FluMist®

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Contains Mercury: | no mercury
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Patient Age: | 2 years through 49 years if healthy and non-pregnant.
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Shot or Mist: | mist
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Manufacturer: | MedImmune
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Safe If Pregnant: | not recommended for preganant women
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FluMist® (Influenza Virus Vaccine Live, Intranasal) is a live trivalent vaccine for administration by intranasal spray. The influenza virus strains in FluMist are (a) cold-adapted (ca) (i.e., they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., they are restricted in replication at 37°C (Type B strains) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c)
attenuated (att) (they do not produce classic influenza-like illness in the ferret model of human influenza infection).
Contraindications
- Hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or life threatening reactions to previous influenza vaccination.
- Concomitant aspirin therapy in children and adolescents.
Warnings And Precautions- Do not administer FluMist to children less than 24 months of age because of increased risk of hospitalization and wheezing observed in clinical trials.
- FluMist should not be administered to any individuals with asthma or children less than 5 years of age with recurrent wheezing because of the potential for increased risk of wheezing post vaccination.
- If Guillain-Barré syndrome has occurred with any prior influenza vaccination, the decision to give FluMist should be based on careful consideration of the potential benefits and risks.
- Administration of FluMist, a live virus vaccine, to immunocompromised persons should be based on careful consideration of potential benefits and risks.
- Safety has not been established in individuals with underlying medical conditions predisposing them to wild-type influenza infection complications.
Adverse Reactions Most common adverse reactions are runny nose or nasal congestion in all ages, fever greater than 100°F in children 2-6 years of age, and sore throat in adults.
Drug Interactions Antiviral agents active against influenza A and/or B: Do not administer FluMist until 48 hours after antiviral cessation. Antiviral agents should not be administered until 2 weeks after FluMist administration
unless medically necessary.
Pregnancy 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.
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
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 (14.1)]. FluMist is not indicated for use in children less than 24 months of age. FluMist use in children less than24 months has been associated with increased risk of hospitalization and wheezing in clinical trials and Adverse Reactions.
Geriatric Use FluMist is not indicated for use in individuals over 50 years of age.
Dosage Information: 0.2 mL pre-filled, single-use intranasal spray. Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza
virus reassortants of each of the three strains for the 2008-2009 season: A/South Dakota/6/2007
(H1N1) (A/Brisbane/59/2007-like), A/Uruguay/716/2007 (H3N2) (A/Brisbane/10/2007-like), and
B/Florida/4/2006.
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