These highlights do not include all the information needed to use FLUAD® safely and effectively. See full prescribing information for FLUAD.
FLUAD® (Influenza Vaccine, Adjuvanted) Injectable Emulsion for Intramuscular Use 2020-2021 Formula
Initial U.S. Approval: 2015
INDICATIONS AND USAGE
FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD 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. (1) Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (14)
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 should be based on careful consideration of the potential benefits and risks. (5.1)
ADVERSE REACTIONS
The most common (≥ 10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%). (6) The most common (≥ 10%) systemic adverse reactions observed in clinical studies were myalgia (15%), headache (13%) and fatigue (13%). (6)
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1- 855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2020
