Explore a selection of our essential drug information below, or:
Identification
- Summary
Human cytomegalovirus immune globulin is a solution of immune globulin G against cytomegalovirus used to prevent transmission of cytomegalovirus after organ transplants.
- Brand Names
- Cytogam
- Generic Name
- Human cytomegalovirus immune globulin
- DrugBank Accession Number
- DB13886
- Background
Cytomegalovirus immunoglobulin is obtained from pooled adult human plasma selected for high titers of antibody for cytomegalovirus (CMV). It contains purified immunoglobulin G (IgG) antibodies targeting cytomegalovirus (CMV)Label.
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 4.
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 6.
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 1, 5.
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Other protein based therapies - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- CMV-immune globulin
- CMVIG
- Cytomegalovirus immune globulin (human)
- Cytomegalovirus immunoglobulin
- Human cytomegalovirus immune globulin
- Human cytomegalovirus immunoglobulin
Pharmacology
- Indication
It is used to prevent cytomegalovirus (CMV) disease after organ transplant 2.
Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart 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 Label.
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Prophylaxis of Cytomegalovirus viremia •••••••••••• Used in combination to prevent Cytomegalovirus viremia Regimen in combination with: Ganciclovir (DB01004) •••••••••••• ••• •••••••••••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
CytoGam (cytomegalovirus immune globulin) contains IgG antibodies representing those of the large number of normal individuals who have contributed to the plasma pools from which the product was derived. The globulin contains a relatively high concentration of antibodies which are directed against cytomegalovirus (CMV). In the case of persons who may possibly be exposed to CMV, CytoGam can increase the relevant antibodies to levels sufficient to prevent or reduce the incidence of serious CMV disease Label.
- Mechanism of action
CMV—IGIV mainly consists of immunoglobulin G (IgG), specifically subclasses IgG1 and IgG3. IgG1 and IgG3 play important roles in viral neutralization in addition to tissue protection and complement activation 3.
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 3.
- Absorption
Protection derived from Cytomegalovirus immune globulin (CMV-IGIV) has a rapid onset, imparting relevant CMV antibody concentrations immediately after infusion. The duration of action of CMV-IGIV is 1—3 months 3.
- Volume of distribution
IgG is distributed from the plasma to various other body compartments 3.
- Protein binding
Not Available
- Metabolism
Cytomegalovirus immune globulin (CMV-IGIV) is administered by the intravenous (IV) route. CMV—IGIV is primarily comprised of immunoglobulin G (IgG), specifically subclasses IgG1 and IgG3. Immunoglobulin catabolism occurs mainly in the plasma, however, the liver may also play a role Label.
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 3.
- Route of elimination
Not Available
- Half-life
IgG1 has a half-life of 23—25 days, whereas, the half-life of IgG3 is only 9 days 3.
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
CMV-IGIV is made from human plasma and, like other plasma products, carries the possibility for transmission of blood-borne viral agents and possibly, the Creutzfeldt-Jakob disease (CJD) prion. The risk of transmission of recognized blood-borne viruses is considered low due to the viral inactivation and removal properties in the Cohn-Oncley cold ethanol 4.
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 7.
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 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 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 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 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 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 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 3.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Human cytomegalovirus immune globulin. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Human cytomegalovirus immune globulin. Aducanumab The risk or severity of adverse effects can be increased when Aducanumab is combined with Human cytomegalovirus immune globulin. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Human cytomegalovirus immune globulin. Alirocumab The risk or severity of adverse effects can be increased when Alirocumab is combined with Human cytomegalovirus immune globulin. - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Cytogam Liquid 50 mg/1mL Intravenous Csl Behring 2009-01-06 2009-01-06 US 
Cytogam Liquid 2500 mg/50mL Intravenous Kamada Ltd. 2023-06-01 Not applicable US Cytogam Liquid 50 mg/1mL Intravenous Csl Behring 2009-01-06 2024-01-10 US Cytogam Liquid 50 mg/1mL Intravenous Saol Therapeutics Inc. 2020-10-30 2024-01-10 US Cytogam Solution 2500 mg/1 Intravenous Ki Biopharma Llc 2000-04-25 Not applicable Canada 
Categories
- ATC Codes
- J06BB09 — Cytomegalovirus immunoglobulin
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Antibodies
- Antiinfectives for Systemic Use
- Blood Proteins
- Globulins
- Human Immunoglobulin G
- Immune Sera and Immunoglobulins
- Immunization, Passive
- Immunoglobulin G
- Immunoglobulin Isotypes
- Immunoglobulins
- Immunoproteins
- Passively Acquired Immunity
- Proteins
- Serum
- Serum Globulins
- Specific Immunoglobulins
- Virus Neutralization
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
- Humans
Chemical Identifiers
- UNII
- 129L90A25N
- CAS number
- 339086-15-6
References
- General References
- Vancikova Z, Dvorak P: Cytomegalovirus infection in immunocompetent and immunocompromised individuals--a review. Curr Drug Targets Immune Endocr Metabol Disord. 2001 Aug;1(2):179-87. [Article]
- Cytomegalovirus Immune Globulin (Intravenous-Human) [Link]
- Cytomegalovirus Immune globulin [Link]
- Roche Document [Link]
- Cytomegalovirus infection in immunosuppressed patients after kidney transplantation [Link]
- Up to date, cytomegalovirus [Link]
- Monograph for Cytogam [Link]
- External Links
- FDA label
- Download (92.5 KB)
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample data4 Completed Prevention Cytomegalovirus Disease 1 somestatus stop reason just information to hide 4 Completed Treatment End Stage Renal Disease (ESRD) 1 somestatus stop reason just information to hide 3 Completed Prevention Cytomegalovirus Congenital Infection / Maternal Cytomegalovirus Infections 1 somestatus stop reason just information to hide 3 Completed Prevention Renal Failure, Chronic Renal Failure 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Liquid Intravenous 2500 mg/50mL Liquid Intravenous 50 mg/1mL Solution Intravenous 2500 mg/1 Injection, solution Parenteral 50 mg/ml Injection, solution Intravenous 100 U/ML Injection, solution Parenteral 1000 U. Injection, solution Parenteral 2500 U. Injection, solution Parenteral 500 U. Injection Intravenous 100 U/ml Powder, for solution Intravenous - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Drug created at September 08, 2017 20:22 / Updated at July 18, 2023 22:57