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  1. Pharmacology. Botulinum antitoxin contains antibodies directed against the toxins produced by the various strains of Clostridium botulinum.

    1. A new heptavalent antitoxin (H-BAT), manufactured by Cangene Corporation but accessible only through the Centers for Disease Control (CDC) via an Investigational New Drug (IND) protocol or an Emergency Use Authorization (EUA), has replaced the bivalent (A, B) and monovalent (E) forms of the antitoxin. (A pentavalent [A, B, C, D, E] toxoid is still used to vaccinate certain laboratory personnel.) H-BAT is an equine-derived antibody that covers toxin types A, B, C, D, E, F, and G. It is composed of less than 2% intact IgG and 90% or more Fab and F(ab′)2 fragments of IgG, created by enzymatic cleavage and removal of the Fc portion of the immunoglobulin.

    2. A human-derived botulism immune globulin (IgG antibodies), BabyBIG, is approved for the treatment of infant botulism caused by toxins A and B and has demonstrated significant reduction in the length of hospitalization associated with infant botulism.

    3. The antitoxins bind and inactivate only freely circulating botulinum toxins; they do not remove toxin that is already bound to nerve terminals. Because antitoxin will not reverse established paralysis once it occurs, it must be administered before paralysis sets in. Treatment within 24 hours of the onset of symptoms may shorten the course of intoxication and prevent progression to total paralysis.

  2. Indications. H-BAT is used to treat children and adults with clinical botulism (See Botulism) resulting from food-borne, wound, or intestinal colonization, and laboratory personnel with accidental exposures to botulism toxin, to prevent the progression of neurologic manifestations. With the availability of the human-derived BabyBIG immune globulin, the equine-derived antitoxin is generally not recommended for treatment of infant botulism.

  3. Contraindications

    1. Equine-derived antibodies. No absolute contraindications. Administration of this product to a patient with known hypersensitivity to botulinum antitoxin or horse serum requires extreme caution.

    2. Human-derived immune globulin. BabyBIG should not be given to patients with a prior history of severe reaction to human immunoglobulin products. BabyBIG contains trace amounts of IgA. Individuals with selective IgA deficiency may develop anaphylactic reactions to subsequently administered blood products with IgA.

  4. Adverse effects

    1. Equine-derived antibodies. Immediate hypersensitivity reactions (anaphylaxis) resulting from the equine source of antibodies.

    2. Human-derived immune globulin. Mild transient erythematous rashes of the face and trunk are reported commonly. Flulike symptoms similar to those seen with the use of other immune globulin intravenous (IGIV) products have been observed. Infusion rate–related reactions ranging from mild flushing to severe anaphylaxis may occur.

    3. Use in pregnancy. There are no data on teratogenicity. Anaphylactic reaction resulting in shock or hypoxemia in the mother could conceivably affect the fetus adversely.

  5. Drug or laboratory interactions. There are no known interactions with equine-derived antibodies. Human-derived immune globulin (BabyBIG) preparations contain antibodies that may interfere with the immune response to live vaccines such as those for polio, measles, mumps, and rubella. Vaccination with live virus vaccines should be delayed until approximately 3 months or more after administration of BabyBIG.

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