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Prescribing Information, including Patient Information

Prescribing Information, including Patient Info

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Living Longer is Possible—and Proven

Overall Survival Results

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 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. 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 after the last dose of KISQALI

Tell your health care provider about all of 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 include:

neutropenia
nausea
infections
fatigue
diarrhea
leukopenia
vomiting
hair loss
headache
constipation
rash
cough

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.

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.

Please see full Prescribing Information including Patient Information.

Approved Uses:

KISQALI^® (ribociclib) is a prescription medicine used in combination 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.

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Prescribing Info including Patient Info

Patient Support Line
1-800-282-7630,
9 am – 8 pm ET

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 th...

Approved Uses:

KISQALI^® (ribociclib) is a prescription medicine used in combination 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...

Important Safety Information:

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

KISQALI may cause serious side effects, including:

trouble breathing or shortness of breath
cough with or without mucus
chest pain

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

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 after the last dose of KISQALI

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 include:

neutropenia
nausea
infections
fatigue
diarrhea
leukopenia
vomiting
hair loss
headache
constipation
rash
cough

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.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

Please see full Prescribing Information including Patient Information.

Approved Uses:

KISQALI^® (ribociclib) is a prescription medicine used in combination 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.

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KISQALI is proven to help women live longer

KISQALI^® (ribociclib) is the first and only medication in its class that's proven in multiple clinical trials to help women live longer with HR+, HER2- metastatic breast cancer (mBC). Now, women with mBC—confident, informed, and determined—are learning what it means to live longer. They call themselves the Thrivers, and you're about to see why.

mBC THRIVERS

Learn more about the difference between progression-free survival and overall survival.

Results for premenopausal women taking KISQALI + a nonsteroidal aromatase inhibitor (NSAI) + goserelin

KISQALI was studied in a clinical trial dedicated exclusively to younger women. The median age was 44 years (range 25 to 58). 495 women were treated with KISQALI + an NSAI (i.e. letrozole or anastrozole) + goserelin or an NSAI + goserelin.

KISQALI® (ribociclib) Estimated Survival Rates

Overall survival

In a clinical trial, KISQALI + an NSAI + goserelin extended the length of time women were alive from the start of treatment—also called overall survival (OS). Median OS is the length of time when half of the women were still alive. Median OS was not reached for KISQALI + an NSAI + goserelin (meaning more than half the women were still alive at the time of the analysis) vs a median of 40.7 months for those taking an NSAI + goserelin.

Progression-Free Survival with KISQALI® (ribociclib) + an NSAI + goserelin

Median progression-free survival

In the same clinical trial, half the women taking KISQALI + an NSAI + goserelin still showed no disease progression after 27.5 months vs 13.8 months for women taking an NSAI + goserelin. Median progression-free survival (PFS) is the length of time when half of the women had not yet progressed.

Response rates for women taking KISQALI® (ribociclib) + an NSAI + goserelin

Proven to shrink tumors

KISQALI + an NSAI + goserelin worked together to shrink tumors in women who had measurable tumors.

Results for postmenopausal women taking KISQALI + fulvestrant

In a clinical trial with 726 women, 484 were treated with KISQALI + fulvestrant and 242 women were treated with fulvestrant alone.

Estimated Survival Rates for postmenopausal women taking KISQALI® (ribociclib) + fulvestrant

Overall survival

In a clinical trial, KISQALI + fulvestrant extended the length of time women were alive from the start of treatment—also called overall survival (OS). Median OS is the length of time when half of the women were still alive. Median OS was not reached for KISQALI + fulvestrant (meaning more than half of the women were still alive at the time of the analysis) vs a median of 40 months for those taking fulvestrant alone.

Postmenopausal progression free-survival while taking KISQALI® (ribociclib) + fulvestrant

Median progression-free survival

In the same clinical trial, half the women taking KISQALI + fulvestrant still showed no disease progression after 20.5 months vs 12.8 months for women taking fulvestrant alone. Median progression-free survival (PFS) is the length of time when half of the women had not yet progressed.