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INTRODUCTION

  1. Pharmacology. Botulism antitoxin contains equine polyclonal antibody fragments directed against the botulinum neurotoxins produced by the various strains of Clostridium botulinum. It provides passive immunization by binding to free circulating botulinum neurotoxins.

    1. Botulism antitoxin heptavalent (BAT) has replaced the bivalent (A, B) and monovalent (E) forms of the antitoxin. BAT contains equine-derived antibody fragments that bind botulinum neurotoxin serotypes A, B, C, D, E, F, and G. It is composed of F(ab')2 and F(ab')2-related immunoglobulin. The investigational pentavalent botulism toxoid vaccine for laboratory workers has been discontinued and is no longer recommended by the CDC.

    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 neurotoxins; 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

    1. BAT heptavalent is indicated for the treatment of symptomatic botulism (see Botulism) following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G.

    2. Human-derived BabyBIG immune globulins used for the treatment of infant botulism.

  3. Contraindications

    1. Equine-derived antibodies (BAT). No absolute contraindications. Administration of this product to a patient with known or suspected hypersensitivity to botulinum antitoxin or horse serum requires extreme caution and skin sensitivity testing (See dosage section).

    2. Human-derived immune globulin. BabyBIG should not be given to patients with a prior history of severe reaction to human immunoglobulin products. Baby-BIG 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. Prepare for monitoring and management of allergic reactions (See dosage section). Monitor for delayed allergic reactions (serum sickness), which may occur 10 to 21 days after administration.

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

    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. BAT heptavalent contains maltose and can produce falsely elevated glucose readings with some testing systems; use of glucose-specific testing is advised. 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 ...

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