AREXVY- respiratory syncytial visus vaccine recombinant, adjuvanted kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RECOMBINANT RESPIRATORY SYNCYTIAL VIRUS PRE-FUSION F PROTEIN (UNII: M739EB7427) (RECOMBINANT RESPIRATORY SYNCYTIAL VIRUS PRE-FUSION F PROTEIN - UNII:M739EB7427)

Available from:

GlaxoSmithKline Biologicals SA

Therapeutic indications:

AREXVY is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older. Do not administer AREXVY to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of AREXVY [see Description (11)] . Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. AREXVY is not approved for use in persons <60 years of age. In a clinical study that enrolled pregnant individuals who received an investigational unadjuvanted RSV vaccine that contained the same RSVPreF3 antigen as AREXVY, an increase in preterm births was observed compared to pregnant individuals who received placebo (sucrose reconstituted with saline). Data In a randomized controlled clinical trial that enroll

Product summary:

AREXVY is supplied as 2 components: A single-dose vial of lyophilized antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid) (packaged without syringes or needles). Presentation Carton NDC Number Components Adjuvant Suspension Component (liquid) Lyophilized Antigen Component (powder) Outer carton of 10 doses 58160-848-11 10 vials NDC 58160-744-03 10 vials NDC 58160-723-03 Adjuvant suspension component vials: Store refrigerated between 2°C and 8°C (36°F and 46°F). Store in the original package in order to protect vials from light. Do not freeze. Discard if the adjuvant suspension component has been frozen. Lyophilized antigen component vials: Store refrigerated between 2°C and 8°C (36°F and 46°F). Store in the original package in order to protect vials from light. Do not freeze. Discard if the antigen component has been frozen.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

AREXVY- RESPIRATORY SYNCYTIAL VISUS VACCINE RECOMBINANT, ADJUVANTED
GLAXOSMITHKLINE BIOLOGICALS SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AREXVY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AREXVY.
AREXVY (RESPIRATORY SYNCYTIAL VIRUS VACCINE, ADJUVANTED) SUSPENSION
FOR INTRAMUSCULAR
INJECTION
INITIAL U.S. APPROVAL: 2023
INDICATIONS AND USAGE
AREXVY is a vaccine indicated for active immunization for the
prevention of lower respiratory tract disease
(LRTD) caused by respiratory syncytial virus in individuals 60 years
of age and older. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR ADMINISTRATION ONLY.
Administer a single dose (0.5 mL) as an intramuscular injection. (2.1)
DOSAGE FORMS AND STRENGTHS
Suspension for injection supplied as a single-dose vial of lyophilized
antigen component to be
reconstituted with the accompanying vial of adjuvant suspension
component. A single dose after
reconstitution is 0.5 mL. (3)
CONTRAINDICATIONS
History of severe allergic reaction (e.g., anaphylaxis) to any
component of the vaccine. (4)
ADVERSE REACTIONS
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
VAERS AT 1-800-822-7967 OR WWW.VAERS.HHS.GOV.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose and Schedule
2.2 Preparation
2.3 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Preventing and Managing Allergic Vaccine Reactions
5.2 Syncope
5.3 Altered Immunocompetence
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
The most commonly reported solicited local adverse reaction (≥10%)
was injection site pain (60.9%).
(6.1)
The most commonly reported solicited systemic adverse reactions
(≥10%) were fatigue (33.6%),
myalgia (28.9%), headache (27.2%), and arthralgia (18.1%). (6.1)
8.2 Lactation
8.4 Pe