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
If dose reduction below 200 mg/day is required, the treatment should be permanently discontinued.
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.
If dose reduction below 200 mg/day is required, the treatment should be permanently discontinued.
If dose reduction below 200 mg/day is required, the treatment should be permanently discontinued.
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
†An individualised benefit-risk assessment should be performed when considering resuming KISQALI
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
- KISQALI® (ribociclib) Summary of Product Characteristics.
- Beck JT, et al. Poster P6-18-05 presented at San Antonio Breast Cancer Symposium, 4–8 December 2018, San Antonio, Texas, USA.
- 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].
