125683 Guide

Xembify is indicated for the treatment of in patients aged 2 years and older. Recent clinical reviews by the FDA have focused on Supplemental Biologics License Applications (sBLA) to increase the maximum allowable infusion rates. Efficacy and Tolerability

: The most common adverse events identified in reviews are Infusion Site Reactions (ISRs) , such as pain, swelling, and redness. Clinical data indicated that increasing the infusion rate did not result in a material difference in the pattern or severity of these reactions compared to slower rates. Regulatory Perspective 125683

Local site reactions (mild to moderate); rare systemic reactions (typical of IGSC products). Statistical Review - XEMBIFY - FDA Xembify is indicated for the treatment of in

High concentration (20%) allows for lower infusion volumes and faster delivery. Generally well-tolerated at rates up to 35 mL/hour/site. Primary Risks Clinical data indicated that increasing the infusion rate

: Recent studies (e.g., Study GTI1503) demonstrated that Xembify is well-tolerated at higher infusion rates of $\geq$35 mL/hour/site , compared to the previously approved maximum of 25 mL/hour/site .