The reference corresponds to the Biologics License Application (BLA) for Xembify (Immune Globulin Subcutaneous [Human], 20%), a subcutaneous immunoglobulin (SCIG) therapy manufactured by Grifols .
High concentration (20%) allows for lower infusion volumes and faster delivery. Generally well-tolerated at rates up to 35 mL/hour/site. Primary Risks 125683
Local site reactions (mild to moderate); rare systemic reactions (typical of IGSC products). Statistical Review - XEMBIFY - FDA 125683
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 125683
