Fluad Quadrivalent

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Fluad Quadrivalent Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Quadrivalent, inactivated, adjuvanted (MF59C.1) influenza vaccine (virus types A and B); contains a total of at least 60mcg of hemagglutinin per 0.5mL dose; formulation changes annually; emulsion for IM inj; may contain trace amounts of neomycin, kanamycin, hydrocortisone, egg protein, formaldehyde or CTAB; preservative-free.

    Pharmacological Class

    Influenza vaccine.

    How Supplied

    Single-dose prefilled syringes (0.5mL)—10

    Storage

    • Store 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. 

    Manufacturer

    Seqirus

    Generic Availability

    NO

    Mechanism of Action

    Inactivated quadrivalent influenza vaccines are standardized to contain the hemagglutinin of influenza virus strains (two subtypes A and two types B), representing the influenza viruses likely to be circulating in the United States in the upcoming influenza season.

    Fluad Quadrivalent Indications

    Indications

    Influenza immunization for patients ≥65yrs of age.

    Fluad Quadrivalent Dosage and Administration

    Adult

    <65yrs: not established. ≥65yrs: 0.5mL IM inj once in the deltoid; 1 dose per year.

    Children

    Not established.

    Fluad Quadrivalent Contraindications

    Contraindications

    Severe allergy to egg protein, or after a previous dose of any flu vaccine.

    Fluad Quadrivalent Boxed Warnings

    Not Applicable

    Fluad Quadrivalent Warnings/Precautions

    Warnings/Precautions

    Use current formulation only. Have appropriate medical treatment and supervision available. Guillain-Barré syndrome within 6 weeks of previous flu vaccine. Immunosuppressed. Syncope. May not protect all vaccine recipients against influenza disease. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Guillain-Barré Syndrome

    • Carefully consider the potential benefits and risks to give Fluad Quadrivalent if Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination.

    • Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than one additional case per 1 million persons vaccinated.

    Preventing and Managing Allergic Reactions

    • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

    Altered Immunocompetence

    • Immune response may be diminished if Fluad Quadrivalent is given to immunocompromised individuals, including those receiving immunosuppressive therapy.

    Syncope

    • Syncope may occur after administration. Procedures should be in place to avoid injury from falling.

    Limitations of Vaccine Effectiveness

    • Fluad Quadrivalent may not protect all individuals.

    Pregnancy Considerations

    Risk Summary

    • Not approved for use in persons < 65 years of age.

    • Insufficient human data to determine whether there is a vaccine-associated risk in pregnancy.

    Nursing Mother Considerations

    • Not approved for use in persons < 65 years of age.

    • No data available to determine the effects of Fluad Quadrivalent on the breastfed infant or on milk production/excretion.

    Pediatric Considerations

    • The safety and effectiveness of Fluad Quadrivalent in infants less than 6 months of age and in children older than 72 months of age have not been evaluated.

    Geriatric Considerations

    • Safety and immunogenicity of Fluad Quadrivalent have been evaluated in adults 65 years of age and older. 

    Fluad Quadrivalent Pharmacokinetics

    See Literature

    Fluad Quadrivalent Interactions

    Interactions

    Concomitant with other vaccines: insufficient data (see full labeling). Immunosuppressants (eg, corticosteroids): may get suboptimal response.

    Fluad Quadrivalent Adverse Reactions

    Adverse Reactions

    Injection site pain, headache, fatigue.

    Fluad Quadrivalent Clinical Trials

    Clinical Trials

    Immunogenicity of Fluad Quadrivalent

    • The immunogenicity of Fluad Quadrivalent was evaluated in Study 1 (NCT02587221), a randomized, observer-blind, non-influenza comparator-controlled multicenter efficacy study. Patients 65 years of age and older received 1 dose of either Fluad Quadrivalent or a US-licensed non-influenza comparator vaccine (Boostrix).

    • Immunogenicity was evaluated 21 days after vaccination in a subgroup of subjects in a 4:1 ratio: Fluad Quadrivalent (N=1324) and non-influenza control vaccines (N=332). 

    • Immunogenicity endpoints measured 3 weeks after vaccination included percentage of subjects with HI titer ≥1:40 and percentage of subjects who achieved seroconversion. Success criteria required the lower bound of the 2-sided 95% CI for the proportion of subjects with an HI titer ≥1:40 to be ≥60% and for the lower bound of the 2-sided 95% CI for the proportion of subjects with seroconversion to be ≥30%.

    • The percentage of patients who achieved seroconversion in the Fluad Quadrivalent vs the non-influenza comparator vaccine are as followed, respectively:

      • A/H1N1: 78% vs 2.1%

      • A/H3N2: 84.6% vs 3.9%

      • B/Yamagata: 60.8% vs 3.6%

      • B/Victoria: 65.5% vs 2.1%

    Fluad Quadrivalent Note

    Not Applicable

    Fluad Quadrivalent Patient Counseling

    Patient Counseling

    • Inform vaccine recipients of the potential benefits and risks of immunization with Fluad Quadrivalent. 

    • Educate vaccine recipients regarding the potential side effects. Clinicians should emphasize that (1) Fluad Quadrivalent contains non-infectious particles and cannot cause influenza and (2) Fluad Quadrivalent is intended to help provide protection against illness due to influenza viruses only. 

    • Instruct vaccine recipients to report adverse reactions to their healthcare provider and/or to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 and www.vaers.hhs.gov. Provide vaccine recipients with the Vaccine Information Statements which are required by the National Childhood Vaccine Injury Act of 1986. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). 

    • Inform vaccine recipients that annual vaccination is recommended.

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