Anthrasil (National Stockpile) (anthrax immune globulin (human))

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

*For intravenous use only.

*Administer anthrax immune globulin IV (human) by slow intravenous infusion using an infusion pump and recommended adult or pediatric infusion rates (see Table 1).

*Maximum infusion rate in adults is 2 mL/min.

Table 1. Dose and Infusion Rate of Anthrax Immune Globulin IV (Human)

Patient Group Dose Starting Incremental Max Infusion Infusion Rate Infusion Rate Rate (first 30 min) if Tolerated (every 30 min) Adults (>=17 7 vials (420 0.5 mL/min 1 mL/min 2 mL/min years) units) Pediatric <1 1-7 vials 0.01 mL/kg/min 0.02 mL/kg/min 0.04 mL/kg/min year to <=16 (60-420 units) (do not exceed (do not exceed years based on the adult the adult patient weight rate) rate) (see Table 2)

Select initial dose based on clinical severity; severe cases may warrant use of 14 vials (840 units) in adults or 2-14 vials (based on weight) in pediatric patients weighing >5 kg.

Adjust dose and consider redosing based on clinical severity and response to treatment.

Table 2. Pediatric Dose of Anthrax Immune Globulin IV (Human) Based on Weight

Body Weight (kg) Vials per Dose Body Weight (kg) Vials per Dose <5 1 25 to <35 4 <10 1 35 to <50 5 10 to <18 2 50 to <60 6 18 to <25 3 >=60 7

Select initial dose based on clinical severity. Dose may be doubled for severe cases in pediatric patients weighing >5 kg.

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There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Selected Immunoglobulins/Selected Live Viral Vaccines

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Immune globulin(IG) products may prevent the immune system from properly responding to the vaccine.(1-19)

CLINICAL EFFECTS: Administration of selected live viral vaccines after immunoglobulins may impair the efficacy of the vaccine.(1-19) Administration of immunoglobulins within 2-4 weeks after selected live viral vaccines impair the efficacy of the vaccine.(1-4,15)

PREDISPOSING FACTORS: The amount of antigen-specific antibody present in the administered immunoglobulin product determines the duration of this interaction.(15)

PATIENT MANAGEMENT: The recommendations regarding this interaction are conflicting. The Centers for Disease Control and Prevention(CDC) immunization recommendations for spacing of live vaccines and antibody-containing products include the following(15): - Live attenuated influenza vaccine, rotavirus, zoster and Ty21a typhoid vaccines may be given any time before, concurrent, with, or after administration of any immune globulin. Yellow fever vaccine may also be given in areas where donor blood products are unlikely to contain a substantial quantity of yellow fever antibody. - Administration of measles or varicella containing vaccines should be postponed for the following intervals after immunoglobulin therapy: Hepatitis B IG, Tetanus IG - 3 months Rabies IG - 4 months Varicella IG - 5 months Measles prophylaxis IG - 6 months if nonimmunocompromised Botulinum IG Intravenous, CMV IG Intravenous, Hepatitis A IG - 6 months Intravenous Immune Globulin(IVIG) - 8 to 11 months depending upon the dose Monoclonal antibody to RSV F protein (palivizumab) - none - Administration of antibody-containing products should be delayed 2 weeks after administration of live vaccines, except for influenza, rotavirus, zoster and typhoid vaccines as noted above. CDC guidelines state that in circumstances where there is high-risk of vaccine-preventable disease, it is acceptable to administer a dose of vaccine prior to completion of these intervals.(16) Manufacturer recommendations are as follows: Administration of a live viral vaccine should be postponed for at least three months in patients who have received the following immunoglobulin therapy: anthrax immunoglobulin,(19) cytomegalovirus immunoglobulin,(1) hepatitis B immunoglobulin,(5,6) rabies immunoglobulin,(7) tetanus immunoglobulin,(8-11) vaccinia immunoglobulin,(18) and zoster immunoglobulin.(2) Administration of a live viral vaccine should be postponed for at least six months in patients who have received the following immunoglobulin therapy: botulinum neurotoxin a/b immune globulin.(17) The US manufacturer of human immunoglobulin states that live viral vaccines should be postponed for three months in patients who have received human immunoglobulin. The Australian and Canadian manufacturers of human immunoglobulin advise postponing live viral vaccines for 3-6 months in patients who have received human immunoglobulin.(6,12,13,18) The UK manufacturer states that vaccines may be compromised for one year and vaccines should be postponed in children for at least seven months.(14) The US manufacturer of immune globulin-hyaluronidase states that immune response to live attenuated vaccines may be impaired for up to 6 months, or for a year or more in the case of measles vaccine.(15) Cytomegalovirus immunoglobulin(1) or human immunoglobulin(3) should not be administered to patients who have received a live vaccine in the previous two weeks. If a live viral vaccine is given within two weeks of zoster immunoglobulin,(1) repetition of the vaccination three months after the completion of immunoglobulin should be considered.

DISCUSSION: CDC Immunization Recommendations(15)provide discussion, charts, and further details regarding appropriate use and timing of vaccine therapy.(16)

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)

*History of anaphylactic or severe systemic reaction to human immune globulins.

*IgA deficiency with antibodies against IgA and a history of IgA hypersensitivity.

There are no contraindication contraindications for this drug.

• Bed-ridden
• Chronic heart failure
• Cryoglobulinemia
• Indwelling vascular catheter
• Monoclonal gammopathy
• Myocardial ischemia
• Thromboembolic disorder
• Thrombotic disorder

• Kidney disease with likely reduction in glomerular filtration rate (GFr)
• Kidney disease with reduction in glomerular filtration rate (GFr)

The most common adverse reactions to anthrax immune globulin IV (human) observed in >5% of healthy volunteers in clinical trials were headache, infusion site pain and swelling, nausea, and back pain.

Less Frequent

• Acute renal failure
• Acute respiratory distress syndrome
• Pleural effusions
• Pulmonary edema

More Frequent

• Back pain
• Headache disorder
• Injection site inflammation
• Injection site pain
• Nausea

Less Frequent

• Glycosuria

Rare or Very Rare

• Ascites
• Chest discomfort
• Edema
• Flushing
• Hyperkalemia
• Hypotension
• Metabolic acidosis
• Tachycardia
• Throat constriction

No enhanced messaging available.

Safety and effectiveness of anthrax immune globulin IV (human) in the pediatric population (<=16 years of age) have not been studied. Allometric scaling was used to derive dosing regimens to provide pediatric patients with exposure comparable to the observed exposure in adults receiving 420 units and 840 units. The dose for pediatric patients is based on body weight.

There are no human data to establish the presence or absence of risk associated with anthrax immune globulin IV (human).

There are no data to assess the presence or absence of anthrax immune globulin IV (human) in human milk, the effects on the breast-fed child, or the effects on milk production/excretion.

Safety and effectiveness of anthrax immune globulin IV (human) in the geriatric population (>65 years of age) have not been studied.