Safety Profile

The safety profile of KISQALI 400 mg was manageable, with no new safety signals. *^(1-3)

AEs generally occurred early in treatment, allowing for prompt dose adjustments. ⁽³⁾
Majority of ≥ grade 3 AEs were laboratory findings that were easily identifiable, manageable and mostly reversible. ⁽³⁾

KISQALI + NSAI

Dose reductions⁽²⁾

22.8%

Discontinuation due to AEs^†(2)

19.7%

Most frequent cause of permanent discontinuation⁽³⁾

9.9%

Liver-related^‡

Median time to discontinuation due to AEs⁽⁴⁾

months

* The majority of adverse events were transient, manageable, and reversible with dose reduction or interruption. ⁽²⁾
^† The stringent protocol requirements likely impacted the discontinuation rate. ⁽⁵⁾
^‡ ALT increase, 7.1%; AST increase, 2.8%. ⁽³⁾

Abbreviations

AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase.

References

Hortobagyi GN, et al. Oral GS03-03. Presented at the San Antonio Breast Cancer Symposium 2023, 5–9 December, San Antonio, Texas, USA.
KISQALI (ribociclib). Summary of Product Characteristics.
Barrios C, et al. Oral 113MO. Presented at the European Society for Medical Oncology, Breast Cancer Congress 2024, 15–17 May, Berlin, Germany.
Slamon D, et al. Presentation LBA500. Presented at the American Society of Clinical Oncology 2023, 2–6 June, Chicago, USA.
Slamon DJ, et al. N Engl J Med. 2024;390(12):1080–1091. Appendix, Protocol.

Safety

Safety Profile

The safety profile of KISQALI 400 mg was manageable, with no new safety signals. *(1-3)

KISQALI + NSAI

The safety profile of KISQALI 400 mg was manageable, with no new safety signals. *^(1-3)