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Contraindications

• Manufacturer states none.1

Warnings/Precautions

Sensitivity Reactions

Severe hypersensitivity reactions (e.g., anaphylaxis, anaphylactoid reactions) may occur.1

Risk of severe reactions may be increased in individuals with history of sensitivity to horses or equine blood products, other allergies (e.g., hay fever), or asthma.1 Consider skin sensitivity testing prior to administration of the antitoxin in such individuals to ascertain risk of allergic reactions.1 (See Intradermal Sensitivity Testing under Dosage and Administration.)

Administer in setting with appropriate equipment, medication (e.g., epinephrine), and personnel trained in management of hypersensitivity, anaphylaxis, and shock.1

Closely monitor for signs and symptoms of acute allergic reactions (e.g., urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, tachycardia) during and after IV infusion of the antitoxin.1

If hypersensitivity reaction occurs, immediately discontinue antitoxin infusion and initiate emergency medical care.1

If used in patients at risk for hypersensitivity reactions, initiate the IV infusion using lowest rate achievable (i.e., <0.01 mL/minute) and closely monitor patient.1

Delayed hypersensitivity or serum sickness reactions reported.1 Usually manifest as fever, urticarial or maculopapular rash, myalgia, arthralgia, and lymphadenopathy and typically occur 10–21 days after IV infusion of the antitoxin.1

Monitor for signs and symptoms of delayed allergic reactions or serum sickness.1 If such reactions suspected, administer appropriate medical care.1

Infusion Reactions

Infusion-related reactions (e.g., chills, fever, difficulty breathing, headache, nausea, vomiting, arthralgia, myalgia, fatigue) reported within 20–60 minutes after IV infusion of the antitoxin.1 Arthralgia, myalgia, fatigue, and vasovagal reactions also reported.1

Monitor patients during and immediately after IV infusion.1 If infusion-related reaction occurs, reduce infusion rate and administer symptomatic care.1 If reaction worsens, discontinue infusion and administer appropriate medical care.1

Interference with Blood Glucose Testing

Parenteral preparations containing maltose, including the antitoxin, may cause falsely elevated results in blood glucose determinations that use glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ).1 May lead to inappropriate administration of insulin resulting in life-threatening hypoglycemia or may mask true hypoglycemic states.1

Use only glucose-specific test methods not affected by maltose.1 Carefully review product information for the blood glucose testing system (including glucose test strips) to determine if appropriate.1 If any uncertainty exists, contact manufacturer of the glucose testing system to determine if the system will provide accurate blood glucose determinations in a patient treated with the antitoxin.1

Risk of Transmissible Infectious Agents

Prepared from equine plasma;1 potentially may transmit infectious agents, including viruses.1 Screening of equine plasma and viral elimination/inactivation procedures included in manufacturing process reduce risk of transmission of viruses.1

Report any suspected infections associated with administration of the antitoxin to the manufacturer at 800-768-2304.1

Antibody Formation

Potential for immunogenicity.1 In healthy volunteers negative for anti-equine antibodies before receiving the antitoxin, 11 of 39 (28%) developed antibodies against the antitoxin.1 7 These were mainly IgG antibodies; IgE antibodies not detected in these individuals.7

Specific Populations

Category C.1

Not known whether distributed into milk.1 Use with caution in nursing women.1

Labeled by FDA for use in pediatric patients.1 Efficacy not established in pediatric patients;1 only limited safety data regarding use in pediatric patients.1

CDC and other experts state treatment of botulism in pediatric patients should be the same as that in adults.8 70 For treatment of infant botulism caused by serotypes A or B, consider that botulism immune globulin IV (BIG-IV) is available for use in those <1 year of age.105

Fifteen pediatric patients ranging from 10 days to 17 years of age received the antitoxin in CDC expanded access study.1

Efficacy and safety not established in geriatric patient; 36 patients ≥65 years of age received the antitoxin in CDC expanded access study.1

Common Adverse Effects

Headache,1 nausea,1 pruritus,1 urticaria,1 fever,1 rash,1 chills,1 edema.1

Data not available regarding drug interactions.1

Storage

Parenteral

Store frozen at -15°C or lower.1 After thawing, may be stored for up to 36 months at 2–8°C or until 48 months from date of manufacture, whichever comes first.1 Do not refreeze.1

Single-use vials;1 discard any unused portion.1 Does not contain preservatives.1

• Advise patients that botulism antitoxin (equine) heptavalent is prepared from horse plasma and that individuals with allergy to horses or equine blood products, other allergies (e.g., hay fever), or asthma may be at increased risk of hypersensitivity reactions and should receive the antitoxin only if benefits outweigh risks.1 Importance of informing clinician of such allergies.1

• Advise patients that the antitoxin may cause immediate sensitivity reactions.1 Importance of immediately contacting clinician or seeking emergency treatment if manifestations of serious allergic reactions (e.g., urticaria, pruritus, erythema, angioedema, bronchospasm, stridor, laryngeal edema, hypotension, tachycardia) develop.1 (See Immediate Hypersensitivity or Anaphylaxis under Cautions.)

• Advise patients that the antitoxin may cause delayed allergic reactions.1 Importance of immediately contacting clinician if manifestations of delayed allergic reactions or serum sickness (e.g., rash, fever, pruritus, myalgia, arthralgia, fever, lymphadenopathy) develop within 10–21 days after administration of the antitoxin.1 (See Delayed Hypersensitivity or Serum Sickness Reactions under Cautions.)

• Advise patients that the antitoxin is a potential vehicle for transmission of infectious agents, including viruses, since it is prepared using horse serum.1 Although screening and viral-inactivating and purification procedures used in manufacture of plasma-derived preparations have reduced the risk of pathogen transmission, the possibility still exists that transmission of viruses and other infectious agents could occur.1

• Advise patients that the antitoxin contains maltose and may cause falsely elevated glucose readings when blood glucose monitoring systems based on glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) are used.1 Falsely elevated glucose determinations may lead to inappropriate insulin administration resulting in life-threatening hypoglycemia or may mask true hypoglycemic states.1 Importance of using glucose-specific test methods not affected by maltose.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Botulism antitoxin type A and B has not been formally assigned to a pregnancy category by the FDA. A previously available trivalent antitoxin (types A, B, E) had been assigned to pregnancy category C. It is unknown whether the antibodies cross the placenta; however, other immunoglobulins do cross the placenta. Case reports have described administration of the antitoxin to pregnant women with no apparent short-term adverse effects.

Five vials of bivalent antitoxin were administered to a woman with severe botulism poisoning who was in her fifth month of pregnancy. She recovered and was discharged after 3 months, and had a normal delivery 1 month later.

There are no data on the excretion of botulism antitoxin into human milk.