Human cytomegalovirus immune globulin

Identification

Name
Human cytomegalovirus immune globulin
Accession Number
DB13886
Description

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 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.

Associated Conditions
Contraindications & Blackbox Warnings
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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
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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.

Affected organisms
  • Humans and other mammals
  • Humans
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.
DrugInteraction
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Human cytomegalovirus immune globulin.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Human cytomegalovirus immune globulin.
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Human cytomegalovirus immune globulin.
AlirocumabThe risk or severity of adverse effects can be increased when Alirocumab is combined with Human cytomegalovirus immune globulin.
Anthrax immune globulin humanThe risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Human cytomegalovirus immune globulin.
Antilymphocyte immunoglobulin (horse)The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Human cytomegalovirus immune globulin.
Antithymocyte immunoglobulin (rabbit)The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Human cytomegalovirus immune globulin.
Asfotase alfaThe risk or severity of adverse effects can be increased when Asfotase alfa is combined with Human cytomegalovirus immune globulin.
AtezolizumabThe risk or severity of adverse effects can be increased when Atezolizumab is combined with Human cytomegalovirus immune globulin.
AtoltivimabThe risk or severity of adverse effects can be increased when Human cytomegalovirus immune globulin is combined with Atoltivimab.
Additional Data Available
  • Extended Description
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    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity
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  • Evidence Level
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    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
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Food Interactions
Not Available

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
CytogamLiquid50 mg/1mLIntravenousCsl Behring Ag2009-01-062009-01-06US flag
CytogamSolution2500 mg/1IntravenousSaol Therapeutics Research Limited2000-04-25Not applicableCanada flag
CytogamLiquid50 mg/1mLIntravenousCsl Behring Ag2009-01-06Not applicableUS flag
CytogamLiquid50 mg/1mLIntravenousSaol Therapeutics Inc.2020-10-30Not applicableUS flag
Additional Data Available
  • Application Number
    Application Number
    Available for Purchase

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code
    Available for Purchase

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Categories

ATC Codes
J06BB09 — Cytomegalovirus immunoglobulin
Drug Categories
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

Chemical Identifiers

UNII
129L90A25N
CAS number
339086-15-6

References

General References
  1. 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. [PubMed:12476798]
  2. Cytomegalovirus Immune Globulin (Intravenous-Human) [Link]
  3. Cytomegalovirus Immune globulin [Link]
  4. Roche Document [Link]
  5. Cytomegalovirus infection in immunosuppressed patients after kidney transplantation [Link]
  6. Up to date, cytomegalovirus [Link]
  7. Monograph for Cytogam [Link]
PubChem Substance
347911455
RxNav
1997443
AHFS Codes
  • 80:04.00 — Serums
FDA label
Download (92.5 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedPreventionCytomegalovirus Disease1
4CompletedTreatmentEnd Stage Renal Disease (ESRD)1
3Active Not RecruitingPreventionCytomegalovirus Congenital Infection / Maternal Cytomegalovirus Infection1
3CompletedPreventionChronic Renal Failure (CRF)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
LiquidIntravenous50 mg/1mL
SolutionIntravenous2500 mg/1
Injection, solutionParenteral50 mg/ml
Injection, solution50 iu/1mL
Injection, solutionIntravenous100 U/ML
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Drug created on September 08, 2017 14:22 / Updated on November 25, 2020 15:48

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