International Inquiries

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.

  

• 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).