IgG replacement by the subcutaneous route using preparations licensed in the USA for administration by other routes

Abstract

Rationale Patients with adverse reactions to multiple IVIG preparations may tolerate IVIG given subcutaneously. However, there is no preparation of IgG licensed for subcutaneous administration in the US. Therefore, we determined whether preparations licensed for use by other routes would be tolerated subcutaneously. Methods Eleven of one-hundred antibody-deficient patients receiving IgG therapy in our practice infuse IgG subcutaneously. Reasons for using the subcutaneous route include poor IV access, migraines, nausea/vomiting, and convenience of self/home administration. Five patients receive a liquid 16% preparation intended for IM use (Baygam R) and six patients receive lyophilized preparations containing sucrose (Carimune TM NF or Panglobulin TM NF). Forty milliliters of sterile water is used to reconstitute lyophilized products to 15%. Patients use 26-27 gauge catheters and portable infusion pumps. Results Over 1500 subcutaneous infusions have been completed without any systemic reactions or migraines. Only one patient premedicates with antihistamines. One patient had a significant local reaction and returned to IVIG. Another patient failed to take infusions as scheduled and was admitted for lower extremity cellilitis with a low IgG level. Conclusions IgG preparations licensed for IM and IV use can be safely administered subcutaneously. Lyophilized preparations containing sucrose are well tolerated, even at higher concentrations than used for IV administration. Careful selection of patients and physician monitoring are necessary to ensure proper compliance and efficacy of subcutaneous IgG replacement.