Kisqali

Question 1

Is it safe to take KISQALI during pregnancy?

Accepted Answer

No, KISQALI can cause fetal harm when administered to a pregnant woman based on findings from animal studies and the mechanism of action. The background risk of major birth defects and miscarriage for the indicated population is unknown. Pregnant women should be advised of the potential risk to a fetus.

Question 2

Can KISQALI be taken while breastfeeding?

Accepted Answer

It is not known if ribociclib, the active ingredient in KISQALI, is present in human milk. Ribociclib and its metabolites readily passed into the milk of lactating rats. Lactating women are advised not to breastfeed while taking KISQALI and for at least 3 weeks after the last dose.

Question 3

Should females of reproductive potential take any precautions while taking KISQALI?

Accepted Answer

Females of reproductive potential should undergo pregnancy testing prior to starting treatment with KISQALI. Effective contraception methods that result in less than 1% pregnancy rates are recommended during treatment with KISQALI and for at least 3 weeks after the last dose.

Question 4

Can KISQALI be used in pediatric patients?

Accepted Answer

No, the safety and efficacy of KISQALI in pediatric patients has not been established.

Question 5

Can KISQALI be used in geriatric patients?

Accepted Answer

No overall differences in safety or effectiveness of KISQALI were observed between geriatric patients (≥65 years old) and younger patients in clinical studies.

Question 6

Are there any dosage adjustments required for patients with hepatic impairment?

Accepted Answer

No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh class A). A reduced starting dose of 400 mg is recommended for patients with moderate (Child-Pugh class B) and severe hepatic impairment (Child-Pugh class C).

Question 7

Are there any dosage adjustments required for patients with renal impairment?

Accepted Answer

No dose adjustment is necessary for patients with mild or moderate renal impairment. For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m2), a starting dose of 200 mg is recommended based on a renal impairment study in healthy subjects and non-cancer subjects.

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