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Flumist (Influenza Virus Vaccine Live Intranasal) - Warnings and Precautions

 
 



WARNINGS

The safety of FluMist in individuals with asthma or reactive airways disease has not been established. In a large safety study in children 1-17 years of age, children <5 years of age who received FluMist were found to have an increased rate of asthma within 42 days of vaccination when compared to placebo recipients (see ADVERSE REACTIONS). FluMist should not be administered to individuals with a history of asthma or reactive airways disease.

The safety of FluMist in individuals with underlying medical conditions that may predispose them to severe disease following wild-type influenza infection has not been established. FluMist is not indicated for these individuals. High-risk individuals include, but are not limited to, adults and children with chronic disorders of the cardiovascular and pulmonary systems, including asthma; pregnant women; adults and children who required regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies; and adults and children with congenital or acquired immunosuppression caused by underlying disease or immunosuppressive therapy (see CONTRAINDICATIONS). Intramuscularly administered inactivated influenza vaccines are available to immunize high-risk individuals [1].

As with any vaccine, FluMist may not protect 100% of individuals receiving the vaccine.

PRECAUTIONS

GENERAL

CARE IS TO BE TAKEN BY THE HEALTH CARE PROVIDER FOR THE SAFE AND EFFECTIVE USE OF THIS PRODUCT.

Prior to administration of FluMist, individuals or their parent/guardian should be asked about their current health status and their personal medical history, including immune status, to determine the existence of any contraindications to immunization with FluMist (see CONTRAINDICATIONS and WARNINGS) FluMist recipients should avoid close contact (e.g., within the same household) with immunocompromised individuals for at least 21 days.

EPINEPHRINE INJECTION (1:1000) OR COMPARABLE TREATMENT MUST BE READILY AVAILABLE IN THE EVENT OF AN ACUTE ANAPHYLACTIC REACTION FOLLOWING VACCINATION. The health care provider should ensure prevention of any allergic or other adverse reactions by reviewing the individual's history for possible sensitivity to influenza vaccine components, including eggs and egg products.

Administration of FluMist should be postponed until after the acute phase (at least 72 hours) of febrile and/or respiratory illnesses.

INFORMATION FOR VACCINE RECIPIENTS OR PARENTS/GUARDIANS

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 for the first use of FluMist in 5-8 year olds. Due to the possible transmission of vaccine virus, vaccine recipients or their parents/guardians should be advised that vaccine recipients should avoid close contact (e.g., within the same household) with immunocompromised individuals for at least 21 days.

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 (see ADVERSE EVENT REPORTING).

DRUG INTERACTIONS

Children or adolescents who are receiving aspirin therapy or aspirin-containing therapy should not receive FluMist (see CONTRAINDICATIONS). FluMist should not be administered to persons on immunosuppressive therapy.

The concurrent use of FluMist with antiviral compounds that are active against influenza A and/or B viruses has not been evaluated. However, based upon the potential for interference between such compounds and FluMist, it is advisable not to administer FluMist until 48 hours after the cessation of antiviral therapy and that antiviral agents not be administered until two weeks after administration of FluMist unless medically indicated.

There are no data regarding co-administration of FluMist with other intranasal preparations, including steroids.

CONCURRENT ADMINISTRATION WITH OTHER VACCINES

The safety and immunogenicity of FluMist when administered concurrently with other vaccines have not been determined. Therefore, FluMist should not be administered concurrently with other vaccines. Studies of FluMist in healthy individuals excluded subjects who received any live virus vaccine within one month of enrollment and any inactivated or subunit vaccine within two weeks of enrollment; therefore, health care providers should adhere to these intervals when administering FluMist.

LABORATORY INTERACTIONS

Data related to the length of time that FluMist can be recovered from nasal specimens of children and adults are limited. Nasopharyngeal secretions or swabs collected from vaccinees may test positive for influenza virus for up to three weeks.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

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

PREGNANCY (CATEGORY C)

Animal reproduction studies have not been conducted with FluMist. It is also not known whether FluMist can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Therefore, FluMist should not be administered to pregnant women.

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

The safety of FluMist in infants and children <60 months of age has not been established (see CLINICAL STUDIES, INDICATIONS AND USAGE, and ADVERSE REACTIONS).

GERIATRIC USE

Clinical studies with FluMist did not include sufficient numbers of adults age 65 years and older to determine if they respond differently from younger individuals. The safe use of FluMist in persons 65 years and older has not been established (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Page last updated: 2006-11-23

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