FLUCELVAX® QUADRIVALENT Influenza Vaccine

The first FDA-approved quadrivalent influenza vaccine made with cell culture technology2

Indications and Usage

FLUCELVAX QUADRIVALENT is a cell culture-based inactivated influenza vaccine for people aged 4 years and older. It helps protect against the 4 strains of influenza (2 A strains and 2 B strains) recommended by the CDC for the current influenza season.1

What makes FLUCELVAX QUADRIVALENT different?

FLUCELVAX QUADRIVALENT is made using the same modern cell culture technology as its predecessor, FLUCELVAX ® (influenza vaccine). With cell culture technology, the vaccine is produced in sterile bioreactors, eliminating the need for antibiotics. It is also preservative and latex-free.1

How Supplied

Presentation Carton NDC Number Components
Pre-filled syringe 70461-318-03 0.5 mL single-dose pre-filled syringe, package of 10 syringes per carton [NDC 70461-318-04]
Multi-dose vial 70461-418-10 5 mL multi-dose vial, individually packed in a carton [NDC 70461-418-11]

Storage and Handling

  • Store this product refrigerated at 2°C to 8°C (36°F to 46°F).
  • Do not freeze.
  • Protect from light.
  • Do not use after the expiration date.

FLUCELVAX® QUADRIVALENT Important Safety Information

INDICATION AND USAGE FOR FLUCELVAX® QUADRIVALENT (INFLUENZA VACCINE)

FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 4 years of age and older.

CONTRAINDICATIONS

  • Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.

WARNINGS & PRECAUTIONS

  • Guillain-Barré Syndrome (GBS): If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX QUADRIVALENT should be based on careful consideration of the potential benefits and risks.

ADVERSE REACTIONS

  • The most common (≥10%) local and systemic reactions in adults 18-64 years of age were injection site pain (45.4%) headache (18.7%), fatigue (17.8%) and myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%).
  • The most common (≥10%) local and systemic reactions in adults ≥65 years of age were injection site pain (21.6%) and injection site erythema (11.9%).
  • The most common (≥10%) local and systemic reactions in children 4 to < 6 years of age were tenderness at the injection site (46%), injection site erythema (18%), sleepiness (19%), irritability (16%), injection site induration (13%), and change in eating habits (10%).
  • The most common (≥10%) local and systemic reactions in children 6 through 8 years of age were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%), and myalgia (12%).
  • The most common (≥10%) local and systemic reactions in children and adolescents 9 through 17 years of age were pain at the injection site (58%), headache (22%), injection site erythema (19%), fatigue (18%) myalgia (16%), and injection site induration (15%).

To report Suspected Adverse Reactions, contact Seqirus Vaccines 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 FLUCELVAX QUADRIVALENT.

FLUCELVAX QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.


References:

  1. FLUCELVAX QUADRIVALENT (package insert). Holly Springs, NC. Seqirus, Inc: 2016.
  2. FDA approves first seasonal influenza vaccine manufactured using cell culture technology (news release). Silver Spring, MD: U.S. Food and Drug Administration; November 20, 2012.