What is the most important information I should know about KISQALI?
KISQALI may cause serious side effects, including:
Low white blood cell counts (neutropenia). Low white blood cell counts are very common when taking KISQALI® (ribociclib) and may cause serious infections that can lead to death. Your health care provider should check your white blood cell counts before and during treatment. If you develop low white blood cell counts during treatment with KISQALI, your health care provider may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. 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.
Liver problems (hepatobiliary toxicity). KISQALI can cause serious liver problems. Your health care provider will do blood tests to check your liver before you start and while you take KISQALI. Tell your health care provider right away if you get any of these signs and symptoms during treatment with KISQALI:
- yellowing of your skin or the whites of your eyes (jaundice)
- dark urine
- unusual tiredness
- nausea or vomiting
- loss of appetite
- pain on the right side of your stomach area (abdomen)
- bruise easily
Heart problems (QT prolongation). KISQALI may cause very slow, very fast, or abnormal heartbeats. Your health care provider may check your heart during treatment with KISQALI. Tell your health care provider right away if you feel dizzy or faint or have abnormal heartbeats. Tell your health care provider if you take any heart or blood pressure medicines.
If you have any of the serious side effects listed above, you may need to stop taking KISQALI for a while, use a lower dose, or stop taking it permanently. Follow your health care provider’s instructions.
What should I tell my health care provider before taking KISQALI?
Before you take KISQALI, tell your health care provider if you:
- have fever, chills, or any other signs or symptoms of infection.
- had or have liver problems
- have any other medical conditions
- have heart problems or an irregular heartbeat
- are a female who is able to become pregnant and who takes KISQALI; you should use effective birth control during treatment and for at least 21 days after stopping KISQALI. Talk to your health care provider about birth control methods that may be right for you during this time
- 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. You and your health care provider should decide if you will take KISQALI or breastfeed. You should not do both
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 pomegranate or pomegranate juice, and grapefruit or grapefruit juice while taking KISQALI. These foods may increase the amount of KISQALI in your blood.
The most common side effects of KISQALI when used with letrozole include:
- white blood cell count decreased
- hair thinning or hair loss
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 may report side effects to FDA at 1-800-FDA-1088.