Verzenio (abemaciclib) is a prescription medicine used in combination with other cancer treatments to treat certain patients with HR-positive, HER2-negative breast cancer. It is used in adults when the cancer has progressed or has spread to other parts of the body (metastatic) after other treatments have failed. Abemaciclib belongs to a class of medications called kinase inhibitors.

Verzenio is a targeted treatment known as a CDK4/6 inhibitor. It works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells.

Verzenio is used in combination with an aromatase inhibitor such as anastrozole (Arimidex), exemestane (Aromasin), or letrozole (Femara) to treat a certain type of hormone receptor-positive, early breast cancer.

Verzenio is also used along with fulvestrant (Faslodex) to treat a certain type of hormone receptor-positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or breast cancer that has spread to other parts of the body after treatment with an antiestrogen medication such as tamoxifen.

Verzenio is also used along with anastrozole (Arimidex), exemestane (Aromasin), or letrozole (Femara) as a first treatment of hormone receptor-positive, advanced breast cancer or breast cancer that has spread to other parts of the body.

Verzenio is also used alone to treat a certain type of hormone receptor-positive, advanced breast cancer or breast cancer that has spread to other parts of the body in people who have already been treated with an antiestrogen medication and chemotherapy.

Abemaciclib works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

When Verzenio is used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor, also read the Patient Information for the associated prescribed medicine. Ask your healthcare provider if you are not sure.

Verzenio can cause severe diarrhea, which can lead to dehydration or infection. Call your doctor right away if you have diarrhea. Drink extra fluids and start taking anti-diarrhea medicine such as loperamide (Imodium).

Abemaciclib can cause blood clots, liver problems, and even serious or fatal infections. Call your doctor right away if you have symptoms such as: fever, chills, easy bruising or bleeding, unusual tiredness, loss of appetite, right-sided upper stomach pain, chest pain, shortness of breath, rapid breathing, fast heartbeats, or pain or swelling in your arms or legs.

Take Verzenio exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take the medicine at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it. Do not use a cracked, broken or damaged tablet.

If you vomit shortly after taking Verzenio, do not take another dose. Take your next dose as scheduled.

Call your doctor if you have diarrhea while taking Verzenio. Start taking anti-diarrhea medicine such as loperamide (Imodium) to quickly treat diarrhea. Drink extra fluids and call your doctor.

Your blood will need to be tested often and your cancer treatments may be delayed based on the results.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Breast Cancer:

IN COMBINATION WITH FULVESTRANT OR AN AROMATASE INHIBITOR:
150 mg orally 2 times a day

MONOTHERAPY:
200 mg orally 2 times a day

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:
-If using this drug in combination with fulvestrant on pre/perimenopausal women, treat these patients with a gonadotropin-releasing hormone agonist according to current clinical practice standards.
-When used in combination with this drug, the recommended dose of fulvestrant is 500 mg on Days 1, 15, and 29, then once monthly thereafter; refer to the manufacturer product information for fulvestrant.

Uses:
-In combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
-In combination with fulvestrant for women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
-As monotherapy for adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting

You should not use Verzenio if you are allergic to abemaciclib, or any of the ingredients in Verzenio tablets.

To make sure this medicine is safe for you, tell your doctor if you have ever had::

• a fever, chills, or other signs of infection;

• lung or breathing problems;

• blood clots; or

• liver or kidney disease.

Abemaciclib may harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using Verzenio and for at least 3 weeks after your last dose. Tell your doctor right away if you become pregnant.

It may be harder for you to get a woman pregnant while you are using this medicine.

You should not breastfeed while using this medicine and for at least 3 weeks after your last dose.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with abemaciclib and cause side effects. Avoid consuming grapefruit products.

Get emergency medical help if you have signs of an allergic reaction to Verzenio: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Abemaciclib may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing diarrhea;

• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• signs of inflammation in the lungs - sudden chest pain, wheezing, dry cough or hack, feeling short of breath; or

• signs of a blood clot deep in the body or in the lung - chest pain, sudden cough or shortness of breath, dizziness, coughing up blood, or pain, swelling, or warmth in your arms or legs.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Verzenio side effects may include:

• diarrhea, nausea, vomiting, stomach pain;

• loss of appetite;

• hair loss;

• infections;

• feeling tired;

• headache; or

• low blood cell counts.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• ketoconazole.

This list is not complete. Other drugs may interact with abemaciclib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.