Contraindications & Warnings

CONTRAINDICATIONS1

Hypersensitivity
FluMist is contraindicated in individuals with a history of hypersensitivity, especially anaphylactic reactions, to egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations.

Concomitant Pediatric and Adolescent Aspirin Therapy and Reye’s Syndrome
FluMist is contraindicated in children and adolescents (2 through 17 years of age) receiving aspirin therapy or aspirin-containing therapy, because of the association of Reye’s syndrome with aspirin and wild-type influenza infection.

WARNINGS AND PRECAUTIONS1

Risks in Children <24 Months of Age
Do not administer FluMist to children <24 months of age. In clinical trials, an increased risk of wheezing post-vaccination was observed in FluMist recipients <24 months of age. An increase in hospitalizations was observed in children <24 months of age after vaccination with FluMist.

Asthma/Recurrent Wheezing
FluMist should not be administered to any individuals with asthma or children <5 years of age with recurrent wheezing, because of the potential for increased risk of wheezing post vaccination, unless the potential benefits outweigh the potential risks.

Do not administer FluMist to individuals with severe asthma or active wheezing because these individuals have not been studied in clinical trials.

Guillain-Barré Syndrome
If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist should be based on careful consideration of the potential benefits and potential risks.

Altered Immunocompetence
Administration of FluMist, a live virus vaccine, to immunocompromised persons should be based on careful consideration of potential benefits and risks. Although FluMist was studied in 57 asymptomatic or mildly symptomatic adults with HIV infection, data supporting the safety and effectiveness of FluMist administration in immunocompromised individuals are limited.

Medical Conditions Predisposing to Influenza Complications
The safety of FluMist in individuals with underlying medical conditions that may predispose them to complications following wild-type influenza infection has not been established. FluMist should not be administered unless the potential benefit outweighs the potential risk.

Preventing and Managing Allergic Vaccine Reactions
Prior to vaccination, review the individual's medical history for possible sensitivity to influenza vaccine or vaccine components. Treatment must be readily available in the event of an acute anaphylactic reaction following vaccination (see CONTRAINDICATIONS).

Limitations of Vaccine Effectiveness
FluMist may not protect all individuals receiving the vaccine.

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