Botulism Immune Globulin Intravenous (BIG-IV)

Trade Names:BabyBIG- Powder for injection, lyophilized 100 ± 20 mg (50 mg/mL when reconstituted)

Pharmacology

Botulism immune globulin contains IgG antibodies representative of the immunized donors who contribute to the plasma pool of the derived product.

Pharmacokinetics

Elimination

The t _½ is approximately 28 days in infants.

Indications and Usage

Treatment of patients younger than 1 yr of age with infant botulism caused by toxin type A or B.

Contraindications

Prior history of severe reaction to other human immunoglobulin preparations; individuals with selective immunoglobulin A deficiency may develop antibodies to immunoglobulin A, resulting in anaphylactic reactions to subsequent administration of blood products containing immunoglobulin A.

Dosage and Administration

IV 50 mg/kg (1 mL/kg) as a single infusion as soon as clinical diagnosis of infant botulism is made.

General Advice

• Reconstitute powder for injection following manufacturer's guidelines using the diluent provided with medication. Allow at least 30 min to reconstitute powder for injection.
• Do not shake the vial during reconstitution, reconstitute with diluents other than those supplied, or add other medications to vial.
• Do not administer if particulate matter, cloudiness, or discoloration noted.
• Begin infusion within 2 h of reconstitution and conclude infusion within 4 h of reconstitution.
• Infuse intravenously using low-volume tubing with disposable filter (18 mcm) and constant infusion pump following manufacturer's recommendations regarding rate of administration.
• Infuse using separate IV line. If separate IV line is not available, “piggyback” into preexisting line containing sodium chloride injection or dextrose in water (with or without sodium chloride) solutions.

Storage/Stability

Store unopened vials in refrigerator (36° to 46°F). Discard any unused solution or reconstituted solution that is not used within 4 h of reconstitution.

Drug Interactions

May interfere with immune response to live virus vaccines (eg, polio, mumps, rubella); therefore, vaccination with live virus vaccines should be deferred until about 5 mo after administration of BIG-IV.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Increased BP (75%); decreased BP (16%); cardiac murmur (15%); tachycardia (7%).

CNS

Irritability (41%); agitation (10%).

Dermatologic

Contact dermatitis (24%); erythematous rash (22%).

EENT

Dysphagia (65%); nasal congestion (18%); otitis media (11%).

Electrolytes

Hyponatremia (6%).

GI

Loose stools (25%); vomiting (20%); oral candidiasis (8%); nausea (less than 5%).

Hematologic

Decreased hemoglobin (9%); anemia (5%).

Metabolic

Dehydration (10%); acidosis (5%).

Respiratory

Atelectasis (39%); rhonchi (34%); stridor (9%); lower respiratory tract infection (8%); dyspnea (6%); tachypnea (5%).

Miscellaneous

Pallor (28%); edema (18%); pyrexia, decreased oxygen saturation (17%); decreased body temperature (16%); cough (13%); rales (13%); abdominal distension (11%); decreased breath sounds (10%); injection-site reactions (including erythema), peripheral coldness (7%); chills, muscle cramps, back pain, fever, wheezing (less than 5%).

Precautions

Pregnancy

Undetermined .

Lactation

Undetermined.

Children

Safety and efficacy not established in children (or adults) 1 yr of age and older.

Renal Function

Ensure that medication is administered to patient with renal function impairment, or condition predisposing to renal function impairment, at minimum concentration available and at minimum rate of administration. Ensure that renal function and urine output are periodically assessed in patient judged to have potential risk for developing acute renal failure.

Associated risks

Patients may be at increased risk of contracting or experiencing blood-borne viruses, anaphylaxis, angioneurotic edema, renal function impairment, acute renal failure, osmotic nephrosis, and death.

Overdosage

Symptoms

Volume overload.

Patient Information

• Advise family or caregiver that medication will be prepared and administered by a health care provider in a hospital setting.

Copyright © 2009 Wolters Kluwer Health.