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