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BabyBIG
[Botulism Immune Globulin Intravenous (Human) (BIG-IV)]
BabyBIG, Botulism Immune Globulin Intravenous (Human) (BIG-IV), is a 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 who were immunized with pentavalent botulinum toxoid and selected for their high titers of neutralizing antibody against botulinum neurotoxins type A and B. All donors were tested and their sera found to be 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, modified to yield a product suitable for intravenous administration.[24,25] Several steps in the manufacturing process have been validated for their ability to inactivate or remove viruses that may not have been detected in the Source Plasma.[1,26-29]
These include Cohn/Oncley fractionation (Fraction I through Supernatant III Filtrate); nanofiltration through one 75-nm and two 35-nm filters; and solvent/detergent viral inactivation. These viral reduction steps have been validated in a series of in vitro experiments for their capacity to inactivate and/or remove Human Immunodeficiency Virus type 1 (HIV-1) and the following model viruses: bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; mouse encephalomyelitis virus (MEMV) as a model for hepatitis A virus; and pseudorabies virus (PRV), feline calicivirus (FCV), and Sindbis virus to cover a wide range of physicochemical properties in the model viruses studied. Total mean log10 reductions range from 4.63 to greater than 16 log10 as shown in the following table.
| Process Step | Mean Reduction Factor (log10) | |||||
| Enveloped Viruses (size in nm) | Non-Enveloped Viruses (size in nm) | |||||
| Sindbis (60-70) | HIV-1 (80- 100) | PRV (120- 200) | BVDV (40-60) | MEMV (22-30) | FCV (35-39) | |
| Cohn/Oncley fractionation | 6.6 | > 9.44 | > 10.37 | 6.25 | 4.06 | Not done |
| Nanofiltration | ≥ 6.84 | Not done | Not done | ≥ 5.4 | Not done | ≥ 6.92 |
| Solvent/detergent treatment | Not done | > 4.51 | > 5.53 | > 4.85 | 0.57* | Not done |
| Cumulative Reduction Factor (log10) | ≥ 13.44 | > 13.95 | > 15.9 | ≥ 16.5 | 4.63 | ≥ 6.92 |
| * Included hydrophobic chromatography after solvent/detergent treatment. | ||||||
Additional testing performed with bovine parvovirus (as a model for parvovirus B19) showed a mean cumulative reduction factor of greater than 7.34 log10 for Cohn/Oncley fractionation and solvent/detergent treatment followed by hydrophobic chromatography. A mean cumulative reduction factor of 2.55 log10 was observed for removal of porcine parvovirus by nanofiltration.
When reconstituted with Sterile Water for Injection USP, each cubic centimeter (milliliter) contains approximately 50 ± 10 mg immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg sucrose; 10 mg albumin (human); and approximately 20 × 10-3 mEq sodium. The reconstituted solution should appear colorless and translucent [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
REFERENCES
1. 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.
24. Siber GR, Syndman DR. Use of immune globulins in the prevention and treatment of infections. Curr Clin Top Infect Dis 1992; 12:208-256.
25. Berkman SA, Lee ML, Gale RP. Clinical uses of intravenous immunoglobins. Ann Intern Med 1990; 112:278-292.
26. 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.
27. 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.
28. 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.
29. 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.
BabyBIG® , Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age.
For Intravenous Use Only
The recommended total dosage of BabyBIG is 1.0 mL/kg (50 mg/kg), given as a single intravenous infusion as soon as the clinical diagnosis of infant botulism is made. BabyBIG should be used with caution in patients with pre-existing renal insufficiency and in patients judged to be at increased risk of developing renal insufficiency (including, but not limited to, those with diabetes mellitus, volume depletion, paraproteinemia, sepsis, or who are receiving known nephrotoxic drugs) [see WARNINGS AND PRECAUTIONS].
| Time (minutes ) | Rate of 5% Solution | mg/kg/hr |
| 0-15 | 0.5 mL/kg/h | 25 |
| 15 to end of infusion | 1.0 mL/kg/h | 50 |
REFERENCES
17. Schreiner MS, et al. Infant botulism: a review of 12 years' experience at the Children's Hospital of Philadelphia. Pediatrics 1991; 87:159-165.
18. 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.
19. Anderson TD, et al. Airway complications of infant botulism: ten-year experience with 60 cases. Otolaryngol Head Neck Surg 2002; 126:234-239.
20. Arnon SS. Infant botulism. In: Textbook of Pediatric Infectious Diseases. 5th ed. Philadelphia: WB Saunders 2004; 1758-1766.
Manufactured by: Baxter Healthcare Corporation. Westlake Village, CA 91362, USA. Revised: Nov 2015.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Two clinical studies of BabyBIG were performed: (1) an adequate and well-controlled study to evaluate safety and efficacy of BabyBIG, which used BabyBIG Lot 1, and (2) an open label study to collect additional safety data and confirm efficacy, which used BabyBIG Lot 2 [see Clinical Studies].[14,15] Different methodolog10ies were used to collect adverse events in the controlled study and open label study. Minor clinical events that were not recorded as adverse events in the controlled study were recorded as adverse events in the open label study.
The only adverse event considered possibly related to BabyBIG administration was a mild, transient erythematous rash of the face or trunk. The following table summarizes the occurrence of rash by day of study relative to day of treatment for the randomized, controlled clinical trial (RCT) and for the open label study (OLS).
| Day of Study Relative to Treatment | RCT | OLS | ||
| Placebo* (N=64) |
BabyBIG (N=65) |
BabyBIG (N=293) |
||
| n (%) | ||||
| Day -5 | 0 (0) | 1 (2) | 6 (2) | |
| Day -4 | 2 (3) | 1 (2) | 5 (2) | |
| Day -3 | 3 (5) | 4 (6) | 6 (2) | |
| Day -2 | 5 (8) | 2 (3) | 22 (8) | |
| Day -1 | 4 (6) | 11 (17) | 28 (10) | |
| Day 0† | Before† | 5 (8) | 9 (14) | 32 (11) |
| During & After‡ | 2 (3) | 9 (14) | 39 (13) | |
| Day +1 | 2 (3) | 1 (2) | 18 (6) | |
| Day +2 | 1 (2) | 2 (3) | 13 (4) | |
| Day +3 | 3 (5) | 0 (0) | 7 (2) | |
| Day +4 | 1 (2) | 2 (3) | 11 (4) | |
| Day +5 | 2 (3) | 0 (0) | 5 (2) | |
| * Both Gammagard 5% and Gammagard S/D 5% were
used as placebo in this study. † Day 0 is the day of treatment. ‡ In reference to treatment. |
||||
In the controlled study, when only treatment emergent events are considered, 14% of the BabyBIGtreated patients experienced erythematous rash during or after study infusion. Eight percent of placebotreated patients also experienced erythematous rash in this study. A similar rash is known to occur both in infant botulism patients who have not received any IGIV products[16] and in patients treated with other IGIVs,[2,3] making it difficult to ascertain the causality of the rash.
In the controlled study only, the following adverse events occurred in at least 5% of the patients receiving BabyBIG or placebo:
| Adverse Event | BabyBIG N=65 |
Placebo N=64 |
| n (%) | ||
| N (%) of Patients with any AE | 20 (31) | 29 (45) |
| Rash erythematous | 9 (14) | 5 (8) |
| Otitis media | 7 (11) | 5 (8) |
| Pneumonia | 7 (11) | 9 (14) |
| Anemia | 3 (5) | 9 (14) |
| Hyponatremia | 3 (5) | 9 (14) |
| Hypertension | 1 (2) | 3 (5) |
| Respiratory arrest | 1 (2) | 6 (9) |
| Urinary tract infection | 1 (2) | 8 (13) |
| Convulsions | 0 | 3 (5) |
| * Both Gammagard 5% and Gammagard S/D 5% were used as placebo in this study. | ||
In the open label study only, the following adverse events occurred in at least 5% of the patients:
| Adverse Event | BabyBIG N=293 |
| N (%) | |
| Patients with Any AE | 285 (97) |
| Blood pressure increased | 221 (75) |
| Dysphagia | 190 (65) |
| Irritability | 121 (41) |
| Atelectasis | 113 (39) |
| Rhonchi | 100 (34) |
| Pallor | 83 (28) |
| Loose stools | 73 (25) |
| Dermatitis contact | 70 (24) |
| Rash erythematous | 64 (22) |
| Vomiting | 58 (20) |
| Nasal congestion | 54 (18) |
| Edema | 54 (18) |
| Oxygen saturation decreased | 51 (17) |
| Pyrexia | 51 (17) |
| Body temperature decreased | 48 (16) |
| Blood pressure decreased | 47 (16) |
| Cardiac murmur | 45 (15) |
| Cough | 39 (13) |
| Rales | 37 (13) |
| Abdominal distension | 33 (11) |
| Breath sounds decreased | 30 (10) |
| Dehydration | 30 (10) |
| Agitation | 29 (10) |
| Hemoglobin decreased | 27 (9) |
| Stridor | 26 (9) |
| Lower respiratory tract infection | 23 (8) |
| Oral candidiasis | 23 (8) |
| Injection-site reaction | 21 (7) |
| Tachycardia NOS | 20 (7) |
| Peripheral coldness | 19 (7) |
| Dyspnea NOS | 16 (6) |
| Hyponatremia | 16 (6) |
| Injection-site erythema | 15 (5) |
| Intubation NOS | 15 (5) |
| Metabolic acidosis | 15 (5) |
| Neurogenic bladder | 15 (5) |
| Anemia | 14 (5) |
| Tachypnea | 14 (5) |
Adverse event coding was used in the open label study to distinguish between minor clinical events that required no intervention and more significant events that required intervention. For example, "increased blood pressure" or "decreased blood pressure" was assigned when transient changes in blood pressure were observed, whereas "hypertension" or "hypotension" was assigned when more prolonged or significant changes were observed.
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.
Experience with BabyBIG. No adverse reactions have been identified or reported that are ascribed to the use of BabyBIG during postapproval use. Retrospective publications have shown safety-related information consistent with the safety-related information in the approved product labeling, and no new safety-related information has been presented for BabyBIG.[22. 23]
Experience with Other IGIV Products. Some classes of adverse reactions that have not been reported in BabyBIG clinical studies or postmarketing experience have been observed with the overall postapproval use of other IGIV products, as shown in the following table.
| Respiratory | Apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion Related Acute Lung Injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm |
| Cardiovascular | Cardiac arrest, thromboembolism, vascular collapse, hypotension |
| Neurolog10ical | Coma, loss of consciousness, seizures, tremor |
| Integumentary | Steven-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis |
| Hematolog10ic | Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs') test |
| General / Body as a Whole | Pyrexia, rigors |
| Musculoskeletal | Back pain |
| Gastrointestinal | Hepatic dysfunction, abdominal pain |
REFERENCES
2. Immune globulin intravenous (human) Iveegam En IGIV. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:816-820.
3. 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.
7. Important Drug Warning ("Dear Doctor") letter. Center for Biolog10ics Evaluation and Research, Food and Drug Administration, 1998.
14. 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.
15. Arnon SS. Creation and development of the public service orphan drug Human Botulism Immune Globulin. Pediatrics 2007; 119:785-789.
16. Long SS, Gajewski JL, Brown LW, Gilligan PH. Clinical, laboratory, and environmental features of infant botulism in southeastern Pennsylvania. Pediatrics 1985; 75:935-941.
21. 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.
22. Tseng-Ong L, Mitchell WG. Infant botulism: 20 years' experience at a single institution. J Child Neurol 2007; 22:1333-1337.
23. 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.
Included as part of the "PRECAUTIONS" Section
Only administer BabyBIG as an intravenous infusion, since other routes of administration have not been evaluated. Do not use BabyBIG if the reconstituted solution is turbid [see DOSAGE AND ADMINISTRATION].
Other IGIV products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death.[5-6] While these reports of renal dysfunction and acute renal failure have been associated with the use of many licensed IGIV products, those that contained sucrose as a stabilizer and were administered at daily doses of 400 mg/kg or greater have accounted for a disproportionate share of the total number.[7] BabyBIG contains sucrose as a stabilizer. Patients predisposed to acute renal failure include those patients with any degree of pre-existing renal insufficiency, diabetes mellitus, volume depletion, sepsis, paraproteinemia, or who are receiving known nephrotoxic drugs. Especially in such patients, BabyBIG should be administered at the minimum concentration available and at the minimum rate of infusion practicable.[1]
BabyBIG is made from human plasma and, like other plasma products, carries the possibility for transmission of blood-borne viral agents and, theoretically, the Creutzfeldt-Jakob disease agent. The risk of transmission of recognized blood-borne viruses has been reduced by screening plasma donors for prior exposure to certain viruses, for the presence of certain viral infections, and by the viral inactivation and/or removal properties of the precipitation procedures used for the purification of BabyBIG [see DESCRIPTION]. Despite these measures, some as yet unrecognized blood-borne infectious agents may not be inactivated by the manufacturing process; therefore, BabyBIG, like any other blood product, should be given only if a benefit is expected [see PATIENT INFORMATION].
An aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV administration.[10-13] The syndrome usually begins within several hours to two days following IGIV treatment. It is characterized by symptoms and signs that include the following: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting. Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per cubic millimeter, predominately from the granulocytic series, and with elevated protein levels up to several hundred mg/dL. Conduct a thorough neurolog10ical examination in patients exhibiting such symptoms and signs to rule out other causes of meningitis.[10-13] AMS may occur more frequently in association with high total doses (2 g/kg) of IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.[1] AMS was not observed in clinical trials of BabyBIG.
Hyperproteinemia, hyponatremia, and increased serum viscosity have been observed following administration of IGIV products. It is clinically critical to distinguish true hyponatremia from pseudohyponatremia caused by decreased calculated serum osmolality or elevated osmolar gap, because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity and a higher risk of thromboembolic events.
These adverse events have not been observed with BabyBIG.
Thrombotic events may occur following IGIV treatment. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients judged to be at risk of developing thrombotic events, administer BabyBIG at the minimum rate of infusion practicable.
IGIV products may contain blood group antibodies, which can act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Hemolytic anemia may develop subsequent to IGIV therapy due to enhanced red blood cell sequestration.
Monitor patients for clinical signs and symptoms of hemolysis. If these are present after BabyBIG infusion, perform appropriate confirmatory laboratory testing.
Non-cardiogenic pulmonary edema may occur in patients following IGIV treatment.[31] TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically occur within 1 to 6 hours following treatment [see PATIENT INFORMATION].
Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and patient serum.
TRALI may be managed using oxygen therapy with adequate ventilatory support.
BabyBIG has been studied for safety and efficacy only in patients below one year of age [see ADVERSE REACTIONS and Clinical Studies]. It has not been tested in other populations.
REFERENCES
1. 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.
2. Immune globulin intravenous (human) Iveegam En IGIV. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:816-820.
3. 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.
4. Immune globulin intravenous (human) Sandoglobulin® lyophilized preparation. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:2210-2213.
5. Perazella MA, Cayco AV. Acute renal failure and intravenous immune globulin: sucrose nephropathy in disguise? Am J Ther 1998; 5:399-403.
6. 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.
7. Important Drug Warning ("Dear Doctor") letter. Center for Biolog10ics Evaluation and Research, Food and Drug Administration, 1998.
8. 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.
9. 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.
10. 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.
11. Kato E, Shindo S, Eto Y, et al. Administration of immune globulin associated with aseptic meningitis. JAMA 1988; 259:3269-3270.
12. Casteels-Van Daele M, Wijndaele L, Hunninck K. Intravenous immunoglobulin and acute aseptic meningitis. N Engl J Med 1990; 323:614-615.
13. Scribner C, Kapit R, Philips E, Rickels N. Aseptic meningitis and intravenous immunoglobulin therapy. Ann Intern Med 1994; 121:305-306.
31. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001; 41: 264-268.
Although limited data are available, clinical experience with other immunoglobulin preparations suggests that the major manifestations would be those related to volume overload.[1]
REFERENCES
1. 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.
2. Immune globulin intravenous (human) Iveegam En IGIV. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:816-820.
3. 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.
4. Immune globulin intravenous (human) Sandoglobulin® lyophilized preparation. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:2210-2213.
BabyBIG contains IgG antibodies from the immunized donors who contributed to the plasma pool from which the product was derived. The titer of antibodies in the reconstituted product against type A botulinum toxin is at least 15 IU/mL and against type B toxin is at least 4.0 IU/mL. For toxin types A and B, by definition, 1 IU of botulinum antitoxin neutralizes 10,000 intraperitoneal mouse LD50 of botulinum toxin. The titers of antibody against botulinum neurotoxins C, D, and E have not been determined. In the case of infants who may be exposed to botulinum neurotoxin type A or B, this product is expected to provide the relevant antibodies at levels sufficient to neutralize the expected levels of circulating neurotoxin.[14, 30]
BabyBIG contains antibodies specific for botulinum neurotoxin types A and B that bind to and neutralize circulating toxin types A and B in the patient.
Formal studies on pharmacodynamics have not been conducted with BabyBIG.
Traditional pharmacokinetic studies of BabyBIG have not been performed. However, the following table summarizes the mean serum titer of the anti-A component of BabyBIG following administration
| Time | BabyBIG Lot 1 Anti-A Titer (mean ± S.D.) |
BabyBIG Lot 1 Anti-A Titer (mean ± S.D.) |
| mIU/mL | ||
| Day 1 | Not done | 537.1 ± 213.4 |
| Week 2 | 106.7 ± 44.6 | 192.2 ± 71.2 |
| Week 4 | 90.0 ± 39.2 | 155.5 ± 56.7 |
| Week 8 | 54.9 ± 22.8 | 96.0 ± 33.2 |
| Week 12 | 26.0 ± 20.5 | 61.4 ± 32.3 |
| Week 16 | 15.6 ± 10.4 | 33.0 ± 22.3 |
| Week 20 | 7.6 ± 6.6 | 19.3 ± 14.1 |
| NOTE: 1 IU of anti-type A or anti-type B antibody neutralizes, by definition, 104 mouse LD50 of botulinum toxin. | ||
The half-life of injected BabyBIG has been shown to be approximately 28 days in infants[14], which is in agreement with existing data for other immunoglobulin preparations.[2,14]
Two clinical studies in infant botulism were performed: (1) an adequate and well-controlled study to evaluate the safety and efficacy of BabyBIG (N=129), and (2) an open label study to collect additional safety data and confirm efficacy (N=293). In the adequate and well-controlled clinical study, BabyBIG, given within the first 3 days of hospital admission to 59 patients with laboratory-confirmed infant botulism, has been shown to reduce the following:
| Average Length in Weeks | p-value | ||
| Placebo* N=63 |
BabyBIG N=59 |
||
| Hospital stay | 5.7 | 2.6 | p<0.0001 |
| Intensive Care Unit stay | 3.6 | 1.3 | p<0.01 |
| Mechanical ventilation | 2.4 | 0.7 | p<0.05 |
| Tube-feeding | 10.0 | 3.6 | p<0.01 |
| * Both Gammagard 5% and Gammagard S/D 5% were used as placebo in this study. | |||
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 Hos pital Stay in Weeks | ||
| Placebo* N=63 |
BabyBIG (RCT) N=59 |
BabyBIG (OLS) N=206 |
|
| 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) |
| RCT = randomized clinical trial OLS = open label study * Both Gammagard 5% and Gammagard S/D 5% were used as placebo in this study. |
|||
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 Hos pital Stay in Weeks | |
| Placebo* | BabyBIG (RCT) | |
| White | 6.3 (N=40) |
2.8 (N=35) |
| Non-white | 4.6 (N=23) |
2.4 (N=24) |
| * Both Gammagard 5% and Gammagard S/D 5 % were used as placebo in this study. | ||
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
2. Immune globulin intravenous (human) Iveegam En IGIV. In: Physician's Desk Reference. 55th Ed. Montvale, New Jersey: Medical Economics Company, Inc.; 2001:816-820.
14. 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.
30. Paton JC, Lawrence AL, Steven IM. Quantitation of Clostridium botulinum organisms and toxin infeces and presence of Clostridium botulinum toxin in the serum of an infant with botulism. J Clin Microbiol 1983; 17:13-15.
