Human rabies virus immune globulin

Identification

Name
Human rabies virus immune globulin
Accession Number
DB11603
Description

IMOGAM Rabies Pasteurized is indicated for post-exposure prophylaxis in persons suspected of exposure to rabies, who have not previously received a complete immunization regimen with a cell culture produced rabies vaccine.

Persons previously vaccinated with other types of rabies vaccines in whom adequate antibody levels have not been demonstrated should receive full post-exposure prophylaxis with RIG and a cell culture-produced rabies vaccine.

IMOGAM Rabies Pasteurized should be administered promptly after exposure, in conjunction with rabies vaccine. If IMOGAM Rabies Pasteurized is not administered as recommended at the initiation of the post-exposure rabies vaccine series, it can be administered up to eight days following the first dose of the rabies vaccine. Since rabies vaccine-induced antibody begins to appear within one week, there is no value in administering rabies immune globulin more than eight days after rabies vaccination has begun.

Recommendations for passive and/or active immunization after exposure to an animal suspected of having rabies have been outlined by the National Advisory Committee on Immunization (NACI), the Advisory Committee on Immunization Practices (ACIP), and the World Health Organization (WHO).

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
  • Rabies immune globulin
  • Rabies immune globulin (human)
  • Rabies immune globulin human
  • Rabies immune globulin, human
  • Rabies immune globulin,human
  • Rabies immunoglobulin (human)
  • Rabies immunoglobulins

Pharmacology

Indication

For use in prophylaxis against rabies virus in patients who have been exposed to the virus and are immunocompromised or have not previously recieved the rabies vaccine [FDA Label].

Associated Therapies
Contraindications & Blackbox Warnings
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Pharmacodynamics

Rabies immune globulin prevents viral invasion of the central nervous system.

Mechanism of action

Rabies immune globulin binds the rabies virus, preventing it from invading the central nervous system [FDA Label]. This affords time for the rabies vaccine, which is also administered in cases of rabies exposure, to induce an immune response to destroy the virus. Rabies immunoglobulin should only be administered up to eight days after exposure as the host begins to produce sufficient antibodies to the virus one week after exposure. Repeat dosing should also be avoided as it may interfere with induction of immune response by the rabies vaccine.

TargetActionsOrganism
ARabies Virus Proteins
antibody
Rabies virus (strain Pasteur vaccins / PV)
Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half-life
Not Available
Clearance
Not Available
Adverse Effects
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Toxicity

No toxicological studies have been performed. Isolated cases of angioneurotic edema, skin rash, nephrotic syndrome, and anaphylactic shock after injection have been noted [FDA Label].

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
AbataceptThe therapeutic efficacy of Human rabies virus immune globulin can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of Human rabies virus immune globulin can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of Human rabies virus immune globulin can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Human rabies virus immune globulin can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Human rabies virus immune globulin can be decreased when used in combination with Alemtuzumab.
AltretamineThe therapeutic efficacy of Human rabies virus immune globulin can be decreased when used in combination with Altretamine.
AmsacrineThe therapeutic efficacy of Human rabies virus immune globulin can be decreased when used in combination with Amsacrine.
AnakinraThe therapeutic efficacy of Human rabies virus immune globulin can be decreased when used in combination with Anakinra.
Antilymphocyte immunoglobulin (horse)The therapeutic efficacy of Human rabies virus immune globulin can be decreased when used in combination with Antilymphocyte immunoglobulin (horse).
Antithymocyte immunoglobulin (rabbit)The therapeutic efficacy of Human rabies virus immune globulin can be decreased when used in combination with Antithymocyte immunoglobulin (rabbit).
Additional Data Available
  • Extended Description
    Extended Description
    Available for Purchase

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

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

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

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  • Action
    Action
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Food Interactions
Not Available

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Hyperab Rabies Immune Globulin HumanLiquidIntramuscularCutter Med & Biol, Division Of Miles Canada Ltd.1985-12-311998-09-25Canada flag
HyperRABSolution300 unitIntramuscularGrifols Therapeutics Llc2019-07-02Not applicableCanada flag
HyperRABInjection, solution300 [iU]/1mLInfiltration; IntramuscularGRIFOLS USA, LLC1974-06-12Not applicableUS flag
Hyperrab S/dInjection150 [iU]/1mLIntramuscularGRIFOLS USA, LLC1996-08-14Not applicableUS flag
Hyperrab S/dSolution150 unitIntramuscularGrifols Therapeutics Llc1997-10-09Not applicableCanada flag
Imogam Rabies Inj 150unit/mlLiquidIntramuscularPasteur mÉrieux Serums Et Vaccins, s.a.1991-12-311999-08-12Canada flag
Imogam Rabies PasteurizedSolutionIntramuscularSanofi Pasteur Limited1999-04-30Not applicableCanada flag
Imogam Rabies-HTInjection, solution150 [iU]/1mLIntramuscularSanofi Pasteur Inc.1984-04-27Not applicableUS flag
KamrabSolutionIntramuscularKamada Ltd2020-04-06Not applicableCanada flag
KamrabSolutionIntramuscularKamada LtdNot applicableNot applicableCanada 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

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
95F619ATQ2
CAS number
Not Available

References

General References
Not Available
PubChem Substance
347911213
RxNav
89886
AHFS Codes
  • 80:04.00 — Serums
  • 80:12.00 — Vaccines

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedBasic ScienceRabies2
4RecruitingTreatmentPrimary Immune Deficiency (PID)1
4WithdrawnPreventionVirus Diseases1
3Active Not RecruitingPreventionVirus Diseases1
3CompletedPreventionChildren, Only / Malaria caused by Plasmodium falciparum1
3CompletedPreventionPlasmodium Infections1
3CompletedPreventionRabies Infection1
3CompletedPreventionRabies Prevention1
3RecruitingPreventionRabies (Healthy Volunteers)3
3RecruitingTreatmentRabies1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solution1500 iu/10mL
Injection, solution300 iu/2mL
Injection, solutionIntramuscular135 mg/ml
SolutionIntramuscular; Subcutaneous1000 iu/5ml
Injection, solution750 iu/5mL
Injection, solutionInfiltration; Intramuscular300 [iU]/1mL
SolutionIntramuscular300 unit
InjectionIntramuscular150 [iU]/1mL
SolutionIntramuscular150 unit
LiquidIntramuscular
SolutionIntramuscular
Injection, solutionIntramuscular150 [iU]/1mL
Powder, for solutionIntramuscular2.5 IU/mL
Injection, powder, for solutionIntramuscular1 ml
Injection, powder, for solutionIntramuscular2.5 IU
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Targets

Kind
Protein group
Organism
Rabies virus (strain Pasteur vaccins / PV)
Pharmacological action
Yes
Actions
Antibody
General Function
Attaches the virus to host cellular receptor, inducing endocytosis of the virion. In the endosome, the acidic pH induces conformational changes in the glycoprotein trimer, which trigger fusion between virus and cell membrane. There is convincing in vitro evidence that the muscular form of the nicotinic acetylcholine receptor (nAChR), the neuronal cell adhesion molecule (NCAM), and the p75 neurotrophin receptor (p75NTR) bind glycoprotein and thereby facilitate rabies virus entry into cells (By similarity).
Specific Function
Not Available

Components:
References
  1. Sikes RK: Human rabies immune globulin. Public Health Rep. 1969 Sep;84(9):797-801. [PubMed:4185138]
  2. Franka R, Carson WC, Ellison JA, Taylor ST, Smith TG, Kuzmina NA, Kuzmin IV, Marissen WE, Rupprecht CE: In Vivo Efficacy of a Cocktail of Human Monoclonal Antibodies (CL184) Against Diverse North American Bat Rabies Virus Variants. Trop Med Infect Dis. 2017 Sep 20;2(3). pii: tropicalmed2030048. doi: 10.3390/tropicalmed2030048. [PubMed:30270905]

Drug created on June 01, 2016 14:49 / Updated on November 25, 2020 08:53

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