---
title: "Safety profile | Kisqali®"
description: "Discover the safety profile of KISQALI for HR+/HER2- early breast cancer. Learn how treatment maintains tolerability with consistent monitoring."
canonical_url: "https://www.kisqali.com/early-breast-cancer/safety-data/safety-profile"
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  "og:description": "Discover the safety profile of KISQALI for HR+/HER2- early breast cancer. Learn how treatment maintains tolerability with consistent monitoring."
  "og:title": "Safety profile"
---

## **Safety Profile**

### **The safety profile of KISQALI 400 mg was manageable, with no new safety signals. \***<sup>(1-3)</sup>

AEs generally occurred early in treatment, allowing for prompt dose adjustments. <sup>(3)</sup>  
 Majority of ≥ grade 3 AEs were laboratory findings that were easily identifiable, manageable and mostly reversible. <sup>(3)</sup>

## **KISQALI + NSAI **

**Dose reductions**<sup>(2)</sup>

22.8%

**Discontinuation due to AEs**<sup>†(2)</sup>

19.7%

**Most frequent cause of permanent discontinuation**<sup>(3)</sup>

9.9%

**Liver-related**<sup>‡</sup>

**Median time to discontinuation due to AEs**<sup>(4)</sup>

4

**months**

\* The majority of adverse events were transient, manageable, and reversible with dose reduction or interruption. <sup>(2)</sup>  
<sup>†</sup> The stringent protocol requirements likely impacted the discontinuation rate. <sup>(5)</sup>  
<sup>‡</sup> ALT increase, 7.1%; AST increase, 2.8%. <sup>(3)</sup>

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