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 < 24months of age after vaccination with FluMist. [See ADVERSE REACTIONS]

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 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 Immunocompetence4

Data supporting the safety and effectiveness of FluMist administration in immunocompromised individuals are limited to 174 individuals with HIV infection and 10 mild to moderately immunocompromised children and adolescents with cancer [see Clinical Studies].

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.

Management of Acute Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine [see CONTRAINDICATIONS].

Limitations of Vaccine Effectiveness

FluMist may not protect all individuals receiving the vaccine.

Patient Counseling Information

See FDA-approved patient labeling (Information for Patients and Their Caregivers).

Vaccine recipients or their parents/guardians should be informed by the health care provider of the potential benefits and risks of FluMist, and the need for two doses at least 1 month apart in children 2-8 years old who have not previously received influenza vaccine.

Asthma and Recurrent Wheezing

Ask the vaccinee or their parent/guardian if the vaccinee has asthma. For children < 5 years of age, also ask if the vaccinee has recurrent wheezing since this may be an asthma equivalent in this age group.

Vaccination with a Live Virus Vaccine

Vaccine recipients or their parents/guardians should be informed by the health care provider that FluMist is an attenuated live virus vaccine and has the potential for transmission to immunocompromised household contacts.

Adverse Event Reporting

The vaccine recipient or the parent/guardian accompanying the vaccine recipient should be told to report any suspected adverse events to the physician or clinic where the vaccine was administered.

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), 250 microliter/rat/occasion (approximately 110-140 human dose equivalents), 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, caution should be exercised if FluMist is administered to nursing mothers.

Pediatric Use

Safety and effectiveness of the vaccine has been demonstrated for children 2 years of age and older with reduction in culture-confirmed influenza rates compared to active control (injectable influenza vaccine made by Sanofi Pasteur Inc.) and placebo [see Clinical Studies]. FluMist is not approved 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 approved 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 approved 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.

Last reviewed on RxList: 1/10/2012
This monograph has been modified to include the generic and brand name in many instances.