What is Verzenio?
Verzenio + hormone therapy is specifically for women with HR+, HER2–, node-positive early breast cancer with a high chance of returning, as determined by a healthcare provider.
Verzenio in addition to your hormone therapy (tamoxifen or an aromatase inhibitor) can reduce your risk of recurrence vs hormone therapy alone.
Verzenio was studied in a clinical study of 5637 adults with HR+, HER2–, node-positive early breast cancer with a high chance of returning who had previously received primary treatment. In this study, 2808 patients were treated with Verzenio plus standard hormone therapy for 2 years, and then hormone therapy alone; 2829 patients received standard hormone therapy alone. The approval was based on a smaller group of 5120 patients from this study.
The 2-year treatment I need, when I need it most
For women with HR+, HER2–, node-positive early breast cancer, the greatest risk of recurrence is in the first 2 years after active treatment.
Treatment with Verzenio continues for 2 years or until disease recurrence or until toxicity levels are unacceptable.
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.
- Each pack contains your dose of 150-mg tablets for 7 days (14 individual 150-mg tablets)
- Multiple tablet strengths (50 mg, 100 mg, and 150 mg) allow your doctor to make dose adjustments based on how you tolerate the drug
- No matter what dose is prescribed, you will take 1 tablet, 2 times a day, unless your doctor tells you otherwise
Verzenio is not a chemotherapy.
Results with Verzenio + hormone therapy
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 were assessed at 48 months; the study is ongoing to see if there is a survival benefit.
For HR+, HER2–, node-positive early breast cancer with a high chance of returning, as determined by your healthcare provider.
In a clinical study, Verzenio was taken for 2 years with hormone therapy (HT). At the 4-year analysis, more people on Verzenio + HT did not have their cancer return compared to HT alone, and this benefit increased over time.
Verzenio + HT showed a 35% reduction in the risk of cancer recurrence compared to HT alone.
Percentage of patients from the clinical trial living without recurrence:
Timepoint
|
Verzenio + HT
|
HT Alone
|
Difference
|
|---|---|---|---|
| 2 Years | Verzenio + HT: 92.6% | HT Alone: 89.5% | Difference: 3.1% |
| 3 Years | Verzenio + HT: 88.8% | HT Alone: 83.8% | Difference: 5.0% |
| 4 Years | Verzenio + HT: 85.5% | HT Alone: 78.6% | Difference: 6.9% |
This data is representative of patients at 2, 3, and 4 years after starting the study. At this analysis (42 months median follow-up), all patients had stopped Verzenio + HT, with 81% completing the full 2-year treatment. No patients received Verzenio beyond 2 years. Most patients continued on HT for at least 5 years if it was deemed medically appropriate.
The 4-year data analysis was preplanned, and it is the data used for FDA approval. The 4-year analysis did not use standard rigorous statistical testing to assess the observed results in this group of patients.
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.
At 5 years, Verzenio + hormone therapy showed a reduced risk of recurrence compared to hormone therapy alone
At the 5-year analysis, all patients had been off Verzenio treatment for at least a year. Verzenio is taken with hormone therapy for 2 years, after which hormone therapy is taken alone.
4-year analysis:
Verzenio + HT showed a 35% reduction in the risk of cancer returning, compared with HT alone. In a study, 85.5% of people taking Verzenio + HT were living without recurrence vs 78.6% taking HT alone. Data was assessed at 48 months; the study is ongoing to see if there is a survival benefit.
5-year analysis:
Verzenio + HT showed a 33% reduction in the risk of cancer returning, compared with HT alone. In a study, 83.2% of people taking Verzenio + HT were living without recurrence vs 75.3% taking HT alone. Data was assessed at 60 months; the study is ongoing to see if there is a survival benefit.
The 5-year data analysis was a preplanned continuation to the 4-year data analysis, which was used for FDA approval. The 5-year data analysis did not use standard rigorous statistical testing to assess the observed results in this group of patients.
FDA=Food and Drug Administration.
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 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.
Hear from a real Verzenio patient
Susan moves forward with her doctor's encouragement
For HR+, HER2–, node-positive early breast cancer with a high chance of returning, as determined by your healthcare provider.
“Taking Verzenio and hormone therapy gave me confidence because I was taking something specifically for my type of cancer.” - Susan
Individual results may vary.
0:00
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.
It is not known if it's safe and effective in children.
Please see Indication and Safety Summary at the end of this video.
Caption: Susan is a real Verzenio patient. Individual results may vary. Talk to your doctor to see if Verzenio is right for you.
00:19
[Susan walks into a kitchen, she smiles]
VO: I'm Susan. I'm a wife. I'm a mother.
00:23
[Susan’s husband walks in, kisses her on the cheek]
VO: My husband, Jamie, and I've been married. We celebrated 30 years last year.
00:27
[Susan’s daughter walks into the kitchen, chats with her. Her son washes his hands at the sink]
VO: I have two grown children, Nicole and Logan.
00:31
[Close Ups of food prep, the two women prepare sushi]
VO: Nicole and I, we love to host. We love to have our friends over. We will cook and make things for them.
00:37
[Susan hugs her friends as they enter house]
VO: And they mean the world to me. My friends are my support system. They are always there for me. Through good times, through bad times.
00:45
[Susan talks to camera]
VO: My friends are like my family. There's like nothing I wouldn't do for them.
00:49
[The group of women talk in the kitchen]
VO: When Mimi found out that she needed a kidney donor, we all wanted to be tested.
00:53
[Susan talks to camera]
VO: And so we went through the testing to see if we'd be a match. And I scheduled my mammogram to get started.
01:03
[The group of women sit at a dining room table and continue to talk]
VO: I remember so vividly, Mimi, when we were just talking about it and getting tested. And I do remember that just thinking that I just had that feeling, you know, that there was going to be something that you're going to save my life and me trying to save your life.
01:14
[Susan sits and reflects]
VO: I was diagnosed with HR positive,
01:17
[Susan talks to camera]
VO: HER2 negative, node positive, early breast cancer.
01:22
[Susan sits, reflects, and talks to camera]
VO: After my diagnosis, it seemed like things move fast. We scheduled a breast MRI and they found that there were four suspicious masses. So then it became from a simple lumpectomy so my doctor, and I discussed that the double mastectomy was going to be the next steps.
01:40
[Susan drinks tea]
VO: During active treatment. It was hard.
01:42
[Susan talks to camera]
VO: I felt like at times things are out of control and I'm somebody that likes to have a plan.
01:49
[Archival photo: Susan poses at the hospital, with staff]
VO: I felt like after my surgery and after my active treatment, in my mind I was like, what's next?
01:56
[Susan talks to camera]
VO: Is there a next step? Is it all done? And I had a worry about, you know,
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.
02:01
[Susan holds a teacup, and reflects]
VO Susan: the cancer coming back reoccurring. And so when my doctor told me about Verzenio and hormone therapy
02:04
[Susan talks to camera]
VO: And the possibility of reducing the risk, it made me feel calm. It made me feel confident in the next steps,
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.
02:13
[The group of women sit around a fire pit at night, talking]
VO: Taking Verzenio gave me confidence because I was taking something specifically for my type of cancer,
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.
02:19
VO: And that made me feel even more confident that I was doing the right thing. I was doing all that I can do.
02:23
[Susan talks to camera]
VO: I felt like my doctor was very good at setting expectations.
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.
02:26
[Susan and her daughter prepare food in the kitchen. Her son and husband join]
VO: She was very good at preparing me to help manage the side effects.
Caption: The most common side effects of taking Verzenio + hormone therapy: Diarrhea, Low white blood cell counts (neutropenia, leukopemia), 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: During my treatment with Verzenio, My oncologist encouraged me to try to do what I normally would do.
02:36
[Archival photos: Susan poses with son at a football game. Her husband and her son pose. Her daughter and friend pose with signs]
VO: When my son, it was a senior year and he's on the football team.
Caption: You should tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Verzenio.
02:42
[Archival photos: Susan’s son and friends on the field after game]
VO: We went to every one of his games, whether they were home or away. So these were long days and I was concerned at first. I wasn't going to be able to do that and my doctor did.
Caption: For more information, you should ask your doctor or pharmacist.
02:51
[Susan talks to camera]
VO: That was one thing that she encouraged.
02:54
[Susan stands in front of a wall of photos, looks at them, then hangs up a photo of the group of women on a beach]
VO: I do like to travel and I was worried, is that something that was going to change now through this treatment? And I was able to get on a plane and I was able to still travel long distances. My friends, we love to go on a girls' trip, and that's been.
03:08
[Susan talks to camera]
VO: Something we just look forward to every year.
03:09
[The group of women sit on a couch, looking at a photo album]
VO: We were down at the beach.
Friend VO: It was like sunset.
03:12
[A page in the photo album is turned]
VO Susan: I'm so glad that we went last year.
03:14
[Susan talks to her friends]
VO:
I was very hesitant after surgery and thinking that I should just stay home.
03:18
[Archival photos: Susan on her beach trip]
VO: And I should skip the trip this year. And I was so glad you guys talked me into it. It's exactly what I needed.
03:25
[The women walk outside on a trail]
VO: Having my friends that I've been friends with for so long that we've been through so much together. Being a part of my journey just meant so much to me.
03:34
[Susan looks at the city skyline]
VO: And I want to do more things and see more places and be around for my children.
03:39
[Susan talks to camera]
VO: And I know that I'm doing all I can do.
03:48
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.
04:14
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.
04:48
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.
05:18
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.
05:43
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.
06:38
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.
07:37
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 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.
08:08
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.
08:48
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.
09:06
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-4275 08/2024 ©Lilly USA, LLC 2024. All rights reserved.
SELECT SAFETY INFORMATION
Verzenio may cause serious side effects, including:
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
How Verzenio + hormone therapy work together
Verzenio is used to treat women with HR+, HER2–, node-positive early breast cancer with a high risk of returning, as determined by your doctor.*
Verzenio works inside the cell to block CDK4 & 6 proteins, which help control how fast cells grow, and help stop the growth of breast cancer cells.† When Verzenio inhibits CDK4 & 6 proteins in healthy cells, it can lead to side effects, some of which may be serious.
Verzenio in combination with hormone therapy helps prevent cancer recurrence after active treatment.
*Verzenio is taken after active therapy.
†Based on pre-clinical studies.
CDK4 & 6=cyclin-dependent kinases 4 and 6.
Illustration of breast cancer cell without treatment and with Verzenio. Highlighting how Verzenio + hormone therapy work inside and outside the cell to stop the growth of cancer cells.
In the untreated cell, we see how, in HR+, HER2– early breast cancer, estrogen and other hormones activate CDK4 & 6 proteins, allowing cancer cells to grow.
In the treated cell, hormone therapy works outside the cell to lower estrogen levels and slow cell growth, while Verzenio works inside the cell to block CDK4 & 6 proteins and help stop the growth of cancer cells.
Hear from a real Verzenio patient
Tan reflects on completing Verzenio
“Ringing my Verzenio bell and completing it, that was a huge accomplishment for me...I'm fighting to be here for my little people.” - Tan
Individual results may vary.
It is not known if Verzenio is safe and effective in children.
0:00
[Overhead shot of orchard with Verzenio logo]
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.
It is not known if it's safe and effective in children.
Please see Indication and Safety Summary at the end of this video.
0:22
[Shots of Tan walking in an orchard]
VO: My name is Tandria, but I go by Tan. I would describe myself as a mother, a student, an advocate.
Caption:
Individual results may vary. Talk to your doctor to see if Verzenio is right for you.
Participants were compensated for their time.
0:32
[Shots of Tan at home, sitting on a couch, followed by shots of Tan's children drawing]
VO: I hate the word strong, but I'm strong. I have twins, a boy, Gabriel, and a girl, Grae...
0:44
[Tan putting makeup on Grae]
VO: Grae, she is everything spice.
0:48
[Tan walking in orchard with her arms around Grae and Gabriel]
VO: Gabriel is more affectionate. He's my artist.
0:53
[Grae drawing at home, followed by Tan sitting on the couch]
VO: Grae, she's... she's an artist, too, and she's always writing a note and saying, Mommy, you're just the best mom ever.
1:00
[Side shot of Tan sitting on the end of her bed]
VO: When I discovered my lump,...
1:05
[Old photos of Tan and her children]
VO: ...I had just moved. My children were four, I was 29, and I felt like I was just getting my life back on track.
1:15
[Tan sitting on her couch]
VO: So my cousin was the one who actually pushed me to go to the doctor.
1:19
[Tan sitting at a table with her computer]
VO: I kind of just put my health on the back burner when she was like, make the appointment. When I did make my appointment, finally I had to go of course do my scans and everything and they had the biopsy...
1:33
[Tan sitting on her couch]
VO: ...and from there, that's when I received the call.
1:42
[Tan sitting at a table with her computer]
VO: I was diagnosed with HR+, HER2 negative, node positive Early breast cancer.
1:51
[Tan sitting on her couch]
VO: I still think like, why is this happening to me?
1:53
[Overhead shot of Tan's children drawing]
VO: My children don't deserve this.
1:58
[Archival photos of Tan during and after treatment]
VO: Active treatment is not easy. It took a toll on me emotionally, physically, mentally.
Caption: Provided footage of Tan completing active treatment
2:05
[Tan standing in bathroom]
VO: When they first mentioned Verzenio to me, it was after active treatment.
2:11
[Tan sitting on couch]
VO: Knowing that Verzenio is specifically for my disease made me feel more...
2:15
[Tan walking in park holding hands with her kids followed by her kids playing on a slide]
VO: ...willing to try. For me, saying OK to Verzenio and hormone therapy was easy because it was mentioned that it might lower the chances of recurrence.
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.
VO: The possibility of recurrence, that's my biggest fear. I think me
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.
2:35
[Shots of Tan's children coloring]
VO: ...ringing my Verzenio bell and completing it ,that was a huge accomplishment for me...
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.
VO: ...because again, single mom,..I'm fighting to be here with my little peoples.
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.
2:42
[Tan sitting on her couch]
VO: They mean the world to me.
2:45
[Tan kicking a soccer ball with her son in the park]
VO: Knowing that at four years after the study started, Verzenio and hormone therapy showed that it reduced the risk more than just taking hormone therapy. Knowing that made me...
Caption: In a 4-year evaluation, Verzenio + hormone therapy showed a lower risk of cancer recurrence beyond the 2-year treatment period compared to hormone therapy alone.
2:54
[Tan and her kids in kitchen sprinkling cheese on pizza]
VO: ...feel grateful that I took it. It's not something that I'm constantly walking around in fear with anymore because I'm just like, OK, well,
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.
3:02
[Tan in park with her children]
VO: ...I know I did everything that I could on my end.
3:06
[Tan's children coloring]
VO: This journey has shaped me because now I'm an advocate, pushed me to continue to school, graduating in May...
Caption: 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 healthcare provider should check your white blood cell counts before and during treatment.
3:14
VO: ...and then going towards...
[Tan sitting on her couch]
VO: ...being a doctor and just, you know...
Caption: 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 or chills.
3:18
[Tan sitting at a table with her computer as her kids bring her their drawings]
VO: ...creating a whole new lifestyle with my twins.
3:23
[Close shot of a sunflower followed by Tan picking a sunflower and placing it behind her daughter's ear. Overhead shot of Tan and her kids walking in orchard. Shot of Tan with her arms around her kids. Close individual shots of Grae and Gabriel]
VO: New Tan is a fighter, even more of a fighter than I was before, and I've been fighting my whole life. Moving forward to me means getting to know the new me, accepting new parts of me that I didn't know I would love, and just growing with my kids.
3:51
[Tan sitting on her couch]
VO: I'm walking in a new light... Tan 2.0.
4:03
Indication and 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.
04:28
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.
05:0
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.
05:32
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.
05:57
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.
06:52
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.
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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.
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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.
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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.
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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-4082 02/2024 ©Lilly USA, LLC 2024. All rights reserved.
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*Governmental beneficiaries excluded, terms and conditions apply. Go to https://www.verzenio.lilly.com/savings-support for additional details.