Adverse Events

A manageable safety profile with mainly reversible and mostly asymptomatic adverse events. ^(1-3)

KISQALI + AI can help patients experience life with minor disruption on a daily basis. Life on their terms. ^(1,3-6)

KISQALI is well tolerated with a consistent safety profile in the broadest range of HR+/HER2– EBC patients, including those with grade 1 disease or no nodal involvement. ^(2,6)

Adverse events reported in the NATALEE study. ⁽⁶⁾

Table comparing the incidence of adverse events (AEs) with KISQALI + AI in two patient populations from the NATALEE studies (n=2525 and n=2442). The table includes percentages for any-grade and grade ≥3 AEs, such as neutropenia, liver-related events, QT prolongation, fatigue, diarrhoea, and others. The data show lower rates of severe AEs in the 2442-patient group receiving KISQALI 400 mg.

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* The majority of adverse events were transient, manageable, and reversible with dose reduction or interruption. ⁽²⁾
^† This is a grouped term that combines neutropenia and neutrophil count decreased. ⁽⁶⁾
Median time to resolution of ≥ grade 3 neutropenia was 0.3 months for KISQALI + AI. ⁽²⁾
^‡ This is a grouped term that includes all preferred terms identified by standardised MedDRA queries for drug-related hepatic disorders. ⁽⁶⁾

Median time to resolution of grade 3 or 4 ALT/AST elevation was 0.7 months for KISQALI + AI. ⁽²⁾

^(§) This is a grouped term. ⁽⁶⁾
^(‖) This is a grouped term that includes all preferred terms identified by standardised MedDRA queries for interstitial lung disease. ⁽⁶⁾
^(¶) Grouped term that includes all preferred terms identified by standardised MedDRA queries for venous thromboembolism. ⁽⁶⁾

Abbreviations

AE, adverse event; AESI, adverse event of special interest; AI, aromatase inhibitor; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECG, electrocardiogram; MedDRA, Medical Dictionary for Regulatory Activities; QT, interval; VTE, venous thromboembolism.

References

Fasching PA, et al. Oral LBA13. Presented at the European Society for Medical Oncology Congress 2024, 13–17 September, Barcelona, Spain.
KISQALI (ribociclib). Summary of Product Characteristics.
Slamon DJ, et al. Ther Adv Med Oncol. 2023:15:1-16.
Peddie N, et al. Breast. 2021 Aug;58:147-159.
Fasching PA, et al. Clin Cancer Res. 2025;31(9):1625-1635.
Hortobagyi GN, et al. Ann Oncol. 2025;36(2):149-157.

Safety

Adverse Events

A manageable safety profile with mainly reversible and mostly asymptomatic adverse events. (1-3)

A manageable safety profile with mainly reversible and mostly asymptomatic adverse events. ^(1-3)