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.

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)

Most common side effects with Verzenio by itself

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.

Learn about Savings & Support, including how to enroll in the Verzenio Continuous Care Program

Side effects with Verzenio + hormone therapy in the adjuvant setting

In a study of Verzenio + hormone therapy, it was common for patients to experience diarrhea that was sometimes severe. In some cases, it led to dehydration or infection. Diarrhea was most common during the first month, and then decreased.

The median time to first symptoms was about 8 days (the median duration of moderate and more significant diarrhea was 6 and 5 days, respectively). However, some patients experienced this earlier or later in therapy.

The diarrhea was managed by their doctor with an anti-diarrheal medicine, like loperamide (sometimes sold under the brand name Imodium^®), and/or by reducing the dose.* You should call your doctor right away if your diarrhea does not go away or gets worse.

^*Of patients who experienced diarrhea 23% of patients required a dose interruption and 21% required a dose reduction.

Imodium^® is a registered trademark of Johnson & Johnson.

Side effects with Verzenio + AI

In a study of Verzenio taken with an AI, it was common for women to experience diarrhea, which was sometimes severe. In some cases, diarrhea led to dehydration or infection. Diarrhea was most common during the first month and then decreased.

The median time to first symptoms was 8 days. The median duration for moderate and more significant diarrhea was 11 days and 8 days, respectively. However, some patients experienced this earlier or later in therapy
The diarrhea was managed by their doctor with an anti-diarrhea medicine (for example, loperamide, which is sometimes sold under the brand name Imodium^®) and/or by reducing the dose*

^*Of patients who experienced diarrhea, 19% had to have their dose omitted, and 13% had to have their dose lowered.

Will my hair fall out with Verzenio?

In a clinical study of patients with HR+, HER2– metastatic breast cancer, 328 patients with no prior system therapy for metastatic breast cancer received Verzenio + an AI
In the same study, 27% of patients who received Verzenio + an AI experienced hair thinning or loss

Side effects with Verzenio + fulvestrant

In a study of Verzenio + fulvestrant, it was common for patients to experience diarrhea that was sometimes severe. In some cases, it led to dehydration or infection. Diarrhea was most common during the first month, and then decreased.

The median time to first symptoms was about a week (the median duration of moderate and more significant diarrhea was 9 and 6 days, respectively). However, some patients experienced this earlier or later in therapy
The diarrhea was managed by their doctor with an anti-diarrhea medicine, like loperamide (sometimes sold under the brand name Imodium^®), and/or by reducing the dose.* You should call your doctor right away if your diarrhea does not go away or gets worse

^*Of patients who experienced diarrhea, 22% of patients required a dose omission, and 22% required a dose reduction.

Will my hair fall out with Verzenio?

In a clinical study of patients with HR+, HER2– metastatic breast cancer, 446 patients who progressed following prior hormone treatments received Verzenio + fulvestrant
In the same study, 16% of patients who received Verzenio + fulvestrant experienced hair thinning or loss

Side effects with Verzenio by itself

In a study of Verzenio alone, it was common for patients to experience diarrhea that was sometimes severe. In some cases, it led to dehydration or infection. Diarrhea was most common during the first month, and then decreased.

The median time to first symptoms was about a week (the median duration of moderate and more significant diarrhea was 7.5 days and 4.5 days, respectively). However, some patients experienced this earlier or later in therapy
The diarrhea was managed by their doctor with an antidiarrheal medicine, like loperamide (sometimes sold under the brand name Imodium^®), and/or by reducing the dose.* One patient stopped participating in the trial due to diarrhea. You should call your doctor right away if your diarrhea does not go away or gets worse

^*Of patients who experienced diarrhea 26.1% of patient required a dose omission, and 22.7% required a dose reduction due to diarrhea.

Will my hair fall out with Verzenio?

In a clinical study of patients with HR+, HER2– metastatic breast cancer, 132 patients who progressed on or after prior hormone treatments, a taxane, and 1 or 2 chemotherapy regimens in the metastatic setting received Verzenio by itself
In the same study, 12% of patients who received Verzenio by itself experienced hair thinning or loss

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 14SEP2022

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 postmenopausal, 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.