Safety Summary | KISQALI® (ribociclib) Professional Site

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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safety-summary-D

Majority of adverse events were predictable, manageable, and reversible across all 3 trials^2,6

INCIDENCE RATES FOR NEUTROPENIA²

incidence-rate-neutropenia

In the MONALEESA trials, 1.4% of patients experienced febrile neutropenia

MEDIAN TIME TO ONSET (Grades 3/4)

median-time-onset

MEDIAN TIME TO RESOLUTION^*

median-time-resolution

Less than 1% (0.8%) of patients discontinued KISQALI due to neutropenia²

REPORTED INCIDENCE RATES FOR TRANSAMINASE ELEVATIONS^6†‡

reported-incidence-rates

Transaminase elevations have been reported with other CDK4/6 inhibitors

MEDIAN TIME TO ONSET (Grades 3/4)

median-time-onset-transaminase

MEDIAN TIME TO RESOLUTION

median-time-resolution-transaminase

Discontinuation of KISQALI plus any combination due to abnormal LFTs or hepatotoxicity occurred in 2.3% vs 0.4% of patients, respectively²

INCIDENCE RATES FOR QT INTERVAL PROLONGATION¹

incidence-rate-qt-interval

MEDIAN TIME TO ONSET FOR QTcF >480 msec

median-time-onset-QTcF

No reported cases of torsade de pointes

*Following treatment interruption, reduction, and/or discontinuation.¹
^†Concurrent elevations in ALT or AST >3x ULN and total bilirubin >2x the ULN, with normal alkaline phosphatase, in the absence of cholestasis occurred in 6 patients and all patients recovered after discontinuation.¹
^‡Reported as laboratory abnormalities.
AE, adverse event; AI, aromatase inhibitor; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CDK, cyclin-dependent kinase; ET, endocrine therapy; LFT, liver function test; QTcF, QT interval corrected by Fridericia's formula; ULN, upper limit of normal.

References: 1. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738-1748. 2. KISQALI [Summary of Product Characteristics]. Novartis Pharma AG; 2019. 3. Slamon DJ, Neven P, Chia S, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465-2472. 4. Data on file. Novartis Pharma AG. 5. Bardia A, Campos-Gomez S, Hurvitz S, et al. Tamoxifen or a non-steroidal aromatase inhibitor with ribociclib in premenopausal patients with hormone receptor-positive, HER2-negative advanced breast cancer: MONALEESA-7 subgroup analysis. Poster presented at: European Society for Medical Oncology Congress; October 19-23, 2019; Munich, Germany. Poster 330P. 6. KISQALI [Core Data Sheet]. Novartis Pharma AG; 2019.