Kisqali (Ribociclib)

Kisqali (Ribociclib) – Important Safety Information & Patient Guide

Kisqali (Ribociclib) is a prescription-only medicine used in the treatment of certain types of hormone receptor–positive (HR+), HER2-negative breast cancer. It is typically prescribed in combination with endocrine therapy and must be used under strict medical supervision.

Important Safety Information

Lung Problems

• Shortness of breath or difficulty breathing
• Persistent cough, with or without mucus
• Chest pain

Severe Skin Reactions

Serious skin reactions have been reported. Seek urgent medical attention if you notice:

• Severe or worsening rash
• Red or peeling skin
• Blistering of the lips, mouth, or eyes
• Skin pain, burning, or flu-like symptoms

Heart Rhythm Problems (QT Prolongation)

KISQALI can cause QT prolongation, a heart rhythm condition that may lead to abnormal heartbeat or death. Your healthcare provider should perform heart monitoring (ECG) and blood tests before and during treatment.

• Report fast or irregular heartbeat immediately
• Tell your provider if you feel dizzy or faint

Liver Problems

KISQALI may cause serious liver injury. Blood tests are required before and during treatment. Contact your healthcare provider if you experience:

• Yellowing of the skin or eyes (jaundice)
• Dark, tea-colored urine
• Severe fatigue
• Loss of appetite
• Upper right abdominal pain
• Unusual bruising or bleeding

Low White Blood Cell Counts (Neutropenia)

Low white blood cell counts are common with KISQALI and may increase infection risk. Inform your healthcare provider immediately if you develop:

• Fever or chills
• Signs of infection

Your healthcare provider may reduce your dose, temporarily stop, or permanently discontinue KISQALI if serious side effects occur.

Before Taking KISQALI

Tell your healthcare provider if you have or have had:

• Heart disease, heart failure, or abnormal heart rhythms
• History of heart attack or slow heartbeat
• Uncontrolled high blood pressure
• Electrolyte imbalances (potassium, calcium, magnesium, phosphorus)
• Liver or kidney problems
• Signs of infection such as fever or chills

Pregnancy & Breastfeeding

KISQALI can harm an unborn baby.

• Pregnancy testing is required before treatment
• Effective contraception should be used during treatment and for at least 3 weeks after the last dose
• Do not breastfeed during treatment and for at least 3 weeks after the final dose

Drug Interactions

Inform your healthcare provider about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. KISQALI may interact with other medications and increase side effect risk.

What to Avoid While Taking KISQALI

• Avoid grapefruit and grapefruit juice, as they may increase ribociclib levels in your blood

Most Common Side Effects

Early Breast Cancer

• Low white and red blood cell counts
• Increased liver or kidney function tests
• Infections
• Nausea
• Headache
• Fatigue

Advanced or Metastatic Breast Cancer

• Low blood cell counts
• Nausea, vomiting, diarrhea, constipation
• Fatigue
• Hair loss
• Rash and cough
• Back pain
• Low blood sugar levels

KISQALI may affect male fertility. Speak with your healthcare provider if this is a concern.

Always report any side effects that persist or worsen. This is not a complete list of possible side effects. Consult your healthcare provider or pharmacist for full medical information.