KOSELUGO requires careful monitoring due to risks of cardiomyopathy, ocular toxicity, and other serious adverse events.

Critical Safety Precautions in KOSELUGO Therapy

Prior to and during KOSELUGO treatment, clinicians must assess cardiac function, as the drug can cause cardiomyopathy and decreased left ventricular ejection fraction. Ophthalmic evaluations are essential due to the risk of ocular toxicities, including retinal vein occlusion and retinal pigment epithelial detachment. Gastrointestinal, skin, and musculoskeletal toxicities, as well as increased creatine phosphokinase and risk of bleeding due to vitamin E content, necessitate regular monitoring and prompt management. Dose interruptions, reductions, or discontinuation may be required based on the severity of adverse reactions. Use in pregnancy, lactation, and in patients with severe hepatic impairment is not specified in the description.