Ribociclib

Name: Ribociclib

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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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 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.

What are some things I need to know or do while I take Ribociclib?

  • Tell all of your health care providers that you take ribociclib. This includes your doctors, nurses, pharmacists, and dentists.
  • An unsafe heartbeat that is not normal (long QT on ECG) has happened with this medicine. This may raise the chance of sudden death. Talk with the doctor.
  • You will need an ECG before starting ribociclib and during treatment. Talk with your doctor.
  • If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • Avoid star fruit, pomegranate or pomegranate juice, and grapefruit or grapefruit juice while you take this medicine.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking ribociclib with your other drugs.
  • This medicine may affect being able to father a child. Talk with the doctor.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting this medicine. Talk with your doctor.
  • Use birth control that you can trust to prevent pregnancy while taking ribociclib and for at least 3 weeks after your last dose.
  • If you get pregnant while taking this medicine or within 3 weeks after your last dose, call your doctor right away.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take ribociclib or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ribociclib. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing Geriatric

Refer to adult dosing.

Dosing Adjustment for Toxicity

Recommended ribociclib dosage adjustment levels:

Starting dose: 600 mg/day.

First dose reduction: Reduce to 400 mg/day.

Second dose reduction: Reduce to 200 mg/day.

If further dose reduction below 200 mg/day is needed, discontinue ribociclib.

Note: For dosage adjustment of concomitant aromatase inhibitor therapy refer to monograph and/or prescribing information.

Hematologic toxicity:

Grade 1 or 2 neutropenia (ANC 1,000/mm3 to below the lower limit of normal): No dosage adjustment necessary.

Grade 3 neutropenia (ANC 500 to <1,000/mm3): Interrupt treatment until recovery to grade 2 or lower and then resume ribociclib at the same dose. For recurrent grade 3 neutropenia, interrupt treatment until recovery and then resume ribociclib at the next lower dose level.

Grade 3 neutropenia with neutropenic fever (a single episode of fever >38.3°C or fever above 38°C for more than 1 hour and/or concurrent infection): Interrupt treatment until recovery to grade 2 or lower and then resume ribociclib at the next lower dose level.

Grade 4 neutropenia (ANC <500/mm3): Interrupt treatment until recovery to grade 2 or lower and then resume ribociclib at the next lower dose level.

Nonhematologic toxicity:

Cardiovascular: QT prolongation:

QTcF >480 msec: Interrupt treatment; when QTcF resolves to <481 msec, may resume ribociclib at the same dose level. If QTcF ≥481 msec recurs, interrupt treatment until QTcF resolves to <481 msec and resume ribociclib at the next lower dose level.

QTcF >500 msec: Interrupt treatment for QTcF >500 msec on at least 2 separate ECGs (within the same visit); if QTcF resolves to <481 msec, may resume ribociclib at the next lower dose level. If QTcF interval prolongation is either >500 msec or >60 msec increase from baseline AND associated with torsades de pointes, polymorphic ventricular tachycardia, unexplained syncope, or signs/symptoms of serious arrhythmia, permanently discontinue ribociclib.

Other nonhematologic toxicities (based on Common Toxicity Criteria for Adverse Events Version 4):

Grade 1 or 2: No dosage adjustment necessary. Initiate appropriate medical management and monitoring as indicated.

Grade 3: Interrupt treatment until recovery to grade 1 or lower and then resume ribociclib at the same dose level. If grade 3 toxicity recurs, interrupt treatment until recovery to grade 1 or lower and then resume ribociclib at the next lower dose level.

Grade 4: Discontinue ribociclib.

Dietary Considerations

Avoid pomegranate, pomegranate juice, and grapefruits.

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