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Kisqali

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    PROFESSIONAL

    CONSUMER

    SIDE EFFECTS

    Kisqali Patient Information Including Side Effects

    Brand Names: Kisqali (200 mg daily dose), Kisqali (400 mg daily dose), Kisqali (600 mg daily dose)

    Generic Name: ribociclib

    What is ribociclib (Kisqali (200 mg daily dose), Kisqali (400 mg daily dose), Kisqali (600 mg daily dose))?

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

    Ribociclib is used when the cancer has progressed or has spread to other parts of the body after other treatments.

    Ribociclib is given in combination with another cancer medicine such as letrozole (Femara) or fulvestrant (Faslodex).

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

    What are the possible side effects of ribociclib (Kisqali (200 mg daily dose), Kisqali (400 mg daily dose), Kisqali (600 mg daily dose))?

    Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

    Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

    Call your doctor at once if you have:

    • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
    • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
    • signs of inflammation in the lungs--new or worsening cough, painful or difficult breathing, wheezing, feeling short of breath even while resting; or
    • liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes).

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

    Common side effects may include:

    • low white blood cells, infections;
    • cough;
    • nausea, vomiting;
    • diarrhea, constipation;
    • feeling tired;
    • rash;
    • headache; or
    • hair loss.

    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 ribociclib (Kisqali (200 mg daily dose), Kisqali (400 mg daily dose), Kisqali (600 mg daily dose))?

    Ribociclib can cause serious side effects on your heart, liver, or lungs. Call your doctor at once if you have chest pain, fast or pounding heartbeats, trouble breathing, cough (with or without mucus), sudden dizziness, right-sided upper stomach pain, loss of appetite, unusual bleeding or bruising, dark urine, or yellowing of your skin or eyes.

    You will need frequent medical tests while taking ribociclib. Your cancer treatments may be delayed based on the results of these tests. Tell your doctor if you have signs of infection, such as fever or chills.

    Kisqali Patient Information including How Should I Take

    What should I discuss with my healthcare provider before taking ribociclib (Kisqali (200 mg daily dose), Kisqali (400 mg daily dose), Kisqali (600 mg daily dose))?

    You should not use ribociclib if you are allergic to it, or if you also take tamoxifen.

    Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using ribociclib.

    Tell your doctor if you have ever had:

    Tell your doctor whether or not you have gone through menopause.

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

    Do not use ribociclib if you are pregnant. It 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 last dose.

    This medicine may affect fertility (ability to have children) in men. Talk with your doctor if you have concerns about this risk.

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

    How should I take ribociclib (Kisqali (200 mg daily dose), Kisqali (400 mg daily dose), Kisqali (600 mg daily dose))?

    Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

    Ribociclib is given in a 28-day treatment cycle. You will take the medicine for the first 21 days of each cycle, followed by 7 days off. Your doctor will determine how long to treat you with ribociclib.

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

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

    If you vomit after taking the medicine, wait until the next day to take your next dose.

    Do not use a broken or damaged pill.

    You may need frequent medical tests to be sure ribociclib is not causing harmful effects. Your cancer treatments may be delayed based on the results.

    Store ribociclib in the original container at room temperature, away from moisture and heat.

    Kisqali Patient Information including If I Miss a Dose

    What happens if I miss a dose (Kisqali (200 mg daily dose), Kisqali (400 mg daily dose), Kisqali (600 mg daily dose))?

    Skip the missed dose. Take your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.

    What happens if I overdose (Kisqali (200 mg daily dose), Kisqali (400 mg daily dose), Kisqali (600 mg daily dose))?

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

    What should I avoid while taking ribociclib (Kisqali (200 mg daily dose), Kisqali (400 mg daily dose), Kisqali (600 mg daily dose))?

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

    Avoid taking an herbal supplement containing St. John's wort at the same time you are taking ribociclib.

    What other drugs will affect ribociclib (Kisqali (200 mg daily dose), Kisqali (400 mg daily dose), Kisqali (600 mg daily dose))?

    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.

    Ribociclib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

    Many drugs can affect ribociclib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

    Where can I get more information (Kisqali (200 mg daily dose), Kisqali (400 mg daily dose), Kisqali (600 mg daily dose))?

    Your pharmacist can provide more information about ribociclib.

    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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