Botulism immune globulin Disease Interactions

Renal abnormalities such as acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, including acute renal dysfunction/failure and death have been reported after immune globulin intravenous (IGIV) products. Cases of renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose as a stabilizer. Ensure that patients are not volume-depleted before administering these agents and assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before initiating the infusion and at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation of the product. Periodic monitoring of renal function and urine output is important in patients at increased risk of developing acute renal failure. Administer these agents at the minimum dose and rate of infusion practicable in patients at risk for renal dysfunction or failure.

Thrombosis has been reported after treatment with immune globulin products. In general, patients at greatest risk of thromboembolic events are those of 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; therefore, it is recommended that patients treated with these agents should be monitored for signs and symptoms of thrombosis and assess blood viscosity in patients at risk. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity.

The botulism immune globulin intravenous (human) injection, BabyBIG contains sucrose as a stabilizer and should be administered with caution to patients with diabetes mellitus. Close monitoring is recommended.