Ribociclib dosage depends on the indication and patient-specific factors. The following summarizes current U.S. KISQALI labeling and is not an individualized prescription.
| Treatment setting | Current U.S. labeled starting regimen |
|---|---|
| HR-positive/HER2-negative stage II–III early breast cancer at high risk of recurrence | 400 mg once daily for 21 days, followed by 7 days off |
| HR-positive/HER2-negative advanced or metastatic breast cancer | 600 mg once daily for 21 days, followed by 7 days off |
Both regimens use 200 mg tablets.
Dose reduction
For early breast cancer, the U.S. label identifies 400 mg/day as the starting dose and 200 mg/day as the dose-reduction level.
For advanced or metastatic disease, the starting dose is 600 mg/day, followed by 400 mg/day and then 200 mg/day if further reduction is required. If a dose below 200 mg/day would be necessary, the label recommends discontinuation.
Dose interruption
Treatment interruption, dose reduction or discontinuation can be required because of adverse reactions. Specific management depends on the toxicity, severity and indication.
Renal and hepatic impairment
Ribociclib exposure can increase with severe renal impairment and certain degrees of hepatic impairment. Dose recommendations therefore require consideration of organ function and the applicable prescribing information.
Administration
Ribociclib can be taken with or without food. Tablets should be swallowed whole and should not be crushed, chewed or split.
Important jurisdictional limitation
The dosing above is based on current U.S. labeling. Requirements can differ between regulatory jurisdictions and product formulations.