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Understanding Side Effects
Understanding Side Effects
It’s only natural to have concerns about side effects when starting a new treatment. KISQALI® (ribociclib) may cause side effects that you are not familiar with. Your health care provider may tell you to decrease your dose, temporarily stop, or completely stop taking KISQALI if you develop certain serious side effects during treatment with KISQALI.
Contact your doctor if you experience any of the following side effects:
Serious Side Effects
Lung Problems. KISQALI® (ribociclib) can cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your health care 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
Severe skin reactions. Tell your health care provider or get medical help right away if you get severe rash or rash that keeps getting worse; reddened skin; flu-like symptoms; skin pain/burning; blistering of the lips, eyes, or mouth; or blisters on the skin or skin peeling, with or without fever.
Heart rhythm problems (QT prolongation). KISQALI® (ribociclib) can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Tell your health care provider right away if you have a change in your heartbeat, or if you feel dizzy or faint.
Liver problems (hepatobiliary toxicity). KISQALI® (ribociclib) can cause serious liver problems. Tell your health care provider right away if you experience:
• yellowing of your skin or the whites of your eyes (jaundice)
• dark or brown (tea-colored) urine
• feeling very tired
• loss of appetite
• pain on the right side of your stomach area (abdomen)
• bleeding or bruising more easily than normal
Low white blood cell counts (neutropenia). KISQALI® (ribociclib) can cause low white blood cell counts that can result in severe infections. Tell your health care provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.
Common Side Effects
The most common side effects of KISQALI include:
• hair loss
KISQALI® (ribociclib) may cause fertility problems if you are male and take KISQALI. This may affect your ability to father a child. Talk to your health care provider if this is a concern for you. If you become pregnant or think you are pregnant, tell your health care provider right away.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of KISQALI. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
In clinical trials, most side effects were mild to moderate and could be managed by reducing the dosage, interrupting treatment, or stopping treatment.