KISQALI FEMARA CO-PACK Rx

Monitor for interstitial lung disease (ILD)/pneumonitis; interrupt immediately and evaluate if suspected. Permanently discontinue if recurrent symptomatic or severe ILD/pneumonitis occurs. Risk of severe cutaneous adverse reactions (eg, SJS, TEN, DiHS/DRESS), QT interval prolongation. Permanently discontinue if SJS, TEN, or DiHS/DRESS is confirmed; do not reintroduce. Assess ECG prior to initiation; start therapy only if QTcF values <450 msec. Repeat ECG at Day 14 of Cycle 1, beginning of Cycle 2, and as clinically indicated; monitor more frequently if any QTcF prolongation occurs. Monitor serum electrolytes prior to initiation, at the beginning of the first 6 cycles, and as clinically indicated; correct any abnormality before starting. Avoid in patients with long QT syndrome, uncontrolled or significant cardiac disease including recent MI, CHF, unstable angina and bradyarrhythmias, electrolyte abnormalities. Perform LFTs prior to initiation; monitor every 2 weeks for first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated; monitor more frequently if Grade ≥2 abnormalities noted. Perform CBC prior to initiation; monitor every 2 weeks for first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated. Hepatic impairment. Severe renal impairment. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥3 weeks after last dose. Nursing mothers: not recommended (during and for ≥3 weeks after last dose).