Dosing & Uses
AdultPediatric
Dosage Forms & Strengths
IV solution
- 20-mL vial
Botulism
Refer to full CDC protocol for more information
Antitoxin indicated for naturally occurring noninfant botulism
20 mL (1 vial) IV infusion; dilute further with 0.9% NaCl to 1:10 ratio before administering
Administration
Administer slowly by IV infusion via volumetric infusion pump; minimize allergic reactions by starting at 0.5 mL/min for initial 30 minutes
If no infusion-related reaction, may increase to 1 mL/min IV for next 30 minutes, then if no reaction evident, may increase to 2 mL/min for remainder of infusion
Other Information
Product to be stored in Strategic National Stockpile for emergency preparedness and responses
To obtain, contact CDC Emergency Operations Center; telephone: (770) 488-7100
Replaces licensed bivalent botulinum antitoxin AB (BAT-AB) and investigational monovalent botulinum antitoxin E (BAT-E)
Dosage Forms & Strengths
IV solution
- 20-mL vial
Botulism
Consult local state division of epidemiology
Infant Botulism
Continue to consult the California Infant Botulism Program (510-231-7600) and obtain BabyBIG (effective against botulism toxin types A and B)
Heptavalent botulinum antitoxin has been used to treat a case of type F infant botulism and, on a case-by-case basis, may be used for future cases of infant botulism
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Adverse Effects
Investigational IND, adverse drug reactions unknown (see cautions)
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Warnings
Contraindications
No absolute contraindications identified in individual with high-risk exposure to botulinum toxin
Cautions
Allergic reactions are expected to be infrequent
Immediate systemic reactions (allergic reactions, shock, anaphylaxis) can occur whenever an equine product is administered; immediate reaction usually occurs within 30 minutes after initiating infusion
Infuse IV slowly as described under administration in adult dosing section
Milder allergic reactions (eg, mild bronchoconstriction, hypotension, hives) may be more common
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Pregnancy & Lactation
Pregnancy Category: C; experience limited in pregnant women; however, A, B and E antitoxins have been given to pregnant women without causing harm to the mother or the fetus
Being pregnant is not a reason to avoid H-BAT administration for botulism; benefit to the mother and the fetus from receiving heptavalent botulinum antitoxin should be weighed against risk of harm from treatment; decisions should be made on a case-by-case basis by treating physician
Lactation: Unknown whether distributed in breast milk
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.
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Pharmacology
Mechanism of Action
Equine derived antitoxin that elicits passive antibody (ie, immediate immunity) against Clostridium botulinum toxins A, B, C, D, E, F, and G
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Administration
IV Preparation
Thaw frozen antitoxin in water bath at 37C (99F)
Prepare infusion under aseptic conditions
Avoid foaming; do NOT shake vial
Visually assess for particulate matter and discoloration
Do not use unless solution is clear, nonturbid, and without particulate matter
Dilute 1:10 in 0.9% NaCl for injection
May store premixed IV bag refrigerated; use within 8-10 hr
IV Administration
In-line filter optional; pore size no smaller than 15 microns (smaller pore size may slow infusion rate)
Administer slowly by IV infusion via volumetric infusion pump; minimize allergic reactions by starting at 0.5 mL/min for initial 30 minutes
If no infusion-related reaction, may increase to 1 mL/min IV for next 30 minutes, then if no reaction evident, may increase to 2 mL/min for remainder of infusion
Epinephrine, diphenhydramine, and intubation capabilities must be immediately available to treat anaphylaxis
Storage
Store frozen -15C (5F); must be used within 1 yr
Once thawed, must be stored at 2-8C (35-46F); must be used within 6 months
If thawed, do not refreeze
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Images
No images available for this drug.
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Patient Handout
A Patient Handout is not currently available for this monograph.
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Formulary
FormularyPatient Discounts
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.
Create Your List of Plans
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.
The above information is provided for generalinformational and educational purposes only. Individual plans may varyand formulary information changes. Contact the applicable planprovider for the most current information.
View explanations for tiers andrestrictions
| Tier | Description |
|---|---|
| 1 | This drug is available at the lowest co-pay. Mostcommonly, these are generic drugs. |
| 2 | This drug is available at a middle level co-pay. Mostcommonly, these are "preferred" (on formulary) brand drugs. |
| 3 | This drug is available at a higher level co-pay. Mostcommonly, these are "non-preferred" brand drugs. |
| 4 | This drug is available at a higher level co-pay. Mostcommonly, these are "non-preferred" brand drugs or specialtyprescription products. |
| 5 | This drug is available at a higher level co-pay. Mostcommonly, these are "non-preferred" brand drugs or specialtyprescription products. |
| 6 | This drug is available at a higher level co-pay. Mostcommonly, these are "non-preferred" brand drugs or specialtyprescription products. |
| NC | NOT COVERED – Drugs that are notcovered by the plan. |
| Code | Definition |
|---|---|
| PA | Prior Authorization Drugs thatrequire prior authorization. This restriction requires thatspecific clinical criteria be met prior to the approval of theprescription. |
| QL | Quantity Limits Drugs thathave quantity limits associated with each prescription. Thisrestriction typically limits the quantity of the drug that willbe covered. |
| ST | Step Therapy Drugs that havestep therapy associated with each prescription. This restrictiontypically requires that certain criteria be met prior toapproval for the prescription. |
| OR | Other Restrictions Drugs thathave restrictions other than prior authorization, quantitylimits, and step therapy associated with each prescription. |
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.
