Clinical Information
Gen. Code and Des.
82984 hepatitis B virus vac S,M,L/PF INTRAMUSC VIAL 10 MCG/ML
GCN and Des.
51815 hepatitis B virus vac S,M,L/PF INTRAMUSC VIAL 10 MCG/ML
Strength
10MCG
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80120000 VACCINES
Active Ingredients
18932 hepatitis B virus vaccine recomb, isoform S,M,L
9870 preservative free
Inactive Ingredients
9283 beef derived (bovine)
These highlights do not include all the information needed to use PREHEVBRIO TM safely and effectively. See full prescribing information for PREHEVBRIO.
PREHEVBRIO [Hepatitis B Vaccine (Recombinant)]
Injectable suspension, for intramuscular use
Initial U.S. Approval: 2021
INDICATIONS AND USAGE
PREHEVBRIO is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PREHEVBRIO is approved for use in adults 18 years of age and older. ( 1)
DOSAGE AND ADMINISTRATION
For intramuscular injection.
Administer a series of three doses (1.0 mL each) of PREHEVBRIO on a 0-, 1- and 6-month schedule. ( 2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
PREHEVBRIO is an injectable suspension, for intramuscular use supplied as a single-dose vial. A single dose of PREHEVBRIO is 1.0 mL ( 3)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PREHEVBRIO. ( 4)
ADVERSE REACTIONS
Individuals 18 through 44 years of age: The most common local reactions following each dose of PREHEVBRIO were injection site pain (52.0 �" 58.3%) and tenderness (52.6 �" 59.6%). The most common systemic reactions following each dose of PREHEVBRIO were headache (17.2 �" 25.8%), fatigue (20.1- 28.3%) and myalgia (22.2 �" 29.9%).
Individuals 45 through 64 years of age: The most common local reactions following each dose of PREHEVBRIO were injection site pain (42.2 �" 48.8%) and tenderness (43.2 �" 50.5%). The most common systemic reactions following each dose of PREHEVBRIO were headache (13.8 �" 21.3%), fatigue (14.3 �" 19.7%) and myalgia (16.7 �" 24.1%).
Individuals ≥ 65 years of age: The most common local reactions following each dose of PREHEVBRIO were injection site pain (26.7 �" 34.8%) and tenderness (30.2 �" 32.8%). The most common systemic reactions following each dose of PREHEVBRIO were headache (7.3 �" 12.2%), fatigue (11.5 �" 14.5%) and myalgia (11.5 - 16.6%). ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov .
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2021
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Table of Contents
Table of Contents
1 INDICATIONS AND USAGE
PREHEVBRIO is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PREHEVBRIO is approved for use in adults 18 years of age and older.
2 DOSAGE AND ADMINISTRATION
For intramuscular injection. 2.1 Dosage and Schedule - Administer a series of three doses (1.0 mL each) of PREHEVBRIO on a 0-, 1- and 6-month schedule. 2.2 Administration - Shake the vial ...
3 DOSAGE FORMS AND STRENGTHS
PREHEVBRIO is an injectable suspension, for intramuscular use supplied as a single-dose vial. A single dose of PREHEVBRIO is 1.0 mL [see - How Supplied/Storage and Handling ...
4 CONTRAINDICATIONS
Do not administer PREHEVBRIO to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PREHEVBRIO [see ...
5 WARNINGS AND PRECAUTIONS
5.1 Managing Allergic Reactions - Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PREHEVBRIO. 5.2 ...
6 ADVERSE REACTIONS
Individuals 18 through 44 years of age: The most common local reactions following each dose of PREHEVBRIO were injection site pain (52.0 �" 58.3%) and tenderness (52.6 �" 59.6%). The most common ...
7 DRUG INTERACTIONS
7.1 Concomitant Administration with Immune Globulin - There are no data to assess the concomitant use of PREHEVBRIO with immune globulin. When concomitant administration of PREHEVBRIO and immune ...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to PREHEVBRIO during pregnancy. Women who receive ...
11 DESCRIPTION
PREHEVBRIO [Hepatitis B Vaccine (Recombinant)] is a sterile suspension for intramuscular injection. PREHEVBRIO contains the small (S), middle (pre-S2) and large (pre-S1) hepatitis B surface ...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action - PREHEVBRIO induces antibodies to HBsAg. Antibody concentrations ≥10 mIU/mL against HBsAg are recognized as conferring protection against hepatitis B virus ...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - PREHEVBRIO has not been evaluated for carcinogenic, mutagenic potential or male infertility in animals. In a developmental toxicity ...
14 CLINICAL STUDIES
14.1 Evaluation of Immunogenicity - The immunogenicity of PREHEVBRIO was evaluated in comparison with a US-licensed hepatitis B vaccine (Engerix-B) in 2 randomized, active controlled ...
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 ...
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 ...
PRINCIPAL DISPLAY PANEL
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 ...
PRINCIPAL DISPLAY PANEL
Principal Display Panel - 10 mcg/mL Vial Label - NDC 75052-001-01 - Hepatitis B Vaccine - (Recombinant) PreHevbrio - For IM administration - Rx only - Storage ...
INGREDIENTS AND APPEARANCE
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