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