Babybig (botulism immune globulin, human)
Botulism Immune Globulin, Human Intravenous Vial (EA)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Botulism immune globulin IV (BIG-IV) is a specific immune globulin (hyperimmune globulin). BIG-IV contains immunoglobulin G (IgG) prepared from plasma of adults immunized with pentavalent botulinum toxoid and is capable of neutralizing botulinum toxin types A and B.
Botulism immune globulin IV (BIG-IV) is a lyophilized powder of immunoglobulin prepared from pooled plasma of adults who were immunized with pentavalent botulinum toxoid and selected for their high titers of neutralizing antibody against botulinum toxin types A and B.
Following reconstitution with sterile water for injection provided by the manufacturer, each mL of BIG-IV contains approximately 40-60 mg of immunoglobulin, primarily immunoglobulin G (IgG) with trace amounts of immunoglobulin A (IgA) and immunoglobulin M (IgM), and 10 mg of albumin human, 50 mg of sucrose, and approximately 20 x 10-3 mEq of sodium. Reconstituted BIG-IV contains antibody titers against botulinum toxin types A and B that are at least 15 and 2 international units (IUs, units), respectively; by definition, 1 unit neutralizes 10,000 intraperitoneal mouse LD50 of these botulinum toxins. Titers of antibody against botulinum toxins C, D, and E in BIG-IV have not been determined.
BIG-IV does not contain thimerosal or any other preservatives.
Following IV administration, the specific antibodies contained in BIG-IV bind to and neutralize circulating botulinum toxin types A and B. In infants younger than 1 year of age, administration of a single dose of BIG-IV is expected to provide protective levels of antibodies sufficient to neutralize circulating levels of botulinum toxins A and B. The pharmacokinetics of BIG-IV have not fully elucidated.
Data indicate that the mean elimination half-life of BIG-IV in infants is approximately 28 days.
Generic name: botulism immune globulin, human
Drug class: Botulism Immune Globulin, Human
Therapeutic class: Biologicals
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Babybig:
- Infant Botulism
Also known as: Infantile Botulism, Neonatal Botulism.
Dosing
No dosing information is available for this tab.
BIG-IV is administered only by IV infusion; other routes of administration have not been evaluated.
IV infusions of BIG-IV should be given using an inline or syringe filter (pore size 18 mcm), low-volume tubing, and a controlled-infusion device (e.g., IVAC(R) pump or equivalent) to control flow rate.
BIG-IV should be administered via a separate IV infusion line. If necessary, BIG-IV may be piggybacked into a preexisting line containing 0.9% sodium chloride injection or 2.5, 5, 10, or 20% dextrose injection (with or without sodium chloride), provided the dilution of BIG-IV with such fluids does not exceed 1:2.
Admixtures with other drugs have not been evaluated.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
Selected Immunoglobulins/Selected Live Viral Vaccines
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Immune globulin(IG) products may prevent the immune system from properly responding to the vaccine.(1-19)
CLINICAL EFFECTS: Administration of selected live viral vaccines after immunoglobulins may impair the efficacy of the vaccine.(1-19) Administration of immunoglobulins within 2-4 weeks after selected live viral vaccines impair the efficacy of the vaccine.(1-4,15)
PREDISPOSING FACTORS: The amount of antigen-specific antibody present in the administered immunoglobulin product determines the duration of this interaction.(15)
PATIENT MANAGEMENT: The recommendations regarding this interaction are conflicting. The Centers for Disease Control and Prevention(CDC) immunization recommendations for spacing of live vaccines and antibody-containing products include the following(15): - Live attenuated influenza vaccine, rotavirus, zoster and Ty21a typhoid vaccines may be given any time before, concurrent, with, or after administration of any immune globulin. Yellow fever vaccine may also be given in areas where donor blood products are unlikely to contain a substantial quantity of yellow fever antibody. - Administration of measles or varicella containing vaccines should be postponed for the following intervals after immunoglobulin therapy: Hepatitis B IG, Tetanus IG - 3 months Rabies IG - 4 months Varicella IG - 5 months Measles prophylaxis IG - 6 months if nonimmunocompromised Botulinum IG Intravenous, CMV IG Intravenous, Hepatitis A IG - 6 months Intravenous Immune Globulin(IVIG) - 8 to 11 months depending upon the dose Monoclonal antibody to RSV F protein (palivizumab) - none - Administration of antibody-containing products should be delayed 2 weeks after administration of live vaccines, except for influenza, rotavirus, zoster and typhoid vaccines as noted above. CDC guidelines state that in circumstances where there is high-risk of vaccine-preventable disease, it is acceptable to administer a dose of vaccine prior to completion of these intervals.(16) Manufacturer recommendations are as follows: Administration of a live viral vaccine should be postponed for at least three months in patients who have received the following immunoglobulin therapy: anthrax immunoglobulin,(19) cytomegalovirus immunoglobulin,(1) hepatitis B immunoglobulin,(5,6) rabies immunoglobulin,(7) tetanus immunoglobulin,(8-11) vaccinia immunoglobulin,(18) and zoster immunoglobulin.(2) Administration of a live viral vaccine should be postponed for at least six months in patients who have received the following immunoglobulin therapy: botulinum neurotoxin a/b immune globulin.(17) The US manufacturer of human immunoglobulin states that live viral vaccines should be postponed for three months in patients who have received human immunoglobulin. The Australian and Canadian manufacturers of human immunoglobulin advise postponing live viral vaccines for 3-6 months in patients who have received human immunoglobulin.(6,12,13,18) The UK manufacturer states that vaccines may be compromised for one year and vaccines should be postponed in children for at least seven months.(14) The US manufacturer of immune globulin-hyaluronidase states that immune response to live attenuated vaccines may be impaired for up to 6 months, or for a year or more in the case of measles vaccine.(15) Cytomegalovirus immunoglobulin(1) or human immunoglobulin(3) should not be administered to patients who have received a live vaccine in the previous two weeks. If a live viral vaccine is given within two weeks of zoster immunoglobulin,(1) repetition of the vaccination three months after the completion of immunoglobulin should be considered.
DISCUSSION: CDC Immunization Recommendations(15)provide discussion, charts, and further details regarding appropriate use and timing of vaccine therapy.(16)
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
History of severe reaction to any immune globulin preparation.
Selective IgA deficiency.
There are no contraindication contraindications for this drug.
- Coronary artery disease
- Hemolytic anemia
- Hypercholesterolemia
- Increased risk of bleeding due to coagulation disorder
- Kidney disease with reduction in glomerular filtration rate (GFr)
- Non-infective meningitis
- Hyponatremia
Adverse reactions
Erythematous rash. (See Sensitivity Reactions under Cautions: Warnings/Precautions.)
Less Frequent
- Acidosis
- Anemia
- Atelectasis
- Dehydration
- Dyspnea
- Hypersensitivity drug reaction
- Hypertension
- Hypotension
- Lower respiratory infection
- Neurogenic bladder
- Tachycardia
Rare or Very Rare
- Abnormal hepatic function tests
- Anaphylaxis
- Apnea
- Bronchospastic pulmonary disease
- Bullous dermatitis
- Cardiac arrest
- Coma
- Cyanosis
- Erythema multiforme
- Hemolysis
- Hemolytic anemia
- Hyperproteinemia
- Hyponatremia
- Hypoxia
- Leukopenia
- Non-infective meningitis
- Pancytopenia
- Pulmonary edema
- Seizure disorder
- Stevens-johnson syndrome
- Thromboembolic disorder
- Transfusion related acute lung injury
- Unconsciousness
More Frequent
- Erythema
- Skin rash
Less Frequent
- Abdominal distension
- Agitation
- Chills
- Contact dermatitis
- Cough
- Dysphagia
- Edema
- Fever
- Hypothermia
- Injection site sequelae
- Irritability
- Loose stools
- Nasal congestion
- Nausea
- Oral candidiasis
- Pallor
- Rales
- Stridor
- Tachypnea
- Vomiting
- Wheezing
Rare or Very Rare
- Acute abdominal pain
- Back pain
- Tremor
Precautions
No enhanced messaging available.
Safety and efficacy are established only in children younger than 1 year of age. Safety and efficacy have not been evaluated in older pediatric patients.
Safety and efficacy have not been evaluated in adults, including pregnant women.
No enhanced messaging available.
Safety and efficacy have not been evaluated in adults, including geriatric adults.
ICD codes
| Code | Type | Description |
|---|---|---|
| Infant botulism | ||
| A48.51 | ICD10CM | Infant botulism |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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