KISQALI® (ribociclib) in eligible patients with HR+/HER2– advanced or early breast cancer
Indications:1
Advanced breast cancer (aBC)
KISQALI is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative aBC in combination with an aromatase inhibitor (AI) or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy (ET)
In pre/perimenopausal women, the ET should be combined with a a luteinising hormone-releasing hormone (LHRH) agonist
KISQALI is not recommended to be used in combination with tamoxifen.
Early breast cancer (eBC)
KISQALI, in combination with an AI, is indicated for the adjuvant treatment of patients with HR+/HER2− eBC at high risk of recurrence (see section 5.1 of the SmPC for selection criteria)
In pre/perimenopausal women, or in men, the AI should be combined with an LHRH agonist
KISQALI is not recommended to be used in combination with tamoxifen.
KISQALI Summary of Product Characteristics (SmPC) in aBC can be found here and for eBC here.
Please consult your local Summary of Product Characteristics for the full KISQALI safety and tolerability profile.
Click the links below to explore the data
aBC, advanced breast cancer; AI, aromatase inhibitor; eBC, early breast cancer; ET, endocrine therapy; HER2–, human epidermal growth receptor 2 negative; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone.
Reference
KISQALI® (ribociclib) Summary of Product Characteristics.
UK | July 2025 | FA-11464285
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.