reatment with ribociclib; more frequent monitoring of LFTs is recommended. If baseline was grade 0 or 1, hold ribociclib therapy. For the first occurrence of grade 2 hepatotoxicity, resume treatment at original dose level when AST/ALT resolve to less than or equal to baseline. For recurrent grade 2 hepatotoxicity, resume therapy at the next lower dose level (reduce 600 mg to 400 mg; reduce 400 mg to 200 mg). More frequent monitoring of LFTs is recommended. If further dose reduction below 200 mg per day is required, discontinue treatment.
AST/ALT greater than 3 times ULN (greater than grade 2); total bilirubin GREATER than 2 times ULN (irrespective of baseline; in the absence of cholestasis): Discontinue ribociclib therapy.
AST/ALT 5.01 to 20 times ULN; (grade 3); total bilirubin less than 2 times ULN: Hold ribociclib therapy. For the first occurrence of grade 3 hepatotoxicity, resume therapy at the next lower dose level when AST/ALT recover to baseline grade or lower (reduce 600 mg to 400 mg; reduce 400 mg to 200 mg). More frequent monitoring of LFTs is recommended. If further dose reduction below 200 mg per day is required, discontinue treatment. Discontinue ribociclib for recurrent grade 3 hepatotoxicity.
AST/ALT greater than 20 times ULN (grade 4); total bilirubin less than 2 times ULN: Discontinue ribociclib therapy.
Renal Impairment
Dosage Adjustments for Baseline Renal Insufficiency:
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
Dosage Adjustments for Treatment-Related Nephrotoxicity:
NOTE: Dose modifications are not recommended for letrozole when administered with ribociclib for the adverse reactions of ribociclib.
Serum creatinine (SCr) less than or equal to 3 times the upper limit of normal (ULN) or glomerular filtration rate (GFR) greater than or equal to 25% of the lower limit of normal (LLN) (grade 1 or 2): No dosage adjustment necessary. Initiate appropriate medical management and monitor as indicated.
SCr 3.01 to 6 times ULN or GFR less than 25% of LLN (chronic dialysis not indicated) (grade 3): Hold ribociclib therapy. For the first occurrence of a grade 3 toxicity, resume ribociclib at the original dose level when upon recovery of the toxicity to grade 1 or less; for a recurrent grade 3 toxicity, resume ribociclib at the next lower dose level (reduce 600 mg to 400 mg; reduce 400 mg to 200 mg). If further dose reduction of ribociclib below 200 mg per day is required, discontinue treatment.
SCr greater than 6 times ULN or requiring chronic dialysis or renal transplant (grade 4): Discontinue ribociclib.
ADMINISTRATION
Oral Administration
Oral Solid Formulations
Take with or without food.
Take ribociclib and letrozole at approximately the same time each day, preferably in the morning.
If a dose is missed or the patient vomits, do not take any additional doses that day. Take the next prescribed dose at the usual time.
Swallow tablets whole; do not crush, break, or chew. Do not take any tablet that is broken, cracked, or otherwise not intact.
STORAGE
KISQALI FEMARA:
- Store at controlled room temperature (between 68 and 77 degrees F)
- Store in original container
CONTRAINDICATIONS / PRECAUTIONS
Alcoholism, bradycardia, cardiac arrhythmias, cardiac disease, coronary artery disease, diabetes mellitus, electrolyte imbalance, females, geriatric, heart failure, hypertension, hypocalcemia, hypokalemia, hypomagnesemia, long QT syndrome, malnutri |
