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BOXED WARNING: Serious Liver Injury 

Acute serious liver injury can occur with ITVISMA. Hepatotoxicity, with elevated alanine transaminase (ALT) and/or aspartate transaminase (AST) levels, has occurred with ITVISMA. Patients with preexisting hepatic impairment or acute hepatic viral infection may be at higher risk of liver injury. To mitigate potential aminotransferase elevations, administer systemic corticosteroid before and after ITVISMA injection. Prior to ITVISMA injection, assess liver function by clinical examination and laboratory testing. Continue to monitor liver function for at least 3 months after ITVISMA administration, and at other times as clinically indicated. In case hepatic injury is suspected, further testing is recommended. Promptly consult with a gastroenterologist or hepatologist, as necessary.

ITVISMA is indicated for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in survival motor neuron 1 (SMN1) gene.