Botulism immune globulin

Indications

Botulism immune globulin is used for: Botulism, Infant Botulism Caused by Toxin Type A or B

Adult Dose

Child Dose

Intravenous Infant Botulism Caused by Toxin Type A or B <1 year: 100 mg/kg IV infusion; infuse at 25 mg/kg/hr for the first 15 minutes; if well tolerated may increase rate to 50 mg/kg/hr >1 year: Not indicated Titer of antibodies in reconstituted product against type A botulinum toxin is at least 15 IU/mL and against type B toxin is at least 2.7 IU/mL

Renal Dose

Renal Impairment Minimize rate of infusion and concentration.

Administration

IV Preparation IV infusion 100 mg ± 20 mg lyophilized immunoglobulin per single-dose vial Reconstitute the lyophilized powder with 2 mL of Sterile Water for Injection USP, to obtain a 50 mg/mL BabyBIG solution. A double-ended transfer needle or large syringe is suitable for adding the water for reconstitution. When using a double-ended transfer needle, insert one end first into the vial of water. The lyophilized powder is supplied in an evacuated vial; therefore, the water should transfer by suction (the jet of water should be aimed to the side of the vial). After the water is transferred into the evacuated vial, the residual vacuum should be released to hasten the dissolution. Rotate the container gently to wet all the powder. An approximately 30-minute interval should be allowed for dissolving the powder. DO NOT SHAKE THE VIAL, AS THIS WILL CAUSE FOAMING. Inspect BabyBIG visually for particulate matter and discoloration prior to administration. Infuse the solution only if it is colorless, free of particulate matter, and not turbid. To prevent the transmission of hepatitis viruses or other infectious agents from one person to another, use sterile disposable syringes and needles. Never reuse syringes and needles. IV Administration Do not pre-dilute BabyBIG before infusion. Begin infusion within 2 hours after reconstitution is complete and conclude within 4 hours of reconstitution, unless infusion is temporarily interrupted for adverse reaction. Monitor vital signs continuously during infusion. Administer intravenously using low volume tubing and a constant infusion pump (i.e., an IVAC pump or equivalent) through a separate intravenous line. If a pre-existing line must be used, do not dilute BabyBIG more than 1:2 with any of the solutions.

Contra Indications

Documented hypersensitivity; selective immunoglobulin A deficiency

Precautions

Aseptic meningitis syndrome reported Acute renal dysfunction may occur Assess renal function prior to and following administration Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving IGIV therapy Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration The product is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent Patients should not be volume depleted (hypovolemic) prior to therapy For IV infusion only; do not exceed recommended rate of administration

Pregnancy-Lactation

Pregnancy Category: Not indicated for adults Lactation: Not indicated for adults

Interactions

Adverse Effects

Side effects of Botulism immune globulin :

Mechanism of Action

Derived from the plasma of adults immunized with botulinum toxoid types A and B. Provides antibodies to neutralize circulating toxins.