Local site reactions (mild to moderate); rare systemic reactions (typical of IGSC products). Statistical Review - XEMBIFY - FDA
: While the Statistical Review noted some limitations due to small sample sizes in higher-rate groups, they concluded there were no major statistical issues that would prevent the labeling changes. 125683
: This increase allows for significantly shorter infusion times, which is a major factor in treatment adherence and quality of life for patients requiring long-term immune globulin replacement therapy. Local site reactions (mild to moderate); rare systemic
: 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 . : Recent studies (e
High concentration (20%) allows for lower infusion volumes and faster delivery. Generally well-tolerated at rates up to 35 mL/hour/site. Primary Risks
The reference corresponds to the Biologics License Application (BLA) for Xembify (Immune Globulin Subcutaneous [Human], 20%), a subcutaneous immunoglobulin (SCIG) therapy manufactured by Grifols .