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 70461-201-01 0.5 mL single-dose pre-filled syringe, package of 10 syringes per carton [NDC 70461-201-11]
Multi-dose vial 70461-301-10 5 mL multi-dose vial, individually packed in a carton [NDC 70461-301-12]

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.

Important Safety Information

Indication and Usage

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.

Contraindication

  • 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.
  • Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
  • Syncope: Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUCELVAX QUADRIVALENT. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.
  • Altered Immunocompetence: After vaccination with FLUCELVAX QUADRIVALENT, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
  • Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease.

Most Common 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%).

Please see accompanying US Full Prescribing Information for FLUCELVAX QUADRIVALENT.


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.