Vaccine Information: PREHEVBRIO (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Single dose vial, 1.0 mL (NDC number 75052-001-01)

Supplied as a package of 10 single dose vials (NDC number: 75052-001-10)

The vial stoppers are not made with natural rubber latex.

16.2 Storage Conditions

Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light.

Do not freeze ; discard if the vaccine has been frozen.

Do not use the vaccine after the expiration date shown on the vial label.

17 PATIENT COUNSELING INFORMATION

• Inform vaccine recipient of the potential benefits and risks associated with vaccination with PREHEVBRIO, as well as the importance of completing the immunization series.
• Emphasize that PREHEVBRIO contains non-infectious purified HBsAg and cannot cause hepatitis B infection.
• Advise vaccine recipient to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 and www.vaers.hhs.gov.
• 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).

Manufactured by: VBI Vaccines Inc.
160 Second St., 3rd Floor, Cambridge, MA, USA, 02142
U.S. License No. 2219
©2021 VBI Vaccines. All rights reserved.

Principal Display Panel — 10 mcg/mL Carton Label

NDC 75052-001-10

Hepatitis B Vaccine
(Recombinant)

PreHevbrio

Rx only

For adults 18 years or older

10 mcg/mL

10 x 1 mL
single-dose vials

For
intramuscular
administration

VBI VACCINES

Principal Display Panel — 10 mcg/mL Vial Label

NDC 75052-001-01

Hepatitis B Vaccine (Recombinant)

PreHevbrio

For IM administration

Rx only

Storage:
2°C to 8°C

1
Dose (1 mL)

PREHEVBRIO hepatitis b vaccine (recombinant) injection, suspension

Product Information Product Type VACCINE Item Code (Source) NDC:75052-001 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC) (RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC)) RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC) 10 ug in 1 mL RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM M/SCI-B-VAC) (RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC)) RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC) 10 ug in 1 mL RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM L /SCI-B-VAC) (RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC)) RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC) 10 ug in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 8450 ug in 1 mL POTASSIUM CHLORIDE 20 ug in 1 mL SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE 380 ug in 1 mL MONOBASIC POTASSIUM PHOSPHATE 20 ug in 1 mL SODIUM HYDROXIDE HYDROCHLORIC ACID ALUMINUM HYDROXIDE 1500 ug in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:75052-001-10 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (75052-001-01) 1 NDC:75052-001-01 1 mL in 1 VIAL, GLASS This package is contained within the CARTON (75052-001-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125737 12/01/2021

Labeler — VBI Vaccines (Delaware) Inc. (103812236)

Establishment
Name	Address	ID/FEI	Operations
SciVac Ltd		514477301	api manufacture, analysis, pack, label, manufacture

Establishment
Name	Address	ID/FEI	Operations
Hy-Labs		600013676	analysis

Establishment
Name	Address	ID/FEI	Operations
BioReliance		505004556	analysis

Establishment
Name	Address	ID/FEI	Operations
IMI TAMI Institute for Research and Development Ltd.		600045280	analysis

Establishment
Name	Address	ID/FEI	Operations
Envigo CRS (Israel) Limited		514627793	analysis

Revised: 12/2022 VBI Vaccines (Delaware) Inc.