Cytogam (cytomegalovirus immune globulin (human))

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Cytomegalovirus immune globulin IV (CMV-IGIV) is administered by IV infusion. CMV-IGIV should not be administered IM or subcutaneously.

CMV-IGIV should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should be colorless and should not be used if turbid. Vials of CMV-IGIV should not be shaken; formation of foam should be avoided. CMV-IGIV contains no preservatives and the manufacturer recommends that vials of the immune globulin be entered only once and that the infusion be initiated within 6 hours and completed within 12 hours after entering the vial. To prevent transmission of hepatitis B infection and/or other infectious agents from one individual to another, a different sterile syringe and needle must be used for each individual who is administered CMV-IGIV.

IV infusions of CMV-IGIV should be administered through an IV line using an administration set that contains in inline filter (pore size 15 mcm) and a controlled-infusion device (i.e., IVAC(R) pump or equivalent) to control the rate of flow. The manufacturer states that a smaller inline membrane filter (0.2 mcm) also may be used during administration of CMV-IGIV. CMV-IGIV should not be diluted prior to IV infusion and preferably should be administered via a separate infusion line. CMV-IGIV may be piggy-backed into a preexisting line containing 0.9% sodium chloride injection or 2.5, 5, 10, or 20% dextrose injection (with or without sodium chloride) provided the dilution of immune globulin does not exceed 1:2 with such fluid. Information on the physical and/or chemical compatibility of CMV-IGIV with other IV infusion fluids or other drugs is not available, and the manufacturer recommends that CMV-IGIV not be admixed with other drugs.

Vital signs should be assessed prior to initiating the CMV-IGIV infusion, midway through the infusion, and after completion of the infusion. Vital signs also should be assessed before any change is made in the rate of administration and closely monitored during and after the change. In addition, renal function, including measurement of BUN, serum creatinine, and urine output, should be assessed before and at appropriate intervals after administration of CMV-IGIV. If renal function decreases, consideration should be given to discontinuing CMV-IGIV.

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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)

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There are no contraindication contraindications for this drug.

• Non-infective meningitis

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

More Frequent

• Dyspnea
• Wheezing

Less Frequent

• Fatigue

Rare or Very Rare

• Acute myocardial infarction
• Acute respiratory distress syndrome
• Anaphylaxis
• Erythema multiforme
• Hemolytic anemia
• Hypotension
• Hypoxia
• Non-infective meningitis
• Pancytopenia
• Pulmonary edema
• Pulmonary thromboembolism
• Renal failure
• Thrombotic disorder
• Transfusion related acute lung injury

More Frequent

• Arthralgia
• Back pain
• Chills
• Fever
• Flushing
• Headache disorder
• Malaise
• Myalgia
• Nausea
• Vomiting

Less Frequent

• Cramps in legs

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Animal reproductive studies have not been performed with CMV-IGIV and it is not known whether CMV-IGIV can cause fetal harm when administered to pregnant women. CMV-IGIV should be used during pregnancy only when clearly needed.

The US Public Health Service Advisory Committee on Immunization Practices (ACIP) states there are no known risks for the fetus from use of immune globulin preparations for passive immunization in pregnant women. CMV-IGIV has been used in a limited number of pregnant women with primary CMV infection in an attempt to treat and prevent congenital CMV infection. (See Uses: Congenital or Neonatal CMV Infection.)

Information on the distribution of CMV-IGIV into milk is not available; it is not known if transmission of CMV-IGIV to a nursing infant presents any unusual risk.

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