Immune globulin (Injection)

Thrombosis may occur with or without known risk factors, including advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, estrogen use, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors . For patients at risk of thrombosis, administer immune globulin at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration; monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity . Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive immune globulin IV (IGIV) products. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Higher rates of renal failure were associated with IGIV products that contain sucrose . The following products do not contain sucrose: Gammaplex(R), Bivigam(R), Octagam(R) 10%, Gamunex(R)-C, Gammagard Liquid(R), Gammagard S/D, Gammaked(TM), Flebogamma(R) 5% DIF, Flebogamma(R) 10% DIF, Privigen(R), and Hizentra(R) .

Thrombosis may occur with immune globulin products. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.For patients at risk of thrombosis, do not exceed the recommended dose. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity .

Warning: ThrombosisThrombosis may occur with immune globulin products, including immune globulin-hipp. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.For patients at risk of thrombosis, administer immune globulin-hipp at the minimum dose and infusion rates practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity .

Warning: Thrombosis, Renal Dysfunction, and Acute Renal FailureThrombosis may occur with immune globulin intravenous (IGIV) products, including immune globulin-ifas. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Immune globulin-ifas does not contain sucrose.For patients at risk of thrombosis, renal dysfunction, or renal failure, administer immune globulin-ifas at the minimum infusion rate practicable. Ensure adequate hydration in patients before a