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Flumist (Influenza Virus Vaccine Live Intranasal) - Indications and Dosage

 
 



INDICATIONS AND USAGE

FOR NASAL ADMINISTRATION ONLY

FluMist is indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5-17 years of age, and healthy adults, 18-49 years of age.

FluMist is not indicated for immunization of individuals less than 5 years of age, or 50 years of age and older, or for therapy of influenza, nor will it protect against infections and illness caused by infectious agents other than influenza A or B viruses.

DOSAGE AND ADMINISTRATION

FOR NASAL USE ONLY. DO NOT ADMINISTER PARENTERALLY.

FluMist™ should be administered according to the following schedule:

Age Group Vaccination Status Dosage Schedule
Children age
5 years through
8 years
Not previously vaccinated with FluMist 2 doses (0.5 mL each, 60 days apart ± 14 days) for initial season
Children age
5 years through
8 years
Previously vaccinated with FluMist 1 dose (0.5 mL) per season
Children and Adults age 9 through 49 years Not applicable 1 dose (0.5 mL) per season

For healthy children age 5 years through 8 years who have not previously received FluMist vaccine, the recommended dosage schedule for nasal administration is one 0.5 mL dose followed by a second 0.5 mL dose given at least 6 weeks later. Only limited data are available on the degree of protection in children who receive one dose (see CLINICAL PHARMACOLOGY).

For all other healthy individuals, including children age 5-8 years who have previously received at least one dose of FluMist, the recommended schedule is one dose.

FluMist should be administered prior to exposure to influenza. The peak of influenza activity is variable from year to year, but generally occurs in the U.S. between late December and early March. Because the duration of protection induced by FluMist over multiple seasons is not known and yearly antigenic variation in the influenza strains is possible, annual revaccination may increase the likelihood of protection.

FluMist must be thawed prior to administration. FluMist may be thawed by holding the sprayer in the palm of the hand and supporting the plunger rod with the thumb (see ADMINISTRATION INSTRUCTIONS); the vaccine should be administered immediately thereafter. Alternatively, FluMist may be thawed in a refrigerator and stored at 2-8°C (36-46°F) for no more than 60 hours prior to use. When thawed for administration, FluMist is a colorless to pale yellow liquid and is clear to slightly cloudy; some proteinaceous particulates may be present but do not affect the use of the product.

Approximately 0.25 mL (i.e., half of the dose from a single FluMist sprayer) is administered into each nostril while the recipient is in an upright position. Insert the tip of the sprayer just inside the nose and depress the plunger to spray. The dose-divider clip is removed from the sprayer to administer the second half of the dose (approximately 0.25 mL) into the other nostril. Once FluMist has been administered, the used sprayer should be disposed of according to the standard procedures for biohazardous waste products.

ADMINISTRATION INSTRUCTIONS

HOW SUPPLIED

FluMist is supplied for intranasal delivery in a package of 10 pre-filled, single-use sprayers (NDC 66019-101-01).

STORAGE

STORE AT OR BELOW -15°C (5°F).

DO NOT REFREEZE AFTER THAWING.

UPON RECEIPT, FluMist SHOULD BE IMMEDIATELY STORED AT -15°C (5°F) OR BELOW.

FluMist may be stored in a non-frost-free freezer to be maintained continuously at -15°C (5°F) or below.

Storage of FluMist in a frost-free freezer should be avoided because the temperature could cycle above -15°C (5°F) and can therefore negatively impact the stability of the product.

FluMist may be thawed in a refrigerator and stored at 2-8°C (36-46°F) for no more than 60 hours prior to use.

The cold chain must be maintained when transporting FluMist prior to use.

For information regarding product storage and stability under conditions other than those recommended, call 1-877-FLUMIST.

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