botulism immune globulin iv (Rx)

>10%

Transient increase in blood pressure

Pallor Edema

Transient decrease in blood pressure

Cardiac murmur

Irritability

Pyrexia

Decrease in body temperature

Contact dermatitis

Erythematous rash

Dysphagia

Loose stools

Vomiting

Abdominal distension

Otitis media

Atelectasis

Rhonchi

Nasal congestion

Decrease in oxygen saturation

Cough

Rales

1-10%

Tachycardia

Peripheral coldness

Central nervous system agitation

Dehydration

Hyponatremia

Metabolic acidosis

Decrease in hemoglobin

Local injection site reaction

Injection site erythema

Neurogenic bladder

Decrease in breath sounds

Stridor

Lower respiratory tract infection

Dyspnea

Tachypnea

Oral candidiasis

Infusion rate reactions

Postmarketing Reports

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.

Contraindications

Documented hypersensitivity; selective immunoglobulin A deficiency

Cautions

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 Category: Not indicated for adults

Lactation: Not indicated for adults

Pregnancy Categories

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.

Pharmacokinetics

Half-life elimination: 28 Days

Duration: 6 months (protective levels of neutralizing antibodies)

IV Incompatibilities

Additive

IV Compatibilities

Solution

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

IV Preparation

IV infusion

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.

IV 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 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.

Storage

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.