For Healthcare Professionals Outside the US
KISQALI is indicated for the treatment of women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)—negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.

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Dose modifications for specific adverse events1

Dose adjustments for neutropenia, ALT/AST elevation, QT prolongation, and other toxicities.
*If dose reduction below 200 mg is required, discontinue treatment.1
†Grade 3 neutropenia with single episode of fever ≥38.3°C (or above 38°C for more than 1 hour and/or concurrent infection).1
‡Without total bilirubin increase >2 × ULN.1
§Baseline=prior to initiation of treatment.1
llExcluding neutropenia, hepatotoxicity, and QT interval prolongation.1
Initiate appropriate medical therapy and monitor as clinically indicated.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; QTcF, QT interval corrected by Fridericia’s formula; ULN, upper limit of normal.
Reference: 1. KISQALI [Summary of Product Characteristics]. Novartis Pharma AG; 2019.
Disclaimer: This is a global website for KISQALI® (ribociclib) and is intended for Healthcare Professionals outside the US. The information on the site is not country-specific and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for the latest information specific to your country. Please contact your local representative for local prescribing information via novartis.com/contacts
IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EUSmPC)
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