125683

: 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 .

As of April 2026, here is an informative review of the clinical and regulatory findings associated with this product, specifically focusing on the data submitted under regarding infusion rate increases. Clinical Review of Xembify (STN: 125683)

: 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 reactions (typical of IGSC products). Statistical Review - XEMBIFY - FDA : 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 . : This increase allows for significantly shorter infusion

: 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