Important Safety Information

FluMist^® is a vaccine indicated for the active immunization of individuals 2-59 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist^® is contraindicated in individuals with a history of hypersensitivity, especially anaphylactic reactions, to eggs, egg proteins, gentamicin, gelatin or arginine or to any other ingredient in the formulation. FluMist^® is contraindicated in individuals with a history of hypersensitivity to previous influenza vaccination.

Do not administer FluMist^® to children <24 months of age due to an increased risk of wheezing. FluMist^® should not be administered to any individual with severe asthma (e.g., currently requiring therapy with oral glucocorticosteroids or high dose inhaled glucocorticosteroids) or active wheezing (medically attended wheezing in the seven days prior to vaccination), as these individuals have not been adequately studied in clinical trials. Those under the age of 18 receiving aspirin or aspirin-containing therapy should avoid vaccination with FluMist^® due to association of Reye’s syndrome with aspirin and wild-type influenza infection.

If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination or if an individual is immunosuppressed, the decision to give FluMist^® should be based on careful consideration of the potential benefits and risks. FluMist^® recipients should not associate with people who are immunocompromised for at least 2 weeks following vaccination. If contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus. FluMist^® should be given to a pregnant woman only if clearly needed. It is not known whether FluMist^® is excreted in human milk. Therefore, caution should be exercised if FluMist^® is administered to nursing mothers.

Most common adverse reactions for FluMist^® (vs. the Trivalent Inactivated Influenza Vaccine) in children were runny/stuffy nose (56.7%, 45.0%), cough (33.6%, 35.6%), decreased appetite (15.9%, 15.2%), irritability (13.8%, 12.5%) and fever > 38°C (17.5%, 17.0%). The most common adverse reactions in adults were runny/stuffy nose (40.0%, 33.8%), headache (25.0%, 36.4%), sore throat (15.0%, 11.7%), malaise (11.4%, 20.5%) and muscle ache (16.3%, 18.2%).

FluMist^® may not protect all individuals receiving the vaccine. FluMist^® is for intranasal administration only (0.1 mL per nostril).