See Supplemental Patient Information
- Botulism immune globulin is indicated only for IV administration. Not to be used by any other route
- Hydrate patients prior to infusion and monitor their vital signs during treatment
- Infusion rate should not exceed beyond 50 mh/kg/hr. If infusion reaction occurs, reduce the rate of infusion or temporarily discontinue therapy
- Renal dysfunction, acute renal failure and osmotic nephrosis may occur in patients treated with botulism immune globulin, which may be associated with sucrose content of the product
- Monitor BUN and creatinine levels prior to infusion and periodically during therapy
- Patients with pre-existing renal insufficiency, diabetes mellitus, volume depletion, sepsis, paraproteinemia and those using nephrotoxic drugs are at a greater risk of renal adverse effects. Use minimum concentration at minimum rate of infusion in such patients
- Botulism immune globulin may potentially transmit blood-borne viral agents and Creutzfeldt-Jakob disease agent. However screening of plasma donors and viral inactivation techniques reduce the risk of transmission of such agents to a large extent
- Severed anaphylaxis may possibly occur in some patients, although not reported in clinical trials. If anaphylaxis is observed, discontinue therapy and initiate treatment with epinephrine
- Aseptic meningitis syndrome (AMS) may occur during treatment with IGIV products, especially with high doses. However no cases were reported in clinical trials of botulism immune globulin. AMS can be confirmed by presence of pleocytosis and elevated protein levels in CSF
- Treatment with IGIV products may result in hyperproteinemia, hyponatremia, and increased serum viscosity, although no cases were seen in trials of botulism immune globulin
- Thrombotic events have been reported after treatment with IVIG products, especially in patients with history of atherosclerosis, cardiovascular risk factors, old age, reduced cardiac output, coagulation disorders, prolonged immobilization, and/or hyperviscosity. Monitor blood viscosity and administer drug at minimum infusion rate in such patients
- Blood group antibodies may be present in IGIV products which may result in positive direct Coombs test and hemolysis in rare cases. Hemolytic anemia may occur as a result of enhanced red blood cell sequestration
- Transfusion-related acute lung injury (TRALI) manifested as severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever has been reported with use of IGIV products. Use oxygen and ventilatory support for treatment of TRALI
Cautions: Use cautiously in
- Renal impairment
- Diabetes mellitus
- Volume depletion
- Paraproteinemia
- Sepsis
- Concomitant use of nephrotoxic drugs
- Atherosclerosis
- Risk of cardiovascular disease
- Impaired cardiac output
- Coagulation disorders
- Prolonged immobilization
- Hyperviscosity
- Elderly
Supplemental Patient Information
- Inform patient's legal guardians that botulism immune globulin may interfere with immune response to live viral vaccines, such as MMR and instruct them to notify their physician of this potential interaction when the patient is to receive vaccinations
Pregnancy Category: Not Applicable
Breastfeeding: Not Applicable