Renal Dysfunction; Acute Renal Failure

• Renal dysfunction, acute renal failure, osmotic nephrosis, proximal tubular nephropathy, and death may occur with IVIG products (particularly those containing sucrose) in predisposed patients .Patients predisposed to acute renal failure include the following: patients with any degree of pre-existing renal insufficiency, diabetes mellitus, patients who are above 65 years of age, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.
• For patients at risk of renal dysfunction or failure, IGIV products should be administered at the minimum concentration available  and the minimum rate of infusion practicalable.
• Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIG products containing sucrose

Statements regarding sucrose content in package inserts of IVIG products

• BIVIGAM does not contain sucrose.
• Flebogamma® 5% DIF does not contain sucrose
• Flebogamma 10% DIF does not contain sucrose.
• Gammagard Liquid/Immune Globulin Intravenous, 10% Solution does not contain sucrose
• GAMMAGARD S/D does not contain sucrose.
• Gammaplex does not contain sucrose.
• Gamunex-C/ Immune Globulin Intravenous, 10% does not contain sucrose
• Octagam 5% liquid does not contain sucrose.
• Privigen does not contain sucrose
• Vaccina-IGIV contains sucrose (5%) as a stabilizer, and the recommended dose is 100 mg/kg.

Immune Globulins (Human)-Intravenous, Subcutaneous, Intramuscular

• FDA has analyzed recent data that has strengthened the association between the use of intravenous, subcutaneous and intramuscular human immune globulin products and the risk of thrombosis. Additional caution regarding the use of these products is warranted.

• FDA is requiring manufacturers to add information on thrombosis to the current boxed warning in the labels of all intravenous human immune globulin products and to add a boxed warning to the labels of all subcutaneous and intramuscular human immune globulin products to highlight the risk of thrombosis and to add information on its mitigation.