FLUAD® Influenza Vaccine, Adjuvanted

The first FDA-approved adjuvanted influenza vaccine in the US for people aged 65+3

Indications and Usage1

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. Approval is based on the immune response elicited by FLUAD.

What makes FLUAD different?1

FLUAD contains at least 15 mcg of hemagglutinin (HA) of each influenza strain recommended for the current influenza season and the proprietary adjuvant MF59.

What is MF59?1,2

MF59®* is derived from squalene, an oil naturally occurring in the body. Though the mechanism of action is not fully understood, studies in animals and humans suggest that MF59 recruits immune cells to the site of injection and enhances their activity.

How might FLUAD help your patients?1,2

In clinical trials, FLUAD induced a strong immune response to the vaccine in adults 65+.

How Supplied

FLUAD is supplied as a 0.5 mL pre-filled needleless syringe:

  • package of 10 pre-filled syringes per carton (NDC number: 70461-002-01)
  • pre-filled single syringe (NDC number: 70461-002-11)

Storage and Handling

  • Store FLUAD 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.

Important Safety Information

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. Approval is based on the immune response elicited by FLUAD. Data demonstrating a decrease in influenza disease after vaccination with FLUAD are not available.

Contraindications

  • Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine.

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.
  • The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.

Adverse Reactions

  • The most common (≥ 10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%).
  • The most common (≥ 10%) systemic adverse reactions observed in clinical studies were myalgia (15%), headache (13%) and fatigue (13%).

To report Suspected Adverse Reactions, contact Seqirus Vaccines and Diagnostics, Inc. at 1-855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.

Please see accompanying US Full Prescribing Information for FLUAD.

* MF59® is a registered trademark of Novartis AG


References:

  1. FLUAD (package insert). Cambridge, MA.
  2. World Health Organization. Squalene-based adjuvants in vaccines. Updated 2015. Accessed October 5, 2016
  3. FDA approves first seasonal influenza vaccine containing an adjuvant [news release]. US Food and Drug Administration; 2015; Accessed October 5, 2016.