Prescribing information

 

Recommended dose adjustments with KISQALI.

KISQALI offers convenient adjustable dosing without the need for a new prescription1

 

 

  • Each film-coated tablet contains 200 mg of ribociclib1
  • Dose adjustments for AEs should be made in a stepwise order by reducing the number of tablets taken1
  • Dose modification of KISQALI is recommended based on individual safety and tolerability1
  • If dose reduction below 200 mg/day is required, discontinue treatment1

In phase III clinical trials, women on KISQALI who required dose reductions due to AEs continued to receive clinical benefits.2

 

Dose adjustments for specific AEs

Algorithm showing the recommended dose adjustment process for neutropenia

 

If dose reduction below 200 mg/day is required, the treatment should be permanently discontinued. 

Algorithm showing the recommended dose adjustment process for ALT/AST elevation

 

 

If patients develop ALT and/or AST >3 x ULN along with total bilirubin >2 x ULN irrespective of baseline grade, discontinue KISQALI.

If dose reduction below 200 mg/day is required, the treatment should be permanently discontinued.

Algorithm showing the recommended dose adjustment process for QT interval prolongation

 

 

If dose reduction below 200 mg/day is required, the treatment should be permanently discontinued.

Algorithm showing the recommended dose adjustment process for other toxicities

 

 

If dose reduction below 200 mg/day is required, the treatment should be permanently discontinued.

*Grading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.3

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

AE, adverse event; ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; ECG, electrocardiogram; LLN, lower limit of normal; QTcF, QT interval corrected by Fridericia’s formula; ULN, upper limit of normal.

References

  1. KISQALI® (ribociclib) Summary of Product Characteristics.
  2. Beck JT, et al. Poster P6-18-05 presented at San Antonio Breast Cancer Symposium, 4–8 December 2018, San Antonio, Texas, USA.
  3. US Department of Health And Human Services. 2010. Available at: https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf [Accessed March 2020].
HCP20-C017 June 2020.
×

Ask Speakers

×

Medical Information Request

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 patient safety information (PSI) tool at https://psi.novartis.com
If you have a question about the product, please contact Medical Information on 01276 692255 or by email at [email protected]