(BOT yoo lism i MYUN GLOB you lin, in tra VEE nus, YU man)
Treatment of infant botulism caused by toxin type A or B
Hypersensitivity to human immune globulin preparations or any component of the formulation; selective immunoglobulin A deficiency
Infant botulism: Infants <1 year: IV: 50 mg/kg as a single dose as soon as diagnosis of infant botulism is made. Note: The recommended dose may vary with each manufactured sublot; verify dose with the prescribing information and guidance provided with each product shipment.
Use with caution; the rate of infusion and concentration of solution should be minimized in patients with renal impairment or those at risk for renal dysfunction.
No dosage adjustment provided in manufacturers labeling.
Reconstitute with SWFI 2 mL. Swirl gently to wet powder; do not shake. Allow ~30 minutes for powder to dissolve.
For IV 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 IV line (preferred). Infusion should take 67.5 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.
Prior to reconstitution, store between 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F). Infusion should begin within 2 hours of reconstitution and be completed within 4 hours of reconstitution.
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]
If necessary, may be piggybacked into an existing IV line containing NS or the following dextrose solutions with or without sodium chloride: D2.5W, D5W, D10W, D20W; do not dilute more than 1:2. Administration with other medications is not recommended.
Vaccines (Live): Immune Globulins may diminish the therapeutic effect of Vaccines (Live). Management: Consult full interaction monograph for dose interval recommendations. This interaction does not apply to oral Ty21a typhoid vaccine or others listed as exceptions. Exceptions: Influenza Virus Vaccine (Live/Attenuated); Rotavirus Vaccine; Yellow Fever Vaccine; Zoster Vaccine. Consider therapy modification
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)
Frequency not always defined. Percentages reported in open-label study except where otherwise noted; may reflect pathophysiology of infant botulism.
>10%:
Cardiovascular: Increased blood pressure (transient, 75%), edema (18%), decreased blood pressure (transient, 16%), heart murmur (15%)
Central nervous system: Irritability (41%), decreased body temperature (16%)
Dermatologic: Pallor (28%), 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%)
Miscellaneous: Fever (17%)
1% to 10%:
Cardiovascular: Cold extremities (7%), tachycardia (7%)
Central nervous system: Agitation (10%)
Endocrine & metabolic: Dehydration (10%), hyponatremia (6%), metabolic acidosis (5%)
Gastrointestinal: Oral candidiasis (8%)
Genitourinary: Neurogenic bladder
Hematologic & oncologic: Decreased hemoglobin (9%), anemia (5%)
Local: Injection site reaction (7%), erythema at injection site (5%)
Respiratory: Decreased breath sounds (10%), stridor (9%), lower respiratory tract infection (8%), dyspnea (6%), tachypnea (5%)
Miscellaneous: Intubation (5%), infusion related reaction (related to rate: <5%, includes back pain, chills, fever, muscle cramps, nausea, vomiting, wheezing)
Concerns related to adverse effects:
- Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur; immediate treatment (including epinephrine 1 mg/mL) 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 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.
- 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.
Disease-related concerns:
- Hypovolemia: Patients should not be volume depleted prior to therapy.
Special populations:
- Adults: Not indicated for use in adults.
- Pediatric: Safety and efficacy established for infants <1 year of age; not indicated for children ≥ 1 year of age.
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 IV infusion only; do not exceed recommended rate of administration.
Botulism immune globulin is only indicated for use in infants <1 year of age.
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.
Protective neutralizing antibody levels: ~6 months
Infants: 28 days
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.