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ribociclib

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

What is ribociclib?

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.

What is the most important information I should know about ribociclib?

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

What should I discuss with my healthcare provider before taking ribociclib?

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 this medicine 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:

  • low white blood cells;

  • nausea, vomiting;

  • diarrhea, constipation;

  • feeling tired;

  • headache, back pain; 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.

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 treatment for a complete cycle of 28 days.

Comments: Refer to the manufacturer product information for dosing and administration recommendations for the co-administered aromatase inhibitor (e.g., letrozole).

Use: 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.

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.

Where can I get more information?

  • Your pharmacist can provide more information about ribociclib.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01.

Date modified: November 15, 2017
Last reviewed: March 29, 2017

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