ion with:
an aromatase inhibitor to treat pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic), as the first endocrine-based therapy; or
fulvestrant to treat postmenopausal women with HR-positive, HER2-negative metastatic breast cancer as the first endocrine-based therapy or with disease progression following endocrine therapy
It is not known if KISQALI is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about KISQALI?
KISQALI may cause serious side effects, including:
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 (hepatobiliary toxicity). 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 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 when taking 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 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 any other medical conditions
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 af |
