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Botulism Immune Globulin Intravenous (BIG-IV)
Pronunciation: BOT-yoo-lizm ih-MYOON GLAH-byoo-lin intravenous
Class: Immune globulin
- Powder for injection, lyophilized 100 ± 20 mg (50 mg/mL when reconstituted)
Botulism immune globulin contains IgG antibodies representative of the immunized donors who contribute to the plasma pool of the derived product.
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.
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 AdministrationChildren younger than 1 yr of age
IV 50 mg/kg (1 mL/kg) as a single infusion as soon as clinical diagnosis of infant botulism is made.
- 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.
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 InteractionsLive virus vaccines
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.
Increased BP (75%); decreased BP (16%); cardiac murmur (15%); tachycardia (7%).
Irritability (41%); agitation (10%).
Contact dermatitis (24%); erythematous rash (22%).
Dysphagia (65%); nasal congestion (18%); otitis media (11%).
Loose stools (25%); vomiting (20%); oral candidiasis (8%); nausea (less than 5%).
Decreased hemoglobin (9%); anemia (5%).
Dehydration (10%); acidosis (5%).
Atelectasis (39%); rhonchi (34%); stridor (9%); lower respiratory tract infection (8%); dyspnea (6%); tachypnea (5%).
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%).
Observe patient and monitor vital signs continuously during administration. If minor side effects develop, immediately slow the rate of infusion or temporarily interrupt the infusion. If hypotension develops, discontinue infusion immediately and be prepared to treat appropriately. Monitor patient for signs and symptoms of aseptic meningitis (severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting) for 48 h following infusion. Inform health care provider immediately if noted.
Safety and efficacy not established in children (or adults) 1 yr of age and older.
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.
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.
- Advise family or caregiver that medication will be prepared and administered by a health care provider in a hospital setting.
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