Liver-related AEs are a known class effect associated with CDK4/6 inhibitors1–3
Similar ALT/AST elevation rates with 400 mg and 600 mg doses suggest no dose-dependent cause1,2
Incidence and management of liver AEs in EBC and MBC1
Across KISQALI phase III studies, most liver-related AEs occurred early during treatment, and were resolved quickly with recommended dose modifications.1
LFT monitoring schedule1
Monitor LFTs more frequently if grade ≥2 abnormalities are noted. Please refer to the KISQALI Product Information for full guidance on monitoring1
Liver AE management algorithmb1
†Grading according to CTCAE Version 5.04
‡If baseline was within normal range4
PBS Information: Authority Required. For the treatment of advanced/metastatic breast cancer and early breast cancer at high risk of recurrence meeting PBS criteria. Refer to the PBS Schedule for full Authority information.
Please see approved Product Information before prescribing. Approved Product Information available on request. For the most up to date Product Information go to https://www.novartis.com.au/products/healthcare-professionals/products
Liver-related AEs were hepatic cytolysis, hepatocellular injury (only in patients with MBC), drug-induced liver injury (<1% in patients with early breast cancer and in patients with advanced or metastatic breast cancer), hepatotoxicity, hepatic failure (only in patients with MBC), autoimmune hepatitis (single case in patients with EBC and single case in patients with MBC)1
aData from four phase III registrational trials and one IIIb trial (n=6,923)2 bAST/ALT increase from baseline, without increase in total bilirubin >2x ULN. If patients develop ALT and/or AST >3x ULN along with total bilirubin >2x ULN irrespective of baseline grade, discontinue KISQALI. Refer to KISQALI Australia approved Product Information for full dosing and safety information1
Abbreviations: AE, adverse event; ALT, alanine transaminase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; EBC, early breast cancer; ECG, electrocardiogram; LFT, liver function test; MBC, metastatic breast cancer; ULN, upper limit of normal.
References
1. KISQALI approved Product Information. 2. Harbeck N, et al. Poster 277P. Presented at the European Society for Medical Oncology Breast Cancer Congress 2024, May 15–17, Berlin, Germany. 3. She Y, et al. Front Pharmacol. 2024;15:1378090. 4. Common Terminology Criteria for Adverse Events (CTCAE), National Institutes of Health, National Cancer Institute. Available at: https://ctep.cancer.gov. Accessed June 2026.
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