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    PROFESSIONAL

    CONSUMER

    SIDE EFFECTS

    Verzenio Patient Information Including Side Effects

    Brand Names: Verzenio

    Generic Name: abemaciclib

    What is abemaciclib (Verzenio)?

    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 are the possible side effects of abemaciclib (Verzenio)?

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

    Call your doctor at once if you have:

    • 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 is the most important information I should know about abemaciclib (Verzenio)?

    Abemaciclib 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, or serious and sometimes 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.

    Verzenio Patient Information including How Should I Take

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

    You should not use abemaciclib if you are allergic to it.

    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.

    Using abemaciclib during pregnancy could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 weeks after your treatment ends. Tell your doctor right away if you become pregnant during this time.

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

    How should I take abemaciclib (Verzenio)?

    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.

    Swallow the tablet whole and do not crush, chew, or break it.

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

    Drink plenty of liquids while you are taking abemaciclib.

    Abemaciclib can cause severe diarrhea, which can be life-threatening if it leads to dehydration or infection.

    If you have diarrhea while taking abemaciclib: start taking anti-diarrhea medicine such as loperamide (Imodium) to quickly treat diarrhea. Drink extra fluids and call your doctor.

    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.

    Store at room temperature away from moisture and heat.

    Verzenio Patient Information including If I Miss a Dose

    What happens if I miss a dose (Verzenio)?

    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 (Verzenio)?

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

    What should I avoid while taking abemaciclib (Verzenio)?

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

    What other drugs will affect abemaciclib (Verzenio)?

    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 (Verzenio)?

    Your pharmacist can provide more information about abemaciclib.

    Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
    Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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