Safety considerations in IGIV utilization

Treatment of scleromyxedema and the dermatoneuro syndrome with intravenous immunoglobulin

“…IVIG has a favorable side effect profile compared with other treatment regimens. 5,[31][32][33] At the time of this writing, 24 cases were published showing clinical J AM ACAD DERMATOL VOLUME 60, NUMBER 6 improvement of scleromyxedema treated with IVIG. 4,5,8,9,11,15,31,[34][35][36][37][38] In the majority of studies, patients were treated with high-dose IVIG (2 g/kg/mo), although improvement has been reported with doses as low as 0.5g/kg/mo.…”

Safety of Intravenous Immunoglobulin in the Treatment of Juvenile Dermatomyositis: Adverse Reactions Are Associated With Immunoglobulin A Content

“…These results differ from earlier work. 17 Differences in IVIg product tolerance because of IgA content could be explained by an Fc-␣ receptor present on white blood cells that is activated through direct interaction with IgA. The interaction of the Fc-␣ receptor with IgA is a potent trigger of metabolic activation of mast cells, leading to degranulation and to superoxide release from granulocytes and monocytes.…”

Relevant Criteria for Selecting an Intravenous Immunoglobulin Preparation for Clinical Use

“…[28] After the transmission of the hepatitis C virus in IVIg preparations in the mid-1990s, it was evident that the fractionation processes used were not sufficient to ensure viral safety. [1,2] Subsequently, IVIg manufacturers have put in place additional steps to remove and or deactivate viruses (see table II for details) [1,2,99] in addition to the introduction of more stringent donor selection and donation screening protocols. [1,2,38] Recording of lot numbers of blood products by patients and healthcare providers is recommended to assist in tracing potential blood-borne disease transmission, if this is required.…”

“…those with pre-existing renal insufficiency, diabetes, age >65 years, volume depletion, sepsis, or paraproteinemia, or those receiving nephrotoxic drugs [99] ), products with high sugar (particularly sucrose) and or sodium content, high osmolality osmolarity, or high volume load should be avoided [61,67,99] and products should be administered at the lowest dose and slowest infusion rate possible. [99] In patients with cardiovascular disease or increased risk of thromboembolic disorders, laboratory parameters should be assessed at baseline and carefully monitored during IVIg treatment, and high-dose products (IVIg >0.5 g kg day) and products with high sodium levels, high osmolality osmolarity and high volume load should not be used. [61,101,102] Conversely, in patients intolerant to large fluid volumes (e.g.…”