Kisqali (Oral)
Ribociclib is used in adults in combination with fulvestrant or with other cancer medicines to treat hormone-related breast cancer that has worsened or has spread to other parts of the body (metastatic).
Your doctor will make sure you have the correct tumor type to be treated with ribociclib.
Ribociclib may also be used for purposes not listed in this medication guide.
uses
What is Kisqali (Oral) used for?
- Breast Cancer
- Breast Cancer -- Male
- Neoplasia -- Estrogen Dependent
warnings
What is the most important information I should know about Kisqali (Oral)?
You should not use ribociclib if you are allergic to it, or if you also take tamoxifen.
Tell your doctor if you have or have ever had:
- heart problems, including heart failure, heart attack, irregular heartbeats, and long QT syndrome (in you or a family member);
- an electrolyte imbalance (such as low levels of calcium, magnesium, phosphorus, or potassium in your blood);
- fever, chills, or other signs of infection; or
- liver or kidney disease.
May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using ribociclib and for at least 3 weeks after your last dose. Tell your doctor if you are pregnant or plan to become pregnant.
It may be harder for you to get a woman pregnant while you are using this medicine.
Do not breastfeed while using this medicine, and for at least 3 weeks after your last dose.
Side Effects
What are the side effects of Kisqali (Oral)?
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.
You may feel faint while taking ribociclib. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.
Call your doctor at once if you have:
- sudden chest pain, wheezing, new or worsening cough, feeling short of breath or trouble breathing;
- low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough; or
- liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Your cancer treatments may be delayed, reduced, or permanently discontinued if you have certain side effects.
Common side effects may include:
- infections;
- abnormal blood tests;
- cough;
- nausea, vomiting, diarrhea, constipation;
- back pain;
- rash;
- headache, tiredness; 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.
Pregnancy & Breastfeeding
Can I take Kisqali (Oral) if I’m pregnant or breastfeeding?
May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using ribociclib and for at least 3 weeks after your last dose. Tell your doctor if you are pregnant or plan to become pregnant.
Do not breastfeed while using this medicine, and for at least 3 weeks after your last dose.
Interactions
What drugs and food should I avoid while taking Kisqali (Oral)?
Grapefruit may interact with ribociclib and cause side effects. Avoid consuming grapefruit products.
Avoid taking an herbal supplement containing St. John's wort at the same time you are taking ribociclib.
Dosage Guidelines & Tips
How to take Kisqali (Oral)?
Use Kisqali (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Your doctor will perform tests to make sure ribociclib is the right treatment for you.
Ribociclib is taken in a 28-day treatment cycle. You will take the medicine only on certain days. Your doctor will determine your treatment cycle.
Take the medicine at the same time each morning, with or without food.
Swallow the tablet whole and do not crush, chew, or break it. Do not use a tablet that is damaged in any way.
You may be given other medications if you have certain conditions. Keep taking these medicines for as long as your doctor has prescribed.
Do not change your dose or stop taking ribociclib without your doctor's advice.
If you vomit shortly after taking ribociclib, do not take another dose. Take your next dose as scheduled.
You will need frequent medical tests before and during treatment with ribociclib, and your next dose may be delayed based on the results.
Call your doctor if your symptoms do not improve, or if they get worse.
Store this medicine in the original container at room temperature, away from moisture and heat.
Skip the missed dose and take your next dose at the regular time. Do not take two doses at one time.
Overdose Signs
What happens if I overdose on Kisqali (Oral)?
Images
RIC, NVR
Color: purple
Shape: round
Form: film coated
Imprint: RIC, NVR