Koselugo

Cardiomyopathy. History of impaired LVEF or if baseline ejection fraction below LLN: not established. Assess ECG prior to initiation, every 3 months during 1^st year, then every 6 months thereafter and as clinically indicated. If treatment interrupted for decreased LVEF, obtain ECG or cardiac MRI every 3–6 weeks. Ocular toxicity (eg, blurred vision, photophobia, cataracts). Perform ophthalmic exam prior to initiation, at regular intervals during therapy, and for visual changes. GI toxicity (eg, diarrhea). Monitor for severe skin rashes. Obtain serum CPK prior to initiation, periodically during, and as clinically indicated. Moderate or severe hepatic impairment (See Adults). Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Nursing mothers: not recommended (during and for 1 week after the last dose).