Cytomegalovirus immunoglobulin human 3g powder for solution for infusion vials
Cytomegalovirus immunoglobulin is obtained from pooled adult human plasma selected for high titers of antibody for cytomegalovirus (CMV).
Safety information for pregnancy and breastfeeding
Pregnancy
Breastfeeding
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
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Cytomegalovirus immunoglobulin human 3g powder for solution for infusion vials
Scottish National Blood Transfusion Service
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
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Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 17 · Randomised trials: 5 · 1975–2026
Showing the 50 most relevant studies, sorted by most relevant.
Edward Gane, Faouzi Saliba, Garcia JC Valdecasas, et al.
The Lancet, 1997
W. Rawlinson, S. Boppana, K. Fowler, et al.
The Lancet. Infectious diseases, 2017
Diao Y, Zong Y, Xu R, et al.
2026
Gutowska K, Kucińska-Chahwan A, Bednarek M, et al.
2026
Congenital cytomegalovirus (cCMV) is the leading infectious cause of long-term neuro-sensory impairment. Aim of meta-analysis was to evaluate the efficacy of antenatal immunoglobulin therapy-particularly cytomegalovirus-specific hyperimmune globulin (HIG)-in preventing vertical transmission and congenital cytomegalovirus infection (cCMV) in pregnancies complicated by primary maternal CMV infection. A search of PubMed, Cochrane Library, Embase, Scopus, ScienceDirect, Taylor & Francis Online, Wiley Online Library, ClinicalTrials.gov, and Google Scholar identified randomized controlled trials, prospective or retrospective cohort studies including pregnant women with serologically confirmed primary CMV infection. Eligible interventions included antenatal CMV-specific or nonspecific immunoglobulins (vs placebo, usual care, historical controls, or no treatment), although all included studies evaluated CMV-specific HIG. Controlled studies showed no significant reduction in transmission (RR 0.73, 95% CI .54-1.00; P = .051) with moderate heterogeneity. The pooled transmission rate after HIG was 27.2%, with substantial heterogeneity. Current evidence does not support routine antenatal immunoglobulin to prevent cCMV.
Abstract licence: CC BY
Jung AW, Supptitz J, Hummes PN, et al.
2026
- Pregnancy Complications, Infectious
- Autism Spectrum Disorder
- Cytomegalovirus Infections
ObjectiveThe aim of this systematic review (SR) is to evaluate the relationship between congenital infections (Toxoplasmosis, Cytomegalovirus, Rubella, Herpes simplex type 1 and 2, HIV, Zika, and Syphilis) and the development of Autism Spectrum Disorder (ASD).Data sourceThe authors seek to identify loopholes in the current knowledge about this content and to understand the role of congenital infections in children's neurodevelopment. After the systematic search, 32 articles were included. Quality of articles was evaluated by the e Newcastle-Ottawa Scale (NOS).FindingsThe data obtained were heterogeneous; the NOS varied from 4 to 9. In 19 studies, an association between congenital infection and the development of ASD and/or features of this spectrum was not observed. Furthermore, the present findings indicate that the link between congenital infections and ASD varies depending on the pathogen and there is no common causal factor among the diseases, as their mechanisms are not yet fully understood.ConclusionThis review highlights that there is a possible correlation between some congenital infections and the development of ASD, as is the case with CMV, Zika, Rubella and Toxoplasmosis infection. As the mechanisms are not yet fully understood, there is a need for further studies and research on this topic to bridge the existing knowledge gap regarding its mechanisms.
Abstract licence: CC BY
American Journal of Ophthalmology, 2002
Brits E, Brown S, Botes L, et al.
2026
BackgroundThe aspartate aminotransferase-to-platelet ratio index (APRi) has been proposed as a non-invasive biomarker of liver injury in biliary atresia (BA). However, conflicting evidence and varying cutoff values have left its association with histologically confirmed liver damage uncertain. This study assessed the relationship between APRi and liver injury severity (Meta-Analysis of Histological Data in Viral Hepatitis [METAVIR] F0-F4) in BA and evaluated its predictive value.MethodsA retrospective analytical review of electronic records was conducted for all BA patients treated at a South African academic hospital between 01 January 2009 and 31 December 2019.ResultsSixty-seven patients were included, 74.6% of whom were female. The most common subtypes were cytomegalovirus (CMV) immunoglobulin M-positive (IgM+) BA (34.3%) and isolated BA (31.3%); about one-third could not be classified because CMV serology was unavailable. Liver biopsy METAVIR scores were F1 (8.3%), F2 (50.0%), F3 (18.3%) and F4 (23.3%). In a sub-analysis (n = 39), APRi modestly differentiated ≤ F2 from ≥ F3 fibrosis at a cutoff of 2.69 (area under the receiver operating characteristic curve 0.61). Decision curve analysis suggested modest clinical utility despite a non-significant logistic regression model (odds ratio 1.25; 95% confidence interval 0.94-1.92; p = 0.2). Of the 55 patients with known outcomes, 94.5% (n = 52) had confirmed mortality or were referred for palliative care.ConclusionAminotransferase-to-platelet ratio index should not replace established clinical decision-making but may provide useful adjunctive information alongside clinical, biochemical and histological assessment. These findings provide contextual evidence from a South African resource-limited setting and support prospective multicentre validation before routine clinical implementation.ContributionThe study contributes evidence supporting continued evaluation of APRi as an adjunctive non-invasive biomarker in BA in the South African setting.
Abstract licence: CC BY
Jiang-Shan Tan, Jia-meng Ren, Lu-Yun Fan, et al.
Frontiers in Cellular and Infection Microbiology, 2022
- Cardiovascular Diseases
- Venous Thrombosis
- Coronary Artery Disease
R. Razonable, A. Humar
Clinical Transplantation, 2019
M. Byrne, A. Langston, Garrett S. Booth
British Journal of Haematology, 2021
- Cytomegalovirus
- Cytomegalovirus Infections
- Immunoglobulin G
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
25 days
Mechanism
CMV—IGIV mainly consists of immunoglobulin G (IgG), specifically subclasses IgG1 and IgG3.
Food interactions
None known
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
3 months
Half-life
25 days
[L2227]
Volume of distribution
[L2227]
Metabolism
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Cytomegalovirus, a member of the herpes virus family, is ubiquitous the human population, leading to infections which are followed by life-long dormancy in the host with occasional reactivations and recurrent infections. The seroprevalence of antibodies in adults ranges from 40-100 % with an inverse correlation to socioeconomic status. The transmission of cytomegalovirus infection requires intimate contact with infected excretions such as saliva, urine, cervical and vaginal excretions, semen, breast milk and blood [L2228].
CMV infection can lead to a high fever and severe organ-specific damage with significant morbidity and mortality rates. Cytomegalovirus (CMV) may lead to a wide spectrum of infection in immunocompetent hosts. Sites most often involved include the lung (severe community-acquired viral pneumonia), liver (transaminitis), spleen (splenomegaly), GI tract (colitis), CNS (encephalitis), the hematologic system (cytopenias), and multisystem involvement [L2230].
During the span of an individual's life, the virus may reactivate, resulting in repeated shedding and spread of the virus. Molecular mechanisms have been identified by which show that CMVs interfere with the host immune system. Finally, however, the infection is normally controlled by the host's immune response. As a consequence, CMV disease is restricted to the immunocompromised or immunologically immature host, in which it can lead the devastating result of transplant rejection [A32498], [L2229].
[L2225]
Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart [FDA label].
In transplants of these organs other than the kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir [FDA label].
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 378 interactions
[L2228]
Renal Failure
Renal dysfunction, acute renal failure (ARF), acute tubular necrosis (ATN), proximal tubular nephropathy, osmotic nephrosis, and death reported in patients receiving IGIV. Increases in blood urea nitrogen (BUN) and serum creatinine have occurred as soon as 1–2 days following IGIV treatment and this has progressed to oliguria or anuria .
[L2231]
TRALI (transfusion-associated lung injury)
TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever.
It typically occurs within 1-6 hours after transfusion of the immunoglobulin. Patients with TRALI should be managed using oxygen therapy combined with ventilatory support [FDA label].
Hemolysis
Immune Globulin Intravenous (Human) (IGIV) products may contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, sometimes, hemolysis. Hemolytic anemia may develop after IGIV therapy due to enhanced red blood cell sequestration [FDA label].
**Thrombotic events
Patients at risk include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity.
The possible risks and benefits of IGIV should be weighed against those of alternative therapies for all patients for whom IGIV administration is being considered. Baseline assessment of blood viscosity are an important consideration for patients at risk for blood hyperviscosity [FDA label].
Aseptic meningitis syndrome**
An aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with Immune Globulin Intravenous (Human) (IGIV) treatment. The syndrome normally begins within several hours to 2 days after treatment.
This syndrome is characterized by symptoms and signs including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting [FDA label].
Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per cu.mm., predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL. Patients experiencing such symptoms and signs must receive a thorough neurological assessment, including CSF studies, to rule out other possible causes of meningitis. This condition may occur more frequently in association with high doses (2 g/kg or greater) of IGIV treatment.
Discontinuation of IGIV treatment has been followed by the remission of aseptic meningitis syndrome within several days without long-term sequelae [FDA label].
Cytomegalovirus immune globulin (CMV-IGIV) is categorized in FDA pregnancy risk category C. No well-controlled studies have been completed in pregnant women and it is unknown whether CMV-IGIV may cause female harm or negatively affect the reproductive system. According to the Advisory Committee on Immunization Practices, administration of immune globulin to pregnant women results in no known risk to the fetus [FDA label].
No data are available from the manufacturer regarding the use of cytomegalovirus immune globulin (CMV-IGIV) while breastfeeding and it is unknown whether CMV-IGIV is excreted in breast milk .
[L2227]
Immunoglobulins, such as CMV-IGIV, inhibit extracellular viruses from infecting their specific target cells. Viral neutralization decreases the capacity of viruses to spread from an extracellular location to an intracellular location. CMV-IGIV inhibits infection of cells with CMV due to the fact that the virus is prevented from accessing key cell membrane targets, or because of interference with uncoating or entry. Cytogam inhibits these process [L2227].
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L2227]
[L2227]
[L2227]
IgG metabolism appears to be a multicompartmental, first-order process.
Higher IgG concentrations increase the rate of metabolism and shorten its half-life. IgG metabolism is likely a multicompartmental, first-order process .
[L2227]
ATC J06BB09
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Human cytomegalovirus immune globulin
Matched from: Cytomegalovirus immunoglobulin
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72