Human Varicella-Zoster Immune Globulin

Identification

Name
Human Varicella-Zoster Immune Globulin
Accession Number
DB11621
Description

Human Varicella-Zoster Immune Globulin is a solvent/detergent-treated sterile liquid preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus (anti-VZV). It is prepared from pools of healthy human donors' plasma via anion-exchange column chromatography and was approved in 2012 under the name VariZIG to reduce the disease severity in high-risk patients who lack evidence of immunity to varicella and for whom varicella vaccine is contraindicated. The therapeutic efficacy is proven if administered within 4 days of exposure to varicella zoster virus.

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Polyclonal antibody (pAb)
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
  • Human herpesvirus 3 immune globulin
  • Varicella zoster immune globulin
  • Varicella zoster immune globulin (human)
  • Varicella zoster immune globulin human
  • Varicella zoster immunoglobulin (human)
  • Varicella-zoster immune globulin
  • Varicella-zoster immune globulin human
  • VZV immune globulin

Pharmacology

Indication

Indicated for preventing and reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals within 4 days of exposure to varicella zoster virus.

Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics

Varicella zoster immune globuline provides passive immunization for non-immune individuals exposed to VZV, reducing the severity of varicella infections.

Mechanism of action

Immunoglobulins are derived from human plasma and synthesized from plasma cells that recognize a broad spectrum of specific antigenic determinants 6. Derived from a pool of healthy human plasma, Human Varicella-Zoster Immune Globulin is a solvent/detergent-treated sterile lyophilized preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus. The anti-VZV antibodies in VariZIG™ are thought to bind to proteins on the varicella virus; thereby, preventing or reducing the severity and progression of varicella infections.

Absorption

Intravenous administration of varicella zoster antibodies tends to persist for 6 weeks or longer. Following intramuscular administration of varicella immune globulin products, varicella antibodies are detectable within 2-3 days. The peak levels of varicella antibodies is expected to occur within 3-7 days of VariZIG administration.

Volume of distribution

Following intravenous administration of varicella zoster VZIG, anti-varicella zoster antibodies are expected to be quickly distributed between plasma and extravascular spaces with complete and immediate bioavailability. Intramuscular administration achieves nearly 100% bioavailability.

Protein binding
Not Available
Metabolism

Immune globulins are metabolized in the reticuloendothelial system.

Route of elimination
Not Available
Half-life

Human Varicella-Zoster Immunoglobulin has a half-life of about 18-24 days following intravenous administration and 24-30 days following intramuscular administration.

Clearance
Not Available
Adverse Effects
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Toxicity

Since the drug was prepared from human plasma pool, it may contain other infectious agents such as viruses and Creutzfeldt-Jakob disease (vCJD) agent. Hypersensitivity reactions such as allergic or anaphylactic reactions may occur. More common adverse effects include pain at injection site, headache, and rash. Rare adverse effects from immune globulin intravenous therapy include thrombotic events, renal dysfunction and acute renal failure, and noncardiogenic pulmonary edema. An LD50 was not determined, as the maximal dose used did not kill any experimental animals.

Affected organisms
Not Available
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 Varicella-Zoster Immune Globulin.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Human Varicella-Zoster Immune Globulin.
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Human Varicella-Zoster Immune Globulin.
AlirocumabThe risk or severity of adverse effects can be increased when Alirocumab is combined with Human Varicella-Zoster Immune Globulin.
Anthrax immune globulin humanThe risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Human Varicella-Zoster Immune Globulin.
Antilymphocyte immunoglobulin (horse)The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Human Varicella-Zoster Immune Globulin.
Antithymocyte immunoglobulin (rabbit)The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Human Varicella-Zoster Immune Globulin.
Asfotase alfaThe risk or severity of adverse effects can be increased when Asfotase alfa is combined with Human Varicella-Zoster Immune Globulin.
AtezolizumabThe risk or severity of adverse effects can be increased when Atezolizumab is combined with Human Varicella-Zoster Immune Globulin.
AvelumabThe risk or severity of adverse effects can be increased when Human Varicella-Zoster Immune Globulin is combined with Avelumab.
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

    An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions
Not Available

Products

Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Varicella Zoster Immune Globulin InjLiquidIntramuscularMassachusetts Public Health Biologic Laboratories1982-01-262000-11-13Canada
Varicella-zoster Immune Globulin (human)LiquidIntramuscularMassachusetts Public Health Biologic Laboratories2000-07-242007-06-19Canada
VariZigSolution125 [iU]/1mLIntramuscularSaol Therapeutics Inc.2019-03-01Not applicableUs
VariZigKit125 unitIntramuscular; IntravenousCangene Corporation A Subsidiary Of Emergent Biosolutions Inc.2006-02-132016-08-02Canada
VarizigKit125 [iU]/1mLIntramuscularCangene Biopharma2013-02-262013-02-26Us
VarizigLiquid1.25 [iU]/1mLIntramuscularCangene Biopharma2015-05-22Not applicableUs
VarizigSolution125 [iU]/1IntramuscularAptevo Biotherapeutics Llc2016-07-01Not applicableUs
VariZigSolution125 unitIntramuscular; IntravenousSaol Therapeutics Research Limited2015-08-14Not applicableCanada
Additional Data Available
  • Application Number
    Application Number

    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

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

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Categories

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
33T61IWL27
CAS number
Not Available

References

General References
  1. Zaia JA, Levin MJ, Preblud SR, Leszczynski J, Wright GG, Ellis RJ, Curtis AC, Valerio MA, LeGore J: Evaluation of varicella-zoster immune globulin: protection of immunosuppressed children after household exposure to varicella. J Infect Dis. 1983 Apr;147(4):737-43. [PubMed:6341478]
  2. Murguia-de-Sierra T, Villa-Guillen M, Villanueva-Garcia D, Molina A, Juarez-Chavez A, Leistikow EA: Varicella zoster virus antibody titers after intravenous zoster immune globulin in neonates, and the safety of this preparation. Acta Paediatr. 2005 Jun;94(6):790-3. [PubMed:16188790]
  3. Andrei G, Snoeck R: Advances in the treatment of varicella-zoster virus infections. Adv Pharmacol. 2013;67:107-68. doi: 10.1016/B978-0-12-405880-4.00004-4. [PubMed:23886000]
  4. Authors unspecified: Varicella-zoster immune globulin for the prevention of chickenpox. Recommendations of the Immunization Practices Advisory Committee, Centers for Disease Control. Ann Intern Med. 1984 Jun;100(6):859-65. [PubMed:6326634]
  5. Authors unspecified: Updated recommendations for use of VariZIG--United States, 2013. MMWR Morb Mortal Wkly Rep. 2013 Jul 19;62(28):574-6. [PubMed:23863705]
  6. Fernandez-Cruz E, Alecsandru D, Sanchez Ramon S: Mechanisms of action of immune globulin. Clin Exp Immunol. 2009 Sep;157 Suppl 1:1-2. doi: 10.1111/j.1365-2249.2009.03955.x. [PubMed:19630862]
  7. Sewell WAC and Jolles S: Immunomodulatory action of intravenous immunoglobulin Immunology. 2002 December 1;107(4):387-393.
  8. DRUGS.COM [Link]
  9. Virizig [Link]
PubChem Substance
347911219
RxNav
39385
Wikipedia
VZV_immune_globulin
AHFS Codes
  • 80:04.00 — Serums
FDA label
Download (182 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
Not AvailableApproved for MarketingNot AvailableVaricella1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
LiquidIntramuscular
KitIntramuscular125 [iU]/1mL
KitIntramuscular; Intravenous125 unit
LiquidIntramuscular1.25 [iU]/1mL
SolutionIntramuscular125 [iU]/1
SolutionIntramuscular125 [iU]/1mL
SolutionIntramuscular; Intravenous125 unit
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Drug created on September 06, 2016 14:50 / Updated on August 04, 2020 17:13

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