The complete official prescribing information should be consulted for authoritative instructions. The following is a structured summary of the current U.S. KISQALI label revised July 2026.
Indications
Current U.S. labeling includes:
- Adjuvant treatment with an aromatase inhibitor for adults with HR-positive/HER2-negative stage II or III early breast cancer at high risk of recurrence.
- Treatment of adults with HR-positive/HER2-negative advanced or metastatic breast cancer with an aromatase inhibitor as initial endocrine-based therapy.
- Treatment of adults with HR-positive/HER2-negative advanced or metastatic breast cancer with fulvestrant as initial endocrine-based therapy or after progression on endocrine therapy.
Dosage
The early-breast-cancer starting dose is 400 mg once daily for 21 consecutive days followed by 7 days off.
The advanced/metastatic starting dose is 600 mg once daily for 21 consecutive days followed by 7 days off.
Dosage form
Current U.S. KISQALI labeling identifies 200 mg tablets.
Contraindications
The current U.S. label lists no contraindications. This does not mean ribociclib is appropriate for every patient; substantial warnings and monitoring requirements remain.
Major warnings
The label addresses:
- ILD/pneumonitis
- Severe cutaneous adverse reactions
- QT-interval prolongation
- Increased QT prolongation with concomitant tamoxifen
- Hepatotoxicity
- Neutropenia
- Embryo-fetal toxicity
Drug interactions
Important interactions involve strong CYP3A inhibitors, strong CYP3A inducers, CYP3A substrates and medicines known to prolong QT.
Monitoring
Monitoring includes CBCs, liver-function tests, ECGs and electrolytes according to the prescribing information.
Authoritative document
This summary must not be treated as a replacement for the official prescribing information. Regulatory labels should be checked for the applicable country and current revision.