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
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 Prevention of Lower respiratory tract infection (lrti) •••••••••••• •••••• ••••••• •••••••••• ••••••• •••••••••••• ••• •••••••••• Prevention of Lower 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
- 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
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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbatacept The therapeutic efficacy of GSK-3844766A can be decreased when used in combination with Abatacept. Adalimumab The therapeutic efficacy of GSK-3844766A can be decreased when used in combination with Adalimumab. Aldesleukin The therapeutic efficacy of GSK-3844766A can be decreased when used in combination with Aldesleukin. Alefacept The therapeutic efficacy of GSK-3844766A can be decreased when used in combination with Alefacept. Alemtuzumab The therapeutic efficacy of GSK-3844766A can be decreased when used in combination with Alemtuzumab. - 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.
- International/Other Brands
- Arexvy (GlaxoSmithKline Biologicals)
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Arexvy Powder, for suspension 120 mcg / 0.5 mL Intramuscular Glaxosmithkline Inc 2023-09-06 Not applicable Canada Arexvy Injection, powder, lyophilized, for suspension; Kit 120 ug/0.5mL Intramuscular GlaxoSmithKline Biologicals SA 2023-05-03 Not applicable US
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- Not Available
- CAS number
- Not Available
References
- General References
- 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]
- FDA Approved Drug Products: AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) suspension for intramuscular injection [Link]
- FDA News Release: FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine [Link]
- Health Canada Approved Drug Proucts: AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) Lyophilized Powder and Suspension for intramuscular injection [Link]
- GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults approved in Canada [Link]
- External Links
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Recruiting Basic Science Coronavirus Disease 2019 (COVID‑19) / Lymphoma 1 3 Active Not Recruiting Prevention Respiratory Syncytial Virus (RSV) Infection 4 3 Active Not Recruiting Prevention Respiratory Syncytial Virus (RSV) / Respiratory Syncytial Virus (RSV) Infection 1 3 Completed Prevention Respiratory Syncytial Virus (RSV) Infection 4 2 Completed Prevention Respiratory Syncytial Virus (RSV) Infection 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, lyophilized, for suspension; kit Intramuscular 120 ug/0.5mL Powder, for suspension Intramuscular 120 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