FLUBLOK QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/wisconsin/588/2019 (h1n1) recombinant hemagglutinin antigen, influ

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Summary of Product characteristics (SPC)

26-09-2022

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Active ingredient:

INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN (UNII: GB6ADZ2ASN) (INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:GB6ADZ2ASN), INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN (UNII: 7VJ7X8PKX3) (INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:7VJ7X8PKX3), INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN (UNII: M48387N67G) (INFLUENZA B VIRUS B/AUST

Available from:

Sanofi Pasteur Inc.

Administration route:

INTRAMUSCULAR

Therapeutic indications:

Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older [see Clinical Studies (14)] . Flublok Quadrivalent 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 Exposure Pregnancy outcomes in women who have been exposed to Flublok Quadrivalent during pregnancy are being monitored. Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes and newborn health status following vaccination with Flublok Quadrivalent during pregnancy. Healthcare providers are encouraged to enroll women who receive Flublok Quadrivalent during pregnancy in Sanofi Pasteur Inc.'s vaccination pregnancy registry by calling 1-800-822-2463. Risk Summary All pre

Product summary:

Flublok Quadrivalent is supplied as a single-dose, 0.5 mL syringe in a 10 syringe carton:

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

FLUBLOK QUADRIVALENT NORTHERN HEMISPHERE- INFLUENZA A VIRUS
A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN,
INFLUENZA A
VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN,
INFLUENZA B
VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN, AND
INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ
ANTIGEN INJECTION
FLUBLOK QUADRIVALENT NORTHERN HEMISPHERE- INFLUENZA A VIRUS A/WEST
VIRGINIA/30/2022 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A
VIRUS
A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B
VIRUS
B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN, AND
INFLUENZA B
VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN INJECTION
SANOFI PASTEUR INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUBLOK QUADRIVALENT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUBLOK
QUADRIVALENT.
FLUBLOK QUADRIVALENT (INFLUENZA VACCINE), STERILE SOLUTION FOR
INTRAMUSCULAR INJECTION
2023-2024 FORMULA
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
Flublok Quadrivalent is a vaccine indicated for active immunization
against disease caused by influenza
A subtype viruses and influenza type B viruses contained in the
vaccine. Flublok Quadrivalent is
approved for use in persons 18 years of age and older. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR (IM) INJECTION ONLY (0.5 ML). (2)
DOSAGE FORMS AND STRENGTHS
A sterile solution for injection supplied in 0.5 mL single dose
prefilled syringes. (3)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to any component of the
vaccine. (4, 6.2, 11)
WARNINGS AND PRECAUTIONS
Appropriate medical treatment and supervision must be available to
manage possible anaphylactic
reactions following administration of Flublok Quadrivalent. (5.1)
If Guillain Barré syndrome has occurred within 6 weeks of receipt of
a prior influenza vaccine, the
decision to give Flublok Quadrivalent should be based on careful
consideration of

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