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

HEPLISAV-B by

Drug Labeling and Warnings

HEPLISAV-B by is a Other medication manufactured, distributed, or labeled by Bamboo US BidCo LLC, Dynavax Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Principal Panel - Carton - Vials

Rx only

Hepatitis B Vaccine
(Recombinant),
Adjuvanted

HEPLISAV-B ™

5 x 0.5 mL
single-dose vials

For intramuscular
administration only

DYNAVAX

PRINCIPAL DISPLAY PANEL

Principal Panel - Carton - Prefilled Syringes

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

PRINCIPAL DISPLAY PANEL

Principal Panel - Label - Prefilled Syringes

HEPLISAV-B ®

1 dose (0.5 mL)

Hepatitis B Vaccine
(Recombinant), Adjuvanted

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 83703-048
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (UNII: XL4HLC6JH6) (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN - UNII:XL4HLC6JH6)	HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN	20 ug  in 0.5 mL

Inactive Ingredients
Ingredient Name	Strength
1018 ISS (UNII: 25DT549L0G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83703-048-05	5 in 1 CARTON
1	NDC: 83703-048-01	0.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

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

Labeler - Bamboo US BidCo LLC (119087615)

Registrant - Dynavax Technologies Corporation (964173801)