KISQALI 200 MG (?RIBOCICLIB ) 63 FILM-COATED TABLETS

WHAT IS RIBOCICLIB (KISQALI (200 MG DAILY DOSE), KISQALI (400 MG DAILY DOSE), KISQALI (600 MG DAILY DOSE))?

Ribociclib 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.

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

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

Ribociclib may also be used for purposes not listed in this medication guide.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF RIBOCICLIB (KISQALI (200 MG DAILY DOSE), KISQALI (400 MG DAILY DOSE), KISQALI (600 MG DAILY DOSE))?

Get emergency medical help if you have signs of an allergic reaction (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 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.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT RIBOCICLIB (KISQALI (200 MG DAILY DOSE), KISQALI (400 MG DAILY DOSE), KISQALI (600 MG DAILY DOSE))?

Ribociclib 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 ribociclib. 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.