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 * Prescribing Information


LEARN HOW KISQALI CAN HELP PEOPLE WITH HR+, HER2- EARLY BREAST CANCER (EBC)


 *  
   KISQALI FOR EBC
   
   .


LEARN HOW KISQALI CAN HELP PEOPLE WITH HR+, HER2- METASTATIC BREAST CANCER (MBC)


 *  
   KISQALI FOR MBC
   
   .




 
THINKING ABOUT EBC TREATMENT OPTIONS?

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YOUR STORY COULD EMPOWER OTHERS

If you or a loved one is taking KISQALI, your experience can help inspire and
educate other patients. Will you share a story only you can tell?

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IMPORTANT SAFETY INFORMATION

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 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.

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.

What should I tell my health care provider before taking KISQALI?

Before you take KISQALI, tell your health care provider if you:

 * have any heart problems, including heart failure, irregular heartbeats, and
   QT prolongation
 * have ever had a heart attack
 * have a slow heartbeat (bradycardia)
 * have high blood pressure that is not controlled
 * have decreased thyroid gland (hypothyroidism) 
 * have problems with the amount of potassium, calcium, phosphorus, or magnesium
   in your blood
 * have fever, chills, or any other signs or symptoms of infection
 * have liver problems
 * have kidney problems 
 * are pregnant, or plan to become pregnant. KISQALI can harm your unborn baby
   * If you are able to become pregnant, your health care provider should do a
     pregnancy test before you start treatment with KISQALI
   * Females who are able to become pregnant and who take KISQALI should use
     effective birth control during treatment and for at least 3 weeks after the
     last dose of KISQALI
   * Talk to your health care provider about birth control methods that may be
     right for you during this time
   * If you become pregnant or think you are pregnant, tell your health care
     provider right away
 * are breastfeeding or plan to breastfeed. It is not known if KISQALI passes
   into your breast milk. Do not breastfeed during treatment with KISQALI and
   for at least 3 weeks after the last dose of KISQALI

Tell your health care provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
KISQALI and other medicines may affect each other, causing side effects. Know
the medicines you take. Keep a list of them to show your health care provider or
pharmacist when you get a new medicine.

What should I avoid while taking KISQALI?

Avoid eating grapefruit and avoid drinking grapefruit juice during treatment
with KISQALI since these may increase the amount of KISQALI in your blood.

The most common side effects of KISQALI in people with early breast cancer
include:

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

The most common side effects of KISQALI in people with advanced or metastatic
breast cancer include:

 * decreased white blood cell counts
 * decreased red blood cell counts
 * increased 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 in males, which may affect your ability to
father a child. Talk to your health care provider if this is a concern for you.

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.

Please see full Prescribing Information including Patient Information.

9/24     FA-11276015

INDICATIONS

What is KISQALI?

KISQALI is a prescription medicine used to treat adults with hormone receptor
(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast
cancer:

 * in combination with an aromatase inhibitor for stage II and III early breast
   cancer with a high risk of coming back
 * that has gotten worse or has spread to other parts of the body (advanced or
   metastatic breast cancer) in combination with: 
   * an aromatase inhibitor as the first endocrine-based therapy; or
   * fulvestrant as the first endocrine-based therapy or following disease
     progression on endocrine therapy

It is not known if KISQALI is safe and effective in children.
 



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