FDA label
What is Kisqali used for?
Kisqali contains ribociclib. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Kisqali lists 2 uses: Early Breast Cancer; Advanced or Metastatic Breast Cancer.
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Kisqali, tablet, film coated
Indications and Usage, quoted from the label by Novartis Pharmaceuticals Corporation (NDA209092). Cross-references to other label sections are left out.
Early Breast Cancer
KISQALI is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.
Advanced or Metastatic Breast Cancer
KISQALI is indicated for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with:
- an aromatase inhibitor as initial endocrine-based therapy; or
- fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.
Source: DailyMed label, set id aaeaef94-f3f5-4367-8ea2-b181d7be2da8, version 28, effective July 1, 2026. NDC 0078-0860, one of 3 listings for this product.
Questions
What is Kisqali used for?
The FDA label for Kisqali lists 2 uses: Early Breast Cancer; Advanced or Metastatic Breast Cancer.
What drug class is Kisqali?
FDA lists ribociclib in the Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.