Kisqali (ribociclib succinate)
Novartis · CDK4/6 Inhibitor
What is Kisqali? Kisqali (ribociclib) is a CDK4/6 inhibitor by Novartis for HR+/HER2-negative advanced or metastatic breast cancer. It is the only CDK4/6 inhibitor with demonstrated overall survival benefit in multiple subgroups.
About Kisqali
| Brand Name | Kisqali |
| Generic / INN | ribociclib succinate |
| Drug Class | CDK4/6 Inhibitor |
| Manufacturer | Novartis |
| Administration | Oral tablet |
| FDA Approval | 2017 |
FDA-Approved Uses
- HR+/HER2-negative advanced or metastatic breast cancer — with letrozole or anastrozole as initial endocrine-based therapy
- HR+/HER2-negative advanced or metastatic breast cancer — with fulvestrant
How Does Kisqali Work?
Ribociclib selectively inhibits CDK4 and CDK6, halting cancer cell progression from G1 to S phase. Used on a 21/7 intermittent schedule. Demonstrated overall survival benefit in the MONALEESA trial program.
Dosage & Administration
600 mg orally once daily for 21 days, then 7 days off. Dose reductions (400 mg or 200 mg) for QTc prolongation or toxicity. Avoid strong CYP3A4 inhibitors.
Dosing is individualized by the treating oncologist. Do not adjust without medical guidance. This page is educational only.
Warnings & Side Effects
- QTc prolongation — EKG monitoring required each cycle
- Hepatotoxicity
- Severe neutropenia
- ILD/pneumonitis
- Embryo-fetal toxicity
Common Side Effects
- Neutropenia
- Nausea
- Fatigue
- Diarrhea
- Alopecia
- Vomiting
- QTc prolongation
- Elevated LFTs
Storage & Handling
Store at room temperature 20°C to 25°C (68°F to 77°F).
💰 Medication Cost & Insurance Coverage
Approximate Wholesale Acquisition Cost (WAC / List Price)
~$17,000–$21,000/month
600mg 21-day cycle
Insurance & Prior Authorization
Kisqali requires prior authorization from all major insurance plans. BiologicHealthPlus handles the full PA process — clinical documentation, peer-to-peer reviews, and appeals — at no cost to patients or providers.
Prior Authorization Guide Patient Assistance Insurance & Savings
Frequently Asked Questions — Kisqali
Kisqali is a CDK4/6 inhibitor by Novartis for HR+/HER2- advanced breast cancer. It is the only CDK4/6 inhibitor with OS benefit across multiple MONALEESA trials.
Kisqali requires QTc EKG monitoring — unique among CDK4/6 inhibitors. It has demonstrated OS benefit in both pre- and postmenopausal women and men.
Kisqali is covered by commercial insurance and Medicare Part D with prior authorization. Novartis patient support available.
Related Medications & Conditions
Related Medications
Ibrance (palbociclib) · Verzenio (abemaciclib) · Letrozole · Fulvestrant · Anastrozole
Related Conditions
HR+/HER2- breast cancer · Advanced breast cancer · Metastatic breast cancer