abemaciclib

What is the most important information I should know about abemaciclib?

What is abemaciclib?

Abemaciclib is used to treat advanced hormone-related breast cancer. Abemaciclib is used for this condition only if your tumor tests negative for a protein called human epidermal growth factor receptor 2 (HER2). HER2 protein can speed the growth of cancer cells.

Abemaciclib is sometimes given with other cancer medicines.

Abemaciclib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking abemaciclib?

Tell your doctor if you have ever had:

• a fever, chills, or other signs of infection; or
• liver or kidney disease.

You may need to have a negative pregnancy test before starting this treatment.

How should I take abemaciclib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

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

If you vomit shortly after taking abemaciclib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Abemaciclib can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

What happens if I miss a 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.

What happens if I overdose?

What should I avoid while taking abemaciclib?

Grapefruit may interact with abemaciclib and lead to unwanted side effects. Avoid the use of grapefruit products.

What are the possible side effects of abemaciclib?

• severe or ongoing diarrhea;
• pain or burning when you urinate;
• liver problems --right-sided upper stomach pain, loss of appetite, easy bruising or bleeding, feeling very tired;
• 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 --new or worsening cough, painful or difficult breathing, wheezing, feeling short of breath even while resting; or
• signs of a blood clot --pain or swelling in an arm or leg, chest pain, fast heartbeats, feeling short of breath.

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

Common 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.

What other drugs will affect abemaciclib?

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

Tell your doctor about all your other medicines, especially:

• ketoconazole.

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

Where can I get more information?

Your pharmacist can provide more information about abemaciclib.