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Infant botulism treatment and prevention program

International Inquiries

The Infant Botulism Treatment and Prevention Program is available 24 hours a day to provide clinical consultation on cases of suspected or confirmed infant botulism. Consultation is available as a public service, regardless of whether or not a clinician wishes to obtain BabyBIG®.
For BabyBIG® requests and/or clinical consultation outside of the United States (US), please contact the Infant Botulism Treatment and Prevention Program (IBTPP) at the 24/7/365 phone number 1-510-231-7600 and ask to speak to the doctor on-call.
BabyBIG® is available internationally on a case-by-case evaluation basis. ​

International requests for BabyBIG®:

  • Access to BabyBIG® is authorized only by one of the IBTPP on-call physicians, who must be contacted by the patient's attending physician to discuss the patient's history and clinical findings before BabyBIG® can be shipped.

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  • An IBTPP on-call physician can be reached 24 hours a day, 7 days a week at exit calling code -1-510-231-7600.

  • Please be advised that the attending physician or hospital must obtain approval from their country's Medicines Regulatory Authority to import BabyBIG® because BabyBIG® is licensed only in the US.

 

Please be advised that the following steps are required for shipment and importation of BabyBIG®:

    • A letter of authorization to import must be provided to the Infant Botulism Treatment and Prevention Program (IBTPP) by the requesting country's Medicines Regulatory Authority or Agency before BabyBIG® is released for shipment.      

    • BabyBIG® will have to clear customs after arrival in the importing country. Arrangements to expedite customs clearance should be initiated as soon as BabyBIG® is shipped.

    • In addition to paying the statutorily required fee to CDPH for BabyBIG®, the receiving hospital will also have to pay for the shipment of BabyBIG® via an expedited courier service and for any customs charges.

    • Before BabyBIG® is released for shipment, IBTPP must receive:

      1. the signed Invoice and Purchase Agreement (IPA) document, which is available here, International Invoice and Purchase Agreement (PDF) (last updated Jan 2019);

      2. medical records submitted either electronically or by fax that include documentation of the patient's weight, and;

      3. the import permit authorization letter from the requesting country's Medicines Regulatory Agency.

International use of BabyBIG®:

  • As of May 2019, BabyBIG® has been used to treat infants in 16 countries 1, spanning 5 continents. If used, BabyBIG® should be given as soon as possible in the patient's illness. Treatment should not be delayed while waiting for laboratory confirmation of the diagnosis. Treatment within the first 3 days of hospitalization shortens the hospital stay the most. Treatment between hospital days 4 through 7 also significantly shortens hospital stay when compared to placebo 2,3 (N Engl J Med 2006;354:462-71) (J Pediatr 2018;193:172-7).

 

1 Argentina, Australia, Austria, Canada, Denmark, France, Germany, Greece, Ireland, Netherlands, Norway, Portugal, Singapore, Spain, United Arab Emirates, United Kingdom 
2 Stephen S. Arnon, M.D., Robert Schechter, M.D., Susan E. Maslanka, Ph.D., Nicholas P. Jewell, Ph.D., and Charles L. Hatheway, Ph.D. Human Botulism Immune Globulin for the Treatment of Infant Botulism. The New England Journal of Medicine. 2006;354:462-71
3 Jessica R. Payne, MPH. Jessica M. Khouri, MD. Nicholas P. Jewell, PhD. Stephen S. Arnon, MD, MPH. Efficacy of Human Botulism Immune Globulin for the Treatment of Infant Botulism: The First 12 Years Post Licensure. 2018; 193:172-7.
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