Rx Item-Heplisav-B hepatitis B vaccine/Cp20 MCG SYR 5X0.5 ML BY Dynavax Vaccines

Clinical Information
Gen. Code and Des.
78645 hepatitis B vaccine/CpG1018/PF INTRAMUSC SYRINGE 20 MCG/0.5
GCN and Des.
45012 hepatitis B vaccine/CpG1018/PF INTRAMUSC SYRINGE 20 MCG/0.5
Strength
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
80120000 VACCINES
Active Ingredients
17414 vaccine adjuvant solution CpG 1018
8320 hepatitis B virus vaccine, recombinant
9870 preservative free

For: Hepatitis B Prophylaxis

Heplisav-B (hepatitis B vaccine, recombinant (adjuvanted)) is a vaccine for use in the immunization against infection caused by all known subtypes of hepatitis B virus
Clinical Information
Gen. Code and Des.
78645 hepatitis B vaccine/CpG1018/PF INTRAMUSC SYRINGE 20 MCG/0.5
Strength
20 mcg/0.5 mL
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
80120000 VACCINES
Active Ingredients
17414 vaccine adjuvant solution CpG 1018
8320 hepatitis B virus vaccine, recombinant
9870 preservative free
Inactive Ingredients
9865 polysorbate 80 9005656

These highlights do not include all the information needed to use HEPLISAV-B® safely and effectively. See full prescribing information for HEPLISAV-B.

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] Solution for Intramuscular Injection
Initial U.S. Approval: 2017
INDICATIONS AND USAGE

HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. HEPLISAV-B is approved for use in adults 18 years of age and older. (1)
DOSAGE AND ADMINISTRATION

For intramuscular administration
Administer two doses (0.5 mL each) of HEPLISAV-B intramuscularly one month apart. (2.1, 2.2)
DOSAGE FORMS AND STRENGTHS

HEPLISAV-B is a solution for injection supplied as a single-dose vial and prefilled syringe. A single dose of HEPLISAV-B is 0.5 mL. (3)
CONTRAINDICATIONS

Severe allergic reaction, such as anaphylaxis, after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. (4)
ADVERSE REACTIONS

The most common local reaction was injection site pain (23% - 39%). The most common systemic reactions were fatigue (11% - 17%) and headache (8% - 17%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Dynavax at 1-844-889-8753 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.
USE IN SPECIFIC POPULATIONS

A pregnancy registry is available for HEPLISAV-B. Women who receive HEPLISAV-B during pregnancy are encouraged to contact 1-844-443-7734. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2018

HEPLISAV-B 20 MCG SYR 5X0.5 ML
HEPLISAV-B 20 MCG SYR 5X0.5 ML HEP-B VACCINE BY Dynavax Vaccines Item No.:RX781359 781359 NDC No.43528-003-05 43528-0003-05 4352800305 43528000305 UPC/GTIN No. 3-43528-00305-5 343528-003055 3435280030

58160-0821-52
ENGERIX B ADULT 20MCG/ML PFS Hepatitis B

HEPATITIS B VIRUS VACCINE
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HEPLISAV-B 20 MCG SYR 5X0.5 ML
HEPLISAV-B 20 MCG SYR 5X0.5 ML HEP-B VACCINE BY Dynavax Vaccines Item No.:RX781359 781359 NDC No.43528-003-05 43528-0003-05 4352800305 43528000305 UPC/GTIN No. 3-43528-00305-5 343528-003055 3435280030

58160-0821-52
ENGERIX B ADULT 20MCG/ML PFS Hepatitis B