Kisqali is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Kisqali is used to treat hormone-related breast cancer in women. Ribociclib is used only if your cancer tests negative for a protein called human epidermal growth factor receptor 2 (HER2). HER2 protein can speed the growth of cancer cells.

Kisqali is used when the cancer has progressed or has spread to other parts of the body after other treatments.

Kisqali is given in combination with another cancer medicine such as letrozole (Femara) or fulvestrant (Faslodex).

Kisqali can cause serious side effects on your heart, liver, or lungs. Call your doctor at once if you have chest pain, fast or pounding heartbeats, trouble breathing, cough (with or without mucus), sudden dizziness, right-sided upper stomach pain, loss of appetite, unusual bleeding or bruising, dark urine, or yellowing of your skin or eyes.

You will need frequent medical tests while taking Kisqali. Your cancer treatments may be delayed based on the results of these tests. Tell your doctor if you have signs of infection, such as fever or chills.

Before taking this medicine

You should not use Kisqali if you are allergic to ribociclib, or if you also take tamoxifen.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Kisqali.

To make sure Kisqali is safe for you, tell your doctor if you have ever had:

• slow heartbeats;

• heart disease or prior heart attack;

• long QT syndrome;

• an electrolyte imbalance (such as low levels of calcium, magnesium, phosphorus, or potassium in your blood);

• liver disease;

• kidney disease; or

• signs of infection (fever, chills).

Tell your doctor whether or not you have gone through menopause.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Kisqali if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 weeks after your last dose.

This medicine may affect fertility (ability to have children) in men. Talk with your doctor if you have concerns about this risk.

You should not breastfeed while using Kisqali and for at least 3 weeks after your last dose.

Take Kisqali exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Kisqali is given in a 28-day treatment cycle. You will take the medicine for the first 21 days of each cycle, followed by 7 days off. Your doctor will determine how long to treat you with Kisqali.

Swallow the tablet whole and do not crush, chew, or break it.

Take the medicine at the same time each morning, with or without food.

If you vomit after taking the medicine, wait until the next day to take your next dose.

Do not use a broken or damaged pill.

You may need frequent medical tests to be sure Kisqali is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Store in the original container at room temperature, away from moisture and heat.

Usual Adult Dose for Breast Cancer:

600 mg orally once a day for 21 consecutive days followed by 7 days off for a complete cycle of 28 days; continue until disease progression or unacceptable toxicity

Comments:
-Refer to the manufacturer product information for dosing and administration recommendations for the co-administered aromatase inhibitor (e.g., letrozole).
-When given with this drug, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Refer to the full prescribing information of fulvestrant.
-Pre/perimenopausal women treated with the combination of this drug plus an aromatase inhibitor or fulvestrant should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards.

Uses:
-In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
-In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

You should not use Kisqali if you are allergic to ribociclib, or if you also take tamoxifen.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Kisqali.

To make sure Kisqali is safe for you, tell your doctor if you have ever had:

• slow heartbeats;

• heart disease or prior heart attack;

• long QT syndrome;

• an electrolyte imbalance (such as low levels of calcium, magnesium, phosphorus, or potassium in your blood);

• liver disease;

• kidney disease; or

• signs of infection (fever, chills).

Tell your doctor whether or not you have gone through menopause.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Kisqali if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 weeks after your last dose.

This medicine may affect fertility (ability to have children) in men. Talk with your doctor if you have concerns about this risk.

You should not breastfeed while using Kisqali and for at least 3 weeks after your last dose.

Skip the missed dose. Take your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with ribociclib and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid taking an herbal supplement containing St. John's wort at the same time you are taking Kisqali.

Get emergency medical help if you have signs of an allergic reaction to Kisqali: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

• signs of inflammation in the lungs - new or worsening cough, painful or difficult breathing, wheezing, feeling short of breath even while resting; or

• liver problems - loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Kisqali side effects may include:

• low white blood cells, infections;

• cough;

• nausea, vomiting;

• diarrhea, constipation;

• feeling tired;

• rash;

• headache; or

• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Ribociclib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can interact with ribociclib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.