Applies to the following strength(s): 200 mg
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Usual Adult Dose for:
Additional dosage 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.
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.
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.
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.
-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.
-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).
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available.
-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.
-Store in the original package at 20 to 25 degrees Celsius (68 to 77 Fahrenheit).
-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.
-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)
-Avoid pomegranates/pomegranate juice, grapefruit/grapefruit juice during treatment with this drug.
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Other brands: Kisqali