How to Obtain Clinical Consultation and Order BabyBIG®

• To obtain BabyBIG® for a patient with suspected infant botulism, the treating physician must first contact the IBTPP on-call physicians for a clinical consultation. For a checklist of requirements for ordering clinicians/hospitals, please visit our infant botulism main page.

• The decision to treat with BabyBIG® should be based on clinical presentation and findings and should not be delayed by waiting for results of laboratory confirmatory testing. Prompt treatment of infant botulism patients with BabyBIG® immediately ends their toxemia and enables motor nerve regeneration to begin.

• The number of vials needed for treatment is based on the weight of the infant and is determined at the time of order.

• BabyBIG®, Botulism Immune Globulin Intravenous (Human) (BIG-IV), is an orphan drug that consists of human-derived anti-botulism-toxin antibodies that is approved by the U.S. Food and Drug Administration for the treatment of infant botulism types A and B.

• The product is solvent-detergent-treated, sterile, lyophilized powder of immunoglobulin G (IgG), stabilized with 5% sucrose and 1% albumin (human). It contains no preservative. The purified immunoglobulin is derived from pooled adult plasma from persons immunized with recombinant botulinum vaccine for serotypes A and B (rBV A/B) who were selected for their high titers of neutralizing antibody against botulinum neurotoxins type A and B. All donors were tested and found negative for antibodies against the human immunodeficiency virus and the hepatitis B and hepatitis C viruses. The pooled plasma was fractionated by cold ethanol precipitation of the proteins according to the Cohn/Oncley method and modified to yield a product suitable for intravenous administration.

• To date, use of BabyBIG® to treat more than 2,100 US infant botulism patients has resulted in more than 123 years of avoided hospital stay and more than $153 million of avoided hospital costs. On average, infant botulism patients have an approximately 3.5 week reduction in time spent in the hospital, resulting in over $97,000 in avoided hospital costs (when compared to the pivotal clinical trial placebo group).

• Invoice and Purchase Agreement (IPA)  The following links are for the form that your facility will need to fill out and send to the IBTPP in order to obtain BabyBIG®. The IBTPP clinical consultant working with your treating medical team will instruct you where to go for the appropriate IPA and will provide an IBTPP invoice number to be entered on the form.   

• Domestic IPA (within USA) (PDF) (1.4MB)
  
• International IPA (PDF) (1.5MB)     
• Package Insert BabyBIG (PDF)
  

If your patient is older than 15 months, please see CDPH Botulism Information for Health Professionals for instructions on requesting antitoxin.

Also visit our main infant botulism page for in-depth information.