elamipretide

　　【Indications】

　　This product is a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome who weigh at least 30 kg.

　　【Recommended Dosage】

　　For patients weighing≥30 kg,the recommended dose is 40 mg administered subcutaneously once daily,preferably at the same time each day.

　　Dose adjustment is required for adult patients with severe renal impairment.

　　【Adverse Reactions】

　　The most commonly reported adverse reaction is injection site reaction.

　　【Pharmacological Action】

　　As a mitochondrial cardiolipin binder,this product localizes to the inner mitochondrial membrane to improve mitochondrial morphology and function.

　　【Storage】

　　Unopened vials should be refrigerated at 2°C–8°C(36°F–46°F);do not freeze.

　　After first use,opened vials may be stored either under refrigeration at 2°C–8°C(36°F–46°F)or at room temperature of 20°C–25°C(68°F–77°F).

　　Opened vials must be discarded 8 days after first entry;do not use beyond this period.