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Note: The recommended dose has changed multiple times since 2009; verify dose provided with the most current available prescribing information. Reference for dose is from the October 2011 prescribing information for BabyBIG®. Dosage Forms: U.S. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Injection, powder for reconstitution [preservative free]: BabyBIG®: ~ 100 mg [contains albumin (human), sucrose; supplied with diluent] Generic Equivalent Available: U.S. No Prescribing and Access Restrictions Access to botulism immune globulin is restricted through the Infant Botulism Treatment and Prevention Program (IBTPP). Healthcare providers must contact the IBTPP on-call physician at (510) 231-7600 to review treatment indications and to obtain the medication. For more information, refer to file://www.infantbotulism.org or contact IBTPP@infantbotulism.org. Administration For I.V. infusion only. Begin infusion at 25 mg/kg/hour for the first 15 minutes; if well tolerated, may increase to a maximum rate of 50 mg/kg/hour. Infuse using low volume tubing and an infusion pump with an in-line or syringe tip 18 micron filter. Infuse through a separate I.V. line (preferred). Infusion should take 97.5 minutes at the recommended rates and should be concluded within 4 hours of reconstitution (unless infusion temporarily interrupted for adverse reaction). Do not administer if solution is turbid. Infusion should be slowed or temporarily interrupted for minor side effects; discontinue in case of hypotension or anaphylaxis. Epinephrine should be available for the treatment of acute allergic reaction. Compatibility Administration with other medications is not recommended. If necessary, may be piggybacked into an existing I.V. line containing NS or the following dextrose solutions with or without sodium chloride: D 2.5 W, D 5 W, D 10 W, D 20 W; do not dilute more than 1:2. Use Treatment of infant botulism caused by toxin type A or B Medication Safety Issues Sound-alike/look-alike issues: BabyBIG® may be confused with HBIG Adverse Reactions Significant Percentages reported in open-label study except where otherwise noted; may reflect pathophysiology of infant botulism. >10%: Cardiovascular: Blood pressure increased (transient, 75%), pallor (28%), edema (18%); blood pressure decreased (transient, 16%), cardiac murmur (15%)

BabyBIG® may be confused with HBIG Adverse Reactions Significant Percentages reported in open-label study except where otherwise noted; may reflect pathophysiology of infant botulism. >10%: Cardiovascular: Blood pressure increased (transient, 75%), pallor (28%), edema (18%); blood pressure decreased (transient, 16%), cardiac murmur (15%) Central nervous system: Irritability (41%), pyrexia (17%), body temperature decreased (16%) Dermatologic: Contact dermatitis (24%), erythematous rash (22%, reported as 14% vs 8% in placebo-controlled study) Gastrointestinal: Dysphagia (65%), loose stools (25%), vomiting (20%), abdominal distension (11%) Otic: Otitis media (11%, reported in placebo-controlled study) Respiratory: Atelectasis (39%), rhonchi (34%), nasal congestion (18%), oxygen saturation decreased (17%), cough (13%), rales (13%) 1% to 10%: Cardiovascular: Tachycardia (7%), peripheral coldness (7%) Central nervous system: Agitation (10%) Endocrine & metabolic: Dehydration (10%), hyponatremia (6%), metabolic acidosis (5%) Hematologic: Hemoglobin decreased (9%), anemia (5%) Local: Injection site reaction (7%), injection site erythema (5%) Renal: Neurogenic bladder Respiratory: Breath sounds decreased (10%), stridor (9%), lower respiratory tract infection (8%), dyspnea (6%), tachypnea (5%) Miscellaneous: Oral candidiasis (8%), intubation (5%), infusion rate reactions (<5%, includes chills, back pain, fever, muscle cramps, nausea, vomiting, wheezing) Contraindications Hypersensitivity to human immune globulin preparations or any component of the formulation; selective immunoglobulin A deficiency Warnings/Precautions

Concerns related to adverse effects: • Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur; immediate treatment (including epinephrine 1:1000) should be available. • Aseptic meningitis: Aseptic meningitis syndrome (AMS) has been reported with intravenous immune globulin administration (rare); may occur with high doses (≥2 g/kg). • Hemolysis: Immune globulin intravenous (IGIV) has been associated with antiglobulin hemolysis; monitor for signs of hemolytic anemia. • Hyperproteinemia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur following administration of IGIV products; distinguish hyponatremia from pseudohyponatremia to prevent volume depletion, a further increase in serum viscosity and a higher risk of thrombotic events. These adverse events have not reported with botulism immune globulin. • Pulmonary edema: Monitor for transfusion-related acute lung injury (TRALI); noncardiogenic pulmonary edema has been reported with IGIV use. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, and fever in the presence of normal left ventricular function. Usually occurs within 1-6 hours after infusion. • Renal impairment: Acute renal dysfunction (increased serum creatinine, oliguria, acute renal failure) can rarely occur; usually within 7 days of use (more likely with products stabilized with sucrose). Use with caution in the elderly, patients with renal disease, diabetes mellitus, volume depletion, sepsis, paraproteinemia, and nephrotoxic medications due to risk of renal dysfunction. In patients at risk of renal dysfunction, the rate of infusion and concentration of solution should be minimized. discontinue if renal function deteriorates. • Thrombotic events: Thrombotic events have been reported with administration of IGIV; use with caution in patients with a history of atherosclerosis or cardiovascular and/or thrombotic risk factors or patients with known/suspected hyperviscosity. Consider a baseline assessment of blood viscosity in patients at risk for hyperviscosity. Infuse at lowest practical rate in patients at risk for thrombotic events.

Dosage form specific issues: • Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.

Other warnings/precautions: • Administration: For I.V. infusion only; do not exceed recommended rate of administration. Metabolism/Transport Effects None known. Drug Interactions (For additional information: Launch Lexi-Interact™ Drug Interactions Program ) Vaccines (Live): Immune Globulins may diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for up to 6 months following immune globulin administration. Live vaccine given immediately prior to immune globulin may require repeat vaccination.

Exceptions: Yellow Fever Vaccine. Risk D: Consider therapy modification Pregnancy Implications Botulism immune globulin is only indicated for use in neonates. Monitoring Parameters Renal function (BUN, serum creatinine, urinary output); vital signs (continuously during infusion); aseptic meningitis syndrome (may occur hours to days following IGIV therapy); signs of relapse (may occur up to 1 month following recovery) Mechanism of Action BIG-IV is purified immunoglobulin derived from the plasma of adults immunized with botulinum toxoid types A and B. BIG-IV provides antibodies to neutralize circulating toxins. Pharmacodynamics/Kinetics Duration: Protective neutralizing antibody levels: 6 months Half-life elimination: 28 days Use of UpToDate is subject to the Subscription and License Agreement . Topic 8708 Version 32.0 © 2013 UpToDate, Inc. All rights reserved. | Subscription and License Agreement | Release: 21.6- C21.56 Licensed to: AsanBook Dig. Med. Lib. | Support Tag: [0603-190.81.197.98-881851AA78-S244013.14]