Vaccine Information: Shingrix (Page 4 of 4)

14.4 Immunological Evaluation to Support Dosing Schedule

A measure of the immune response that confers protection against HZ is unknown. Anti-gE antibody levels were measured by anti-gE enzyme-linked immunosorbent assay (gE ELISA) and were used to support the dosing schedule.

In an open-label clinical study, 238 subjects 50 years and older received SHINGRIX on either a 0- and 2-month or 0- and 6-month schedule. Non-inferiority of the 0- and 6-month schedule compared with the 0- and 2-month schedule based on anti-gE ELISA GMCs 1 month after the second dose was demonstrated.

14.5 Concomitant Administration with Influenza Vaccine

In an open-label clinical study, subjects 50 years and older received 1 dose each of SHINGRIX and FLUARIX QUADRIVALENT (QIV) at Month 0 and 1 dose of SHINGRIX at Month 2 (n = 413), or 1 dose of QIV at Month 0 and 1 dose of SHINGRIX at Months 2 and 4 (n = 415). There was no evidence for interference in the immune response to any of the antigens contained in SHINGRIX or the coadministered vaccine.

16 HOW SUPPLIED/STORAGE AND HANDLING

SHINGRIX is supplied as 2 components: A single-dose vial of lyophilized gE antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid) (packaged without syringes or needles).

Table 6: Product Presentations for SHINGRIX

Presentation

Carton NDC Number

Components

Adjuvant Suspension Component (liquid)

Lyophilized gE Antigen Component (powder)

An outer carton of 1 dose

58160-819-12

Vial 1 of 2

NDC 58160-829-01

Vial 2 of 2

NDC 58160-828-01

An outer carton of 10 doses

58160-823-11

10 vials

NDC 58160-829-03

10 vials

NDC 58160-828-03

16.1 Storage before Reconstitution

Adjuvant suspension component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light. Do not freeze. Discard if the adjuvant suspension has been frozen.

Lyophilized gE antigen component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light. Do not freeze. Discard if the antigen component has been frozen.

16.2 Storage after Reconstitution

Administer immediately or store refrigerated between 2° and 8°C (36° and 46°F) for up to 6 hours prior to use.
Discard reconstituted vaccine if not used within 6 hours.
Do not freeze. Discard if the vaccine has been frozen.

17 PATIENT COUNSELING INFORMATION

Inform patients of the potential benefits and risks of immunization with SHINGRIX and of the importance of completing the 2-dose immunization series according to the schedule.
Inform patients about the potential for adverse reactions that have been temporally associated with administration of SHINGRIX.
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

Research Triangle Park, NC 27709

©2019 GSK group of companies or its licensor.

SHX:4PI

gE Recombinant Varicella Zoster Virus (VZV) glycoprotein E

Label ImageLabel Image
SHINGRIX
zoster vaccine recombinant, adjuvanted kit
Product Information
Product Type VACCINE Item Code (Source) NDC:50090-5147(NDC:58160-819)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5147-0 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 VIAL 1 mL
Part 2 2 VIAL 1 mL
Part 1 of 2
SHINGRIX
ge recombinant varicella zoster virus (vzv) glycoprotein e injection, powder, lyophilized, for suspension
Product Information
Item Code (Source) NDC:58160-828
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN (RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN) RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN 50 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
POLYSORBATE 80
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
DIBASIC POTASSIUM PHOSPHATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-828-01 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Part 2 of 2
AS01B
as01b suspension
Product Information
Item Code (Source) NDC:58160-829
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
MONOPHOSPHORYL LIPID A
QS-21
DIOLEOYLPHOSPHATIDYLCHOLINE, DL-
CHOLESTEROL
POTASSIUM PHOSPHATE, MONOBASIC
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-829-01 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5147)

Revised: 10/2020 A-S Medication Solutions

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