Kisqali Patient Counseling Information

Advise the patient to read the Patient Information section.
Interstitial Lung Disease/Pneumonitis: Advise patients to immediately report new or worsening respiratory symptoms [see Precautions].
Severe Cutaneous Adverse Reactions: Inform patients of the signs and symptoms of severe cutaneous adverse reactions (e.g., skin pain/burning, rapidly-spreading skin rash, and/or mucosal lesions accompanied by fever or flu-like symptoms). Advise patients to contact their healthcare provider immediately if they develop signs and symptoms of severe cutaneous adverse reactions [see Precautions].
QT Prolongation: Inform patients of the signs and symptoms of QT prolongation. Advise patients to contact their healthcare provider immediately for signs or symptoms of QT prolongation [see Precautions].
Hepatobiliary Toxicity: Inform patients of the signs and symptoms of hepatobiliary toxicity. Advise patients to contact their healthcare provider immediately for signs or symptoms of hepatobiliary toxicity [see Hepatotoxicity under Precautions].
Neutropenia: Advise patients of the possibility of developing neutropenia and to immediately contact their healthcare provider should they develop a fever, particularly in association with any suggestion of infection [see Precautions].
Embryo-Fetal Toxicity: Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Precautions and Use in Pregnancy & Lactation].
Advise females of reproductive potential to use effective contraception during KISQALI therapy and for at least 3 weeks after the last dose [see Use in Pregnancy & Lactation].
Lactation: Advise lactating women not to breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose [see Use in Pregnancy & Lactation].
Drug Interactions: Inform patients to avoid strong CYP3A inhibitors, strong CYP3A inducers, and drugs known to prolong the QT interval [see Interactions].
Dosing: Instruct patients to take the doses of KISQALI at approximately the same time every day and to swallow whole (do not chew, crush, or split them prior to swallowing) [see Dosage & Administration].
If patient vomits or misses a dose, advise the patient to take the next prescribed dose at the usual time [see Dosage & Administration].
Advise the patient that KISQALI may be taken with or without food [see Dosage & Administration].