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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).

 

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