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Frequently Asked Questions

Find answers to common questions about Verzenio by exploring the list below. If you can’t find what you’re looking for, Lilly Support Services is available at 1-800-LillyRx or you can speak with your healthcare provider.

Side Effects
Dosing
General Information
Verzenio for EBC
Cost & Insurance

Side Effects

SELECT SAFETY INFORMATION

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.

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.

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.

The degree and duration (or length) of diarrhea may vary from person to person. 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.

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.

Please see Addressing Side Effects for more information.

Dosing

Most common side effects of Verzenio can be managed with a reduced dose. When a dose reduction is recommended by your doctor, the benefit of Verzenio + hormone therapy is maintained.

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.

Please see Taking Verzenio for more information.

For HR+, HER2–, node-positive early breast cancer with a high chance of returning, as determined by your healthcare provider.

Verzenio is the only treatment of its kind for early breast cancer that is taken for just 2 years.*†

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, for 2 years.

*Verzenio is taken with hormone therapy.

†Unless your doctor tells you otherwise.


Learn more about how to take Verzenio for EBC.

Take each dose of Verzenio orally 2 times a day, once in the morning and once in the evening at about the same time every day, unless your doctor tells you otherwise.

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.

If you vomit or miss a dose of Verzenio, take your next dose at the time you usually would. Do not take an extra dose of Verzenio to make up for any dose(s) you may have missed.

Try to establish a routine of taking your dose at about the same time each day for your morning and evening doses.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. For each of these, it may be a good idea to keep track of the dose, when you started taking it, and for what reason. Verzenio and certain other medicines can affect each other, causing serious side effects or changing the effect of Verzenio or other medicines. Your doctor may need to change your dose.

Swallow the prescribed number of Verzenio tablets whole. Do not chew, crush, or split before swallowing.

You can take Verzenio with or without food.

General Information

No, Verzenio is not chemotherapy. It's a prescription medicine that works inside cells to block specific proteins, CDK4 & 6, that help control cell growth. Because it targets these proteins, Verzenio is classified as a CDK4 & 6 inhibitor, also known as a kinase inhibitor. When Verzenio inhibits CDK4 & 6 in healthy cells, it can lead to side effects, some of which may be serious.

Learn more about how Verzenio works for EBC and MBC.

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.

No, Verzenio is not an aromatase inhibitor. It's a prescription medicine that works inside cells to inhibit specific proteins, CDK4 & 6, that help control cell growth. Because it targets these proteins, Verzenio is classified as a CDK4 & 6 inhibitor, also known as a kinase inhibitor. When Verzenio blocks CDK4 & 6 in healthy cells, it can lead to side effects, some may be serious.

Learn more about how Verzenio works for EBC and MBC.

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.

Verzenio received its initial FDA approval in the US in 2017 for the treatment of HR+, HER2– advanced or metastatic breast cancer.

In 2021, the FDA expanded its approval to include adjuvant treatment for HR+, HER2–, node-positive, high-risk early breast cancer.

Verzenio for EBC

After an early breast cancer diagnosis, your doctor may discuss several risk factors with you. These factors can influence your doctor's plan for your treatment, and the chance of the cancer returning. They also help guide decisions about which treatments may be most appropriate.

"High risk" describes a greater chance that cancer may come back and is based on clinical factors such as:

  • Tumor size
  • Lymph node involvement, or whether the cancer has spread from the breast to the nearby lymph nodes
  • Tumor grade refers to the degree to which the cells in the breast tumor look like normal cells vs cancer cells

Along with hormone receptor status and HER2 status, these disease factors help to determine the best path forward for treatment. They are also used to help understand the risk of the breast cancer recurring, or coming back again, after or during treatment.

Please see What is Early Breast Cancer to learn more.

Verzenio has multiple FDA-approved indications based on several different clinical studies of varying lengths. Learn more about how Verzenio works in EBC and MBC.

Cost & Insurance

Coverage is dependent on your plan and provider. Find more information.

Eligible patients with commercial insurance may pay as little as $0 a month with the Verzenio Savings Card. When you enroll in Lilly Support Services for Verzenio, you can download your savings card and access other helpful support services. Enroll today.

Governmental beneficiaries excluded. Eligibility required, terms and conditions apply. Savings subject to monthly and annual limits. Month is defined as 28-days. Card eligibility and terms and conditions may be terminated, rescinded, revoked, or amended by Lilly at any time without notice and for any reason. PROGRAM IS NOT INSURANCE. Click to see the full terms and conditions.

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.

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