subcutaneous immunoglobulin-g replacement therapy with preparations currently available in the united states for intravenous or intramuscular use reasons and regimens皮下免疫球蛋白g替代疗法与制剂目前在美国静脉或肌内使用的原因和方法.pdfVIP

Review Article Subcutaneous Immunoglobulin-G Replacement Therapy with Preparations Currently Available in the United States for Intravenous or Intramuscular Use: Reasons and Regimens Akhilesh Chouksey, MD; Kimberly Duff, RN, BSN; Nancy Wasserbauer, DO; Melvin Berger, MD, PhD Abstract For patients who require replacement therapy for primary immunodeficiency, subcutaneous infusions of immunoglobulin G (IgG) may be preferable to intravenous infusions for several reasons. However, at present, there is no preparation marketed for use by this route in North America. In this article, we describe the reasons patients have selected this route of therapy and the range of treatment regimens used. Approx- imately 20% of our patients have chosen the subcutaneous route, mainly because of adverse effects from intravenous (IV) infusions or difficulties with venous access. Unit dose regimens using whole bottles of currently available 16% intramuscular preparations or sucrose-containing lyophilized prepa- rations intended for IV use but reconstituted to 15% IgG for subcutaneous administration were individ- ually tailored to each patient. In most cases, self-infusions or home infusions were administered once or twice a week, most commonly requiring two subcutaneous sites and 2 to 3 hours per infusion. On average, patients took 0.18 mL of IgG per kilogram of body weight per site per hour. There were no sys- temic adverse effects. In patients for whom comparative data were available, trough serum IgG levels were higher with subcutaneous therapy than with IV therapy. Because immunoglobulin G (IgG) is distributed injected intravenously. Indeed, when IgG is admin- equally between the intravascular and extravascular istered to otherwise normal individuals for specific compartments,1 it seems logical to expect that reasons—such as prophylaxis against measles, IgG injected into tissue spaces will equilibrate hepatitis, and other