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KISQALI, in combination with an aromatase inhibitor (AI), is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative eBC at high risk of recurrence (see section 5.1 of the SmPC for selection criteria).
In pre- or perimenopausal women, or in men, the AI should be combined with a luteinising hormone-releasing hormone (LHRH) agonist
KISQALI is indicated for the treatment of women with HR+/HER2− aBC in combination with an AI or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy (ET).
In pre- or perimenopausal women, the ET should be combined with a LHRH agonist
KISQALI is not recommended to be used in combination with tamoxifen.
KISQALI Summary of Product Characteristics (SmPC) can be found here.
Please consult your local SmPC for the full KISQALI safety and tolerability profile.
aBC, advanced or metastatic 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; SmPC, summary of product characteristics.
Reference
KISQALI® (ribociclib) Summary of Product Characteristics. Available at www.medicines.ie.
IE11636716 | April 2026