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

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (UNII: XL4HLC6JH6) (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN - UNII:XL4HLC6JH6)

Beschikbaar vanaf:

A-S Medication Solutions

Toedieningsweg:

INTRAMUSCULAR

therapeutische indicaties:

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. Do not administer HEPLISAV-B 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 HEPLISAV-B, including yeast [see Description (11)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to HEPLISAV-B during pregnancy. Women who receive HEPLISAV-B during pregnancy are encouraged to contact 1-844-443-7734. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In clinically recognized pregnancies in the US general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20%. There are no clinical studies of HEPLISAV-B in pregnant women. Available human data on HEPLISAV- B administered to pregnant wo

Product samenvatting:

Product: 50090-3469 NDC: 50090-3469-9 .5 mL in a VIAL / 5 in a CARTON

Autorisatie-status:

Biologic Licensing Application

Productkenmerken

HEPLISAV-B- HEPATITIS B VACCINE (RECOMBINANT) ADJUVANTED INJECTION,
SOLUTION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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.
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: 6/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose and Regimen
2.2 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Managing Allergic Reactions
5.2 Immunocompromised Individuals
5.3 Limitations of Vaccine Effectiveness
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7. DRUG INTERACTIONS
7.1 Use with Immune Globulin
7.2 Interferenc