Version May 2024
Botulism: Treatment: IV: One vial; administer as soon as possible in the course of illness. A repeat dose may be administered when the suspicion of botulism is high and the progression of paralysis continues after the initial dose should have taken effect (Ref). Note: The total volume contained in one vial (regardless of vial size) will differ by lot number (~10 to 26 mL per vial).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Equine serum heptavalent botulism antitoxin (United States: Availability limited to Strategic National Stockpile distribution): Pediatric drug information")
Note: The total volume contained in one vial (regardless of vial size) will differ by lot number (~10 to 26 mL per vial). In order to calculate partial vial doses (eg, pediatric dosing), withdraw the entire contents of the vial to determine the total volume in the vial. Monitor patients closely for hypersensitivity reactions; patients with asthma, hay fever, history of hypersensitivity to horses, or previous exposure to equine-derived products are at a greater risk.
Botulism, treatment: Note: A repeat dose may be administered when the suspicion of botulism is high and the progression of paralysis continues after the initial dose should have taken effect (ie, >24 hours after initial dose) (Ref).
Infants <1 year: IV: 10% of the adult dose (one vial), regardless of body weight.
Children ≥1 year and Adolescents <17 years: IV: 20% to 100% of the adult dose (adult dose is one vial) dependent upon patient weight; minimum dose: 20% of one vial; maximum dose: One vial.
The percentage of the adult dose to be administered is based on patient weight according to the following Salisbury Rule equations:
≤30 kg: Percentage (%) of Adult Dose to be Administered = Weight (kg) × 2
>30 kg: Percentage (%) of Adult Dose to be Administered = Weight (kg) + 30
The following doses are recommended using the above equations:
|
Body weight (kg) |
Percent of Adult Dose (% of one vial) |
|---|---|
|
10 to 14 |
20% |
|
15 to 19 |
30% |
|
20 to 24 |
40% |
|
25 to 29 |
50% |
|
30 to 34 |
60% |
|
35 to 39 |
65% |
|
40 to 44 |
70% |
|
45 to 49 |
75% |
|
50 to 54 |
80% |
|
≥55 |
100% |
Adolescents ≥17 years: One vial.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Cardiovascular: Edema (≤1%)
Central nervous system: Headache (9%), chills (1%)
Dermatologic: Pruritus (5%), urticaria (5%), skin rash (2%)
Gastrointestinal: Nausea (≤5%), sore throat (<4%)
Miscellaneous: Fever (4%)
<1%, postmarketing, and/or case reports: Agitation, anaphylactic shock, anaphylactoid reaction, anaphylaxis, angioedema, anxiety, asystole, bradycardia, bronchospasm, chest discomfort, erythema, hyperhidrosis, hypersensitivity reaction, hypotension, increased blood pressure, infusion related reaction, jitteriness, leukocytosis, serum sickness, tachycardia, urinary retention, vomiting
There are no contraindications listed in the manufacturer’s labeling.
Concerns related to adverse effects:
• Delayed allergic reaction: Delayed allergic reaction or serum sickness (eg, arthralgia, fever, lymphadenopathy, myalgia, urticarial or maculopapular rash) may occur 10 to 21 days after administration. Monitor all patients for delayed allergic reactions and administer appropriate medical care as needed.
• Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and anaphylactoid reactions, may occur. The risk is greatest in patients with a history of hypersensitivity to horses or equine blood products, asthma, or hay fever; initiate treatment at the lowest achievable infusion rate (<0.01 mL/minute) is recommended. Monitor all patients for acute allergic reactions during and following the infusion; discontinue antitoxin administration in patients who develop a hypersensitivity reaction. Immediate treatment (including epinephrine 1 mg/mL) should be available.
• Infusion reactions: Infusion reactions (eg, arthralgia, chills, fatigue, fever, headache, myalgia, nausea, vasovagal reactions, vomiting) may occur; monitor all patients for infusion reactions during and following the infusion. In patients who develop an infusion reaction, decrease the infusion rate and treat symptomatically; if symptoms worsen, discontinue the infusion.
Dosage form specific issues:
• Maltose: May contain maltose which may falsely elevate glucose readings
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.
• Vial contents: Each vial contains a minimum antitoxin potency. The total volume contained in one vial (regardless of vial size) will differ by lot number (10 to 26 mL per vial); therefore, withdrawal of the entire vial contents will be required to calculate the dose.
Other warnings/precautions:
• Appropriate use: Botulism: Antitoxin is most effective if administered as early as possible (ideally within 12 to 48 hours) after the onset of neurologic symptoms (Fagan 2011a). Antitoxin does not reverse existing paralysis, but it arrests its progression and may lead to faster resolution of the disease process (Yu 2017).
• Disease transmission: Product of equine (horse) plasma; may potentially contain infectious agents (eg, viruses) which could transmit disease. Infections thought to be transmitted by this product should be reported to the manufacturer at 1-800-768-2304 and the state health department supplying the antitoxin.
The safety and efficacy information in pediatric patients is derived from animal model studies. Dosing in pediatric patients is based on the Salisbury Rule. Limited pediatric data safety data available; a CDC expanded access clinical study including 15 pediatric subjects (age range: 10 days to 17 years) reported adverse reactions in two patients; one subject experienced tachycardia, bradycardia, and asystole during infusion; pyrexia was reported in the other patient.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free]: Each vial contains no less than serotype A antitoxin 4500 units, serotype B antitoxin 3300 units, serotype C antitoxin 3000 units, serotype D antitoxin 600 units, serotype E antitoxin 5100 units, serotype F antitoxin 3000 units, and serotype G antitoxin 600 units (20 mL, 50 mL)
Yes
Heptavalent botulism antitoxin is not available for general public use. All supplies are currently owned by the federal government for inclusion in the Strategic National Stockpile and are distributed by the Centers for Disease Control and Prevention (CDC). Clinicians who suspect botulism in a patient are instructed to call their state health department’s emergency 24-hour telephone number; the state health department will contact the CDC to request release of botulism antitoxin, if indicated. State health departments can contact the CDC at their 24-hour telephone number at (770) 488-7100. Additional information from the CDC is available at https://www.cdc.gov/laboratory/drugservice/formulary.html.
IV: Use an IV line with constant infusion pump. Use a 15-micron, sterile, nonpyrogenic, low protein-binding, in-line filter. A slower infusion rate should be used during the first 30 minutes of treatment; if tolerated, may increase rate every 30 minutes up to the maximum infusion rate for the remainder of the infusion. Monitor vital signs throughout the infusion. Initiate and increase the infusion rate as follows:
Initial: 0.5 mL/minutes; may double the infusion rate every 30 minutes to a maximum infusion rate of 2 mL/minute
IV: Should be diluted to a 1:10 dilution in NS prior to administration. Infuse through a 15-micron, sterile, nonpyrogenic, low protein-binding, in-line filter. A slower infusion rate should be used during the first 30 minutes of treatment; if tolerated, may increase rate every 30 minutes up to the maximum infusion rate for the remainder of the infusion. For patients at risk for hypersensitivity reaction, begin administration at the lowest achievable rate (<0.01 mL/minute) and monitor. Monitor vital signs throughout the infusion. Initiate and increase the infusion rate as follows:
Neonates and Infants <1 year: Initial: 0.01 mL/kg/minute; may increase the rate by 0.01 mL/kg/minute every 30 minutes to a maximum infusion rate of 0.03 mL/kg/minute.
Children ≥1 year and Adolescents <17 years: Initial: 0.01 mL/kg/minute (maximum initial rate: 0.5 mL/minute); may increase the rate by 0.01 mL/kg/minute every 30 minutes to a maximum infusion rate of 0.03 mL/kg/minute not to exceed 2 mL/minute.
Adolescents ≥17 years: Initial: 0.5 mL/minute; may double the infusion rate, if tolerated, every 30 minutes to a maximum infusion rate of 2 mL/minute.
Botulism: Treatment of symptomatic botulism in adult and pediatric patients following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G.
None known.
There are no known significant interactions.
Based on limited information with the use of the previous equine products (BAT-AB; BAT-E), there is no indication that treatment of pregnant patients with botulism should differ from standard therapy (Arnon 2001).
Signs and symptoms of foodborne botulism may present differently in pregnant or postpartum patients. Weakness or fatigue and dry mouth may be more common than in nonpregnant patients. Pregnant patients may also be at an increased risk for respiratory failure (CDC [Rao 2021]).
In general, medications used as antidotes should take into consideration the health and prognosis of the mother; antidotes should be administered to pregnant patients if there is a clear indication for use and should not be withheld because of fears of teratogenicity (Bailey 2003). Pregnant patients with suspected foodborne botulism should be treated with botulism antitoxin in the same manner as non-pregnant patients (CDC [Rao 2021]).
It is not known if botulism antitoxin is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Information related to patients diagnosed with botulism who are breastfeeding is limited. Lactating patients with suspected foodborne botulism should be treated with botulism antitoxin in the same manner as nonpregnant patients. Breastfed infants should be closely monitored. Patients who prefer to temporarily withhold breastfeeding may express and discard milk (CDC [Rao 2021]).
Monitor vital signs and for the presence of infusion-related reactions and acute hypersensitivity reactions during and immediately following infusion; monitor for delayed allergic reactions for 10 to 21 days after administration.
Contains toxin-specific F(ab’)2 and F(ab’)2-related antibody fragments which bind and neutralize free botulinum neurotoxin A, B, C, D, E, F, and G. As a result, the neurotoxins are prevented from interacting with the cholinergic nerve ending and internalizing into target cells, thereby minimizing nerve damage and severity of the disease. Clinicians should note that botulism antitoxin does not reverse preexisting toxic manifestations.
Distribution: Vd:
Antitoxin serotype A: 3.6 L
Antitoxin serotype B: 9.6 L
Antitoxin serotype C: 6.1 L
Antitoxin serotype D: 1.5 L
Antitoxin serotype E: 14.2 L
Antitoxin serotype F: 3.4 L
Antitoxin serotype G: 2.4 L
Half-life elimination:
Antitoxin serotype A: 8.6 hours
Antitoxin serotype B: 34.2 hours
Antitoxin serotype C: 29.6 hours
Antitoxin serotype D: 7.5 hours
Antitoxin serotype E: 7.8 hours
Antitoxin serotype F: 14.1 hours
Antitoxin serotype G: 11.7 hours
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