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Understanding and Managing Side Effects

KISQALI + an AI was proven safe and effective

It's natural to have concerns about side effects when starting a new treatment. Before you start treatment, talking to your care team about potential side effects and how they can be managed may help you feel more in control of your treatment plan. Side effect management tips are also featured on this page.

If you begin to experience any side effects of treatment, it's important to let your doctor know.

Common side effects

The most common side effects from the clinical trial were generally mild to moderate and included:

decreased white blood cell counts
increased liver function tests
decreased red blood cell counts
infections
increased kidney function test
decreased platelet counts
nausea
headache
tiredness

KISQALI may cause fertility problems in males, which may affect your ability to father a child. Talk to your health care provider if this is a problem for you.

If you are pregnant or plan to become pregnant, talk to your doctor. KISQALI can harm your unborn baby.

Talk to your doctor 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 care team 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.

Serious side effects

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 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 or burning, blistering of the lips, eyes, or mouth, 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. Your health care provider should check your heart and do blood tests before and during treatment with KISQALI. Tell your health care provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint.

Liver problems
KISQALI can cause serious liver problems. Your health care provider should do blood tests to check your liver before and during treatment with KISQALI. Tell your health care provider right away if you get any of the following signs and symptoms of liver problems:

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 upper right side of your stomach area (abdomen)
bleeding or bruising more easily than normal

Low white blood cell counts (neutropenia)
Low white blood cell counts are very common during treatment with KISQALI and may result in infections that may be severe. Your health care provider should check your white blood cell counts before and during treatment with KISQALI. 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.

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ACT on any side effects

... your doctor if you’re feeling a side effect. Explain what you’re feeling and how you’re feeling.

... for yourself by carefully following your doctor’s instructions. Do not change your dose on your own.

... how your side effect feels as your treatment continues. Your doctor may recommend other medications to manage side effects.

In a study, it was shown that KISQALI will keep working, even if your doctor lowers your dose*
In a study of people taking KISQALI + hormone therapy, people who had their dose reduced cut the risk of cancer coming back by the same amount as those who did not have their dose reduced.

*Data from a clinical trial were further analyzed to assess the results when a dose reduction was required. This analysis was not preplanned and results should be interpreted with caution. Take KISQALI exactly as your doctor tells you to and do not stop taking KISQALI or change the dose without talking to your doctor. The recommended dose of KISQALI (in combination with an aromatase inhibitor) for eBC is 400 mg orally once a day for 3 weeks on, followed by 1 week off.

Tips to help manage common side effects of KISQALI

Managing certain side effects may be easier than you think. The tips below can help you manage these common side effects if you experience them.

Nausea

Tiredness

Infections

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Understanding and managing side effects glossary

Learn more about key terms used on this page by tapping or clicking on the words below.

Understanding and Managing Side Effects

KISQALI + an AI was proven safe and effective

Common side effects

Serious side effects

ACT on any side effects

Tips to help manage common side effects of KISQALI

Nausea

Tiredness

Infections

Understanding and managing side effects glossary

Hormone therapy

Neutropenia

QT prolongation

IMPORTANT SAFETY INFORMATION

INDICATIONS