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Kisqali Dosage

Generic name: RIBOCICLIB SUCCINATE 200mg
Dosage form: tablet, film coated
Drug class: CDK 4/6 inhibitors

Medically reviewed by Drugs.com. Last updated on Feb 25, 2025.

2.1 Recommended Dosage

Important Administration Instructions

KISQALI can be taken with or without food.

​Pre/perimenopausal women, or men, treated with the combination KISQALI plus an aromatase inhibitor or fulvestrant, should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards.

Patients should take their dose of KISQALI 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.

Early Breast Cancer

​The recommended dosage of KISQALI is 400 mg (two 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off in 28-day treatment cycles. KISQALI should be given in combination with an aromatase inhibitor. Refer to the Full Prescribing Information for the recommended dosage of the aromatase inhibitor.

​In patients with early breast cancer, treatment with KISQALI should continue for 3 years or until disease recurrence or unacceptable toxicity occurs.

Advanced or Metastatic Breast Cancer

The recommended dosage of KISQALI is 600 mg (three 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off in 28-day treatment cycles. KISQALI should be given in combination with endocrine therapy (fulvestrant or an aromatase inhibitor). Refer to the Full Prescribing Information for the recommended dose of endocrine therapy.

2.2 Dose Modifications

Dose Modifications for Adverse Reactions

​The recommended dose modifications for adverse reactions are listed in Table 1.

Table 1: Recommended Dose Modification for Adverse Reactions
Level KISQALI
Dose Number of tablets
Early breast cancer
Starting dose 400 mg/day two 200 mg tablets
Dose reduction 200 mg/day* one 200 mg tablet
Advanced or metastatic breast cancer
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 dose reduction below 200 mg/day is required, discontinue KISQALI.

Tables 2, 3, 4, 5, 6, and 7 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 patient safety and tolerability.

Table 2: Dose Modification and Management for Interstitial Lung Disease/Pneumonitis
Grade 1
(asymptomatic)		 Grade 2
(symptomatic)		 Grade 3 (severe symptomatic)
or 4 (life-threatening)
ILD/Pneumonitis
 No dose interruption or adjustment is required. Initiate appropriate medical therapy and monitor as clinically indicated. Dose interruption until recovery
to Grade ≤ 1 then consider resuming KISQALI at the next lower dose level*.
If Grade 2 recurs, discontinue KISQALI.		 Discontinue KISQALI.
Abbreviation: ILD, interstitial lung disease.
Grading according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
*An individualized benefit-risk assessment should be performed when considering resuming KISQALI.
Table 3: Dose Modification and Management for Cutaneous Adverse Reactions, Including SCARs
Grade 1
(< 10% body surface area (BSA) with active skin toxicity, no signs of systemic involvement)		 Grade 2
(10%-30% BSA with active skin toxicity, no signs of systemic involvement)		 Grade 3
(severe rash not responsive to medical management; > 30% BSA with active skin toxicity, signs of systemic involvement present; SJS*)		 Grade 4
(any % BSA associated with extensive superinfection, with IV antibiotics indicated; life threatening consequences; TEN**)
Cutaneous adverse reactions, including SCARs
 No dose adjustment is required.

Initiate appropriate medical therapy and monitor as clinically indicated.		 Interrupt KISQALI until the etiology of the reaction has been determined.

If the etiology is a SCAR, permanently discontinue KISQALI.

If the etiology is not a SCAR, interrupt dose until recovery to Grade ≤ 1, then resume KISQALI at same dose level.

If the cutaneous adverse reaction still recurs at Grade 3, resume KISQALI at the next lower dose level.		 Permanently discontinue KISQALI.
Abbreviations: BSA, body surface area; SCARs, severe cutaneous adverse reactions; SJS, Stevens-Johnson syndrome; TEN, toxic epidermal necrolysis.
*SJS (Grade 3 and 4) is defined as skin sloughing covering < 10% BSA and 10%-30% BSA, respectively, with associated signs (e.g., erythema, purpura, epidermal detachment, and mucous membrane detachment).
**TEN (Grade 4) is defined as skin sloughing covering ≥ 30% BSA with associated symptoms (e.g., erythema, purpura, epidermal detachment, and mucous membrane detachment).
Grading according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Table 4: Dose Modification and Management for QT Prolongation
QTcF* prolongation Early breast cancer Advanced or metastatic breast cancer
> 480 ms and ≤ 500 ms Interrupt KISQALI treatment and wait until QTcF resolves to ≤ 480 ms
Resume at the same dose Reduce to the next lower dose level
If QTcF > 480 ms recurs, interrupt KISQALI treatment and wait until QTcF resolves to ≤ 480 ms, then resume at next lower dose level.
> 500 ms Interrupt KISQALI treatment and wait until QTcF resolves to ≤ 480 ms, then resume at next lower dose level.
If QTcF > 500 ms recurs, discontinue KISQALI.
Permanently discontinue KISQALI if QTcF interval prolongation is either > 500 ms or > 60 ms change from baseline AND associated with any of the following: Torsades de Pointes, polymorphic ventricular tachycardia, syncope, or signs/symptoms of serious arrhythmia.
Note: If dose reduction below 200 mg/day is required, discontinue KISQALI.
Electrocardiograms (ECGs) should be assessed prior to initiation of treatment in all patients.
Repeat ECGs at approximately Day 14 of the first cycle, and as clinically indicated.
In case of QTcF prolongation at any given time during treatment, monitor ECG more frequently, and as clinically indicated
*QTcF = QT interval corrected by Fridericia’s formula.
Table 5: Dose Modification and Management for Hepatobiliary Toxicity
Grade 1
(> ULN – 3 x ULN)		 Grade 2
(> 3 to 5 x ULN)		 Grade 3
(> 5 to 20 x ULN)		 Grade 4
(> 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.		 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, monitor more frequently, and as clinically indicated.
Abbreviations: AST, aspartate aminotransferase; ALT, alanine aminotransferase; ULN, upper limit of normal.
*Baseline = prior to treatment initiation.
Grading according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Table 6: Dose Modification and Management for Neutropenia
Grade 1 or 2
(ANC 1000/mm3 – < LLN)		 Grade 3
(ANC 500 - < 1000/mm3)		 Grade 3 febrile* neutropenia Grade 4
(ANC < 500/mm3)
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 (CBCs) 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.
Abbreviations: ANC, absolute neutrophil count; LLN, lower limit of normal.
*Grade 3 neutropenia with single episode of fever > 38.3°C (or) 38°C or above for more than one hour and/or concurrent infection.
Grading according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Table 7: Dose Modification and Management for Other Toxicities*
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.		 Discontinue KISQALI.
*Excluding interstitial lung disease (ILD)/pneumonitis, cutaneous adverse reactions, including severe cutaneous adverse reactions (SCARs), QT interval prolongation, hepatobiliary toxicity, and neutropenia.
Grading according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Refer to the Full Prescribing Information for the coadministered aromatase inhibitor or fulvestrant 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.

If a strong CYP3A inhibitor must be coadministered, reduce the KISQALI dose as shown in Table 8.

Table 8: Dose Modification for Use with Strong CYP3A Inhibitors
Indication Co-administration with Strong CYP3A Inhibitors
Early breast cancer Reduce the KISQALI dose to 200 mg once daily.
Advanced or metastatic breast cancer 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.

Dose Modification for Hepatic Impairment

​The recommended dose modifications for patients with hepatic impairment are shown in Table 9.

Table 9: Dose Modification for Hepatic Impairment
Indication Mild hepatic impairment
(Child-Pugh class A)		 Moderate and severe hepatic impairment
(Child-Pugh class B or C)
Early breast cancer No dose adjustment is necessary No dose adjustment is necessary
Advanced or metastatic breast cancer No dose adjustment is necessary KISQALI 400 mg once daily

Review the Full Prescribing Information for the co-administered aromatase inhibitor or fulvestrant for dose modifications related to hepatic impairment.

Dose Modification for Severe Renal Impairment

The recommended starting dose is 200 mg KISQALI once daily for patients with severe renal impairment.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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