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Uses
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.
History
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Other Information
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 |
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 (2.1), WARNINGS AND PRECAUTIONS (5)].
Sources
Babybig Manufacturers
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California Department Of Public Health
![Babybig (Human Botulinum Neurotoxin A/b Immune Globulin) Injection, Powder, Lyophilized, For Solution [California Department Of Public Health]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Babybig | California Department Of Public Health
For Intravenous Use Only
2.1 Preparation for Administration BabyBIG does not contain a preservative. After reconstitution of the lyophilized product, the vial should be entered only once for the purpose of administration, and the infusion should begin within 2 hours of reconstitution. Remove the tab portion of the vial cap and clean the rubber stopper with 70% alcohol or equivalent. Reconstitute the lyophilized powder with 2 mL of Sterile Water for Injection USP, to obtain a 50 mg/mL BabyBIG solution. A double-ended transfer needle or large syringe is suitable for adding the water for reconstitution. When using a double-ended transfer needle, insert one end first into the vial of water. The lyophilized powder is supplied in an evacuated vial; therefore, the water should transfer by suction (the jet of water should be aimed to the side of the vial). After the water is transferred into the evacuated vial, the residual vacuum should be released to hasten the dissolution. Rotate the container gently to wet all the powder. An approximately 30-minute interval should be allowed for dissolving the powder. DO NOT SHAKE THE VIAL, AS THIS WILL CAUSE FOAMING. Inspect BabyBIG visually for particulate matter and discoloration prior to administration. Infuse the solution only if it is colorless, free of particulate matter, and not turbid [see WARNINGS AND PRECAUTIONS (5)]. To prevent the transmission of hepatitis viruses or other infectious agents from one person to another, use sterile disposable syringes and needles. Never reuse syringes and needles. 2.2 Treatment of Infant Botulism Caused by Toxin Type A or BThe 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 (5.1)].
2.3 Administration Do not pre-dilute BabyBIG before infusion. Begin infusion within 2 hours after reconstitution is complete and conclude within 4 hours of reconstitution, unless infusion is temporarily interrupted for adverse reaction. Monitor vital signs continuously during infusion. Administer BabyBIG intravenously using low volume tubing and a constant infusion pump (i.e., an IVAC pump or equivalent) through a separate intravenous line. If a separate line is not possible, it may be "piggybacked" into a pre-existing line if that line contains either Sodium Chloride Injection USP, or one of the following dextrose solutions (with or without NaCl added): 2.5% dextrose in water, 5% dextrose in water, 10% dextrose in water, or 20% dextrose in water. If a pre-existing line must be used, do not dilute BabyBIG more than 1:2 with any of the above-named solutions. Admixtures of BabyBIG with any other solutions have not been evaluated. Use an in-line or syringe-tip sterile, disposable filter (18 μm) for the administration of BabyBIG. In the absence of prospective data allowing identification of the maximum safe dose, concentration, and rate of infusion in these patients, DO NOT EXCEED THE RECOMMENDED DOSE, CONCENTRATION, AND RATE OF INFUSION. Begin infusion slowly. Administer BabyBIG intravenously at 0.5 mL per kg body weight per hour (25 mg/kg/h). If no untoward reactions occur after 15 minutes, the rate may be increased to 1.0 mL/kg/h (50 mg/kg/h). DO NOT EXCEED THIS RATE OF ADMINISTRATION. Monitor the patient closely during and after each rate change [see WARNINGS AND PRECAUTIONS (5.1)]. At the recommended rates, infusion of the indicated dose should take 97.5 minutes total elapsed time. 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 As adverse reactions experienced by patients treated with immune globulin intravenous (human) (IGIV) products have been related to the infusion rate, if the patient develops a minor side effect (i.e., flushing), slow the rate of infusion or temporarily interrupt the infusion. If anaphylaxis or a significant drop in blood pressure occurs, discontinue the infusion and administer epinephrine.
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