Dosing & Uses
Not indicated for adults
Dosage Forms & Strengths
powder for injection-preservative free
- 100mg/vial
Infant Botulism
Indicated for treatment of infant botulism caused by toxin type A or B in patients aged <1 year
≥1 year: Not indicated
<1 year: 50 mg/kg (ie, 1 mL/kg) IV infusion; infuse at 25 mg/kg/hr for the first 15 minutes; if well tolerated may increase rate to 50 mg/kg/hr
Titer of antibodies in reconstituted product against type A botulinum toxin is at least 15 IU/mL and against type B toxin is at least 2.7 IU/mL
Renal Impairment
Minimize rate of infusion and concentration
Adverse Effects
>10%
Transient increase in blood pressure
Pallor Edema
Transient decrease in blood pressure
Cardiac murmur
Irritability
Pyrexia
Decrease in body temperature
Contact dermatitis
Erythematous rash
Dysphagia
Loose stools
Vomiting
Abdominal distension
Otitis media
Atelectasis
Rhonchi
Nasal congestion
Decrease in oxygen saturation
Cough
Rales
1-10%
Tachycardia
Peripheral coldness
Central nervous system agitation
Dehydration
Hyponatremia
Metabolic acidosis
Decrease in hemoglobin
Local injection site reaction
Injection site erythema
Neurogenic bladder
Decrease in breath sounds
Stridor
Lower respiratory tract infection
Dyspnea
Tachypnea
Oral candidiasis
Infusion rate reactions
Postmarketing Reports
Retrospective publications have shown safety-related information consistent with the safety-related information in the approved product labeling, and no new safety-related information has been presented
Warnings
Contraindications
Documented hypersensitivity; selective immunoglobulin A deficiency
Cautions
Aseptic meningitis syndrome reported
Acute renal dysfunction may occur
Assess renal function prior to and following administration
Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving IGIV therapy
Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration
The product is made from human plasma and may contain infectious agents (eg, viruses and, theoretically, Creutzfeldt-Jakob disease)
Patients should not be volume depleted (hypovolemic) before therapy
For IV infusion only; do not exceed recommended rate of administration
Pregnancy & Lactation
Not indicated for adults
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Derived from plasma of adults immunized with botulinum toxoid types A and B; provides antibodies to neutralize circulating toxins
Pharmacokinetics
Half-life elimination: 28 Days
Duration: 6 months (protective levels of neutralizing antibodies)
Administration
IV Compatibilities
0.9% NaCl
Dextrose solutions (with or without NaCl added), including the following concentrations: 2.5%, 5%,10%, or 20%
IV Preparation
100 mg ± 20 mg lyophilized immunoglobulin per single-dose vial
Reconstitute lyophilized powder
- Reconstitute with 2 mL of sterile water for injection to obtain 50 mg/mL solution
- A double-ended transfer needle or large syringe is suitable for adding the water for reconstitution
- When using a double-ended transfer needle, insert one end first into the vial of water
- Lyophilized powder is supplied in an evacuated vial; therefore, the water should transfer by suction (the jet of water should be aimed to the side of the vial)
- After water is transferred into vial, residual vacuum should be released to hasten the dissolution
- Rotate viral gently to wet all the powder
- ~30-minute interval should be allowed to completely dissolve powder
- DO NOT shake vial, as this will cause foaming
- Inspect visually for particulate matter and discoloration before administration
- Infuse solution only if it is colorless, free of particulate matter, and not turbid
- To prevent the transmission of hepatitis viruses or other infectious agents from one person to another, use sterile disposable syringes and needles
- Never reuse syringes and needles
IV Administration
Do not predilute before infusion
Begin infusion within 2 hr after reconstitution is complete and conclude within 4 hr of reconstitution, unless infusion is temporarily interrupted for adverse reaction
Monitor vital signs continuously during infusion
Administer IV using low volume tubing and a constant infusion pump (ie, an IVAC pump or equivalent) through a separate IV line
If a pre-existing line must be used, do not dilute reconstituted solution more than 1:2 with any of the compatible solutions
Storage
Store unopened vial containing lyophilized product between 2-8ºC (35.6-46.4ºF)
Do not store in the reconstituted state
Use reconstituted solution within 2 hr
Do not use beyond expiration date, and dispose unused product in accordance with local requirements
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
