FluMist: INTRANASAL vaccine for INFLUENZA season

… approved for use in persons 2 through 49 years of age

—  5 Warnings and Precautions

In clinical trials, risks of hospitalization and wheezing were increased in children younger than 2 years of age who received FluMist

Children younger than 5 years of age with recurrent wheezing

and persons of any age with asthma

may be at increased risk of wheezing

following administration of FluMist.

FluMist has not been studied in persons with severe asthma or active wheezing

—  5.4 Altered Immunocompetence

The effectiveness of FluMist has not been studied in immunocompromised persons

—  6.1 Clinical Trials Experience

An increase in asthma events was observed in children younger than 5 years of age who received FluMist compared to those who received placebo

—  6.2 Postmarketing Experience

The following events have been spontaneously reported during post approval use of FluMist or FluMist Quadrivalent

Cardiac disorders: Pericarditis

Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema, and urticaria)

Nervous system disorders: Guillain-Barré syndrome, Bell’s Palsy, meningitis, eosinophilic meningitis, vaccine-associated encephalitis, syncope

Respiratory, thoracic, and mediastinal disorders: Epistaxis

Skin and subcutaneous tissue disorders: Rash

—  7 Drug Interactions

Do not administer FluMist to children and adolescents through 17 years of age who are receiving aspirin therapy

or aspirin-containing therapy

because of the association of Reye’s syndrome with aspirin and wild-type influenza.

Avoid aspirin-containing therapy in these age groups during the first 4 weeks after vaccination with FluMist

unless clearly needed

— 8.5 Geriatric Use

FluMist is not approved for use in persons 65 years of age and older,

effectiveness of FluMist to prevent febrile illness was not demonstrated in adults 50 through 64 years of age

—  12.1 Mechanism of Action

Immune mechanisms conferring protection against influenza following receipt of FluMist vaccine are not fully understood

—  13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

FluMist has not been evaluated for its carcinogenic or mutagenic potential

—  17 Patient Counseling Information

Inform the vaccine recipient or caregiver that FluMist is an attenuated live virus vaccine and has the potential for transmission to immunocompromised household contacts