Prescribing information

 

Recommended monitoring with KISQALI.

KISQALI has straightforward monitoring requirements, with no scheduled monitoring after six cycles1*

 

Table showing the recommended monitoring schedule through the first 6 cycles of treatment with KISQALI

 

  • Three scheduled ECGs within the first 30 days of treatment
  • If grade ≥2 abnormalities are noted, more frequent monitoring is recommended
  • Correct any electrolyte abnormalities prior to treatment
  • KISQALI should be initiated only in patients with QTcF <450 msec. In case of QTcF prolongation during therapy, more frequent monitoring is recommended
  • Perform any baseline assessments prior to treatment initiation
  • Any additional monitoring should be performed as clinically indicated

For full information on monitoring, please refer to the summary of product characteristics for KISQALI.

*Any additional monitoring should be performed as clinically indicated.

 

The Your Choice programme is designed to facilitate monitoring with KISQALI in day-to-day practice. To find out more, visit the Resources page.

 

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

Indication: 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 luteinising hormone-releasing hormone (LHRH) agonist.1

Reference

  1. KISQALI® (ribociclib) Summary of Product Characteristics.
HCP20-C018 July 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]