Treatment with JUNEXANT increases the risk of serious infections involving various organ systems and sites that may lead to hospitalization or death.
Treatment with replicamab products increases the risk of serious infections involving various organ systems and sites that may lead to hospitalization or death.
Replicamab products can cause hepatoxicity and acute hepatic failure. In clinical trials of replicamab-hjxf,10% of patients developed elevated ALT or AST greater than three times the upper limit of normal and 5% progressed to acute hepatic failure. Evaluate serum transaminases (ALT and AST) and bilirubin at baseline and monthly during treatment with NEXSYMEO…
For example, FDA says, for the fictitious product NEXSYMEO, the statement should read: NEXSYMEO (replicamab-cznm) is biosimilar* to JUNEXANT (replicamab-hjxf) for the indications listed. (1) The footnote should appear at the end of Highlights (but above the Revision Date) and state: *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
