Storage and Handling of FluMist Quadrivalent

  • The cold chain [2-8°C (35-46°F)] must be maintained when transporting FluMist Quadrivalent1
  • FluMist Quadrivalent should be stored in a refrigerator between 2-8°C (35-46°F) upon receipt and until use. The product must be used before the expiration date on the sprayer label1
  • Do not freeze1
  • A single temperature excursion up to 25°C for 12 hours has been shown to have no adverse impact on the vaccine. After a temperature excursion, the vaccine should be returned immediately to the recommended storage condition (2°C – 8°C) and used as soon as feasible. Subsequent excursions are not permitted
  • Supplied in a package of 10 pre-filled, single-use sprayers1
  • 0.2 mL per sprayer, thimerosal free1

Important Safety Information

FluMist Quadrivalent is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein, or after a previous dose of any influenza vaccine, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

In clinical trials, the risks of hospitalization and wheezing were increased in children <24 months of age who received trivalent FluMist® (Influenza Vaccine Live, Intranasal).

Children <5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following FluMist Quadrivalent administration. FluMist Quadrivalent has not been studied in persons with severe asthma or active wheezing.

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.

FluMist Quadrivalent has not been studied in immunocompromised persons.

The safety of FluMist Quadrivalent in individuals with underlying medical conditions predisposing them to wild-type influenza infection complications has not been established.

FluMist Quadrivalent may not protect all individuals receiving the vaccine.

The most common solicited adverse reactions (occurring ≥10% in vaccine recipients and at least 5% greater than in placebo) reported after FluMist were runny nose or nasal congestion in all persons 2-49 years, fever >100°F in children 2-6 years, and sore throat in adults 18-49 years. Among children 2-17 years who received FluMist Quadrivalent, 32% reported runny nose or nasal congestion and 7% reported fever >100°F. Among adults 18-49 years who received FluMist Quadrivalent, 44% reported runny nose or nasal congestion and 19% reported sore throat.

INDICATION

FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal) is a vaccine indicated for active immunization of persons 2-49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluMist Quadrivalent is for intranasal administration only.

Please see full Prescribing Information for FluMist Quadrivalent, including Patient Information.