken, cracked, or damaged.
Take your doses of Verzenio at about the same time every day.
If you vomit or miss a dose of Verzenio, take your next dose at your regular time. Do not take 2 doses at the same time to make up for the missed dose.

What to avoid during treatment

Avoid taking ketoconazole during treatment with Verzenio. Tell your healthcare provider if you take a medicine that contains ketoconazole
Avoid grapefruit and products that contain grapefruit during treatment with Verzenio. Grapefruit may increase the amount of Verzenio in your blood

Learn more

Verzenio is a prescription medicine. For more information, call 1-800-545-5979.

This summary provides basic information about Verzenio but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Verzenio and how to take it. Your healthcare provider is the best person to help you decide if Verzenio is right for you.

AL CON BS 03MAR2023

Verzenio^® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

INDICATIONS

Verzenio^® (ver-ZEN-ee-oh) is used to treat certain types of breast cancer known as HR+/HER2– (hormone receptor positive/human epidermal growth factor receptor 2 negative) breast cancer.
It is a medicine you can take if:

You have node-positive early breast cancer that has a high risk of coming back as determined by your healthcare provider. Verzenio is given along with hormonal therapy to women and men.
Or, the cancer has spread to other parts of the body (metastasized). If you are female or male, then Verzenio is given with an aromatase inhibitor as initial endocrine-based therapy. If you are a female or male, and the cancer has gotten worse after hormonal therapy, then Verzenio is given with fulvestrant. If you are female or male and the cancer has gotten worse after both hormonal therapy and chemotherapy, then Verzenio is given by itself.

It is not known if Verzenio is safe and effective in children.