Monitoring | 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.

It looks like you are using an older version of Internet Explorer which is not supported. We advise that you update your browser to the latest version of Microsoft Edge, or consider using other browsers such as Chrome, Firefox or Safari.

Recommended monitoring schedule¹

Monitoring schedule for KISQALI from Cycle 1 through Cycle 6.

monitoring

Any additional monitoring should be performed as clinically indicated

Multiple guidelines recommend ongoing monitoring as part of routine follow-up care for aBC:

The European Society for Medical Oncology (ESMO) provides evaluation and monitoring recommendations in order to help preserve a positive benefit/risk balance in these patients²
Due to an increased risk of cardiovascular events in cancer patients, the European Society of Cardiology (ESC) recommends ECG testing for all patients with advanced breast cancer before beginning and during treatment³

*If grade ≥2 abnormalities are noted, more frequent monitoring is recommended.¹
^†Correct any electrolyte abnormalities prior to treatment.¹
^‡KISQALI should be initiated only in patients with QTcF <450 msec. In case of QTcF prolongation during therapy, more frequent monitoring is recommended.¹
^§Perform baseline assessment prior to treatment initiation.¹

aBC, advanced breast cancer; CBC, complete blood count; ECG, electrocardiogram; LFT, liver function test; QTcF, QT interval corrected by Fridericia’s formula.

References: 1. KISQALI [Summary of Product Characteristics]. Novartis Pharma AG; 2019. 2. Cardoso F, Senkus E, Costa A, et al. 4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4). Ann Oncol. 2019;29(8):1634-1657. 3. Zamorano JL, Lancellotti P, Muñoz DR, et al. 2016 ESC position paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur J Heart Fail. 2017;19(1):9-42.