What is metastatic breast cancer?

Metastatic breast cancer (MBC), also known as advanced or stage IV, is breast cancer that has spread beyond the breast to other parts of the body. The common places for breast cancer to spread are the bones, lungs, liver, and brain.

Treatment of metastatic breast cancer depends on several factors, including prior treatment history, menopausal status, HR and HER2 status, and where the cancer has spread.

HER2=human epidermal growth factor receptor 2; HR=hormone receptor.

Facts about metastatic breast cancer

20-30%

20% to 30% of people diagnosed with early-stage breast cancer will develop metastatic breast cancer

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Metastatic breast cancer can occur any number of years after an initial diagnosis of early breast cancer, even after treatment and regular follow-up visits with your doctor

155,000 Americans

An estimated 155,000 Americans are currently living with metastatic breast cancer

men and women

People of all ages, both men and women, can be diagnosed with metastatic breast cancer

6-10%

About 6% to 10% of metastatic breast cancer patients are diagnosed with MBC as their first breast cancer diagnosis. This is called de novo metastatic breast cancer

HR+, HER2–

There’s more than one type of metastatic breast cancer. HR+, HER2– is the most common subtype of metastatic breast cancer, representing roughly 60% of all cases

HER2–=human epidermal growth factor receptor 2–negative; HR+=hormone receptor positive.

Purpose and Safety Summary

Important Facts About Verzenio^® (ver-ZEN-ee-oh). It is also known as abemaciclib.

Verzenio is a prescription medicine used to treat a type of breast cancer. 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 along with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, along with fulvestrant in women whose disease has progressed after hormonal therapy, or by itself in adults whose disease has progressed after hormone therapy and prior chemotherapy

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 be severe and may cause dehydration or infection. The most common time to develop diarrhea is during the first month of Verzenio treatment. Your doctor may stop your treatment, lower your dose, or tell you to wait to begin your treatment cycle if you have diarrhea.

At the first sign of loose stools, tell your doctor. You may be advised to start taking an antidiarrheal medicine (such as loperamide) and drink more fluids.

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.

Verzenio may cause severe or life-threatening inflammation (swelling) of the lungs during treatment that can lead to death. 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 liver problems. Tell your doctor right away if you have any of the following signs or symptoms of liver problems:

Feeling very tired
Loss of appetite
Pain on 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 lungs. These may be serious and have led to death. Tell your doctor if you have 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

Verzenio can harm your unborn baby. Use effective birth control during treatment and for at least 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
Abdominal pain
Infections
Tiredness
Low red blood cell counts (anemia)
Low white blood cell counts (leukopenia)
Decreased appetite
Vomiting
Headache
Low platelet counts (thrombocytopenia)
Hair thinning or hair loss (alopecia)

These are not all the possible side effects of Verzenio.

Tell your doctor 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 doctor:

If you have fever, chills, or other signs of infection
Have liver or kidney problems
About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take a medicine that contains ketoconazole. Avoid grapefruit products while taking Verzenio. Grapefruit may increase the amount of Verzenio in your blood

How to take

Use Verzenio exactly as your doctor tells you
Take your doses of Verzenio at about the same time every day
If you vomit or miss a dose take your next dose at your regular time. Do not take 2 doses of Verzenio at the same time to make up for the missed dose
If you take too much Verzenio, call your doctor or go to the nearest hospital emergency room right away

Learn more

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 doctor. Be sure to talk to your doctor or other healthcare provider about Verzenio and how to take it. Your doctor 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.

AL CON BS 20SEP2019