PREBOOK SEP 2021 WILL BE SENT UPON RECEIPT.
These highlights do not include all the information needed to use FLUMIST® QUADRIVALENT safely and effectively. See full prescribing information for FLUMIST® QUADRIVALENT.
FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal)
Intranasal Spray
2021-2022 Formula
Initial U.S. Approval: 2003
INDICATIONS AND USAGE
FluMist Quadrivalent is a 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. (1, 11)
FluMist Quadrivalent is approved for use in persons 2 through 49 years of age. (1)
DOSAGE AND ADMINISTRATION
For intranasal administration by a healthcare provider. (2)
*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.†Administer as 0.1 mL per nostril.
Age
Dose
Schedule
2 years through 8 years
1 or 2 doses*,
0.2 mL† each
If 2 doses, administer at least 1 month apart
9 years through 49 years
1 dose, 0.2 mL†
-
“-” indicates information is not applicable
DOSAGE FORMS AND STRENGTHS
Each 0.2 mL dose is a suspension supplied in a single-dose pre-filled intranasal sprayer. (3)
CONTRAINDICATIONS
•
Severe allergic reaction (e.g., anaphylaxis) to any component of FluMist Quadrivalent, including egg protein, or after a previous dose of any influenza vaccine. (4.1, 11)
•
Concomitant aspirin therapy in children and adolescents. (4.2)
WARNINGS AND PRECAUTIONS
•
In clinical trials, risks of hospitalization and wheezing were increased in children younger than 2 years of age who received FluMist (trivalent Influenza Vaccine Live, Intranasal). (5.1)
•
Children younger than 5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following the administration of FluMist Quadrivalent. (5.2)
•
If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist Quadrivalent should be based on careful consideration of the potential benefits and risks. (5.3)
•
FluMist Quadrivalent has not been studied in immunocompromised persons. (5.4)
ADVERSE REACTIONS
The most common solicited adverse reactions (≥ 10% in vaccine recipients and at least 5% greater than in placebo recipients) reported after FluMist were runny nose or nasal congestion (ages 2 years through 49 years), fever over 100°F (children ages 2 years through 6 years), and sore throat (adults ages 18 years through 49 years). Among children and adolescents 2 through 17 years of age who received FluMist Quadrivalent, 32% reported runny nose or nasal congestion and 7% reported fever over 100°F. Among adults 18 through 49 years of age who received FluMist Quadrivalent, 44% reported runny nose or nasal congestion and 19% reported sore throat. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact MedImmune at 1-877-633-4411 or VAERS at 1-800-822-7967 or HTTP://VAERS.HHS.GOV.
DRUG INTERACTIONS
•
Antiviral drugs that are active against influenza A and/or B may reduce the effectiveness of FluMist Quadrivalent if administered within 48 hours before, or within 2 weeks after, receipt of the vaccine. (7.2)
USE IN SPECIFIC POPULATIONS
•
In clinical trials, in children 6 through 23 months of age, FluMist was associated with an increased risk of hospitalization and wheezing. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2021
