Kisqali (Ribociclib) - Oral

What Is Kisqali?

Kisqali (ribociclib) is a cancer treatment pill. It is used to treat a type of advanced breast cancer (hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative) in adults. "Hormone receptor-positive" means that this type of breast cancer needs specific hormones (e.g., estrogen) to proliferate (grow).

Ribociclib is available as a tablet and only with a prescription. It belongs to the drug class called kinase inhibitors. Kinase inhibitors stop cancer growth by blocking specific enzymes in cancer cells that would normally cause them to grow and make more cancer cells.

Drug Facts

Generic Name: Ribociclib

Brand Name(s): Kisqali

Drug Availability: Prescription

Therapeutic Classification: Antineoplastic Agent (Cancer Drug)

Available Generically: No

Controlled Substance: N/A

Administration Route: Oral

Active Ingredient: Ribociclib

Dosage Form(s): Tablet

What Is Kisqali Used For?

Kisqali (ribociclib) is used to treat a type of breast cancer called hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, which is present in at least two-thirds of young women with breast cancer.

Ribociclib is usually used as a first-line treatment for advanced breast cancer. It may be taken together with other medicines to treat cancer.

Kisqali ( Ribociclib ) Drug Information - Illustration by Zoe Hansen

Verywell / Zoe Hansen

How to Use Kisqali 

Take Kisqali as directed by your healthcare provider with or without food. Take at the same time daily, preferably in the morning. Do not break, crush or chew your tablet. Swallow it whole. If your tablet is broken, chipped or cracked, do not take it.

This drug may cause you to feel nauseated or throw up. Your healthcare provider may order anti-nausea pills for you to take with or before Kisqali to prevent you from throwing up.

Do not take another dose if you vomit after taking one. Take the next dose at your regular time.

Avoid grapefruit, grapefruit juice, pomegranate or pomegranate juice while taking this drug. They may increase this drug's potency by up to three times which could lead to more side effects.

Do not stop taking this drug, even if you feel better. Do not adjust your dose without speaking with your healthcare provider.

Storage

Store Kisqali at room temperature (68 to 77 degrees F) in a dry place. Do not store it in your bathroom. Store this drug in its original container.

Keep this medicine away from children and pets.

Ribociclib may cause birth defects or affect your fertility and sexual function. Handle with care, as instructed by your healthcare provider.

Properly dispose of your unused or expired drugs. Do not throw unused or expired medicines down the sink, drain, or toilet. Ask your pharmacist about the best ways to dispose of your medicine. Check out drug take-back programs in your area.

How Long Does Kisqali Take to Work?

It takes Kisqali one to four hours to peak in your system.

What Are the Side Effects of Kisqali?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the U.S. Food and Drug Administration (FDA) at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Common side effects of Kisqali include:

  • Back pain
  • Constipation
  • Diarrhea
  • Feeling tired or weak
  • Hair loss
  • Headache
  • Lack of appetite
  • Mouth irritation
  • Mouth sores
  • Nausea
  • Stomach pain
  • Trouble sleeping
  • Vomiting

Severe Side Effects

Kisqali may cause severe side effects. Tell your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you have a medical emergency.

Severe side effects include:

  • Abnormal heartbeat
  • Bleeding
  • Bruising
  • Dizziness
  • Fast heartbeat
  • Flu-like symptoms
  • Infection
  • Passing out
  • Signs of an allergic reaction like hives
  • Signs of electrolyte problems: confusion, lack of appetite, muscle pain or weakness
  • Signs of liver problems: dark urine, light-colored stools, stomach pain
  • Swelling in the arms or legs
  • Symptoms of lung problems: New or worsening cough, shortness of breath
  • Symptoms of urinary tract infection: Blood in your urine, burning or painful urination, lower abdominal pain

Report Side Effects

Kisqali may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Kisqali Should I Use?

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For metastatic breast cancer with letrozole:
      • Adults—600 milligrams (mg) (three 200 mg tablets) taken as a single dose, once a day for 21 consecutive days, followed by 7 days without medicine. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.

Modifications

Pregnancy: Kisqali may be harmful to your fetus during pregnancy. Let your healthcare provider know if you think you may be pregnant or plan to become pregnant before starting this medicine. Also, consider using a reliable birth control method while on Kisqali and for three weeks after your last dose to prevent causing birth defects in your baby.

Nursing: It is unknown if this drug is found in breast milk. However, due to possible harm to your baby, do not breastfeed while using this medicine and for three weeks after your last dose.

Children: Safety and efficacy in children are not well established.

Older Adults: There were no significant differences in the safety or effectiveness of Kisqali between younger and older adults.

Treatment Modifications: Kisqali may cause severe reactions in some people. When this happens, your healthcare provider may modify your treatment. Depending on the severity, some of the toxicities may require your healthcare provider to temporarily or permanently stop ribociclib. These include:

Missed Dose

If a dose of ribociclib is missed or vomited, do not take another dose that day. Skip the missed dose and go back to your regular time. Do not take extra doses or two doses at a time.

Overdose: What Happens If I Use Too Much Kisqali?

Limited information exists on overdose with Kisqali.

What Happens If I Overdose on Kisqali?

If you think you or someone else may have overdosed on Kisqali, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Kisqali, call 911 immediately.

Precautions

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It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is unlikely that a postmenopausal woman may become pregnant. But, using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 weeks after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Interstitial lung disease or pneumonitis can occur while using this medicine. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest pain, cough, difficulty with breathing, fever or chills while using this medicine.

Serious skin reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, fever, painful or difficult urination, red skin lesions, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem including QT prolongation.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Ribociclib can temporarily lower the number of some types of blood cells in your blood. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What Are Reasons I Shouldn't Use Kisqali? 

There are no contraindications listed for Kisqali.

What Other Medications Interact With Kisqali?

Several medications interact with Kisqali, especially strong CYP3A inducers and CYP3A inhibitors, and medications that cause a prolonged QT interval (anti-arrhythmia drugs like quinidine, amiodarone, dofetilide and sotalol). Other drugs to avoid include:

  • Biaxin (clarithromycin)
  • Vaprisol (conivaptan)
  • Crixivan (indinavir)
  • Sporanox (itraconazole)
  • Kaletra (lopinavir/ritonavir)
  • Viracept (nelfinavir)
  • Noxafil (posaconazole)
  • Norvir (ritonavir)
  • Invirase (saquinavir)
  • Vfend (voriconazole)
  • Dilantin (phenytoin)
  • Rifadin (rifampin)
  • Tegretol (carbamazepine)
  • St John’s Wort (Hypericum perforatum)
  • Live vaccines

What Medications Are Similar?

Other drugs similar to Kisqali used to treat breast cancer include:

  • Verzenio (abemaciclib)
  • Ibrance (palbociclib)
  • Kisqali femara co-pack (ribociclib and letrozole) 
  • Cosela (trilaciclib)

You should not use these drugs with Kisqali unless prescribed by your healthcare provider. Ask your pharmacist or a healthcare provider if you have questions.

Frequently Asked Questions

  • What is Kisqali used to treat?

    Kisqali (ribociclib) is used to treat a specific type of breast cancer.

  • What are the common side effects of Kisqali?

    Some common side effects include:

    • Trouble sleeping
    • Mouth irritation
    • Mouth sores
    • Vomiting
    • Hair loss
    • Headache
    • Diarrhea
    • Constipation
    • Abdominal pain
    • Back pain
  • Where should I store Kisqali?

    Store Kisqali at room temperature in a dry place and in its original container.

  • What should I do if I miss a dose of Kisqali?

    Skip the missed dose. Return to your regular schedule. Do not double your dose or take extra pills.

How Can I Stay Healthy While Using Kisqali?

Kisqali is effective in treating hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer. While on this medication, however, you may have a higher chance of getting infections. Remember to wash your hands often with water and soap. Wash your fruit and veggies with soap and water before eating. Try to avoid people who are sick or those who may have infections. While it is vital to stay updated on your vaccinations, avoid getting live vaccines while on this medicine.

There are several ways to support your body during cancer treatment. During your treatment, be sure to stay hydrated, especially if you experience vomiting or diarrhea as a treatment side effect. You can do this by drinking more water or even consuming broth. Be sure to eat a balanced diet with enough protein to help your body stay strong. ESPEN nutrition guidelines suggest that people undergoing cancer treatment need more protein (1.2 to 1.5 grams of dietary protein per kilogram of your body weight) compared to sedentary individuals. While some sources may encourage eating animal protein as the best way to increase your protein intake, there are many ways to get enough protein, including a balanced vegetarian diet. Be sure to talk to a registered dietitian nutritionist as you map out your nutrition plan during treatment. This course may help you avoid malnutrition and can help support your body. Eating smaller meals more frequently through the day can help you manage any nausea.

Try to get enough rest and do an exercise that makes you happy. Spend quality time with the people, pets, or places you love. Be sure to tell your healthcare provider about all medicines, supplements, and herbal preparations that you may be taking during treatment.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

5 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. Kisqali label.

  2. Shah AN, Metzger O, Bartlett CH, Liu Y, Huang X, Cristofanilli M. Hormone receptor-positive/human epidermal growth receptor 2-negative metastatic breast cancer in young women: emerging data in the era of molecularly targeted agentsOncologist. 2020;25(6):e900-e908. doi:10.1634/theoncologist.2019-0729

  3. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. 2016;375(18):1738-1748. doi:10.1056/NEJMoa1609709

  4. Ayad RF, Assar MD, Simpson L, Garner JB, Schussler JM. Causes and management of drug-induced long QT syndromeProc (Bayl Univ Med Cent). 2010;23(3):250-255. doi:10.1080/08998280.2010.11928628

  5. Arends J, Bachmann P, Baracos V, et al. ESPEN guidelines on nutrition in cancer patientsClin Nutr. 2017;36(1):11-48. doi:10.1016/j.clnu.2016.07.015

By Queen Buyalos, PharmD
Queen Buyalos is a pharmacist and freelance medical writer. She takes pride in advocating for cancer prevention, overall health, and mental health education. Queen enjoys counseling and educating patients about drug therapy and translating complex ideas into simple language.