Dosing & Uses
Not indicated for adults
Dosage Forms & Strengths
powder for injection-preservative free
Infant Botulism Caused by Toxin Type A or B
≥1 year: Not indicated
Titer of antibodies in reconstituted product against type A botulinum toxin is at least 15 IU/mL and against type B toxin is at least 2.7 IU/mL
Minimize rate of infusion and concentration.
Transient increase in blood pressure
Transient decrease in blood pressure
Decrease in body temperature
Decrease in oxygen saturation
Central nervous system agitation
Decrease in hemoglobin
Local injection site reaction
Injection site erythema
Decrease in breath sounds
Lower respiratory tract infection
Infusion rate reactions
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.
Documented hypersensitivity; selective immunoglobulin A deficiency
Aseptic meningitis syndrome reported
Acute renal dysfunction may occur
Assess renal function prior to and following administration
Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving IGIV therapy
Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration
The product is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent
Patients should not be volume depleted (hypovolemic) prior to therapy
For IV infusion only; do not exceed recommended rate of administration
Pregnancy & Lactation
Pregnancy Category: Not indicated for adults
Lactation: Not indicated for adults
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Derived from the plasma of adults immunized with botulinum toxoid types A and B. Provides antibodies to neutralize circulating toxins.
Half-life elimination: 28 Days
Duration: 6 months (protective levels of neutralizing antibodies)
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
100 mg ± 20 mg lyophilized immunoglobulin per single-dose vial
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.
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.
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 intravenously using low volume tubing and a constant infusion pump (i.e., an IVAC pump or equivalent) through a separate intravenous line.
If a pre-existing line must be used, do not dilute BabyBIG more than 1:2 with any of the solutions.
Store the vial containing the lyophilized product between 2o and 8oC (35.6o to 46.4oF). 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.
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