FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) (influenza a virus a/nebraska/14/2019 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/delaware/39/2019 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/darwin/7/2019 antigen- mdck cell derived, propiolactone inactivated injection, suspension.
These highlights do not include all the information needed to use FLUCELVAX® QUADRIVALENT safely and effectively. See full prescribing information for FLUCELVAX QUADRIVALENT.
FLUCELVAX QUADRIVALENT (Influenza Vaccine)
Suspension for Intramuscular Injection
Initial U.S. Approval: 23 May 2016
INDICATIONS AND USAGE
FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. (1)
(1) FLUCELVAX is approved for use in persons 4 years of age and older. (1)
For children and adolescents 4 through 17 years of age, approval is based on the immune response elicited by FLUCELVAX QUADRIVALENT. Data demonstrating a decrease in influenza disease after vaccination of children and adolescents 4 through 17 years of age with FLUCELVAX QUADRIVALENT are not available. (14)
DOSAGE AND ADMINISTRATION
For intramuscular use only (2)
a 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines. (2)
Age Dose Schedule
4 through 8 years of age One or two dosesa, 0.5 mL each If 2 doses, administer at least 4 weeks apart
9 years of age and older One dose, 0.5 mL Not Applicable
DOSAGE FORMS AND STRENGTHS
Suspension for injection supplied in two presentations:
0.5 mL single-dose pre-filled syringes. (3, 11)
5 mL multi-dose vial containing 10 doses (each dose is 0.5 mL). (3, 11)
History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine. (4, 11)
WARNINGS AND PRECAUTIONS
If Guillain-Barré syndrome 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. (5.1)
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%). (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%). (6)
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%). (6)
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%). (6)
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%). (6)
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
USE IN SPECIFIC POPULATIONS
Geriatric Use: Antibody responses were lower in adults 65 years and older than in younger adults. (8.5)
Pregnancy: There is a pregnancy exposure registry that monitors outcomes in women exposed to FLUCELVAX QUADRIVALENT during pregnancy. Enroll in the pregnancy registry by calling 1-855-358-8966 or sending an email to [email protected] (8.1)
See 17 for PATIENT COUNSELING INFORMATION.