Version July 2025
Cytomegalovirus disease, prophylaxis in kidney transplant: IV:
Initial dose (within 72 hours of transplant): 150 mg/kg/dose
2-, 4-, 6-, and 8 weeks after transplant: 100 mg/kg/dose
12- and 16 weeks after transplant: 50 mg/kg/dose
Cytomegalovirus disease, prophylaxis in liver, lung, pancreas, or heart transplant: IV:
Initial dose (within 72 hours of transplant): 150 mg/kg/dose
2-, 4-, 6-, and 8 weeks after transplant: 150 mg/kg/dose
12- and 16 weeks after transplant: 100 mg/kg/dose
There are no dosage adjustments provided in the manufacturer's labeling; use with caution. Infuse at minimum rate possible.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Cytomegalovirus immune globulin: Pediatric drug information")
Cytomegalovirus (CMV), prophylaxis in solid organ transplant recipients: Note: Not routinely recommended; antiviral medications (eg, ganciclovir, valganciclovir) are preferred over cytomegalovirus immune globulin (CMV Ig) due to efficacy, toxicity, and cost. Some centers use CMV Ig in combination with antivirals for high-risk patients; specific number and spacing of doses may vary; refer to institutional protocols (Ref).
Heart transplant:
Infants, Children, and Adolescents:
16-week regimen: IV: 150 mg/kg within 72 hours of transplant; 150 mg/kg/dose at weeks 2, 4, 6, and 8 after transplant; 100 mg/kg/dose at weeks 12 and 16 after transplant (Ref).
8-week regimen: Limited data available: IV: 150 mg/kg within 72 hours of transplant, then 100 mg/kg/dose at weeks 4 and 8 after transplant (Ref).
Liver, lung, or pancreas transplant: Infants, Children, and Adolescents: IV: 150 mg/kg within 72 hours of transplant; 150 mg/kg/dose at weeks 2, 4, 6, and 8 after transplant; 100 mg/kg/dose at weeks 12 and 16 after transplant (Ref).
Kidney transplant: Infants, Children, and Adolescents: Initial: IV: 150 mg/kg within 72 hours of transplant; 100 mg/kg/dose at weeks 2, 4, 6, and 8 after transplant; 50 mg/kg/dose at weeks 12 and 16 after transplant (Ref); specific number of doses and duration may vary among patients and institutional protocols.
Intestine or multivisceral transplant: Limited data available:
Infants, Children, and Adolescents:
Low or moderate risk (D-/R-, D-/R+, D+/R+): IV: 150 mg/kg once 7 days after transplant (Ref).
High risk (D+/R-): IV: 150 mg/kg/dose twice weekly for 2 weeks, then weekly for 2 weeks, then every other week for 4 weeks, then monthly for 2 months; if serum CMV IgG negative at that time, continue monthly for 1 year of total therapy following transplantation; if CMV IgG positive, discontinue therapy (Ref).
Cytomegalovirus (CMV), treatment: Limited data available: Note: Use for treatment of CMV is typically not recommended; may be considered in combination with antiviral therapy in certain instances (eg, hematopoietic cell transplant recipients with pneumonitis, patients with hypogammaglobulinemia or drug-resistant virus) (Ref).
Ganciclovir-resistant infection and disease: Infants, Children, and Adolescents: IV: 100 mg/kg/dose weekly in combination with antiviral agents; duration of therapy dependent upon virologic response (Ref).
Pneumonitis, severe: Dosing regimens variable; use in combination with ganciclovir: Children ≥2 years and Adolescents: IV: 400 mg/kg/dose on days 1, 2, and 7 followed by 200 mg/kg on day 14; if still symptomatic, may administer an additional 200 mg/kg on day 21 (Ref); others have used in patients ≥18 years of age a dose of 150 mg/kg/dose twice weekly (Ref).
Post-solid organ (visceral) transplantation, development of viremia during prophylaxis (detectable CMV polymerase chain reaction [PCR] >250 copies/mL): Infants, Children, and Adolescents: IV: 150 mg/kg/dose every 48 hours for at least 3 doses, then taper by reducing dosing frequency similar to prophylaxis schedule (eg, doses administered twice weekly, followed by weekly, every other week, then monthly; monitor CMV PCR weekly until criteria met [eg, two results are undetectable]); used in combination with antiviral medications (eg, ganciclovir, valganciclovir, foscarnet, cidofovir) (Ref).
There are no dosage adjustments provided in manufacturer’s labeling; use with caution. Infuse at minimum rate possible.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined.
<6%:
Cardiovascular: Flushing
Central nervous system: Chills
Gastrointestinal: Nausea, vomiting
Neuromuscular & skeletal: Arthralgia, back pain, muscle cramps
Respiratory: Wheezing
Miscellaneous: Fever
<1%, postmarketing and/or case reports: Abdominal pain, acute renal failure, acute respiratory distress, anaphylactic shock, angioedema, anuria, apnea, aseptic meningitis, bronchospasm, bullous dermatitis, circulatory shock, coma, cyanosis, decreased blood pressure, dyspnea, epidermolysis, erythema multiforme, hemolysis, hepatic insufficiency, hypersensitivity reaction (systemic), hypotension, hypoxemia, increased blood urea nitrogen, increased serum creatinine, leukopenia, loss of consciousness, oliguria, osmotic nephrosis, pancytopenia, positive direct Coombs test, proximal tubular nephropathy, pulmonary edema, renal insufficiency, renal tubular necrosis, rigors, seizure, Stevens-Johnson syndrome, thromboembolism, transfusion-related acute lung injury, tremor
History of severe hypersensitivity to cytomegalovirus immune globulin IV (human), other human Ig preparations, or any component of the formulation; selective Ig A deficiency
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur; discontinue immediately for hypotension or anaphylaxis; immediate treatment (including epinephrine 1 mg/mL) should be available. Systemic allergic reactions are rare; may be treated with epinephrine and diphenhydramine.
• Aseptic meningitis: Aseptic meningitis syndrome (AMS) has been reported with intravenous immune globulin administration (rare); may occur with high doses (≥2 g/kg). Symptoms include severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements and nausea and vomiting. Syndrome usually appears within several hours to 2 days following treatment; usually resolves within several days after discontinuation.
• Hemolysis: Intravenous immune globulin has been associated with antiglobulin hemolysis; monitor for signs of hemolytic anemia.
• Pulmonary edema: Monitor for adverse pulmonary events including transfusion-related acute lung injury (TRALI); noncardiogenic pulmonary edema has been reported with intravenous immune globulin use. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, and fever in the presence of normal left ventricular function and usually occurs within 1 to 6 hours after infusion; may be managed with oxygen and respiratory support.
• Renal impairment: Acute renal dysfunction (increased serum creatinine, oliguria, osmotic nephrosis, acute renal failure) can rarely occur; more likely with products stabilized with sucrose. Patients at risk for renal failure include the elderly, patients with preexisting renal disease, diabetes mellitus, volume depletion, sepsis, paraproteinemia, and nephrotoxic medications. In patients at risk of renal dysfunction, the rate of infusion and concentration of solution should be minimized. Discontinue if renal function deteriorates.
• Thrombotic events: Thrombotic events have been reported with administration of intravenous immune globulin; patients at risk include those with advanced age or a history of atherosclerosis, cardiovascular and/or thrombotic risk factors, or known/suspected hyperviscosity. Consider a baseline assessment of blood viscosity in patients at risk for hyperviscosity.
Disease-related concerns:
• Hypovolemia: Patients should not be volume depleted prior to therapy.
Special populations:
• Older adult: Use with caution in patients >65 years of age.
Dosage form specific issues:
• Albumin: Product is stabilized with albumin.
• Human plasma: Product of human plasma; may potentially contain infectious agents (eg, viruses, the variant Creutzfeldt Jakob disease agent, theoretically the Creutzfeldt Jakob disease agent) that could transmit disease, including unknown or emerging viruses and other pathogens. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduce the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.
• Sucrose: Product is stabilized with sucrose.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Cytogam: 50 mg/mL (50 mL) [contains albumin human]
No
Solution (Cytogam Intravenous)
50 mg/mL (per mL): $42.16
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Cytogam: 50 mg/mL (50 mL) [contains albumin human]
IV: Administer through an IV line containing an in-line 15 micron filter (a 0.2 micron filter is also acceptable) using an infusion pump. The solution must be free of particulate matter and colorless. Do not mix with other infusions; do not use if turbid. Begin infusion within 6 hours of entering vial, complete infusion within 12 hours of vial entry.
Initial dose: Infuse at 15 mg/kg/hour. If no adverse reactions occur within 30 minutes, may increase rate to 30 mg/kg/hour. If no adverse reactions occur within the second 30 minutes, may increase rate to 60 mg/kg/hour; maximum rate of infusion: 75 mL/hour. Monitor closely after each rate change. If patient develops nausea, back pain, or flushing during infusion, slow the rate or temporarily stop the infusion. Discontinue if blood pressure drops or in case of anaphylactic reaction.
Subsequent doses: Infuse at 15 mg/kg/hour for 15 minutes; if no adverse reactions occur, may increase rate to 30 mg/kg/hour for 15 minutes; if no adverse reactions occur, may increase rate to 60 mg/kg/hour; maximum rate of infusion: 75 mL/hour.
Parenteral: IV infusion: Does not require further dilution; administer as a 50 mg/mL solution through a dedicated IV line containing an in-line 15 micron filter (a 0.2 micron filter is also acceptable) using an infusion pump. Do not mix with other infusions; do not use if turbid; do not shake solution; avoid foaming. Begin infusion within 6 hours of entering vial; complete infusion within 12 hours of vial entry.
Initial dose: Initiate at 15 mg/kg/hour; if there are no infusion-related reactions after 30 minutes, increase to 30 mg/kg/hour; if no infusion-related reactions after 30 minutes, may increase to 60 mg/kg/hour for the remainder of the infusion; infusion rate should not exceed 75 mL/hour. Monitor closely during and after each rate change. If patient develops minor adverse effects (eg, nausea, back pain, or flushing) during infusion, slow the rate or temporarily stop the infusion. Discontinue infusion if anaphylaxis or drop in blood pressure occurs.
Subsequent doses: Initiate at 15 mg/kg/hour for the first 15 minutes; if no infusion-related reactions, increase to 30 mg/kg/hour for the next 15 minutes; if rate is tolerated, increase to 60 mg/kg/hour and maintain this rate until completion of dose; maximum infusion rate: 60 mg/kg/hour, not to exceed 75 mL/hour. If patient develops minor adverse effects (eg, nausea, back pain, or flushing) during infusion, slow the rate or temporarily stop the infusion. Discontinue if blood pressure drops or in case of anaphylactic reaction.
Cytomegalovirus, prophylaxis: Prophylaxis of cytomegalovirus (CMV) disease associated with kidney, lung, liver, pancreas, and heart transplants; concomitant use with ganciclovir should be considered in organ transplants (other than kidney) from CMV seropositive donors to CMV seronegative recipients
Cytomegalovirus (CMV) pneumonitis in solid organ transplant (adjunctive therapy); Cytomegalovirus (CMV) pneumonitis in hematopoietic stem cell transplant (HSCT) (adjunctive therapy)
CytoGam may be confused with Cytoxan, Gamimune N
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Dinutuximab Beta: Immune Globulins may decrease therapeutic effects of Dinutuximab Beta. Risk X: Avoid
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Vaccines (Live): Immune Globulins may decrease therapeutic effects of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider Therapy Modification
Cytomegalovirus (CMV) immune globulin is obtained from pooled human plasma and primarily contains IgG. Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
CMV immune globulin has been evaluated for the treatment and prevention of congenital CMV infection (Devlieger 2021; Hughes 2021; Revello 2014). Maternal CMV infection may be associated with adverse pregnancy outcomes including congenital CMV infection; however, until additional data are available, use of CMV immune globulin for the treatment of congenital CMV infection outside of a clinical trial is not currently recommended (SMFM 2016).
Cytomegalovirus immune globulin is obtained from pooled human plasma and primarily contains IgG.
Human immune globulin concentrations in breast milk are dependent upon IgG subclass and postpartum age (Anderson 2021).
May contain sodium.
Renal function (BUN, serum creatinine prior to initial infusion and periodically thereafter); urine output; vital signs, including blood pressure (throughout infusion); signs/symptoms of infusion-related adverse reactions, anaphylaxis; signs and symptoms of hemolytic anemia; blood viscosity (baseline; in patients at risk for hyperviscosity); presence of antineutrophil antibodies (if TRALI is suspected); volume status; weight gain, clinical response
CMV-IGIV is a preparation of immunoglobulin G (and trace amounts of IgA and IgM) derived from pooled healthy blood donors and contains a high titer of CMV antibodies; administration provides a passive source of antibodies against cytomegalovirus to attenuate or reduce the incidence of serious CMV disease
Half-life elimination: 8 to 24 days
