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botulinum antitoxin, heptavalent (Rx)Brand and Other Names:HBAT

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 20-mL vial
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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
more...

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

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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