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KISQALI (ribociclib) side effects
Understanding KISQALI Side Effects


It’s only natural to have concerns about side effects when starting a new treatment. KISQALI 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.

Find tips to help manage some of the side effects of KISQALI.

Contact your doctor if you experience any of the following side effects:

 

Serious Side Effects

Lung problems. 
KISQALI 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 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 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 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:

  • decreased white blood cell counts

  • decreased red blood cell counts

  • abnormal liver function tests

  • infections

  • nausea

  • increased kidney function test

  • tiredness

  • decreased platelet counts

  • diarrhea

  • vomiting

  • headache

  • constipation

  • hair loss

  • cough

  • rash

  • back pain

  • low blood sugar level

KISQALI  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 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. 

Important Safety Information

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

KISQALI may cause serious side effects, including:

Lung problems. KISQALI may 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...

Indications

KISQALI is a prescription medicine used to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has gotten worse or has spread to other parts of the body (metastatic), in combination with:

  • an aromatase inhibitor as the first endocrine-based therapy; or...
Click or scroll to see IMPORTANT SAFETY INFORMATION AND APPROVED USE