By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Medical Information, Documents, News - TheMediTary.Com Logo Medical Information, Documents, News - TheMediTary.Com Logo

TheMediTary.Com

Medical Information, Documents, News - TheMediTary.Com

  • Home
  • News
  • Drugs
  • Drugs A-Z
  • Medical Answers
  • About Us
  • Contact
Medical Information, Documents, News - TheMediTary.Com Logo Medical Information, Documents, News - TheMediTary.Com Logo
Search Drugs
  • Drugs
    • Latest Drugs
    • Drugs A-Z
    • Medical Answers
  • News
    • FDA Alerts
    • Medical News
    • Health
    • Consumer Updates
    • Children's Health
  • More TheMediTary.Com
    • About Us
    • Contact
Follow US
Home > Drugs > CDK 4/6 inhibitors > Kisqali (400 mg daily-dose) > Ribociclib Dosage
CDK 4/6 inhibitors
https://themeditary.com/dosage-information/ribociclib-dosage-12383.html

Ribociclib Dosage

Drug Detail:Kisqali (400 mg daily-dose) (Ribociclib [ rye-boe-sye-klib ])

Drug Class: CDK 4/6 inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Usual Adult Dose for Breast Cancer

600 mg orally once a day for 21 consecutive days followed by 7 days off for a complete cycle of 28 days; continue until disease progression or unacceptable toxicity

Comments:

  • Refer to the manufacturer product information for dosing and administration recommendations for the co-administered aromatase inhibitor (e.g., letrozole).
  • When given with this drug, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Refer to the full prescribing information of fulvestrant.
  • Pre/perimenopausal women treated with the combination of this drug plus an aromatase inhibitor or fulvestrant should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards.

Uses:
  • 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.
  • In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

Renal Dose Adjustments

  • Mild (CrCl 60 to less than 90 mL/min) or moderate (CrCl 30 to less than 60 mL/min): No adjustment recommended.
  • Severe renal impairment CrCl 15 to less than 30 mL/min): A starting dose of 200 mg is recommended.

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

HEPATIC TOXICITY:
AST and/or ALT 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 therapy until recovery to baseline grade or less; resume at next lower dose level.
  • Baseline at Grade 2: No adjustment recommended.
  • Grade 3 (greater than 5 to 20 x ULN): Interrupt therapy until recovery to baseline grade or less; resume at the next lower dose level; if Grade 3 recurs, discontinue therapy.
GRADE 4: Discontinue therapy.

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 therapy

Dose Adjustments

DOSE REDUCTIONS FOR ADVERSE REACTIONS/TOXICITIES:

  • 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 further dose reduction required below 200 mg/day: Discontinue therapy

DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
NEUTROPENIA:
Absolute neutrophil count (ANC):
  • Grade 1 or 2 (ANC 1000/mm3 to less than lower limit of normal [LLN]): No adjustment recommended.
  • Grade 3 (ANC 500 to less than 1000/mm3): Interrupt therapy until recovery to Grade 2 or less; resume therapy at the same dose level; if toxicity recurs at Grade 3, interrupt therapy until recovery then resume at the next lower dose level.
  • Grade 3 febrile neutropenia (with single episode of fever greater than 38.3C or above 38C for more than 1 hour and/or concurrent infection: Interrupt therapy until recovery of neutropenia to Grade 2 or less; resume therapy at the next lower dose level.
  • Grade 4: Interrupt therapy until recovery of neutropenia to Grade 2 or less; resume therapy at the next lower dose level.
QT PROLONGATION:
  • ECGs with QTcF GREATER THAN 480 MSEC: Interrupt therapy; if QTcF resolves to less than 481 msec, resume therapy at the next lower dose level. If QTcF of 481 msec or greater recurs, interrupt dose until QTcF resolves to less than 481 msec; then resume at next lower dose level.
  • ECGs with QTcF GREATER THAN 500 MSEC: Interrupt therapy if QTcF greater than 500 msec; if QTcF prolongation resolves to less than 481 msec, resume therapy the next lower dose level.
  • Permanently discontinue therapy 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.
INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS:
  • Grade 1 (asymptomatic): No dose interruption or adjustment is required; initiate medical therapy and monitor as indicated.
  • Grade 2 (symptomatic): Interrupt therapy until recovery to Grade 1 or less; consider resuming at the next lower dose level; if Grade 2 recurs, discontinue therapy.
  • Grade 3 (severe symptomatic) OR Grade 4 (life-threatening): Discontinue therapy.
CUTANEOUS ADVERSE REACTIONS, INCLUDING SEVERE CUTANEOUS ADVERSE REACTIONS (SCARS):
  • Grade 1 or 2 (less than 10% to 30% body surface area [BSA] with active skin toxicity, no signs of systemic involvement): No adjustment recommended.
  • Grade 3 (severe rash not responsive to medical management; grater than 30% BSA with active skin toxicity, signs of systemic involvement present; Stevens-Johnson Syndrome):
  • Interrupt treatment until the etiology of the reaction has been determined.
  • Permanently discontinue treatment if the etiology is a SCAR.
  • If the etiology is not a SCAR, interrupt dose until recovery to Grade 1 or less, then resume at same dose level.
  • If the cutaneous adverse reaction still recurs at Grade 3, resume 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 therapy.

OTHER TOXICITIES:
  • Grade 1 or 2: No adjustment recommended; initiate medical therapy and monitor as indicated.
  • Grade 3: Interrupt dose; upon recovery to Grade 1 or less, resume therapy at same dose level.
  • Grade 3 Recurrence: Interrupt dose; upon recovery to Grade 1 or less, resume therapy at the next lower dose level.
  • Grade 4: Discontinue therapy.

Comments: Consult the manufacturer product information for dose adjustment guidelines in the event of toxicity and other relevant safety information for the coadministered agents.

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.

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 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.

Storage Requirements:
  • Store in the original package at 20 to 25 degrees Celsius (68 to 77 Fahrenheit).

General:
  • 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.

Monitoring:
  • 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)
  • Respiratory: Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis.

Patient Advice:
  • Avoid pomegranates/pomegranate juice, grapefruit/grapefruit juice during treatment with this drug.
  • Advise patients to immediately report new or worsening respiratory symptoms.
  • Advise patients to contact their healthcare provider immediately if they develop signs and symptoms of severe cutaneous adverse reactions.
Share this Article
Latest News
Medical News

Shingles vaccine may lower heart disease risk by up to 8 years

May 09, 2025
Obesity, unhealthy lifestyles may cause heart to age by 5–45 years
Aging: As little as 5 minutes of exercise may keep the brain healthy
Prostate cancer: Simple urine test may help with early detection
Cancer treatment side effects: Exercise may reduce pain, fatigue
Alzheimer's: Exercising in middle age may reduce beta-amyloid in brain...
Related Drugs
Fidanacogene Elaparvovec
Cerave Anti-Itch
Centrum Adult
Crovalimab
Cyltezo Prefilled Syringe
Zepbound Pen
Mylanta One
Uretron Ds
Medihoney Wound And Burn Dressing
Lidotrode

Other drugs

Name Drug Class Updated
Fidanacogene Elaparvovec Drugs 03-Oct-2024
Cerave Anti-Itch Drugs 02-Oct-2024
Centrum Adult Drugs 02-Oct-2024
Crovalimab Drugs 02-Oct-2024
Cyltezo Prefilled Syringe Drugs 01-Oct-2024
Zepbound Pen Drugs 30-Sep-2024
Mylanta One Drugs 27-Sep-2024
Uretron Ds Drugs 27-Sep-2024
Medihoney Wound And Burn Dressing Drugs 26-Sep-2024
Lidotrode Drugs 26-Sep-2024
Libervant Drugs 26-Sep-2024
Moderna Covid-19 Drugs 25-Sep-2024
Beqvez Drugs 24-Sep-2024
Beqvez Drugs 24-Sep-2024
Beqvez Drugs 24-Sep-2024

Categories

  • FDA Alerts
  • Medical News
  • Health
  • Consumer Updates
  • Children's Health

About US

Welcome to TheMediTary.Com

Our website provides reliable and up-to-date information on various medical topics. We empower individuals to take charge of their health by simplifying complex medical jargon and providing practical tips and advice. We prioritize the privacy and confidentiality of our users and welcome feedback to improve our services.

Website use data of FDA and other sources

DMCA.com Protection Status Truste Protection Status Trust Mark Protection Status
HONcode logo We comply with the HONcode standard for trustworthy health information.
Quick Link
  • About Us
  • Contact Us
  • Editorial Policy
  • Privacy Policy
  • Accessibility Policy
  • Terms & Conditions
  • Disclaimer
  • DMCA
  • Do Not Sell My Personal Information
  • Sitemap
  • Care Notes
  • Health Guide
  • Professional
Drugs
  • New Drugs
  • Medical Answers
  • Drugs A-Z
  • Drug Classes
  • Drug Dosage
  • Pill Identifier
  • Consumer Infor
  • Side Effects
  • Inactive Ingredients
  • Pregnancy Warnings
  • Patient Tips
  • Treatments
News
  • Latest News
  • FDA Alerts
  • Medical News
  • Health
  • Consumer Updates
  • Children's Health
Find US
  • Medium
  • Google Site
  • Blogspot
  • API
  • Reddit
  • Tumblr
  • Scoop.it
  • Substack
  • Wordpress
  • Wix
  • Behance

© 2025 TheMediTary.Com All rights reserved. Operated by