Babybig Generic Name & Formulations
Botulism immune globulin intravenous (human) 100mg ± 20mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Single-dose vial (100mg ± 20mg)—1 (w. diluent)
Infant botulism caused by toxin types A or B.
Babybig Dosage and Administration
>1yr: not established. Give by slow IV infusion using an infusion pump. <1yr: 1mL/kg (50mg/kg), given as a single IV infusion. Initially 0.5mL/kg/h; increase to 1mL/kg/h after 15mins if no reactions occur; max rate 1mL/kg/h.
Selective IgA-deficiency with anti-IgA antibodies.
Babybig Boxed Warnings
Have epinephrine available. Do not exceed recommended infusion rate. Monitor for infusion reactions; slow infusion rate or interrupt if occur; discontinue if anaphylaxis or hypotension occurs. Ensure adequate hydration. Pre-existing renal insufficiency or risk of (eg, diabetes mellitus, volume depletion, paraproteinemia, sepsis, taking nephrotoxic drugs); infuse at minimum concentration and rate practicable; monitor. Assess renal function, urine output, BUN, serum creatinine, prior to initial infusion and periodically thereafter; consider discontinuing if renal function deteriorates. Increased thrombosis risk in history of atherosclerosis, multiple CV risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged immobilization, and/or known or suspected hyperviscosity; infuse at minimum rate practicable; monitor. Consider baseline assessment of blood viscosity in those at risk of hyperviscosity, including cryoglobulins, chylomicronemia, markedly high triglycerides, or monoclonal gammopathies. Monitor for hemolysis. Perform neurological exam if signs/symptoms of aseptic meningitis syndrome develop (including CSF studies). Monitor for pulmonary adverse reactions; if transfusion-related acute lung injury (TRALI) suspected, perform appropriate tests. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent).
May impair efficacy of live viral vaccines (eg, polio, measles, mumps, rubella); defer until ~3 months after BabyBIG administration; revaccination may be necessary if live vaccine was received shortly before or after BabyBIG administration.
Babybig Adverse Reactions
Mild, transient erythematous rash (face, trunk); anaphylaxis, acute renal dysfunction/failure.
Babybig Clinical Trials
Babybig Patient Counseling