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 Hero Banner.  KISQALI® (ribociclib) logo.
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 Hero Banner.  KISQALI® (ribociclib) logo.

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KISQALI® (ribociclib) in eligible patients with HR+/HER2– advanced or early breast cancer

Indications:1

Early breast cancer (eBC)

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

Advanced or metastatic breast cancer (aBC) 

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.


Click the links below to explore the data


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

  1. KISQALI® (ribociclib) Summary of Product Characteristics. Available at www.medicines.ie.

IE11636716 | April 2026

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance at www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing [email protected] or by calling (01) 2080 612.