VERZENIO PP-AL-US-1938

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
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 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 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 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 & Company, its subsidiaries, or affiliates.

AL CON BS 20SEP2019