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⁾

Monitoring schedule diagram for KISQALI treatment showing timing of CBC, LFT, electrolytes, and ECG assessments from baseline through cycles 1 to 6. CBC and LFTs are assessed regularly at baseline, Day 14 of Cycle 1, Day 1 of Cycles 2–6. Electrolytes and ECGs are monitored at baseline, Day 1 of Cycle 1, and Day 1 of Cycle 2, with no routine checks after unless clinically indicated.

* If grade ≥2 abnormalities are observed, more frequent monitoring is recommended. ⁽¹⁾

^† Correct electrolyte abnormalities prior to and during treatment. Monitoring of serum electrolytes should include potassium, calcium, phosphorus and magnesium. ⁽¹⁾

^‡ Only initiate KISQALI in patients with QTcF <450 ms. In case of QTcF prolongation during therapy, more frequent assessments are recommended. Beyond cycle 1, ECG monitoring is only required as clinically indicated. ⁽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⁾