Verzenio for Metastatic Breast Cancer

Whether you're newly diagnosed or just starting treatment, learn more about Verzenio and how it works.

What is Verzenio?

How Verzenio works

How is Verzenio different?

Results with Verzenio

Hear from Nancy, a Verzenio patient

What is Verzenio?

Verzenio is a targeted treatment known as a CDK4 & 6 inhibitor. Verzenio is a non-chemotherapy oral tablet.

Verzenio is a prescription medicine used to treat a type of breast cancer in adults. It is a medicine you can take if you have a type of breast cancer called HR+, HER2– (hormone receptor positive, human epidermal growth factor receptor 2 negative) and the cancer has spread to other parts of the body (metastasized).

Verzenio is given with an aromatase inhibitor as initial endocrine based therapy. If the cancer has gotten worse after hormone therapy, then Verzenio is given with fulvestrant. If the cancer has gotten worse after both hormone therapy and chemotherapy, then Verzenio is given by itself.

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

CDK4 & 6=cyclin-dependent kinases 4 and 6.

How Verzenio works

Verzenio works inside the cell to block CDK4 & 6 activity and help stop the growth of cancer cells, so they may eventually die*

Verzenio is a CDK4 & 6 inhibitor used to treat HR+, HER2– metastatic breast cancer. Verzenio works to block specific proteins called CDK4 & CDK6. CDK4 & 6 proteins help control how fast cells grow. These proteins, along with hormones like estrogen, play an important role in the growth and division process of normal cells.

But if you have HR+, HER2– breast cancer, CDK4 & 6 proteins become overactive, causing the cancer cells to grow and divide uncontrollably, which makes the tumor grow. This can also lead to cancer cells spreading to other parts of the body, which is called metastasis.

Verzenio can be taken alone, but it is usually taken with hormone therapy to slow the growth of cancer cells. Hormone therapy (an aromatase inhibitor or fulvestrant) works outside the cell to help cut off estrogen that feeds the cancer. Verzenio works inside the cell to block CDK4 & 6 activity and help stop the growth of cancer cells, so they may eventually die.* When Verzenio inhibits CDK4 & 6 in healthy cells, it can lead to side effects, some of which may be serious.

*Based on pre-clinical studies.

Video thumbnail — **00:00-0:13**

[The Verzenio abemaciclib 50 | 100 | 150 mg tablets logo is to the left of captions.]

**Caption:** Verzenio is a prescription medicine used to treat a type of breast cancer in adults. It is a medicine:

You can take if you have a type of breast cancer called HR+, HER2– (hormone receptor positive, human epidermal growth factor receptor 2 negative) and the cancer has spread to other parts of the body (metastasized)

That is given with an aromatase inhibitor as initial endocrine-based therapy. If the cancer has gotten worse after hormone therapy, then Verzenio is given with fulvestrant. If the cancer has gotten worse after both hormone therapy and chemotherapy, then Verzenio is given by itself

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

Please read and listen to the Indication and Safety Summary following this video.

**00:14-0:28**

[The Verzenio logo and captions are center screen.]

**AVO:** Receiving your diagnosis can be overwhelming for you and those you love. To help you navigate and better understand your treatment, we created this video to explain how Verzenio works inside the body.

**Caption:** How Verzenio works.

**Caption:** Please read and listen to the Indication and Safety Summary following this video.

**00:29-00:42**

[The captions fade out. Transition to an animated cell.]

**AVO:** Verzenio is a treatment for HR+, HER2–, metastatic breast cancer. Metastatic breast cancer is breast cancer that has spread beyond the breast to other parts of the body like the bones, lungs, liver, and brain.

**Caption:** HR+, HER2–, hormone receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer.

**00:43-01:01**

[On the animated cell diagram, the CDK4 & 6 proteins are labeled. The cell membrane, nucleus, hormone receptors, and estrogen hormones are labeled on the normal breast tissue animated cell diagram.]

**AVO:** Verzenio works to block specific proteins called CDK4 and CDK6. CDK4 & 6 proteins help control how fast cells grow. These proteins, along with hormones like estrogen, play an important role in the growth and division process of normal cells.

**Cell diagram label:** CDK4 & CDK6 proteins.

**Cell diagram label:** Normal breast tissue cell. Estrogen hormones. Cell membrane. Hormone receptors. Nucleus.

**01:02-01:18**

[The animation of a breast tissue cancer cell is labeled to show the overactive CDK4 & 6 proteins on the cell. The cancer cell divides into two cells.]

**AVO:** But if you have HR+, HER2– breast cancer, CDK4 & 6 proteins become overactive, causing the cancer cells to grow and divide uncontrollably, which makes the tumor grow. This can lead to cancer cells spreading to other parts of the body.

**Cell diagram label:** Breast tissue cancer cell.

**Cell diagram label:** Overactive CDK4 & 6 proteins.

**01:19-01:41**

[The animated cell diagram shows how Verzenio works inside the cell to inhibit the CDK4 & 6 proteins.]

**AVO:** Just as cancer cells prepare to divide, Verzenio works to block specific CDK4 & 6 proteins. Verzenio is a CDK4 & 6 inhibitor used to treat HR+, HER2– metastatic breast cancer. Verzenio can be taken alone or with a hormone therapy like an aromatase inhibitor.

**Caption:** Verzenio blocks CDK4 & 6 proteins.

**Cell diagram label:** Verzenio. CDK4 & 6 inhibitor. Aromatase inhibitor.

**01:42-02:06**

[The animated cell diagram is exhibiting how Verzenio works alone and with fulvestrant.]

**AVO:** It can also be taken with fulvestrant hormone therapy to slow the growth of cancer cells.

When Verzenio is added to fulvestrant, the hormone therapy works outside the cell to help cut off estrogen that feeds the cancer. Verzenio works inside the cell to block CDK4 & 6 activity and help stop the growth of cancer cells so they may eventually die.

**Cell diagram label:** Fulvestrant. Hormone therapy works outside the cell. Verzenio works inside the cell.

**Caption:** So they may eventually die*.

**Caption:** *Based on pre-clinical studies.

**02:07-02:21**

[Transition to Verzenio protecting the animated cell. The Verzenio and Lilly logos appear on the bottom of the screen.]

**AVO:** When Verzenio inhibits CDK4 & 6 in healthy cells it can lead to side effects, some of which may be serious. Whether you take it alone or with other therapy, Verzenio can help slow down the growth of cancer cells in your body.

**02:22-03:40**

[The Verzenio logo bottom is in the bottom right corner.]

**AVO/Caption: INDICATION AND SAFETY SUMMARY**

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:

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.

**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.

**03:41-05:27**

[The Verzenio logo bottom is in the bottom right corner.]

**Caption: INDICATION AND SAFETY SUMMARY**

**AVO/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.

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

**05:28-6:52**

[The Verzenio logo bottom is in the bottom right corner.]

**Caption: INDICATION AND SAFETY SUMMARY**

**AVO/Caption:** 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

**06:53-08:24**

[The Verzenio logo is in the bottom right corner.]

**Caption: INDICATION AND SAFETY SUMMARY**

**AVO/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 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 or go to **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.

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

**Caption:** AL CON BS_MBC 03MAR2023

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

PP-AL-US-3853 08/2023 ©Lilly USA, LLC 2023. All rights reserved.

**08:25-08:34**

[The Verzenio and Lilly logos are center screen.]

**AVO:** Talk to your doctor if you have any other questions about Verzenio.

**Caption: Talk to your doctor about Verzenio.**

For pricing information, please visit **lillypricinginfo.com/verzenio** or call **1-844-VERZENIO (1-844-837-9364)**

PP-AL-US-3853 08/2023 ©Lilly USA, LLC 2023. All rights reserved.

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

How is Verzenio different?

Verzenio is taken differently—it's the first CDK4 & 6 inhibitor that can be taken every day, twice a day^†

Verzenio is a CDK4 & 6 inhibitor. It is the first oral tablet of its kind that can be taken every day for the treatment of HR+, HER2– metastatic breast cancer.

Because Verzenio is an oral medication and not an infusion, you can take it in the convenience of your home. This may allow for more flexibility in your daily life. However, you may need to see your doctor for other treatments.

^†150 mg or 200 mg orally twice a day, as directed by your doctor.

Results with Verzenio

How effective is Verzenio + fulvestrant?

Verzenio was studied in a clinical trial of 669 women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2–) metastatic breast cancer (MBC), whose disease had progressed after hormone treatment: 446 patients were treated with Verzenio + fulvestrant, and 223 were treated with fulvestrant alone.

Verzenio is helping to raise the bar of what is possible in HR+, HER2– metastatic breast cancer treatment.

Proven to help women live significantly longer

In a clinical study, women taking Verzenio + fulvestrant lived for a median of 46.7 months vs 37.3 months on fulvestrant alone, regardless of menopausal status.

Live longer without disease progression

In the same study, Verzenio + fulvestrant delayed disease progression for a median of 16.4 months vs 9.3 months with fulvestrant alone.

What is overall survival?

Overall survival (OS) is how long someone lives with cancer, either after being diagnosed or starting treatment. When taking treatment, OS is the days, months, or years that treatment may add to life.

What is progression-free survival?

Progression-free survival (PFS) is the amount of time during and after treatment that the cancer doesn't get worse. In other words, PFS is how long cancer growth is delayed from the time a treatment is started.

What is the difference between progression-free survival and overall survival?

Progression-free survival (PFS) is the amount of time during and after treatment that the cancer doesn't get worse. Overall survival (OS) is how long someone lives with cancer after being diagnosed or starting treatment.

SELECT SAFETY INFORMATION

Verzenio may cause serious side effects, including:

Diarrhea is common with Verzenio, may 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, 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.

Twice as many women saw their tumors shrink

48.1% of patients on Verzenio + fulvestrant saw their tumors shrink vs 21.3% with fulvestrant alone.

Complete response: no detectable signs of cancer

In a clinical study, 3.5% of women on Verzenio + fulvestrant had a complete response, or no detectable sign of cancer, vs 0% with fulvestrant alone.

Partial response: tumor shrinkage of 30% or more

In a clinical study, 44.7% of women on Verzenio + fulvestrant had a partial response with tumor shrinkage of 30% or more vs 21.3% with fulvestrant alone.

SELECT SAFETY INFORMATION

Verzenio may cause serious side effects, including:

Low white blood cell counts (neutropenia) are common with Verzenio and may cause serious infections that can lead to death. Your doctor should check your white blood cell counts before and during treatment. Tell your doctor right away if you have fever or chills.

SELECT SAFETY INFORMATION

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 (neuroperia) are common with Verzenio and may cause serious infections that can lead to death. Your doctor shoud check your white blood cell counts before and during treatment. Tell your doctor right away if you have fever or chills.

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

*Governmental beneficiaries excluded, terms and conditions apply. Go to https://www.verzenio.lilly.com/savings-support for additional details.

Learn more

Hear from a real Verzenio patient

How Verzenio helped Nancy find hope after diagnosis

For Nancy, a real Verzenio patient, being there for her family is everything to her. She talks about her feelings about her diagnosis as well as how treatment with Verzenio has helped her feel more hopeful.

00:00-00:11
[The Verzenio abemaciclib 50 | 100 | 150 | 200 mg tablets logo is to the left of the captions.]

Caption: Verzenio is a prescription medicine used to treat a type of breast cancer in adults. It is a medicine:

You can take if you have a type of breast cancer called HR+, HER2– (hormone receptor positive, human epidermal growth factor receptor 2 negative) and the cancer has spread to other parts of the body (metastasized)
That is given with an aromatase inhibitor as initial endocrine-based therapy. If the cancer has gotten worse after hormone therapy, then Verzenio is given with fulvestrant. If the cancer has gotten worse after both hormone therapy and chemotherapy, then Verzenio is given by itself

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

Caption: Individual results may vary. Statements made in this video are unique to Nancy's individual experience on Verzenio in combination with hormone therapy. Please read the Indication and Safety Summary following this video. Patient was compensated for her time.

00:12-00:24
[A series of photographs of Nancy with her family and grandchildren appear on screen. The Verzenio logo and the Lilly Support Services™logo are in the top left corner.]

Narrator: Meet one real, relentless woman taking Verzenio in combination with hormone therapy for her HR+, HER2- metastatic breast cancer, and learn more about the support she received from the Lilly Support Services for Verzenio Program.

00:24-00:36
[Lilly Support Services logo appears on screen]

Narrator: Lilly Support Services can help you get started on Verzenio, navigate the insurance process, answer any questions you might have, or just lend an ear if you need someone to talk to.

Caption:Getting started on Verzenio

Caption:Navigate the insurance process

Caption:Answer your questions

Caption:Lend an ear

Caption:The Lilly Support Services™ for Verzenio^® team, including the Companion in Care™, is not made up of medical professionals. Your doctor is your source for medical advice. Once prescribed Verzenio, you are eligible to enroll in the program.

00:37-01:06
[Cut to a close-up of Nancy looking happy at home. The camera pans to a few photos of Nancy with her grandchildren. The Lilly Support Services™ logo is in the upper left corner.]

Nancy: My name is Nancy. I am proud to say that I am 71 years old. I have a total of four grandchildren. They are the light of my life. I love watching what they do. I wish I had more but that's not up to me. It's extremely important for me to be present; good times, bad times, whatever it is. I will show up and maybe it just means I stand there.

Caption:The next verse: Stories of strength and connection - Nancy

Caption:Nancy actual patient living with HR+, HER2- MBC

01:07-01:23
[Cut to more photos of Nancy with her grandchildren and family.]

Nancy: I was very angry when I found out I had metastatic breast cancer. I had done this whole cancer thing 10 years previous. Had been through surgery, radiation, chemo and so when this came up, I was like this just isn't fair.

01:24-01:40
[Continue to pan over photos of Nancy with her family. The Verzenio logo is in the bottom right corner.]

Nancy: When my doctor suggested that I take Verzenio, there was really no question in my mind that I wouldn't take it. To be able to slow this progression, it is allowing me time with my family and friends and that's all that's important.

Caption: Verzenio + an aromatase inhibitor delayed disease progression for a median of 28.2 months vs 14.8 months with an aromatase inhibitor alone. Individual results may vary. Statements made in this video are unique to Nancy's individual experience on Verzenio in combination with an aromatase inhibitor. Clinical trials are still ongoing to see if there is an overall survival benefit.

01:41-02:05
[Pan over photos of Nancy with her family, friends and enjoying a day out on a boat with her granddaughter. Cut to a photo in a frame of Nancy with her family. The Verzenio logo is in the bottom right corner.]

Nancy: From an emotional point of view, to be able to just get this stuff in the mail and know I have it is just, it's one less thing I have to worry about. For me, the most important treatment is that you continue to have hope.

02:06-02:15
[Transition to a woman (the poet) now holding a framed photo. She puts down the frame and takes out a fountain pen and paper. She sits down and starts to write. We cut and she's finishing her poem and puts the pen cap back on. The Verzenio logo is in the bottom right corner.]

Narrator: A poet surprised Nancy by capturing her relentless spirit in a poem.

Caption:A poet surprised Nancy by capturing her relentless spirit in a poem.

Caption:Poet and poem are not offerings of the Lilly Support Services for Verzenio Program.

02:16-04:14
[Cut to an exterior shot of Nancy's house. Nancy opens the door and receives a parcel. She sits down in her living room and opens the gift box addressed to her.]

Nancy: Thank you! Wow, wonder what this is! This is pretty exciting! It says, "For Nancy."

[She sits down in her living room and opens the gift box addressed to her. Inside is a small recording device. She places it down and presses play to listen to the recording.]

Farrah:Hi Nancy, this is Farrah. Thank you so much for that wonderful interview along with your items. Your story really inspired me and I know it will inspire others—I hope you're inspired by my poem. Much love to you. Nancy; the giver, the nurturer, the art within the art, the thread that pulls everything together when it all falls apart. You stand on the shoulders of hope and never accept the defeat. Your unwavering strength enhances your joie de vivre. The joy of living like reading to your grandchildren. The art of giving and caring about the human condition. We're only as strong as the people we stand next to. That's why Verzenio is honored to stand with you. Every brave step, quiet work and good deed circles back to the precious moments we get to share with family.

Caption:Verzenio is honored to stand with you.

Nancy:Well, I'm crying, I knew I would. That was beautiful. I feel extremely grateful and humble and I want to just kind of sob my eyes out a bit but I won't. Do I feel listened to by Verzenio? Absolutely. They call. They ask me how I'm doing, if I'm having any problems. If you quit hoping, you're going to quit living. If you have the hope, it frees you up to live.

04:15-04:25
[The Lilly Support Services™ logo is centered on the screen.]

Narrator:Lilly Support Services for Verzenio. Personalized care that's here for you. To learn more or enroll in the program visit verzenio.lilly.com/support.

Caption:Personalized care. Here for you. To learn more or to enroll, visit verzenio.com/support

Caption:The Lilly Support Services™ for Verzenio® team, including the Companion in Care™, is not made up of medical professionals. Your doctor is your source for medical advice. Once prescribed Verzenio, you are eligible to enroll in the program.

04:26-10:21
[Safety information appears on screen, with the Verzenio logo in the bottom right corner.]

Narrator/Caption:INDICATION AND SAFETY SUMMARY

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:

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.

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 or go to 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.

AL CON BS_MBC 03MAR2023

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

10:22-10:43
[The Verzenio, Lilly Support Services™ and Lilly logos appear on screen.]

Caption:Enroll today

Caption:For pricing information, please visit lillypricinginfo.com/verzenio or call 1-800-LillyRx (1-800-545-5979)

Caption:Verzenio^® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates. Lilly Support Services™ and Companion in Care™ are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

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.

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

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

Loss of appetite
Bleeding or bruising more easily than normal

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

Fast breathing
Fast heart rate

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.

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.

Verzenio for Metastatic Breast Cancer

What is Verzenio?

How Verzenio works

How is Verzenio different?

Results with Verzenio

Expand accordion Verzenio + an aromatase inhibitor

Expand accordion Verzenio + fulvestrant

Expand accordion Verzenio by itself

SAFETY SUMMARY

INDICATIONS