HEPLISAV-B: Package Insert and Label Information (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

  • Vial, 1 dose (0.5 mL) — (NDC number: 43528-002-01)
  • Package of 5 single dose vials — (NDC number: 43528-002-05)
  • 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 and vial stoppers are not made with natural rubber latex.

16.2 Storage Conditions

Store in a refrigerator at 2°C to 8°C (35°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 vial or 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
Berkeley, CA 94710 USA

© 2018, 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

Image of Carton of Vials- Principal Panel
(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

Image of Carton of Syringes- Principal Panel
(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: 11/2019 Dynavax Technologies Corporation

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