Cnj-016 (National Stockpile) (vaccinia immune globulin human)

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VIGIV is administered only by IV infusion.

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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)

*Isolated vaccinia keratitis.

*History of anaphylaxis or severe systemic reaction to VIGIV or any other parenteral immune globulin preparation.

*Individuals with immune globulin A (IgA) deficiency, antibodies against IgA, and a history of IgA hypersensitivity.

• Vaccinia virus keratitis

• Non-infective meningitis
• Predisposition to thrombosis
• Thromboembolic disorder

• Bed-ridden
• Chronic heart failure
• Diabetes mellitus
• Hemolytic anemia
• Hypovolemia
• Kidney disease with reduction in glomerular filtration rate (GFr)
• Monoclonal gammopathy
• Sepsis
• Transfusion related acute lung injury

Adverse effects reported in more than 10% of patients receiving VIGIV in clinical trials include headache, nausea, rigors, and dizziness.

Rare or Very Rare

• Acute renal failure
• Acute respiratory distress syndrome
• Apnea
• Bronchospastic pulmonary disease
• Bullous dermatitis
• Cardiac arrest
• Coma
• Cyanosis
• Erythema multiforme
• Hemolysis
• Hypersensitivity drug reaction
• Hypotension
• Leukopenia
• Neutropenic disorder
• Pancytopenia
• Pulmonary edema
• Seizure disorder
• Stevens-johnson syndrome
• Thromboembolic disorder
• Unconsciousness
• Urticaria

More Frequent

• Chills
• Dizziness
• Headache disorder
• Myalgia
• Nausea
• Pain
• Sensation of cold
• Tremor

Less Frequent

• Anorexia
• Back pain
• Fatigue
• Fever
• General weakness
• Hyperhidrosis
• Muscle spasm
• Pallor
• Paresthesia
• Sensation of warmth
• Vomiting

Rare or Very Rare

• Abnormal desquamation
• Acute abdominal pain
• Arthralgia
• Diarrhea
• Dyspnea
• Lymphadenopathy
• Tachycardia
• Wheezing

No enhanced messaging available.

Safety and efficacy of VIGIV have not been established in pediatric patients younger than 16 years of age.

Animal reproduction studies have not been conducted with VIGIV and data are not available on use of VIGIV in pregnant women to inform drug-associated risk.

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) states that there are no known risks associated with the use of immune globulins in pregnant women.

CDC states that VIGIV is not indicated for prophylaxis in pregnant women unintentionally vaccinated with smallpox vaccine; however, VIGIV should not be withheld if a pregnant woman develops a smallpox vaccination complication (e.g., eczema vaccinatum).

It is not known whether VIGIV is distributed into human milk, affects milk production, or affects a breast-fed child.

Safety and efficacy of VIGIV have not been established in geriatric adults older than 65 years of age.