: 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
: 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 . 125683
The reference corresponds to the Biologics License Application (BLA) for Xembify (Immune Globulin Subcutaneous [Human], 20%), a subcutaneous immunoglobulin (SCIG) therapy manufactured by Grifols . : The most common adverse events identified 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 Primary Risks