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

IgG replacement by the subcutaneous route using preparations licensed in the USA for administration by other routes
February 2004
K.A. Duff, a, S. Roy, b, J. Pollb, M. Berger,b
aAllergy and Immunology, Case Western Reserve University, University Hospitals of Cleveland/Rainbow Babies and Childrens' Hospital, Cleveland, OH, USA
bAllergy and Immunology, Case Western Reserve University, University Hospitals of Cleveland/Rainbow Babies and Childrens' Hospital, Cleveland, OH, USA
Journal of Allergy and Clinical Immunology February 2004, Supplement ? Volume 113 ? Number 2
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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 (BaygamR) and six patients receive lyophilized preparations containing sucrose (CarimuneTM NF or PanglobulinTM 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.