Botulism Antitoxin Heptavalent (botulism antitoxin heptavalent A,B,C,D,E,F,G(equine)/maltose)

For the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G, botulism antitoxin (equine) heptavalent is given as a single dose.

Each single-use vial of botulism antitoxin (equine) heptavalent (regardless of vial size or fill volume) contains at least 4500, 3300, 3000, 600, 5100, 3000, and 600 units of serotype A, B, C, D, E, F, and G antitoxin, respectively.

Botulism antitoxin (equine) heptavalent is administered only by slow IV infusion.

Botulism antitoxin (equine) heptavalent must be diluted in 0.9% sodium chloride prior to administration. (See Dilution under Dosage and Administration: Administration.) The diluted solution of antitoxin should be administered using a constant infusion pump; use of an inline filter is optional.

Patients should be monitored closely for signs and symptoms of acute sensitivity or infusion reactions during and immediately after completion of the IV infusion. (See Sensitivity Reactions and see Infusion Reactions under Cautions: Warnings/Precautions.)

Botulism antitoxin (equine) heptavalent is provided in single-use vials and may arrive from CDC either frozen or thawed. If frozen, the antitoxin should be thawed by placing the vials in a refrigerator at 2-8degreesC for approximately 14 hours until the contents are thawed. More rapid thawing can be accomplished by placing the vials at room temperature for 1 hour, followed by immersion in a water bath at 37degreesC until thawed. The antitoxin should not be thawed in a microwave oven and should not be refrozen.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal drug interaction studies have not been performed with botulism antitoxin (equine) heptavalent.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

Igg Antibodies And Derivatives/Nipocalimab-Aahu

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Igg Antibodies And Derivatives/Rozanolixizumab-Noli

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)

DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)

The manufacturer states there are no contraindications.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Adverse effects reported in 5% or more of healthy individuals who received botulism antitoxin (equine) heptavalent include headache, nausea, pruritus, and urticaria. Adverse effects reported in 1% or more of patients who received the antitoxin in the CDC expanded access observational study were pyrexia, rash, chills, nausea, and edema.

Less Frequent

• Hypersensitivity drug reaction

Rare or Very Rare

• Anaphylaxis
• Serum sickness

More Frequent

• Headache disorder
• Nausea
• Pruritus of skin
• Urticaria

Less Frequent

• Chills
• Edema
• Fever
• Skin rash

Rare or Very Rare

• Arthralgia
• Myalgia

No enhanced messaging available.

Botulism antitoxin (equine) heptavalent is labeled by FDA for use in pediatric patients. However, efficacy of botulism antitoxin (equine) heptavalent has not been established in pediatric patients, and only limited safety data are available regarding use of the antitoxin in pediatric patients.

Although only limited data are available, the US Centers for Disease Control and Prevention (CDC) and other experts state that treatment of botulism in pediatric patients should be the same as that in adults. For treatment of infant botulism caused by botulinum toxin serotypes A or B, botulism immune globulin IV (BIG-IV) is available for use in those younger than 1 year of age. (See Botulism Immune Globulin IV 80:04.)

In the CDC expanded access observational study of botulism antitoxin (equine) heptavalent, 15 children ranging from 10 days to 17 years of age received the antitoxin. Pyrexia occurred in one child following IV infusion of the antitoxin; a serious adverse reaction consisting of hemodynamic instability, characterized by tachycardia, bradycardia, and asystole, occurred in another child during IV infusion of the antitoxin.

Category C. (See Users Guide.)

It is not known whether botulism antitoxin (equine) heptavalent is distributed into milk. The antitoxin should be used with caution in nursing women.

Efficacy and safety of botulism antitoxin (equine) heptavalent have not been established in geriatric patients. In the CDC expanded access observational study of botulism antitoxin (equine) heptavalent, 36 patients were 65 years of age or older.