Included as part of the PRECAUTIONS section.

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. [See ADVERSE REACTIONS]

Asthma/Recurrent Wheezing

FluMist should not be administered to any individuals with asthma and children < 5 years of age with recurrent wheezing because of the potential for increased risk of wheezing post vaccination unless the potential benefit outweighs the potential risk.

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 [see also ADVERSE REACTIONS].

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 [see Clinical Studies], 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.

NonClinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

FluMist has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with FluMist. It is not known whether FluMist can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FluMist should be given to a pregnant woman only if clearly needed.

The effect of the vaccine on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rats receiving the frozen formulation. Groups of animals were administered the vaccine either once (during the period of organogenesis on gestation day 6) or twice (prior to gestation and during the period of organogenesis on gestation day 6), 250mcL/rat/occasion (approximately 110-140 human dose equivalents based on TCID₅₀), by intranasal instillation. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no vaccine related fetal malformations or other evidence of teratogenesis noted in this study.

Nursing Mothers

It is not known whether FluMist is excreted in human milk. Therefore, as some viruses are excreted in human milk and additionally, because of the possibility of shedding of vaccine virus and the close proximity of a nursing infant and mother, caution should be exercised if FluMist is administered to nursing mothers.

Pediatric Use

FluMist is not indicated for use in children < 24 months of age. FluMist use in children < 24 months has been associated with increased risk of hospitalization and wheezing in clinical trials [see Warnings and PRECAUTIONS and ADVERSE REACTIONS].

Geriatric Use

FluMist is not indicated for use in individuals ≥ 65 years of age. Subjects with underlying high-risk medical conditions (n=200) were studied for safety. Compared to controls, FluMist recipients had a higher rate of sore throat.

Use in Individuals 50-64 Years of Age

FluMist is not indicated for use in individuals 50-64 years of age. In Study AV009, effectiveness was not demonstrated in individuals 50-64 years of age (n=641). Solicited adverse events were similar in type and frequency to those reported in younger adults.

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