FLUBLOK- influenza vaccine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN (UNII: 69H0YJ871T) (INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:69H0YJ871T), INFLUENZA A VIRUS A/HONG KONG/4801/2014 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN (UNII: 2I1EOL437M) (INFLUENZA A VIRUS A/HONG KONG/4801/2014 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:2I1EOL437M), INFLUENZA B VIRUS B/BRISBANE/60/2008 RECOMBINANT HEMAGGLUTININ ANTIGEN (UNII: 058U2312CR) (INFLUENZA B VIRUS B/BRI

Available from:

Protein Sciences Corporation

INN (International Name):

INFLUENZA A VIRUS A/MICHIGAN/45/2015 RECOMBINANT HEMAGGLUTININ ANTIGEN RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:69H0YJ871T)

Composition:

INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug in 0.5 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

Flublok is a vaccine indicated for active immunization against disease caused by influenza A virus subtypes and influenza type B virus contained in the vaccine. Flublok is approved for use in persons 18 years of age and older. Flublok is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine (see Postmarketing Experience [6.2] and Description [11] ). Pregnancy outcomes in women who have been exposed to Flublok during pregnancy are being monitored. Contact: Protein Sciences Corporation by calling 1-888-855-7871. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Available data on Flublok administered to pregnant women are insufficient to inform vaccine-associated risks in pregnant women. A developmental study of Flublok has been performed in

Product summary:

Flublok is supplied as a single-dose, 0.5 mL vial in a 10 vial carton: Presentation Carton NDC Number Components and NDC Number Single-Dose Vial 42874-017-10 Ten 0.5 mL single-dose vials [NDC 42874-017-01]

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

FLUBLOK- INFLUENZA VACCINE INJECTION, SOLUTION
PROTEIN SCIENCES CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUBLOK SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FLUBLOK.
FLUBLOK (INFLUENZA VACCINE)
STERILE SOLUTION FOR INTRAMUSCULAR INJECTION
2017-2018 FORMULA
INITIAL U.S. APPROVAL: 2013
RECENT MAJOR CHANGES
Indications and Usage (1) 10/2014
INDICATIONS AND USAGE
•
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR (IM) INJECTION ONLY (0.5 ML). (2)
DOSAGE FORMS AND STRENGTHS
A sterile solution for injection supplied in 0.5mL single dose vials.
(3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PROTEIN SCIENCES
CORPORATION AT 1-888-855-7871 OR
VAERS AT 1-800-822-7967 OR WWW.VAERS.HHS.GOV.
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
®
Flublok is a vaccine indicated for active immunization against disease
caused by influenza A virus subtypes and
influenza type B virus contained in the vaccine. Flublok is approved
for use in persons 18 years of age and older. (1)
Severe allergic reaction (e.g., anaphylaxis) to any component of the
vaccine. (4, 6.2, 11)
Appropriate medical treatment and supervision must be available to
manage possible anaphylactic reactions following
administration of Flublok. (5.1)
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of
a prior influenza vaccine, the decision to give
Flublok should be based on careful consideration of potential benefits
and risks. (5.2)
In adults 18 through 49 years of age, the most common (≥10%)
injection-site reaction was pain (37%); the most
common (≥10%) solicited systemic adverse reactions were headache
(15%), fatigue (15%) and myalgia (11%). (6.1)
In adults 50 through 64 years of age, the most common (≥10%)
injection site reaction was pain (32%); the most
common (≥10%) solicite