Vaccine Information: Arexvy (Page 3 of 3)

14.2 Concomitant Administration

In Study 3 (NCT04841577), an open-label, Phase 3, clinical study conducted in New Zealand, Panama, and South Africa, participants 60 years of age and older received 1 dose of AREXVY and FLUARIX QUADRIVALENT at Month 0 (n = 442) or 1 dose of FLUARIX QUADRIVALENT at Month 0 followed by a dose of AREXVY at Month 1 (n = 443).

There was no evidence for interference in the immune response to any of the antigens contained in both concomitantly administered vaccines. The criteria for non-inferiority of the immune responses in the control versus “co-administration” group were met as the 2-sided 95% confidence interval upper limits on the group geometric mean titer ratios were below 1.5 for the RSV-A neutralizing antibodies and haemagglutinin inhibition antibodies against the strains Flu A/Hong Kong/H3N2, Flu A/Victoria/H1N1, Flu B/Phuket/Yamagata, and Flu B/Washington/Victoria.

Data are not available for concomitant administration with other vaccines.

16 HOW SUPPLIED/STORAGE AND HANDLING

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).

Table 3: Product Presentation for AREXVY

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

16.1 Storage before Reconstitution

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.

16.2 Storage after Reconstitution

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Administer immediately or store in the refrigerator between 2°C and 8°C (36°F to 46°F) or at room temperature [up to 25°C (77°F)] for up to 4 hours prior to use.

•

Protect vials from light.

•

Discard reconstituted vaccine if not used within 4 hours.

•

Do not freeze. Discard if the vaccine has been frozen.

17 PATIENT COUNSELING INFORMATION

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Inform vaccine recipients of the potential benefits and risks of vaccination with AREXVY.

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Inform vaccine recipients about the potential for adverse reactions that have been observed following administration of AREXVY.

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Provide the Vaccine Information Statements, which are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Trademarks are owned by or licensed to the GSK group of companies.

Manufactured by GlaxoSmithKline Biologicals
Rixensart, Belgium, U.S. License 1617, and
Distributed by GlaxoSmithKline
Durham, NC 27701

©2023 GSK group of companies or its licensor.
ARV:1PI

PRINCIPAL DISPLAY PANEL

NDC 58160-848-11

AREXVY

Respiratory Syncytial Virus Vaccine, Adjuvanted

Rx only

For 60 Years of Age and Older

Contents (10 doses fo AREXVY):

10 Vials containing Adjuvant Suspension Component

10 Vials containing Lyophilized Antigen Component

After reconstitution, a single dose of AREXVY is 0.5 mL

GSK

AREXVY

Adjuvant and Antigen Made in Belgium

©2023 GSK group of companies or its licensor.

Rev. 04/23

513500

(click image for full-size original)

Arexvy 10 dose carton

PRINCIPAL DISPLAY PANEL (Antigen)

NDC 58160-723-03

Lyophilized Antigen Component

Vial 2 of 2

NOT TO BE USED ALONE

Reconstitute with Adjuvant Suspension Component to form Respiratory Syncytial Virus Vaccine, Adjuvanted (AREXVY)

0.5-mL Single Dose After Reconstitution

Mfd. By GlaxoSmithKline Biologicals

Rev 04/23

513499

PRINCIPAL DISPLAY PANEL (Antigen)

NDC 58160-744-03

Adjuvant Suspension Component

Vial 1 of 2

NOT TO BE USED ALONE

Add to 1 vial of Lyophilized Antigen Component to form Arexvy

Mft. By GlaxoSmithKline Biologicals

Rev 04/23

513531

AREXVY respiratory syncytial visus vaccine recombinant, adjuvanted kit

Product Information Product Type VACCINE Item Code (Source) NDC:58160-848

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58160-848-11 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 10 VIAL 5 mL Part 2 10 VIAL 5 mL

Part 1 of 2 ANTIGEN respiratory syncytial virus glycoprotein f injection, powder, lyophilized, for suspension

Product Information Item Code (Source) NDC:58160-723 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RECOMBINANT RESPIRATORY SYNCYTIAL VIRUS PRE-FUSION F PROTEIN (RECOMBINANT RESPIRATORY SYNCYTIAL VIRUS PRE-FUSION F PROTEIN) RECOMBINANT RESPIRATORY SYNCYTIAL VIRUS PRE-FUSION F PROTEIN 120 ug in 0.5 mL

Inactive Ingredients Ingredient Name Strength TREHALOSE DIHYDRATE POLYSORBATE 80 POTASSIUM PHOSPHATE, MONOBASIC DIBASIC POTASSIUM PHOSPHATE

Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58160-723-03 0.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125775 05/03/2023

Part 2 of 2 ADJUVANT as01 inhalant

Product Information Item Code (Source) NDC:58160-744 Route of Administration INTRAMUSCULAR DEA Schedule

Inactive Ingredients Ingredient Name Strength MONOPHOSPHORYL LIPID A TRIETHYLAMINE SALT QS-21 1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE CHOLESTEROL SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS POTASSIUM PHOSPHATE, MONOBASIC WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58160-744-03 0.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125775 05/03/2023

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125775 05/03/2023

Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 05/2023 GlaxoSmithKline Biologicals SA