botulism antitoxin, heptavalent

REMS

Treatment of symptomatic botulism after documented/suspected exposure to botulism neurotoxins A, B, C, D, E, F or G.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None.

Use Cautiously in:

Patients at risk of acute hypersensitivity reactions, including history of hypersensitivity to horses, equine products, asthma or hay fever (consider skin sensitivity testing)
OB: Use only if benefits outweigh risks
Lactation: Use cautiously if breastfeeding

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema, vasovagal reaction

Derm: pruritus, urticaria, rash

GI: nausea

MS: arthralgia, myalgia

Neuro: headache, fatigue

Misc: chills, delayed allergic reactions including serum sickness, fever, hypersensitivity reactions including anaphylaxis, infusion reactions, tranmission of infectious agents (equine plasma source)

Interactions ⬆ ⬇

Drug-drug:

May interfere with blood glucose testing due to presense of maltose and alter decisions regarding insulin and antidiabetic agents (use glucose-specific test).

Availability ⬆ ⬇

Solution for injection (requires dilution, contains maltose): serotype A antitoxin 4,500 U, serotype B antitoxin 3,300 U, serotype C antitoxin 3,000 U, serotype D antitoxin 600 U, serotype E antitoxin 5,100 U, serotype F antitoxin 3,000 U, serotype G antitoxin 600 U /vial

Route/Dosage ⬆ ⬇

IV (Adults and Children ≥17 yr): One vial.
IV (Children 1 – <17 yr): Body weight > 55 kg: 100% of adult dose; body weight 50–54 kg: 80% of adult dose; body weight 45–49 kg: 75% of the adult dose; body weight 40–44 kg: 70% of adult dose; body weight 35–39 kg: 65% of adult dose; body weight 30–34 kg: 60% of adult dose; body weight 25–29 kg: 50% of adult dose; body weight 20–24 kg: 40% of adult dose; body weight 15–19 kg: 30% of adult dose; body weight 10–14 kg: 20% of adult dose.
IV (Infants <1 yr): 10% of the adult dose.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Contains antibody fragments prepared from immunized horses. Provides passive immunization by binding the neurotoxins, bound complex is then cleared from circulation.

Therapeutic effects:

Decreased duration/sequelae of neurotoxin poisoning (muscle paralysis) in botulism.

Classifications ⬆ ⬇

Therapeutic Classification: antidotes

Pharmacologic Classification: immune globulins

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability

Distribution: Unknown.

Metabolism/Excretion: Neurotoxin/antitoxin complex cleared by organs involved in immune processing

Half-Life: Serotype A antitoxin: 8.6 hr, serotype B antitoxin: 34.3 hr, serotype C antitoxin: 29.6 hr, serotype D antitoxin: 7.5 hr, serotype E antitoxin: 7.7 hr, serotype F antitoxin: 14.1 hr, serotype G antitoxin: 11.7 hr—

Time/Action Profile ⬆ ⬇

(preservation of muscle function)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	up to 28 days

Patient/Family Teaching ⬆ ⬇

Explain purpose of medication to patient.
Advise patient to report signs and symptoms of delayed allergic reactions (serum sickness, fever, urticarial or maculopapular rash, myalgia, arthralgia, lymphadenopathy) to health care professional promptly. Usually occurs 10–21 days after infusion, but may occur sooner.
Inform patient that despite screening of horses, botulism antitoxin heptavalent is prepared from equine plasma and may contain infectious agents such as viruses that can cause disease.
Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇