Rx Item-Arexvy RSV PreF3 antigen/AS01E/PF IM Vaccine 120 MCG KIT 10 DOSEBy Glaxo

Clinical Information
Gen. Code and Des.
84744 RSVPreF3 antigen/AS01E/PF INTRAMUSC KIT 120MCG/0.5
GCN and Des.
54118 RSVPreF3 antigen/AS01E/PF INTRAMUSC KIT 120MCG/0.5
Strength
120MCG
Dose Form
KIT
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
80120000 VACCINES
Active Ingredients
19408 vaccine adjuvant system, AS01E liposomal
19409 respiratory syncytial virus vaccine, antigen
9870 preservative free

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

•
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)

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

Arexvy RSV PreF3 antigen/AS01E
AREXVY- respiratory syncytial visus vaccine recombinant, adjuvanted kit AREXVY- respiratory syncytial visus vaccine recombinant, adjuvanted kit Item No.: RX739141 739141 NDC No.58160-0848-11 58160-8

Arexvy RSV PreF3 antigen/AS01E
AREXVY- respiratory syncytial visus vaccine recombinant, adjuvanted kit AREXVY- respiratory syncytial visus vaccine recombinant, adjuvanted kit Item No.: RX739141 739141 NDC No.58160-0848-11 58160-8

Arexvy RSV PreF3 antigen/AS01E
AREXVY- respiratory syncytial visus vaccine recombinant, adjuvanted kit AREXVY- respiratory syncytial visus vaccine recombinant, adjuvanted kit Item No.: RX739141 739141 NDC No.58160-0848-11 58160-8

Rotarix 10E6 Ml Suspension 10X1Ml By Gla
Item No.: RX750469 750469 NDC No.58160-0740-21 58160-0740-21 58160-0740-21 58160-0740-21 UPC No.:3-58160-74021-3 358160740213 3-58160-74021-3 MPN 74021

ROTAVIRUS VAC,LIVE ATT, 8
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