Generic name: RIBOCICLIB 200mg
Dosage form: tablet, film coated
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2.1 Dosing and Administration
The recommended dose of KISQALI is 600 mg (three 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days. KISQALI can be taken with or without food [see Clinical Pharmacology (12.3)].
Coadminister KISQALI with letrozole 2.5 mg taken once daily throughout the 28-day cycle. Refer to the full prescribing information of letrozole. For dosing and administration with other aromatase inhibitors refer to the applicable full prescribing information.
Patients should take their dose of KISQALI and letrozole at approximately the same time each day, preferably in the morning.
If the patient vomits after taking the dose, or misses a dose, no additional dose should be taken that day. The next prescribed dose should be taken at the usual time. KISQALI tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.
2.2 Dose Modifications
Dose Modifications for Adverse Reactions
The recommended dose modifications for adverse reactions are listed in Table 1.
|Dose||Number of Tablets|
|Starting dose||600 mg/day||three 200 mg tablets|
|First dose reduction||400 mg/day||two 200 mg tablets|
|Second dose reduction||200 mg/day*||one 200 mg tablet|
|*If further dose reduction below 200 mg/day is required, discontinue the treatment.|
Tables 2, 3, 4 and 5 summarize recommendations for dose interruption, reduction, or discontinuation of KISQALI in the management of specific adverse reactions. Dose modification of KISQALI is recommended based on individual safety and tolerability.
|Grade 1 or 2
(ANC 1000/mm3 – <LLN)
(ANC 500 - <1000/mm3)
|Grade 3 febrile* neutropenia||Grade 4
|Neutropenia||No dose adjustment is required.||Dose interruption until recovery to Grade ≤ 2.
Resume KISQALI at the same dose level.
If toxicity recurs at Grade 3, dose interruption until recovery, then resume KISQALI at the next lower dose level.
|Dose interruption until recovery of neutropenia to Grade ≤ 2. Resume KISQALI at the next lower dose level.||Dose interruption until recovery to Grade ≤ 2.
Resume KISQALI at the next lower dose level.
|Perform Complete Blood Counts (CBC) before initiating treatment with KISQALI.
Monitor CBC every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated.
|*Grade 3 neutropenia with single episode of fever >38.3°C (or) above 38°C for more than one hour and/or concurrent infection.
Grading according to CTCAE Version 4.03. CTCAE=Common Terminology Criteria for Adverse Events.
ANC = absolute neutrophil count; LLN = lower limit of normal
(> ULN – 3 x ULN)
(>3 to 5 x ULN)
(>5 to 20 x ULN)
(>20 x ULN)
|AST and/or ALT elevations from baseline*, WITHOUT increase in total bilirubin above 2 x ULN||No dose adjustment is required.||Baseline* at < Grade 2:
Dose interruption until recovery to ≤ baseline grade, then resume KISQALI at same dose level. If Grade 2 recurs, resume KISQALI at next lower dose level.
Baseline* at Grade 2:
No dose interruption.
|Dose interruption until recovery to ≤ baseline* grade, then resume at next lower dose level.
If Grade 3 recurs, discontinue KISQALI.
|Combined elevations in AST and/or ALT WITH total bilirubin increase, in the absence of cholestasis||If patients develop ALT and/or AST > 3 x ULN along with total bilirubin > 2 x ULN irrespective of baseline grade, discontinue KISQALI.|
|Perform Liver Function Tests (LFTs) before initiating treatment with KISQALI.
Monitor LFTs every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated.
If Grade ≥2 abnormalities are noted, more frequent monitoring is recommended.
|*Baseline = prior to treatment initiation.
Grading according to CTCAE Version 4.03.
ULN = upper limit of normal
AST = aspartate aminotransferase; ALT = alanine aminotransferase
|ECGs with QTcF > 480 msec||
|ECGs with QTcF > 500 msec||
Permanently discontinue KISQALI if QTcF interval prolongation is either 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.
|Electrocardiograms (ECGs) should be assessed prior to initiation of treatment.
Repeat ECGs at approximately Day 14 of the first cycle and at the beginning of the second cycle, and as clinically indicated.
In case of (QTcF) prolongation at any given time during treatment, more frequent ECG monitoring is recommended.
|Grade 1 or 2||Grade 3||Grade 4|
|Other toxicities||No dose adjustment is required. Initiate appropriate medical therapy and monitor as clinically indicated.||Dose interruption until recovery to Grade ≤1 then resume KISQALI at same dose level.
If Grade 3 recurs, resume KISQALI at the next lower dose level.
|*Excluding neutropenia, hepatobiliary toxicity and QT interval prolongation.
Grading according to CTCAE Version 4.03.
Refer to the Full Prescribing Information for the coadministered aromatase inhibitor for dose modification guidelines in the event of toxicity and other relevant safety information.
Dose Modification for Use with Strong CYP3A Inhibitors
Avoid concomitant use of KISQALI with strong CYP3A inhibitors and consider an alternative concomitant medication with less potential for CYP3A inhibition [see Drug Interactions (7.1)]. If a strong CYP3A inhibitor must be coadministered, reduce the KISQALI dose to 400 mg once daily. If the strong inhibitor is discontinued, change the KISQALI dose (after at least 5 half-lives of the strong CYP3A inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
Dose Modification for Hepatic Impairment
No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh class A). The recommended starting dose is 400 mg KISQALI once daily for patients with moderate (Child-Pugh class B) and severe hepatic impairment (Child-Pugh class C) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Review the Full Prescribing Information for the aromatase inhibitor for dose modifications related to hepatic impairment.
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