Respiratory syncytial virus vaccine, adjuvanted

Identification

Summary

Respiratory syncytial virus vaccine, adjuvanted is an adjuvanted respiratory syncytial virus vaccine in older adults.

Brand Names
Arexvy
Generic Name
Respiratory syncytial virus vaccine, adjuvanted
DrugBank Accession Number
DB17762
Background

Arexvy (respiratory syncytial virus vaccine, adjuvanted) is an adjuvanted vaccine developed by GlaxoSmithKline Biologicals. It comprises lyophilized recombinant respiratory syncytial virus glycoprotein F (RSVPreF3) stabilized in pre-fusion conformation as the antigen component, which is reconstituted at the time of use with the accompanying vial of AS01E adjuvant as the adjuvant suspension component.2

On May 3, 2023, it was approved by the FDA for immunization against lower respiratory tract disease (LRTD) as the first respiratory syncytial virus (RSV) vaccine approved in the United States.3 It was also later approved by Health Canada on August 4, 2023.5

Type
Biotech
Groups
Approved
Biologic Classification
Vaccines
Other vaccines
Synonyms
  • GSK 3844766A
  • GSK-3844766A
  • RECOMBINANT RESPIRATORY SYNCYTIAL VIRUS PRE-FUSION F PROTEIN
  • RESPIRATORY SYNCYTIAL VIRUS PREFUSION F PROTEIN (RSVPREF3)
  • RSVPreF3 OA
  • RSVPreF3 OA vaccine

Pharmacology

Indication

Arexvy is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older by the FDA and Health Canada.2,4

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Prevention ofLower respiratory tract infection (lrti)•••••••••••••••••• ••••••••••••••••• ••••••• •••••••••••• ••• ••••••••••
Prevention ofLower respiratory tract infection (lrti)•••••••••••••••••• •••••••••••••••••
Associated Therapies
Contraindications & Blackbox Warnings
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Pharmacodynamics

GSK-3844766A is a vaccine used to prevent lower respiratory tract disease caused by RSV infection.2 Because GSK3844766A is a subunit vaccine, it requires adjuvants for maximal effectiveness.1

Mechanism of action

Respiratory tract infections caused by RSV can be severe in high-risk populations, such as infants and elderly patients. Immunization remains one of the key preventative measures against RSV infection.1

GSK-3844766A is an adjuvanted vaccine consisting of an antigen (RSVPreF3), which induces a CD4 T cell response against RSV glycoprotein F stabilized in pre-fusion conformation, and the AS01E adjuvant, which stabilizes the antigen.1,2

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

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 GSK-3844766A can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of GSK-3844766A can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of GSK-3844766A can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of GSK-3844766A can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of GSK-3844766A can be decreased when used in combination with Alemtuzumab.
Food Interactions
No interactions found.

Products

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International/Other Brands
Arexvy (GlaxoSmithKline Biologicals)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
ArexvyPowder, for suspension120 mcg / 0.5 mLIntramuscularGlaxosmithkline Inc2023-09-06Not applicableCanada flag
ArexvyInjection, powder, lyophilized, for suspension; Kit120 ug/0.5mLIntramuscularGlaxoSmithKline Biologicals SA2023-05-03Not applicableUS flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
Not Available
CAS number
Not Available

References

General References
  1. Biagi C, Dondi A, Scarpini S, Rocca A, Vandini S, Poletti G, Lanari M: Current State and Challenges in Developing Respiratory Syncytial Virus Vaccines. Vaccines (Basel). 2020 Nov 11;8(4):672. doi: 10.3390/vaccines8040672. [Article]
  2. FDA Approved Drug Products: AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) suspension for intramuscular injection [Link]
  3. FDA News Release: FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine [Link]
  4. Health Canada Approved Drug Proucts: AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) Lyophilized Powder and Suspension for intramuscular injection [Link]
  5. GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults approved in Canada [Link]
RxNav
2636588

Clinical Trials

Clinical Trials

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, powder, lyophilized, for suspension; kitIntramuscular120 ug/0.5mL
Powder, for suspensionIntramuscular120 mcg / 0.5 mL
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Drug created at May 09, 2023 16:30 / Updated at January 13, 2024 23:36