Scheduled Monitoring

Scheduled monitoring

KISQALI monitoring requirements. ⁽¹⁾

KISQALI monitoring requirements have been simplified and there is no scheduled monitoring beyond cycle 6, unless clinically indicated. ⁽¹⁾

Table displaying KISQALI monitoring schedule from baseline through cycle 6, showing when to perform CBC and LFT, electrolytes, and ECG tests. All three tests are required at baseline. CBC/LFT and ECG are repeated on Cycle 1 Day 14. Electrolytes and CBC/LFT are tested on Cycle 2 Day 1. From cycles 3 to 6, Day 1, CBC/LFT and electrolytes are required, while ECG is not.

* If grade ≥2 abnormalities are observed, more frequent monitoring is recommended. ⁽¹⁾
^† Correct electrolyte abnormalities prior to and during treatment. ⁽¹⁾
^‡ Only initiate KISQALI in patients with QTcF <450 ms. In case of QTcF prolongation during therapy, more frequent assessments are recommended. ⁽¹⁾

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

References

KISQALI (ribociclib). Summary of Product Characteristics.

Monitoring and dosing

Scheduled monitoring

KISQALI monitoring requirements. (1)

KISQALI monitoring requirements. ⁽¹⁾