Vaccine Information: HEPLISAV-B (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

• Prefilled syringe, 1 dose (0.5 mL) — (NDC number: 43528-003-01)
• Package of 5 single dose prefilled syringes — (NDC number: 43528-003-05)

The tip caps and stoppers of the prefilled syringes 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).
Do not freeze; discard if the vaccine has been frozen.
Do not use the vaccine after the expiration date shown on the prefilled syringe label.

17 PATIENT COUNSELING INFORMATION

• Inform vaccine recipient of the potential benefits and risks associated with vaccination, as well as the importance of completing the immunization series.
• Emphasize that HEPLISAV-B 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).

DYNAVAX

Manufactured by:
Dynavax Technologies Corporation
Emeryville, CA 94608 USA

© 2017 — 2023, Dynavax Technologies Corporation.
All rights reserved.

Principal Panel — Carton — Vials

Rx only

Hepatitis B Vaccine
(Recombinant),
Adjuvanted

HEPLISAV-B^™

NDC 43528-002-05

5 x 0.5 mL
single-dose vials

For intramuscular administration only

DYNAVAX

(click image for full-size original)

Principal Panel — Carton — Prefilled Syringes

NDC 43528-003-05 Rx only

Hepatitis B Vaccine
(Recombinant),
Adjuvanted

HEPLISAV-B^®

5 x 0.5 mL single-dose syringes

For intramuscular administration only

For Adult Use Only

NEEDLES NOT INCLUDED

DYNAVAX

(click image for full-size original)

Principal Panel — Label — Prefilled Syringes

HEPLISAV-B^®

1 dose (0.5 mL)

Hepatitis B Vaccine
(Recombinant), Adjuvanted

NDC 43528-003-01 Rx only
For IM use only DO NOT FREEZE
Store at 2-8°C (36-46°F)Mfd. by Dynavax Tech. Corp.

(click image for full-size original)

HEPLISAV-B hepatitis b vaccine (recombinant) adjuvanted injection, solution

Product Information Product Type VACCINE Item Code (Source) NDC:43528-002 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN) HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 20 ug in 0.5 mL

Inactive Ingredients Ingredient Name Strength 1018 ISS SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE POLYSORBATE 80 WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43528-002-05 5 VIAL in 1 CARTON contains a VIAL (43528-002-01) 1 NDC:43528-002-01 0.5 mL in 1 VIAL This package is contained within the CARTON (43528-002-05)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125428 01/01/2018 10/17/2019

HEPLISAV-B hepatitis b vaccine (recombinant) adjuvanted injection, solution

Product Information Product Type VACCINE Item Code (Source) NDC:43528-003 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN) HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 20 ug in 0.5 mL

Inactive Ingredients Ingredient Name Strength 1018 ISS SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE POLYSORBATE 80 WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43528-003-05 5 SYRINGE in 1 CARTON contains a SYRINGE (43528-003-01) 1 NDC:43528-003-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (43528-003-05)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125428 01/01/2018

Labeler — Dynavax Technologies Corporation (964173801)

Registrant — Dynavax Technologies Corporation (964173801)

Establishment
Name	Address	ID/FEI	Operations
Rhein Biotech GmbH		318031242	ANALYSIS (43528-002), API MANUFACTURE (43528-002), ANALYSIS (43528-003), API MANUFACTURE (43528-003)

Revised: 05/2023 Dynavax Technologies Corporation