Ribociclib Dosage

Medically reviewed by Drugs.com. Last updated on Dec 23, 2024.

Usual Adult Dose for Breast Cancer

Early Breast Cancer: 400 mg orally once a day for 21 consecutive days followed by 7 days off in 28-day treatment cycles
Duration of therapy: 3 years or until disease recurrence or unacceptable toxicity occurs

Advanced/Metastatic Breast Cancer: 600 mg orally once a day for 21 consecutive days followed by 7 days off in 28-day treatment cycles

Comments:

• Early breast cancer: This drug should be administered in combination with an aromatase inhibitor; the manufacturer product information for the aromatase inhibitor should be consulted for the recommended dosage.
• Advanced/metastatic breast cancer: This drug should be administered in combination with endocrine therapy (fulvestrant or an aromatase inhibitor); the manufacturer product information for the endocrine therapy should be consulted for the recommended dosage.

Uses:

• In combination with an aromatase inhibitor, for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence
• For the treatment of patients with HR-positive, HER2-negative advanced/metastatic breast cancer in combination with:
• an aromatase inhibitor as initial endocrine-based therapy; or
• fulvestrant as initial endocrine-based therapy or after disease progression on endocrine therapy

Renal Dose Adjustments

Mild or moderate renal dysfunction (estimated GFR 30 to 89 mL/min/1.73 m2): No adjustment recommended
Severe renal dysfunction:

• Starting dose: 200 mg orally once a day

Liver Dose Adjustments

Early Breast Cancer:

• Mild, moderate, or severe liver dysfunction (Child-Pugh A, B, or C): No adjustment recommended

Advanced/Metastatic Breast Cancer:

• Mild liver dysfunction (Child-Pugh A): No adjustment recommended
• Moderate or severe liver dysfunction (Child-Pugh B or C):
• Starting dose: 400 mg orally once a day

If Hepatobiliary Toxicity Develops During Therapy:
AST and/or ALT elevations from baseline (prior to treatment initiation), WITHOUT increase in total bilirubin above 2 times the upper limit of normal (2 x ULN):

• Grade 1 (greater than 1 to 3 times ULN): No dose adjustment is required.
• Grade 2 (greater than 3 to 5 x ULN):
• Baseline at less than grade 2: Interrupt dose until recovery to baseline grade or lower, then resume this drug at the same dose level.
• If grade 2 recurs: Resume this drug at the next lower dose level.
• Baseline at grade 2: No dose interruption
• Grade 3 (greater than 5 to 20 x ULN): Interrupt dose until recovery to baseline grade or lower, then resume at the next lower dose level.
• If grade 3 recurs: Discontinue this drug.
• Grade 4 (greater than 20 x ULN): Discontinue this drug.

Combined elevations in AST and/or ALT WITH total bilirubin increase, in the absence of cholestasis:

• If patients develop ALT and/or AST greater than 3 x ULN plus total bilirubin greater than 2 x ULN irrespective of baseline grade: Discontinue this drug.

Comments:

• The manufacturer product information for the coadministered aromatase inhibitor or fulvestrant should be consulted for dose adjustments related to liver dysfunction.
• Liver function tests (LFTs) should be performed before starting this drug; LFTs should be monitored every 2 weeks for the first 2 cycles, at the start of each subsequent 4 cycles, and as clinically indicated.
• If grade 2 or higher abnormalities are seen, monitor more frequently and as clinically indicated.

Dose Adjustments

The management of specific adverse reactions may require dose interruption, reduction, or discontinuation. Dose modification is recommended based on individual patient safety and tolerability.

RECOMMENDED DOSE MODIFICATION FOR ADVERSE REACTIONS:
Early Breast Cancer:

• Starting dose: 400 mg orally once a day
• Dose reduction: 200 mg orally once a day
• If dose reduction below 200 mg/day is required: Discontinue this drug.

Advanced/Metastatic Breast Cancer:

• Starting dose: 600 mg orally once a day
• First dose reduction: 400 mg orally once a day
• Second dose reduction: 200 mg orally once a day
• If dose reduction below 200 mg/day is required: Discontinue this drug.

DOSE MODIFICATION AND MANAGEMENT FOR ADVERSE REACTIONS:
Interstitial Lung Disease (ILD)/Pneumonitis:

• Grade 1 (asymptomatic): No dose interruption or adjustment is required; start appropriate medical therapy and monitor as clinically indicated.
• Grade 2 (symptomatic): Interrupt dose until recovery to grade 1 or lower, then consider resuming this drug at the next lower dose level.
• When considering resuming this drug: Perform an individualized benefit-risk assessment.
• If grade 2 recurs: Discontinue this drug.
• Grade 3 (severe symptomatic) or 4 (life-threatening): Discontinue this drug.

Cutaneous Adverse Reactions, Including Severe Cutaneous Adverse Reactions (SCARs):

• Grade 1 (less than 10% BSA with active skin toxicity, no signs of systemic involvement) or 2 (10% to 30% BSA with active skin toxicity, no signs of systemic involvement): No dose adjustment is required; start appropriate medical therapy and monitor as clinically indicated.
• Grade 3 (severe rash not responsive to medical management; greater than 30% BSA with active skin toxicity, signs of systemic involvement present; Stevens-Johnson syndrome): Interrupt this drug until the etiology of the reaction has been determined.
• If the etiology is a SCAR: Permanently discontinue this drug.
• If the etiology is not a SCAR: Interrupt dose until recovery to grade 1 or lower, then resume this drug at the same dose level.
• If the cutaneous adverse reaction still recurs at grade 3: Resume this drug at the next lower dose level.
• Grade 4 (any % BSA associated with extensive superinfection, with IV antibiotics indicated; life-threatening consequences; toxic epidermal necrolysis): Permanently discontinue this drug.

QT Prolongation:

• QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than 480 milliseconds (ms) and up to 500 ms: Interrupt this drug and wait until QTcF resolves to 480 ms or less, then:
• Early breast cancer: Resume at the same dose.
• Advanced/metastatic breast cancer: Reduce to the next lower dose level.
• If QTcF greater than 480 ms recurs: Interrupt this drug and wait until QTcF resolves to 480 ms or less, then resume at the next lower dose level.
• QTcF greater than 500 ms: Interrupt this drug and wait until QTcF resolves to 480 ms or less, then resume at the next lower dose level.
• If QTcF greater than 500 ms recurs: Discontinue this drug.
• If QTcF interval prolongation is either greater than 500 ms or greater than 60 ms change from baseline AND associated with torsade de pointes, polymorphic ventricular tachycardia, syncope, or signs/symptoms of serious arrhythmia: Permanently discontinue this drug.

Neutropenia:

• Grade 1 or 2 (absolute neutrophil count [ANC] 1000/mm3 to less than the lower limit of normal): No dose adjustment is required.
• Grade 3 (ANC 500 to less than 1000/mm3): Interrupt dose until recovery to grade 2 or lower, then resume this drug at the same dose level.
• If toxicity recurs at grade 3: Interrupt dose until recovery, then resume this drug at the next lower dose level.
• Grade 3 febrile neutropenia (grade 3 neutropenia with single episode of fever higher than 38.3C [or] 38C or above for more than 1 hour and/or concurrent infection): Interrupt dose until recovery of neutropenia to grade 2 or lower, then resume this drug at the next lower dose level.
• Grade 4 (ANC less than 500/mm3): Interrupt dose until recovery to grade 2 or lower, then resume this drug at the next lower dose level.

Other Toxicities (excluding ILD/pneumonitis, cutaneous adverse reactions [including SCARs], QT interval prolongation, hepatobiliary toxicity, and neutropenia):

• Grade 1 or 2: No dose adjustment is required; start appropriate medical therapy and monitor as clinically indicated.
• Grade 3: Interrupt dose until recovery to grade 1 or lower, then resume this drug at the same dose level.
• If grade 3 recurs: Resume this drug at the next lower dose level.
• Grade 4: Discontinue this drug.

Comments:

• Stevens-Johnson syndrome (grade 3 and 4) is defined as skin sloughing covering less than 10% BSA and 10% to 30% BSA, respectively, with associated signs (e.g., erythema, purpura, epidermal detachment, mucous membrane detachment).
• Toxic epidermal necrolysis (grade 4) is defined as skin sloughing covering at least 30% BSA with associated symptoms (e.g., erythema, purpura, epidermal detachment, mucous membrane detachment).
• ECGs should be assessed before starting treatment in all patients; ECGs should be repeated at about Day 14 of the first cycle, and as clinically indicated.
• If QTcF prolongation develops at any given time during therapy, ECG should be monitored more frequently, and as clinically indicated.
• CBCs should be performed before starting this drug; CBC should be monitored every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated.
• The manufacturer product information for the coadministered aromatase inhibitor or fulvestrant should be consulted for dose adjustment guidelines in case of toxicity and other relevant safety information.

DOSE MODIFICATION FOR USE WITH STRONG CYP450 3A INHIBITORS:

• Avoid concomitant use of this drug with strong CYP450 3A inhibitors; consider an alternative concomitant agent with less potential for CYP450 3A inhibition.
• If a strong CYP450 3A inhibitor must be coadministered:
• Early breast cancer: Reduce the dose of this drug to 200 mg orally once a day.
• Advanced/metastatic breast cancer: Reduce the dose of this drug to 400 mg orally once a day.
• If the strong inhibitor is discontinued: Change the dose of this drug (after at least 5 half-lives of the strong CYP450 3A inhibitor) to the dose used before starting the strong CYP450 3A inhibitor.

Precautions

CONTRAINDICATIONS: None

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 dose at about the same time each day, preferably in the morning, with or without food.
• Swallow tablets whole; do not chew, crush, or split before swallowing. Do not ingest a tablet that is broken, cracked, or otherwise not intact.
• If vomiting occurs after administration of the dose, or a dose is missed, do not administer an additional dose that day; administer the next prescribed dose at the usual time.

Storage requirements:

• Store refrigerated at 2C to 8C (36F to 46F); excursions permitted between 2C and 15C (36F and 59F).
• After dispensing: May be stored at room temperature at 20C to 25C (68F to 77F) for up to 2 months
• Store tablets in original blister pack.

General:

• Pre/perimenopausal women (or men) receiving this drug in combination with an aromatase inhibitor or fulvestrant should be treated with a luteinizing hormone-releasing hormone agonist according to current clinical practice standards.

Monitoring:

• Cardiovascular: ECG in all patients (before starting therapy, at about Day 14 of first cycle, and as clinically indicated)
• Hematologic: CBCs (every 2 weeks for first 2 cycles, at start of each subsequent 4 cycles, and as clinically indicated)
• Hepatic: LFTs (every 2 weeks for first 2 cycles, at start of each subsequent 4 cycles, and as clinically indicated)
• Metabolic: Serum electrolytes including potassium, calcium, phosphorus, and magnesium (before starting therapy, at start of first 6 cycles, and as clinically indicated)
• Respiratory: For pulmonary symptoms indicative of ILD/pneumonitis

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Immediately report new/worsening respiratory symptoms.
• Contact your health care provider immediately if signs/symptoms of severe cutaneous adverse reactions develop.
• Contact your health care provider immediately for signs/symptoms of QT prolongation or hepatobiliary toxicity.
• Immediately contact your health care provider if a fever develops, especially when associated with any sign of infection.
• Patients of childbearing potential: Inform your health care provider of a known/suspected pregnancy; use effective contraception during therapy and for at least 3 weeks after the last dose.
• Do not breastfeed during therapy and for at least 3 weeks after the last dose.
• Avoid strong CYP450 3A inhibitors, strong CYP450 3A inducers, and drugs known to prolong the QT interval.

Frequently asked questions

• How do you take Kisqali?

Further information

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