Botulism Immune Globulin (BabyBIG®) for Infantile Botulism

Baby girl being bottle fed by mom on sofa
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Take Home Points 

  • Patients with infantile botulism typically present with constipation, hypotonia, poor feeding, and a weak cry, often progressing to descending paralysis.
  • Utah is a high-incidence state; therefore, early recognition is essential.
  • BabyBIG® is the only FDA-approved treatment for infant botulism caused by Clostridium botulinum toxin types A and B.
  • Do not delay BabyBIG® therapy pending stool testing.
  • Recent infant botulism outbreak linked to powdered infant formula highlights the importance of rapid Utah Poison Control Center consultation.

Infantile Botulism 

Infantile botulism is a life-threatening illness that occurs when Clostridium botulinum spores colonize the immature intestinal tract of an infant and release botulinum neurotoxin, most commonly types A or B.1-6 Infants <12 months are affected, with up to 95% of cases occurring before 6 months of age.6 

Botulinum neurotoxin cleaves presynaptic SNARE proteins, preventing acetylcholine vesicle fusion and release at the neuromuscular junction.1-7 The incubation period is estimated at 3 to 30 days from the time of ingestion of spores.1 Constipation is present in more than 90% of cases and is often the earliest clinical manifestation.1,4,6 Neurologic findings include a weak cry, poor feeding, hypotonia (“floppy baby”), diminished reflexes, and ptosis.1,4,6 Progressive toxin activity results in descending weakness and may ultimately lead to respiratory failure.1,4,6

Clostridium botulinum spores are highly resilient and are found in soil, dust, and certain foods (notably honey or unpasteurized corn syrup).1,4,6 Infantile botulism occurs most commonly in infants who live in regions that favor the persistence of Clostridium botulinum spores in soils, with the highest incidences being in California, Utah, and eastern Pennsylvania.4-6 Features that support Clostridium botulinum spores include:5 

  • Alkaline pH
  • Low organic content
  • High-water table
  • Residential construction and immature landscaping 

Recent Outbreak: Infant Formula Associated Infantile Botulism 

In November 2025, ByHeart Inc. recalled all infant formula products following a CDC and FDA announcement of a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition powdered infant formula.12 A total of 51 hospitalized infants across 19 states had suspected or confirmed infantile botulism after consuming recalled formula products.12 No deaths have been reported, and all affected infants were treated with BabyBIG®.12

Botulism Treatment Indications 

BabyBIG® is indicated for infants less than 12 months of age with clinically suspected or confirmed botulism (types A or B).1-6,9,10 Do not wait for confirmatory stool testing.1,4,9 Treatment should be administered as soon as infant botulism is suspected.1,4,9

BabyBIG® is not indicated for:9

  • Wound botulism
  • Foodborne botulism
  • Children ≥12 months or adults

BabyBIG® | Botulism Immune Globulin Intravenous [Human] 

BabyBIG® contains human-derived antibodies specific for botulinum neurotoxin types A and B.1-6,9,11 These antibodies bind and neutralize circulating neurotoxins, preventing further binding to presynaptic terminals at the neuromuscular junction.3,6 This halts progression of paralysis but does not reverse existing symptoms. Recovery occurs via regeneration of nerve terminals and can take up to several weeks or months.1,3,4 Not only is BabyBIG® potentially lifesaving, but it also decreases days of mechanical ventilation, days requiring intensive care, and days of hospital admission by approximately 1 month.1,3,4 

In clinical trials, serious adverse reactions were not observed with BabyBIG®. The most commonly reported reaction was skin rash, occurring in >5% of infants.3,10 Other reactions such as chills, muscle cramps, back pain, fever, nausea, vomiting, and wheezing have been reported with similar Immune Globulin Intravenous (IGIV) products but were rare (<5%) with BabyBIG®.3,10 Overall, BabyBIG® is well tolerated in infants treated for botulism. 

BabyBIG® is supplied exclusively through the California Department of Public Health Infant Botulism Treatment and Prevention Program (IBTPP), which provides 24-hour clinical consultation and coordinates rapid shipment to inquiring hospitals.1,3,4,8,9 

Dosing 

The recommended total dosage of BabyBIG® is 50 mg/kg given as a single intravenous infusion as soon as the clinical diagnosis of infant botulism is made.3,4,10 Each vial contains 100 mg, and the number of vials required is weight-based and determined at the time of order based on the infant’s weight.3,4,10

BabyBIG® should be reconstituted with 2 ml of Sterile Water for Injection USP, and the infusion should be started within 2 hours of reconstitution.10 The product should be administered through a dedicated intravenous line.10 Infusion should begin at 0.5 ml/kg/hour, and if no adverse reaction occurs after 15 minutes, may increase to 1.0 ml/kg/hour.10 

Pharmacokinetics 

Traditional pharmacokinetic studies of BabyBIG® have not been performed; however, the elimination half-life is estimated to be approximately 28 days.1,3,4,6,10 

  • A single infusion will neutralize botulinum toxin for at least 6 months.1,3,4
  • As with other Immune Globulin intravenous preparations, routine live-virus vaccines should be delayed for 6 months after receipt of BabyBIG® because of potential interference with immune response.1

Contraindications 

Prior history of severe reaction to other human immunoglobulin preparations or selective immunoglobulin A deficiency with anti-IgA antibodies.10 

Monitoring 

  • Respiratory status and need for ventilatory support
  • Feeding tolerance and swallowing ability
  • Vital signs during and after infusion
  • Neuromuscular function improvement over time
  • Signs of hypersensitivity or rash

The UPCC is available 24 hours a day, 7 days a week at 1-800-222-1222 to answer questions about any suspected cases of infantile botulism.  

References

  1. American Academy of Pediatrics. Botulism and infant botulism. In: Red Book: 2024-2027 Report of the Committee on Infectious Diseases, 33rd, Kimberlin DW, Banerjee R, Barnett ED, Lynfield R, Sawyer MH (Eds), American Academy of Pediatrics, Itasca, IL 2024. p.308.
  2. Barash JR, Castles JB, Arnon SS. Antimicrobial Susceptibility of 260 Clostridium botulinum Type A, B, Ba, and Bf Strains and a Neurotoxigenic Clostridium baratii Type F Strain Isolated from California Infant Botulism Patients. Antimicrob Agents Chemother. 2018;26(12): e01594-18. doi:10.1128/AAC.01594-18
  3. Arnon SS, Schechter R, Maslanka SE, Jewell NP, Hatheway CL. Human Botulism Immune Globulin for the Treatment of Infant Botulism. N Engl J Med. 2006;354(5):462-471. doi:10.1056/NEJMoa051926
  4. Pifko E, Price A, Sterner S. Infant Botulism and Indications for Administration of Botulism Immune Globulin: Pediatric Emergency Care. 2014;30(2):120-124. doi:10.1097/PEC.0000000000000079
  5. Thompson JA, Filloux FM, Van Orman CB, et al. Infant botulism in the age of botulism immune globulin. Neurology. 2005;64(12):2029-2032. doi: 10.1212/01.WNL.0000166950.35189.5E
  6. Rosow LK, Strober JB. Infant Botulism: Review and Clinical Update. Pediatric Neurology. 2015;52(5):487-492. doi:10.1016/j.pediatrneurol.2015.01.006
  7. Chalk CH, Benstead TJ, Keezer M. Medical treatment for botulism. Cochrane Neuromuscular Group, ed. Cochrane Database of Systematic Reviews. Published online February 20, 2014. doi:10.1002/14651858.CD008123.pub3
  8. Huntsman RE, Schauble A. The Role of the Pharmacist in the Treatment of Infantile Botulism. HCA Healthcare Journal of Medicine. 2021;2(4). doi:10.36518/2689-0216.1293
  9. Health CD of P. Infant Botulism Treatment and Prevention Program. Accessed January 6, 2026. https://www.infantbotulism.org/
  10. Cangene bioPharma Inc. BabyBIG [package insert]. Cangene bioPharma Inc.; 2021. https://www.fda.gov/media/150406/download
  11. Arnon SS. Creation and Development of the Public Service Orphan Drug Human Botulism Immune Globulin. Pediatrics. 2007;119(4):785-789. doi:10.1542/peds.2006-0646
  12. CDC. Infant Botulism Outbreak Linked to Infant Formula, November 2025. Botulism. December 16, 2025. Accessed January 6, 2026. https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/index.html

Author: Emma Horton, PharmD Candidate, University of Utah College of Pharmacy

Poison Control
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