INFANT BOTULISM TREATMENT AND PREVENTION PROGRAM

Important Notice

The Infant Botulism Treatment and Prevention Program (IBTPP) is currently receiving a high volume of calls and emails.

Parents and caregivers

If you have questions, e-mail IBOHotline@cdph.ca.gov.
The Infant Botulism Hotline (1-833-398-2022) is available Monday to Friday 7 a.m. –7 p.m. Pacific Time (PT).

Health care providers

The clinical support line (510-231-7600) remains open 24/7 for suspected infant botulism cases. Calls from medical providers receive priority response.

If your child has clinical symptoms or you are concerned about their health, contact your health care provider. In an emergency, seek medical care immediately.

International Inquiries

The Infant Botulism Treatment and Prevention Program is available 24 hours a day, seven days a week 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 international BabyBIG® requests or clinical consultation, contact IBTPP at +1-510-231-7600 and ask for the doctor on call.
BabyBIG® may be provided internationally on a case-by-case basis.

International requests for BabyBIG®

How authorization works

Only an IBTPP on call physician can authorize access to BabyBIG®.
The patient's attending physician must speak directly with the on call IBTPP physician to review the patient's history and clinical findings.

Regulatory Requirement

BabyBIG® is licensed only in the United States. To receive BabyBIG®, the attending physician or hospital must obtain approval from their country’s Medicines Regulatory Authority to import BabyBIG®.

Required Documents and Steps for Shipment

Before BabyBIG® can be shipped, IBTPP must receive all of the following:

Authorization to Import

A letter from the requesting country’s Medicines Regulatory Authority that:

Authorizes importation of BabyBIG®
Specifies the number of vials
Names the receiving hospital

Payment Responsibility

The receiving hospital or purchasing institution must pay for:

Expedited international shipping using the hospital’s courier service
Any customs charges
The CDPH fee required for BabyBIG®

Customs Clearance

BabyBIG® must clear customs after arrival.
Hospital personnel should begin customs arrangements as soon as the shipment is initiated.
A commercial customs broker may be helpful.

Hospital Courier Account

Your hospital must have an active international courier account (World Courier and FedEx have locations close to the U.S. distribution facilities for BabyBIG®. DHL locations are more distant.)
This account must:

Be in good standing
Allow CDPH/IBTPP and its distributor (FFF Enterprises) to use it quickly

Attending physicians should notify hospital administration immediately if they are considering ordering BabyBIG®.
CDPH/IBTPP will not use its own courier accounts to ship BabyBIG® internationally.

Required Documents before Release

Before BabyBIG® is shipped, IBTPP must receive:

Signed International Invoice and Purchase Agreement (IPA)
Patient’s medical records, including weight
Import permit authorization letter
Written permission to use the hospital’s international courier account, plus contact information for a hospital staff member who can assist if needed

Shipping timeline

BabyBIG® must be shipped expedited, because earlier treatment shortens hospital stay.
It is shipped in validated packaging that maintains proper temperature for approximately 96 hours (4 days).

International use of BabyBIG®

As of February 2021, BabyBIG® has been used to treat infants in 16 countries across 5 continents, including Argentina, Australia, Austria, Canada, Denmark, France, Germany, Greece, Ireland, Netherlands, Norway, Portugal, Singapore, Spain, United Arab Emirates, and the United Kingdom.

BabyBIG® should be given as soon as possible in the patient’s illness.

Treatment must not be delayed while waiting for laboratory confirmation.
Treatment within the first 3 days of hospitalization produces the greatest reduction in hospital stay.

Treatment on days 4–7 still significantly shortens hospital stay compared to placebo.^1,2

¹Stephen 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 (PDF)

²Jessica 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.(PDF) 2018; 193:172-7.