Ribociclib tablets (Kisqali) - selected U.S. label sections
- Product / population
- KISQALI oral tablets for breast cancer; not a combined letrozole package instruction.
- Renal measure
- eGFR in mL/min/1.73 m2; severe category as specified by the label.
Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.
Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.
Renal dose comments
Mild or moderate renal impairment does not require adjustment. For severe impairment, the recommended starting dose is 200 mg once daily. Preserve the treatment cycle of 21 days on treatment followed by 7 days off, rather than converting this into continuous daily therapy.
Scope and monitoring
The concomitant endocrine therapy, toxicity modifications, ECG and electrolyte monitoring remain separate requirements. This summary does not assign a hemodialysis regimen.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aaeaef94-f3f5-4367-8ea2-b181d7be2da8