FLUAD QUADRIVALENT (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: AU5C98U4BB) (INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:C46XJT9FQ9), INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: F5QV7AF326) (INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:N969QK7XD2), INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN

Available from:

Seqirus, Inc.

Administration route:

INTRAMUSCULAR

Therapeutic indications:

FLUAD QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUAD QUADRIVALENT is approved for use in persons 65 years of age and older. This indication is approved under accelerated approval based on the immune response elicited by FLUAD QUADRIVALENT [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Do not administer FLUAD QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein [see Description (11)] , or to a previous influenza vaccine. Risk Summary FLUAD QUADRIVALENT is not approved for use in persons < 65 years of age. There are insufficient human data to establish whether there is a vaccine-associated risk with use of FLUAD QUADRIVALENT in pregnancy. There were no development

Product summary:

FLUAD QUADRIVALENT is supplied in the product presentation listed below: Store FLUAD QUADRIVALENT refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date. The syringe, syringe plunger stopper and tip cap are not made with natural rubber latex.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

FLUAD QUADRIVALENT- INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238
(H1N1)
ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/6/2021
IVR-227
(H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS
B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED),
INFLUENZA
B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (FORMALDEHYDE
INACTIVATED) INJECTION, SUSPENSION
SEQIRUS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUAD QUADRIVALENT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUAD
QUADRIVALENT.
FLUAD QUADRIVALENT (INFLUENZA VACCINE, ADJUVANTED)
INJECTABLE EMULSION FOR INTRAMUSCULAR USE
2023-2024 FORMULA
INITIAL U.S. APPROVAL: 2020
INDICATIONS AND USAGE
FLUAD QUADRIVALENT is an inactivated influenza vaccine indicated for
active immunization against
influenza disease caused by influenza virus subtypes A and types B
contained in the vaccine. FLUAD
QUADRIVALENT is approved for use in persons 65 years of age and older.
(1)
This indication is approved under accelerated approval based on the
immune response elicited by FLUAD
QUADRIVALENT (1). Continued approval for this indication may be
contingent upon verification and
description of clinical benefit in a confirmatory trial.
DOSAGE AND ADMINISTRATION
A single 0.5 mL dose for intramuscular injection. (2.1)
DOSAGE FORMS AND STRENGTHS
Injectable emulsion supplied in 0.5 mL single-dose pre-filled
syringes. (3)
CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including
egg protein, or after a previous dose of
any influenza vaccine. (4, 11)
WARNINGS AND PRECAUTIONS
If Guillain-Barré Syndrome (GBS) has occurred within six weeks of
previous influenza vaccination, the
decision to give FLUAD QUADRIVALENT should be based on careful
consideration of the potential benefits
and risks. (5.1)
ADVERSE REACTIONS
The most common (≥ 10%) local and systemic reactions in elderly
subjects 65 years of age and older
were injection site pain (16.3%), headach