Koselugo Disease Interactions

Cardiomyopathy, defined as a decrease in left ventricular ejection fraction (LVEF) >=10% below baseline, occurred in over 20% of pediatric patients who received selumetinib. The safety of this drug has not been established in patients with a history of impaired LVEF or an ejection fraction below the limit of normal. Caution is advised if using on these patients. Assess ejection fraction by echocardiogram prior to initiating treatment, and periodically during therapy.

Selumetinib exposure is increased in patients with moderate or severe hepatic impairment. A recommended dosage has not been established for patients with severe hepatic impairment (Child-Pugh C), and a dose reduction is required in patients with moderate hepatic impairment (Child-Pugh B). Caution is advised when using in patients with these levels of hepatic impairment.