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 B
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 (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.
