Prescribing information

 

KISQALI offers convenient & adjustable dosing1

 

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

Tablets shown are not actual size.

Dose modification and management

FULL BLOOD COUNTS SHOULD BE PERFORMED BEFORE INITIATING TREATMENT WITH KISQALI.
After initiation of KISQALI, full blood count should be monitored every two weeks for the first two cycles, at the beginning of each of the subsequent 4 cycles, then as clinically indicated.1

* Grading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.2

LIVER FUNCTION TESTS SHOULD BE PERFORMED BEFORE INITIATING TREATMENT WITH KISQALI.
After initiation, liver function tests should be performed every two weeks for the first two cycles, at the beginning of each of the subsequent four cycles, then as clinically indicated. If grade ≥2 abnormalities are noted, more frequent monitoring is recommended.1

* From baseline, without increase in total bilirubin >2 x ULN.1

Grading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.2

ECG SHOULD BE ASSESSED BEFORE INITIATING TREATMENT WITH KISQALI.
Treatment with KISQALI should be initiated only in patients with QTcF values <450 msec. After initiation, ECG should be repeated at approximately day 14 of the first cycle and at the beginning of the second cycle, then as clinically indicated. In case of QTcF prolongation during treatment, more frequent ECG monitoring is recommended.1

MANAGEMENT OF SEVERE OR INTOLERABLE ADVERSE EVENTS WITH KISQALI.
may require temporary dose interruption, reduction or discontinuation.

* Grading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.2
An individualised benefit-risk assessment should be performed when considering resuming KISQALI.1

MANAGEMENT OF SEVERE OR INTOLERABLE ADVERSE EVENTS WITH KISQALI
may require temporary dose interruption, reduction or discontinuation.

* Grading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.2

KISQALI has straightforward monitoring requirements

RECOMMENDED MONITORING SCHEDULE1

 

 

RECOMMENDED MONITORING SCHEDULE1

Three scheduled ECGs within the first 30 days of treatment1

 

KISQALI should be initiated only in patients with QTcF <450 msec. In case of QTcF prolongation during therapy, more frequent monitoring is recommended

 

If grade ≥2 abnormalities are noted, more frequent monitoring is recommended

 

Perform any baseline assessments prior to treatment initiation

 

Correct any electrolyte abnormalities prior to treatment

 

Any additional monitoring should be performed as clinically indicated

 

 

SAFETY

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RESOURCE CENTRE

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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; CBC, complete blood count; ECG, electrocardiogram; ILD, interstitial lung disease; LFT, liver function test; LLN, lower limit of normal; QTcF, QT interval corrected for Fridericia’s formula; ULN, upper limit of normal.

  1. KISQALI (ribociclib). Summary of Product Characteristics.  
  2. US Department of Health And Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Available at: https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReferen.... Accessed June 2021.
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UK I July 2021 I 126695
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via uk.p[email protected] or online through the pharmacovigilance intake (PVI) tool at 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]