What is KISQALI (Ribociclib)?
KISQALI is a prescription medicine used in combination with a certain type of medicine as the first hormonal based therapy to treat women who have gone through menopause 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).
It is not known if KISQALI is safe and effective in children.
What is the most important information I should know about KISQALI?
KISQALI can cause serious side effects. These serious side effects include:
- 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 healthcare provider should check your heart and do blood tests before and during treatment with KISQALI. Tell your healthcare 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. KISQALI can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment with KISQALI. Tell your healthcare 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)
- Loss of appetite
- Dark or brown (tea-colored) urine
- Pain on the upper right side of your stomach area (abdomen)
- Bleeding or bruising more easily than normal
- Feeling very tired
- 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 healthcare provider should check your white blood cell counts before and during treatment with KISQALI. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.
- The most common side effects of KISQALI include:
- Nausea
- Vomiting
- Tiredness
- Constipation
- Diarrhea
- Headache
- Hair loss
- Back pain
Your healthcare 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.
How should I take KISQALI?
- Take KISQALI exactly as your healthcare provider tells you.
- Do not change your dose or stop taking KISQALI unless your healthcare provider tells you.
- Take KISQALI each day at about the same time, preferably in the morning.
- You may take KISQALI with or without food.
- Swallow KISQALI tablets whole. Do not chew, crush, or split KISQALI tablets before swallowing them.
- Do not take any KISQALI tablets that are broken, cracked, or that look damaged. If you miss a dose of KISQALI or vomit after taking a dose of KISQALI, do not take another dose on that day. Take your next dose at your regular time.
- If you take too much KISQALI, call your healthcare provider right away or go to the nearest hospital emergency room.
Important Safety Information
- Avoid eating pomegranate or grapefruit and avoid drinking pomegranate or grapefruit juice during treatment with KISQALI since these may increase the amount of KISQALI in your blood.
- KISQALI can harm your unborn baby. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
- Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI.
- If you take too much KISQALI, call your healthcare provider right away or go to the nearest hospital emergency room.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking KISQALI?
Before you take KISQALI, tell your healthcare 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.
- 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 healthcare 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.
General information about KISQALI
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use KISQALI for a condition for which it was not prescribed. Do not give KISQALI to other people, even if they have the same symptoms you have. It may harm them.
What are the ingredients in KISQALI?
Active ingredient: Ribociclib
Inactive ingredient: Colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate and
microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide red, lecithin (soya), polyvinyl alcohol
(partially hydrolyzed), talc, titanium dioxide, and xanthan gum