occasion [0.0001:<0.01 Mechanical ventilation 2.4 0.7 p> <0.05 Tube-feeding 10.0 3.6 p> <0.01 Length of hospital stay was also analyzed by patient age in both the adequate and well-controlled study and in an open label study. Age (days) Mean Length of Hospital Stay in Weeks Placebo * N=63 BabyBIG (RCT) N=59 BabyBIG (OLS) N=206 RCT = randomized clinical trial OLS = open label study * Both Gammagard 5% and Gammagard S/D 5% were used as placebo in this study. 0-60 3.8 (N=10) 2.8 (N=10) 2.0 (N=46) 61-120 5.6 (N=29) 1.9 (N=17) 2.0 (N=68) >120 6.6 (N=24) 3.0 (N=32) 1.8 (N=92) The observed reduction in length of hospital stay was statistically significant (p> <0.01) with the exception of the 0 to 60-day age stratum, where small patient numbers limited the statistical power. Length of hospital stay was analyzed in the adequate and well-controlled study by race (white versus non-white): RACE Mean Length of Hospital Stay in Weeks Placebo * BabyBIG (RCT) * Both Gammagard 5% and Gammagard S/D 5 % were used as placebo in this study. White 6.3 (N=40) 2.8 (N=35) Non-white 4.6 (N=23) 2.4 (N=24) Length of hospital stay was significantly reduced in both white and non-white patients (p=0.002). BabyBIG has not been tested for safety and efficacy in adults. REFERENCES Cytogam , cytomegalovirus immune globulin intravenous (human) (CMV-IGIV). In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:1861-1863. Immune globulin intravenous (human) Iveegam En IGIV. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:816-820. Immune globulin intravenous (human) (IGIV) Gammagard S/D. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:812-815. Immune globulin intravenous (human) Sandoglobulin lyophilized preparation. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:2210-2213. Perazella MA, Cayco AV. Acute renal failure and intravenous immune globulin: sucrose nephropathy in disguise? Am J Ther 1998; 5:399-403. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after intravenous immune globulin therapy: a report of two cases and an analysis of the literature. J Am Soc Nephrol 1997; 8:1788-1793. Important Drug Warning ("Dear Doctor") letter. Center for Biologics Evaluation and Research, Food and Drug Administration, 1998. Denepoux S, et al. Molecular characterization of human IgG monoclonal antibodies specific for major birch pollen allergen Bet v 1. Anti-allergen IgG can enhance the anaphylactic reaction. FEBS Lett 2000; 465:39-46. Burks AW, Sampson HA, Buckley RH. Anaphylactic reactions after gamma globulin administration in patients with hypogammaglobulinemia. Detection of IgE antibodies to IgA. N Engl J Med 1986; 314:560-564. Sekul EA, Cupler EJ, Dalakas MC. Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: frequency and risk factors. Ann Intern Med 1994; 121:259-262. Kato E, Shindo S, Eto Y, et al. Administration of immune globulin associated with aseptic meningitis. JAMA 1988; 259:3269-3270. Casteels-Van Daele M, Wijndaele L, Hunninck K. Intravenous immunoglobulin and acute aseptic meningitis. N Engl J Med 1990; 323:614-615. Scribner C, Kapit R, Philips E, Rickels N. Aseptic meningitis and intravenous immunoglobulin therapy. Ann Intern Med 1994; 121:305-306. Arnon SS, Schechter R, Maslanka SE, Jewell NP, Hatheway CL. Human botulism immune globulin for the treatment of infant botulism. N Engl J Med 2006; 354:462-471. Arnon SS. Creation and development of the public service orphan drug Human Botulism Immune Globulin. Pediatrics 2007; 119:785-789. Long SS, Gajewski JL, Brown LW, Gilligan PH. Clinical, laboratory, and environmental features of infant botulism in southeastern Pennsylvania. Pediatrics 1985; 75:935-941. Schreiner MS, et al. Infant botulism: a review of 12 years' experience at the Children's Hospital of Philadelphia. Pediatrics 1991; 87:159-165. Wilson R, et al. Clinical characteristics of infant botulism in the United States: a study of the non-California cases. Pediatr Infect Dis 1982; 1:148-150. Anderson TD, et al. Airway complications of infant botulism: ten-year experience with 60 cases. Otolaryngol Head Neck Surg 2002; 126:234-239. Arnon SS. Infant botulism. In: Textbook of Pediatric Infectious Diseases. 5th ed. Philadelphia: WB Saunders 2004; 1758-1766. Snydman DR, Werner BG, Tilney NL, et al. Final analysis of primary cytomegalovirus disease prevention in renal transplant recipients with cytomegalovirus immune globulin: comparison of the randomized and open-label trials. Transplant Proc 1991; 23:1357-1360. Tseng-Ong L, Mitchell WG. Infant botulism: 20 years' experience at a single institution. J Child Neurol 2007; 22:1333-1337. Underwood K, Rubin S, Deakers T, Newth C. Infant botulism: A 30-year experience spanning the introduction of botulism immune globulin intravenous in the intensive care unit at Childrens Hospital Los Angeles. Pediatrics 2007; 120:e1380-e1385. Siber GR, Syndman DR. Use of immune globulins in the prevention and treatment of infections. Curr Clin Top Infect Dis 1992; 12:208-256. Berkman SA, Lee ML, Gale RP. Clinical uses of intravenous immunoglobins. Ann Intern Med 1990; 112:278-292. Bossell J, et al. Safety of therapeutic immune globulin preparations with respect to transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus infection. Morb Mortal Wkly Rep 1986; 35:231-233. Wells MA, Wittek AE, Epstein JS, et al. Inactivation and partition of human T-cell lymphotrophic virus, type III, during ethanol fractionation of plasma. Trans 1986; 26:210-213. Horowitz B, Wiebe ME, Lippin A, Stryker MH. Inactivation of viruses in labile blood derivatives. I. Disruption of lipid-enveloped viruses by tri(n-butyl)phosphate detergent combinations. Transfusion 1985; 25:516-522. Edwards CA, Piet MPJ, Chin S, Horowitz B. Tri(n-butyl) phosphate/detergent treatment of licensed therapeutic and experimental blood derivatives. Vox Sang 1987; 52:53-59. Paton JC, Lawrence AL, Steven IM. Quantitation of Clostridium botulinum organisms and toxin in feces and presence of Clostridium botulinum toxin in the serum of an infant with botulism. J Clin Microbiol 1983; 17:13-15. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001; 41: 264-268. How Supplied/Storage and Handling NDC 68403-1100-6, 100 mg 20 mg lyophilized immunoglobulin single-dose vial individually packaged in a carton, supplied with 2 mL Sterile Water for Injection USP for reconstitution. Store the vial containing the lyophilized product between 2° and 8°C (35.6° to 46.4°F). Do not store BabyBIG in the reconstituted state. Use reconstituted BabyBIG within 2 hours. Do not use beyond expiration date, and dispose unused product in accordance with local requirements. Patient Counseling Information Discuss the risks and benefits of BabyBIG use with the patient's legal guardians, including the possibility of adverse reactions, e.g., hypersensitivity reactions such as anaphylaxis, as well as aseptic meningitis, TRALI, hemolysis, renal failure, and thrombosis [ see WARNINGS AND PRECAUTIONS (5) ]. Inform patient's legal guardians that BabyBIG is made from human plasma and may contain infectious agents that can cause disease. While the risk of transmitting an infection has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing, the patient's guardian should report any symptoms that concern them [see WARNINGS AND PRECAUTIONS (5.3) ]. Inform patient's legal guardians that BabyBIG may interfere with immune response to live viral vaccines (e.g., MMR) and instruct them to notify the healthcare provider of this potential interaction when the patient is to receive vaccinations [ see DRUG INTERACTIONS (7) ]. For additional information concerning BabyBIG, contact: Infant Botulism Treatment and Prevention Program California Department of Public Health 850 Marina Bay Parkway, Room E-361 Richmond, California 94804 Telephone: 510-231-7600 US Govt. License No. 1797 Manufactured by: Baxter Healthcare Corporation Westlake Village, CA 91362, USA US Govt. License No. 140; and Cangene Corporation Winnipeg, Manitoba, R3T 5Y3, Canada US Govt. License No. 1201 Distributed by: FFF Enterprises Temecula, California 92591, USA Distributed for: Infant Botulism Treatment and Prevention Program California Department of Public Health 850 Marina Bay Parkway, Room E-361 Richmond, California 94804 Revised October 2011 PRINCIPAL DISPLAY PANEL - 2 mL Vial Label Botulism Immune Globulin Intravenous (Human) (BIG-IV) BabyBIG DO NOT SHAKE VIAL AFTER RECONSTITUTION; AVOID FOAMING. See package insert for reconstitution, dosage, and administration. Rx only. Single use container. Manufactured for: California Department of Public Health by: Baxter Healthcare Corporation and Cangene Corporation LOT EXP. PRINCIPAL DISPLAY PANEL - 1 Single Use Vial Carton NDC 68403-1100-6 Rx Only 100 mg IgG, 100 mg Sucrose 20 mg Albumin (Human) Lyophilized Solvent Detergent Treated Botulism Immune Globulin Intravenous (Human) (BIG-IV) BabyBIG Store between 2°C and 8°C (35.6°F and 46.4°F). BabyBIG human botulinum neurotoxin a/b immune globulin injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68403-1100 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength human botulinum neurotoxin a/b immune globulin (human botulinum neurotoxin a/b immune globulin) human botulinum neurotoxin a/b immune globulin 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength sucrose 50 mg in 1 mL albumin human 10 mg in 1 mL sodium phosphate, monobasic, anhydrous Packaging # Item Code Package Description 1 NDC:68403-1100-6 1 VIAL, SINGLE-USE in 1 CARTON 1 2 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125034 10/23/2003 Labeler - CALIFORNIA DEPARTMENT OF PUBLIC HEALTH (004519216) Establishment Name Address ID/FEI Operations Baxalta Inc. 085206634 MANUFACTURE(68403-1100) Establishment Name Address ID/FEI Operations Cangene BioPharma Inc. 050783398 MANUFACTURE(68403-1100) Establishment Name Address ID/FEI Operations Catalent Pharma Solutions 962674474 LABEL(68403-1100), PACK(68403-1100) Revised: 11/2015 CALIFORNIA DEPARTMENT OF PUBLIC HEALTH Next Interactions Print this page Add to My Med List More about BabyBIG (botulism immune globulin) Side Effects Dosage Information Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: immune globulins Consumer resources BabyBIG Professional resources BabyBIG (AHFS Monograph) Related treatment guides Botulism> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Immune globulins Related Drugs immune globulins Gammagard , RhoGAM , Hizentra , Synagis , Privigen , Gamunex Botulism penicillin g sodium , Pfizerpen , botulism antitoxin , More... 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