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Generic Name: ribociclib (RYE boe SYE klib)
Brand Name: Kisqali

Medically reviewed on March 29, 2017

What is ribociclib?

See also: Kisqali

Ribociclib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Ribociclib is used to treat a certain type of advanced breast cancer in postmenopausal women. Ribociclib is given in combination with another cancer medicine called letrozole (Femara).

Ribociclib may also be used for purposes not listed in this medication guide.

Important Information

You will need frequent medical tests while taking ribociclib. Your cancer treatments may be delayed based on the results of these tests.

Before taking this medicine

You should not use ribociclib if you are allergic to it.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using ribociclib.

To make sure ribociclib is safe for you, tell your doctor if you have:

  • liver disease;

  • signs of infection (fever, chills);

  • heart disease or prior heart attack;

  • long QT syndrome;

  • slow heartbeats; or

  • an electrolyte imbalance (such as low levels of calcium, magnesium, phosphorus, or potassium in your blood).

Do not use ribociclib if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using ribociclib and for at least 3 weeks after your last dose.

You may need to have a negative pregnancy test before starting this treatment.

This medicine may affect fertility (ability to have children) in men. Talk with your doctor if you have concerns about this risk.

It is not known whether ribociclib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 3 weeks after your last dose.

How should I take ribociclib?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ribociclib is given in a 28-day treatment cycle. You will take the medicine for the first 21 days of each cycle, followed by 7 days off. Your doctor will determine how long to treat you with ribociclib.

Do not crush, chew, or break a ribociclib tablet. Swallow it whole.

You may take ribociclib with or without food. Take the medicine in the morning, at the same time each day.

If you vomit after taking the medicine, wait until the next day to take your next dose.

Do not use a broken or damaged pill.

Your blood cells, liver function, and heart function will need to be tested before and during treatment. You will need frequent blood tests while taking ribociclib. Your heart function will be checked using an electrocardiograph or ECG (sometimes called an EKG). Your cancer treatments may be delayed based on the results of these tests.

Store ribociclib in the original container at room temperature, away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ribociclib?

Certain foods and juices may interact with ribociclib and lead to unwanted side effects. Avoid the use of grapefruit and pomegranate products while taking ribociclib.

Avoid taking an herbal supplement containing St. John's wort at the same time you are taking ribociclib.

Ribociclib side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or

  • liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

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.

See also: Side effects (in more detail)

Ribociclib dosing information

Usual Adult Dose for Breast Cancer:

600 mg orally once a day for 21 consecutive days followed by 7 days off for a complete cycle of 28 days; continue until disease progression or unacceptable toxicity

-Refer to the manufacturer product information for dosing and administration recommendations for the co-administered aromatase inhibitor (e.g., letrozole).
-When given with this drug, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Refer to the full prescribing information of fulvestrant.
-Pre/perimenopausal women treated with the combination of this drug plus an aromatase inhibitor or fulvestrant should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards.

-In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
-In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

What other drugs will affect ribociclib?

Ribociclib can cause a serious heart problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, antipsychotic medicines, stomach acid reducers, heart rhythm medicine, and medicines to treat cancer, malaria, HIV or AIDS.

Many drugs can interact with ribociclib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ribociclib. Give a list of all your medicines to any healthcare provider who treats you.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.