Botulism Immune Globulin IV (Intravenous-Human)

Table of contents

  • Brand Names
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Drug Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

North America

USA: BabyBIG.

Drug combinations

Chemistry

Pharmacologic Category

Serums, Toxoids, and Vaccines; Serums; Immune Globulin. (ATC-Code: J06AA04).

Mechanism of action

Botulism immune globulin IV (BIG-IV), an immunoglobulin G (IgG) prepared from plasma of adults immunized with pentavalent botulinum toxoid, neutralizes botulinum toxin types A and B.

Therapeutic use

Treatment of infant botulism caused by toxin type A or B in patients <1 year of age.

Pregnancy and lactiation implications

Reproduction studies not conducted.

Unlabeled use

Contraindications

Hypersensitivity to human immune globulin preparations or any component of the formulation. Selective immunoglobulin A deficiency.

Warnings and precautions

Hypersensitivity and anaphylactic reactions may occur. Aseptic meningitis syndrome reported with intravenous immune globulin administration (rare). Acute renal dysfunction (increased serum creatinine, oliguria, acute renal failure) can rarely occur. Not indicated for use in adults. Not indicated for children ≥1 year of age. As a product of human plasma it may potentially contain infectious agents which could transmit disease (risk of Creutzfeldt-Jakob disease). For I.V. administration exclusively. May facilitate oral candidiasis. Irritability is common. May cause agitation. Rash is common (be mindful if patient is also receiving lamotrigine). Gastrointestinal side-effects are common. Concomitant use with SSRIs, lithium, or valproic acid may produce additive effects. If hypotension or anaphylaxis occurs, BIG-IV should be discontinued immediately.

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