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Ribociclib Dosage

Applies to the following strength(s): 200 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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.

Renal Dose Adjustments

-Mild and Moderate Renal Impairment: Data not available regarding dosage adjustments; however, a population pharmacokinetics analysis of this drug showed no effect on drug exposure.
-Severe Renal Impairment: Data not available.

Liver Dose Adjustments

-Mild Hepatic Impairment (Child-Pugh A): No adjustment recommended.
-Moderate and Severe Hepatic Impairment (Child-Pugh B/C): Initial Dose: 400 mg orally once a day.

HEPATOBILIARY TOXICITY DURING TREATMENT:
ALT and/or AST ELEVATIONS FROM BASELINE, WITHOUT INCREASE IN TOTAL BILIRUBIN ABOVE 2 TIMES THE UPPER LIMIT OF NORMAL (ULN):
-Grade 1 (Greater than ULN to 3 x ULN): No adjustment recommended.
-Grade 2 (Greater than 3 to 5 x ULN):
Baseline Less than Grade 2: Interrupt dose; upon recovery to baseline grade or less, resume at same dose level.
Baseline at Grade 2: No dose interruption.
-Grade 2 Recurrence or Grade 3 (Greater than 5 to 20 x ULN): Interrupt dose; upon recovery to baseline grade or less, resume at next lower dose level.
-Grade 3 Recurrence or Grade 4 (Greater than 20 x ULN): Discontinue treatment.

COMBINED ELEVATIONS IN ALT and/or AST ELEVATIONS WITH TOTAL BILIRUBIN INCREASE IN THE ABSENCE OF CHOLESTASIS:
ALT and/or AST Greater than 3 x ULN Along with Total Bilirubin Greater than 2 x ULN Irrespective of Baseline Grade: Discontinue treatment.

Dose Adjustments

CONCOMITANT USE WITH STRONG CYP450 3A INHIBITORS: Avoid concomitant use if possible and consider an alternative concomitant medication with less potential for CYP450 3A inhibition.
-If Concomitant Use Necessary: Reduce dose of this drug to 400 mg orally once a day.
-If Strong CYP450 3A Inhibitor Discontinued: Change dose of this drug (after at least 5 half-lives of the strong CYP450 3A Inhibitor) to the dose used prior to the initiation of the inhibitor.

DOSE REDUCTIONS FOR ADVERSE REACTIONS/TOXICITIES:
-First Dose Reduction: 400 mg/day
-Second Dose Reduction: 200 mg/day
-If Further Dose Reduction Required Below 200 mg/day: Discontinue treatment.

NEUTROPENIA:
Absolute Neutrophil Count (ANC)
-Grade 1 or 2 (ANC 1000/mm3 to Less than Lower Limit of Normal): No adjustment recommended.
-Grade 3 (ANC 500 to less than 1000/mm3): Interrupt dose; upon recovery to Grade 2 or less, resume treatment at the same dose level.
-Grade 3 Recurrence; Grade 3 Febrile (single episode of fever greater than 38.3 degrees Celsius OR above 38 degrees Celsius for more than 1 hour and/or concurrent infection); OR Grade 4 (ANC less than 500/mm3): Interrupt dose; upon recovery to Grade 2 or less, resume treatment at the next lower dose level.

QT PROLONGATION:
-ECGs with QTcF GREATER THAN 480 MSEC: Interrupt treatment and resume treatment at the same dose level if QTcF prolongation resolves to less than 481 msec; if QTcF 481 msec or greater recurs, interrupt dose and resume treatment at the next lower dose level once QTcF resolves to less than 481 msec.
-ECGs with QTcF GREATER THAN 500 MSEC: Interrupt treatment if QTcF greater than 500 msec on at least 2 separate ECGs within the same visit OR resume treatment at the next lower dose level if QTcF prolongation resolves to less than 481 msec.
-ECGs with QTcF GREATER THAN 500 MSEC OR GREATER THAN 60 MSEC CHANGE FROM BASELINE AND ASSOCIATED WITH ANY OF THE FOLLOWING: Torsades De Pointes, Polymorphic Ventricular Tachycardia, Unexplained Syncope, or Signs/Symptoms of Serious Arrhythmia: Permanently discontinue treatment.

OTHER TOXICITIES:
-Grade 1 or 2: No adjustment recommended.
-Grade 3: Interrupt dose; upon recovery to Grade 1 or less, resume treatment at same dose level.
-Grade 3 Recurrence: Interrupt dose; upon recovery to Grade 1 or less, resume treatment at the next lower dose level.
-Grade 4: Discontinue treatment.

Comments: Consult the manufacturer product information for dose adjustment guidelines in the event of toxicity and other relevant safety information for the co-administered aromatase inhibitor (e.g., letrozole).

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration Advice:
-Administer this drug with or without food, and at approximately the same time each day (preferably in the morning).
-Missed and vomited doses should not be replaced; dosing should be resumed with the next scheduled daily dose.

Storage Requirements:
-Store in the original package at 20 to 25 degrees Celsius (68 to 77 Fahrenheit).

General:
-In studies using patient-derived estrogen receptor positive breast cancer xenograft models, the combination of this drug with an antiestrogen (e.g., letrozole) resulted in increased tumor growth inhibition compared to each drug alone.
-There are no known cases of overdose with this drug; initiate general symptomatic and supportive measures in all cases of overdosage as necessary.

Monitoring:
-Cardiac: ECGs (before treatment initiation, at approximately Day 14 of the first cycle, at the beginning of the second cycle, and as clinically indicated; more frequent monitoring if QTcF prolongation occurs at any given time during treatment); serum electrolytes (before treatment initiation, at the beginning of the first 6 cycles, and as clinically indicated)
-Hematological: CBC (before treatment initiation, every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated)
-Hepatic: LFTs (before treatment initiation, every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated; more frequent monitoring if Grade 2 or greater abnormalities noted)

Patient Advice:
-Avoid pomegranates/pomegranate juice, grapefruit/grapefruit juice during treatment with this drug.

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