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FluMist


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FluMist Drug Description


FluMist®
Influenza Vaccine Live, Intranasal Intranasal Spray 2010-2011

DRUG DESCRIPTION

FluMist (Influenza Vaccine Live, Intranasal) is a live trivalent vaccine for administration by intranasal spray. The influenza virus strains in FluMist (influenza virus vaccine) 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). The cumulative effect of the antigenic properties and the ca, ts, and att phenotypes is that the attenuated vaccine viruses replicate in the nasopharynx to induce protective immunity.

No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) [see Clinical Studies]. For each of the three reassortant strains in FluMist (influenza virus vaccine) , the six internal gene segments responsible for ca, ts, and att phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses that have been recommended by the LJSPHS for inclusion in the annual vaccine formulation. Thus, the three viruses contained in FluMist (influenza virus vaccine) maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses that are related to strains expected to circulate during the 2010-2011 influenza season. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the teand an phenotypes. For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to both the ts and att properties; five genetic loci in three gene segments control the ca property.

Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. Ethylene diamine tetracetic acid (EDTA) is added to the dilution buffer for H3N2 strains. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the three strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration.

Each pre-filled refrigerated FluMist (influenza virus vaccine) sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU of live attenuated influenza virus reassortants of each of the three strains: A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrplyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, 0.96 mg/dose monobasic potassium phosphate, and < 0.015 mcg/mL gentamicin sulfate. FluMist (influenza virus vaccine) contains no preservatives. The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist (influenza virus vaccine) is a colorless to pale yellow liquid and is clear to slightly cloudy.

 

What are the possible side effects of influenza virus nasal vaccine (FluMist)?

Nasal influenza virus (live virus) vaccine may cause you to have mild flu-like symptoms. However, you may have flu-like symptoms at any time during flu season that may be caused by strains of influenza virus that are not contained in the vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first dose.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another nasal influenza virus vaccine in the future, you...

Read All Potential Side Effects and See Pictures of FluMist »

 

What are the precautions when taking influenza virus vaccine (FluMist)?

Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to eggs; or if you have previously had a severe allergic reaction to flu vaccine; or if you have any other allergies. This product may contain inactive ingredients (such as gentamicin, gelatin, arginine), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccine, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, wheezing, chronic lung disease), current infection/fever, diabetes, history of Guillain-Barre syndrome, immune system problems (e.g., due to cancer treatment, HIV infection), kidney disease.

This vaccine contains a weakened form of the flu virus. After receiving the...

 

 

FluMist


FluMist Indications & Dosage


INDICATIONS

FluMist (influenza virus vaccine) is a vaccine indicated for the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

DOSAGE AND ADMINISTRATION

FOR INTRANASAL ADMINISTRATION BY A HEALTH CARE PROVIDER.

Dosing Information

FluMist (influenza virus vaccine) should be administered according to the following schedule:

Age Group Vaccination Status Dosage Schedule
Children age 2 years through 8 years Not previously vaccinated with influenza vaccine 2 doses (0.2 ml* each, at least 1 month apart)
Children age 2 years through 8 years Previously vaccinated with influenza vaccine 1 dose (0.2 ml*)
Children, adolescents and adults age 9 through 49 years Not applicable 1 dose (0.2 ml*)
* Administer as 0.1 ml per nostril.

For children age 2 years through 8 years who have not previously received influenza vaccine, the recommended dosage schedule for nasal administration is one 0.2 ml dose (0.1 ml per nostril), followed by a second 0.2 ml dose (0.1 ml per nostril) given at least 1 month later.

For all other individuals, including children age 2-8 years who have previously received influenza vaccine, the recommended schedule is one 0.2 ml dose (0.1 ml per nostril).

FluMist (influenza virus vaccine) should be administered prior to exposure to influenza. Annual revaccination with influenza vaccine is recommended.

Administration Instructions

Each sprayer contains a single dose of FluMist (influenza virus vaccine) ; approximately one-half of the contents should be administered into each nostril. Refer to the administration diagram (Figure 1) for step-by-step administration instructions. Once FluMist (influenza virus vaccine) has been administered, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container).

Figure 1


Note: Active inhalation (i.e., sniffing) is not required by the patient during FluMist (influenza virus vaccine) administration

HOW SUPPLIED

Dosage Forms And Strengths

0.2 ml pre-filled, single-use intranasal spray.

Each 0.2 ml dose of FluMist (influenza virus vaccine) is formulated to contain 106.5-7.5 FFU (fluorescent focus units) of each of three live attenuated influenza virus reassortants: A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008.

FluMist (influenza virus vaccine) is supplied for intranasal delivery in a package of 10 pre-filled, single-use sprayers. The single-use intranasal sprayer contains no latex. NDC 66019-108-10

Storage and Handling

Once FluMist (influenza virus vaccine) has been administered, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container).

FLUMIST (influenza virus vaccine) SHOULD BE STORED IN A REFRIGERATOR BETWEEN 2-8°C (35-46°F) UPON RECEIPT AND UNTIL USE. THE PRODUCT MUST BE USED BEFORE THE EXPIRATION DATE ON THE SPRAYER LABEL. DO NOT FREEZE.

The cold chain (2 to 8°C) must be maintained when transporting FluMist (influenza virus vaccine) .

Manufactured by: Medlmmune, LLC Gaithersburg, MD 20878. 1-877-633-4411

 

 

FluMist


FluMist Side Effects & Drug Interactions


SIDE EFFECTS

FluMist (influenza virus vaccine) is not indicated in children < 24 months of age. In a clinical trial, among children 6-23 months of age, wheezing requiring bronchodilator therapy or with significant respiratory symptoms occurred in 5.9% of FluMist (influenza virus vaccine) recipients compared to 3.8% of active control (injectable influenza vaccine made by Sanofi Pasteur Inc.) recipients (Relative Risk 1.5, 95% Cl: 1.2, 2.1). Wheezing was not increased in children ≥ 24 months of age.

Hypersensitivity, including anaphylactic reaction, has been reported post-marketing. [See WARNINGS AND PRECAUTIONS]

Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 9537 children and adolescents 1-17 years of age and 3041 adults 18-64 years of age received FluMist (influenza virus vaccine) in randomized, placebo-controlled Studies D153-P501, AV006, D153-P526, AV019, and AV009 described below. In addition, 4179 children 6-59 months of age received FluMist (influenza virus vaccine) in Study MI-CP111, a randomized, active-controlled trial. Among pediatric FluMist (influenza virus vaccine) recipients 6 months-17 years of age, 50% were female; in the study of adults, 55% were female. In MI-CP111, AV006, D153-P526, AV019, and AV009, subjects were White (71%), Hispanic (11%), Asian (7%), Black (6%), and Other (5%), while in D153-P501,99% of subjects were Asian.

Adverse Reactions in Children and Adolescents

In a placebo-controlled safety study (AV019) conducted in a large Health Maintenance Organization (HMO) in children 1-17 years of age (n = 9689), an increase in asthma events, captured by review of diagnostic codes, was observed in children < 5 years of age (Relative Risk 3.53,90% Cl: 1.1,15.7). This observation was prospectively evaluated in Study MI-CP111.

In MI-CP111, an active-controlled study, increases in wheezing and hospitalization (for any cause) were observed in children < 24 months of age, as shown in Table 1.

Table 1: Percentages of Children with Hospitalizations and Wheezing from MI-CP111

Adverse Reaction Age Group FluMist Active Controla
Hospitalizationsb 6-23 months
(n = 3967)
4.2 % 3.2 %
24-59 months
(n = 4385)
2.1 % 2.5 %
Wheezingc 6-23 months
(n = 3967)
5.9 % 3.8 %
24-59 months
(n = 4385)
2.1 % 2.5 %
a Injectable influenza vaccine made by Sanofi Pasteur Inc.
b From randomization through 180 days post last vaccination.
c Wheezing requiring bronchodilator therapy or with significant respiratory symptoms evaluated from randomization through 42 days post last vaccination.

Most hospitalizations observed were gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. In post-hoc analysis, rates of hospitalization in children 6-11 months of age (n = 1376) were 6.1% in FluMist (influenza virus vaccine) recipients and 2.6% in active control recipients.

Table 2 shows an analysis of pooled solicited events, occurring in at least 1% of FluMist (influenza virus vaccine) recipients and at a higher rate compared to placebo, post Dose 1 for Study D153-P501 and AV006 and solicited events post Dose 1 for Study MI-CP111. Solicited events were those about which parents/guardians were specifically queried after vaccination with FluMist (influenza virus vaccine) . In these studies, solicited events were documented for 10 days post vaccination. Solicited events post Dose 2 for FluMist (influenza virus vaccine) were similar to those post Dose 1 and were generally observed at a lower frequency.

Table 2: Summary of Solicited Events Observed within 10 Days after Dose 1 for Vaccinea and either Placebo or Active Control Recipients; Children 2-6 Years of Age

D153- P501 & AV006 MI-CP111
FluMist (influenza virus vaccine)
N=876-1759c
Placebo
N=424-1034c
FluMist (influenza virus vaccine)
N=2170c
Active Controlb
N=2165c
Event % % % %
Runny Nose/ Nasal Congestion 58 50 51 42
Decreased Appetite 21 17 13 12
Irritability 21 19 12 11
Decreased Activity (Lethargy) 14 11 7 6
Sore Throat 11 9 5 6
Headache 9 7 3 3
Muscle Aches 6 3 2 2
Chills 4 3 2 2
Fever
100-1 01°F Oral 9 6 6 4
101-102°F Oral 4 3 4 3
a Frozen formulation used in AV006; Refrigerated formulation used in D153-P501 and MI-CP111.
b Injectable influenza vaccine made by Sanofi Pasteur Inc.
c Number of evaluable subjects (those who returned diary cards) for each event. Range reflects differences in data collection between the 2 pooled studies.

In clinical studies D153-P501 and AV006, other adverse reactions in children occurring in at least 1 % of FluMist (influenza virus vaccine) recipients and at a higher rate compared to placebo were: abdominal pain (2% FluMist (influenza virus vaccine) vs. 0% placebo) and otitis media (3% FluMist (influenza virus vaccine) vs. 1% placebo).

An additional adverse reaction identified in the active-controlled trial, MI-CP111, occurring in at least 1 % of FluMist (influenza virus vaccine) recipients and at a higher rate compared to active control was sneezing (2% FluMist (influenza virus vaccine) vs. 1% active control).

In a separate trial (MI-CP112) that compared the refrigerated and frozen formulations of FluMist (influenza virus vaccine) in children and adults 5-49 years of age, the solicited events and other adverse events were consistent with observations from previous trials. Fever of > 103°F was observed in 1 to 2% of children 5-8 years of age. In a separate placebo-controlled trial (D153-P526) using the refrigerated formulation in a subset of older children and adolescents 9-17 years of age who received one dose of FluMist (influenza virus vaccine) , the solicited events and other adverse events were generally consistent with observations from previous trials. Abdominal pain was reported in 12% of FluMist (influenza virus vaccine) recipients compared to 4% of placebo recipients and decreased activity was reported in 6% of FluMist (influenza virus vaccine) recipients compared to 0% of placebo recipients.

Adverse Reactions in Adults

In adults 18-49 years of age in Study AV009, summary of solicited adverse events occurring in at least 1 % of FluMist (influenza virus vaccine) recipients and at a higher rate compared to placebo include runny nose (44% FluMist (influenza virus vaccine) vs. 27% placebo), headache (40% FluMist (influenza virus vaccine) vs. 38% placebo), sore throat (28% FluMist (influenza virus vaccine) vs. 17% placebo), tiredness/weakness (26% FluMist (influenza virus vaccine) vs. 22% placebo), muscle aches (17% FluMist (influenza virus vaccine) vs. 15% placebo), cough (14% FluMist (influenza virus vaccine) vs. 11% placebo), and chills (9% FluMist (influenza virus vaccine) vs. 6% placebo). In addition to the solicited events, other adverse reactions from Study AV009 occurring in at least 1 % of FluMist (influenza virus vaccine) recipients and at a higher rate compared to placebo were: nasal congestion (9% FluMist (influenza virus vaccine) vs. 2% placebo) and sinusitis (4% FluMist (influenza virus vaccine) vs. 2% placebo).

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of FluMist (influenza virus vaccine) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

Cardiac disorders: Pericarditis

Congenital, familial, and genetic disorders: Exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome) Gastrointestinal disorders: Nausea, vomiting, diarrhea

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

Nervous system disorders: Guillain-Barre syndrome, Bell's Palsy, meningitis, eosinophilic meningitis, vaccine-associated encephalitis

Respiratory, thoracic, and mediastinal disorders: Epistaxis Skin and subcutaneous tissue disorders: Rash

DRUG INTERACTIONS

Aspirin Therapy

Do not administer FluMist (influenza virus vaccine) to children or adolescents who are receiving aspirin therapy or aspirin-containing therapy [see CONTRAINDICATIONS].

Antiviral Agents Against Influenza A and/or B

The concurrent use of FluMist (influenza virus vaccine) with antiviral agents that are active against influenza A and/or B viruses has not been evaluated. However, based upon the potential for antiviral agents to reduce the effectiveness of FluMist (influenza virus vaccine) , do not administer FluMist (influenza virus vaccine) until 48 hours after the cessation of antiviral therapy, and antiviral agents should not be administered until two weeks after administration of FluMist (influenza virus vaccine) unless medically indicated. If antiviral agents and FluMist (influenza virus vaccine) are administered concomitantly, revaccination should be considered when appropriate.

Concomitant Inactivated Vaccines

The safety and immunogenicity of FluMist (influenza virus vaccine) when administered concurrently with inactivated vaccines have not been determined. Studies of FluMist (influenza virus vaccine) excluded subjects who received any inactivated or subunit vaccine within two weeks of enrollment. Therefore, healthcare providers should consider the risks and benefits of concurrent administration of FluMist (influenza virus vaccine) with inactivated vaccines.

Concomitant Live Vaccines

Concurrent administration of FluMist (influenza virus vaccine) with the measles, mumps, and rubella vaccine and the varicella vaccine was studied in 1245 children 12-15 months of age. Adverse events were similar to those seen in other clinical trials with FluMist (influenza virus vaccine) [see ADVERSE REACTIONS]. No evidence of interference with immune responses to measles, mumps, rubella, varicella, and FluMist (influenza virus vaccine) vaccines was observed. Concurrent administration of FluMist (influenza virus vaccine) with the measles, mumps, and rubella vaccine and the varicella vaccine in children > 15 months of age has not been studied.

Intranasal Products

There are no data regarding co-administration of FluMist (influenza virus vaccine) with other intranasal preparations.

 

 

FluMist


FluMist Warnings & Precautions


WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Risks in Children < 24 Months of Age

Do not administer FluMist (influenza virus vaccine) to children < 24 months of age. In clinical trials, an increased risk of wheezing post-vaccination was observed in FluMist (influenza virus vaccine) recipients < 24 months of age. An increase in hospitalizations was observed in children < 24 months of age after vaccination with FluMist. [See ADVERSE REACTIONS.]

Asthma/Recurrent Wheezing

FluMist (influenza virus vaccine) 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 (influenza virus vaccine) to individuals with severe asthma or active wheezing because these individuals have not been studied in clinical trials.

Guillain-Barre Syndrome

If Guillain-Barre syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist (influenza virus vaccine) should be based on careful consideration of the potential benefits and potential risks [see also ADVERSE REACTIONS].

Altered Immunocompetence

Administration of FluMist (influenza virus vaccine) , a live virus vaccine, to immunocompromised persons should be based on careful consideration of the potential benefits and risks. Although FluMist (influenza virus vaccine) was studied in 57 asymptomatic or mildly symptomatic adults with HIV infection [see Clinical Studies], data supporting the safety and effectiveness of FluMist (influenza virus vaccine) administration in immunocompromised individuals are limited.

Medical Conditions Predisposing to Influenza Complications

The safety of FluMist (influenza virus vaccine) in individuals with underlying medical conditions that may predispose them to complications following wild-type influenza infection has not been established. FluMist (influenza virus vaccine) 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 (influenza virus vaccine) 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 (influenza virus vaccine) , 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 (influenza virus vaccine) 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 (influenza virus vaccine) 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 (influenza virus vaccine) . It is not known whether FluMist (influenza virus vaccine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FluMist (influenza virus vaccine) 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 (influenza virus vaccine) is excreted in human milk. Therefore, as some viruses are excreted in human milk, caution should be exercised if FluMist (influenza virus vaccine) 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 (influenza virus vaccine) is not indicated for use in children < 24 months of age. FluMist (influenza virus vaccine) use in children < 24 months has been associated with increased risk of hospitalization and wheezing in clinical trials [see ADVERSE REACTIONS].

Geriatric Use

FluMist (influenza virus vaccine) is not indicated 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 (influenza virus vaccine) recipients had a higher rate of sore throat.

Use in Individuals 50-64 Years of Age

FluMist (influenza virus vaccine) is not indicated 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.

 

FluMist

FluMist Overdosage & Contraindications


OVERDOSE

No information provided.

CONTRAINDICATIONS

Hypersensitivity

FluMist (influenza virus vaccine) is contraindicated in individuals with a history of hypersensitivity, especially anaphylactic reactions, to eggs, egg proteins, gentamicin, gelatin, or arginine, or with life-threatening reactions to previous influenza vaccinations.

Concomitant Pediatric and Adolescent Aspirin Therapy and Reye's Syndrome

FluMist (influenza virus vaccine) is contraindicated in children and adolescents (2-17 years of age) receiving aspirin therapy or aspirin-containing therapy, because of the association of Reye's syndrome with aspirin and wild-type influenza infection.

 

FluMist


FluMist Clinical Pharmacology


CLINICAL PHARMACOLOGY

Mechanism of Action

Immune mechanisms conferring protection against influenza following receipt of FluMist (influenza virus vaccine) vaccine are not fully understood. Likewise, naturally acquired immunity to wild-type influenza has not been completely elucidated. Serum antibodies, mucosal antibodies and influenza-specific T cells may play a role in prevention and recovery from infection.

Influenza illness and its complications follow infection with influenza viruses. Global surveillance of influenza identifies yearly antigenic variants. For example, since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. Antibody against one influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year's influenza vaccine. Therefore, influenza vaccines are standardized to contain the strains (i.e., typically two type A and one type B), representing the influenza viruses likely to be circulating in the United States in the upcoming winter.

Annual revaccination with the current vaccine is recommended because immunity declines during the year after vaccination, and because circulating strains of influenza virus change from year to year [1 ].

Pharmacokinetics

Biodistribution

A biodistribution study of intranasally administered radiolabeled placebo was conducted in 7 healthy adult volunteers. The mean percentage of the delivered doses detected were as follows: nasal cavity 89.7%, stomach 2.6%, brain 2.4%, and lung 0.4%. The clinical significance of these findings is unknown.

Clinical Studies

FluMist (influenza virus vaccine) , in refrigerated and frozen formulations, was administered to approximately 35,000 subjects in controlled clinical studies. FluMist (influenza virus vaccine) has been studied in placebo-controlled trials over multiple years, using different vaccine strains. Comparative efficacy has been studied where FluMist (influenza virus vaccine) was compared to an inactivated influenza vaccine made by Sanofi Pasteur Inc.

Studies in Children and Adolescents

Study MI-CP111: Pediatric Comparative Study

A multinational, randomized, double-blind, active-controlled trial (MI-CP111) was performed to assess the efficacy and safety of FluMist (influenza virus vaccine) compared to an injectable influenza vaccine made by Sanofi Pasteur Inc. (active control) in children < 5 years of age, using the refrigerated formulation. During the 2004-2005 influenza season, a total number of 3916 children < 5 years of age and without severe asthma, without use of bronchodilator or steroids and without wheezing within the prior 6 weeks were randomized to FluMist (influenza virus vaccine) and 3936 were randomized to active control. Participants were then followed through the influenza season to identify illness caused by influenza virus. As the primary endpoint, culture-confirmed modified CDC-ILI (CDC-defined influenza-like illness) was defined as a positive culture for a wild-type influenza virus associated within ±7 days of modified CDC-ILI. Modified CDC-ILI was defined as fever (temperature ≥ 100°F oral or equivalent) plus cough, sore throat, or runny nose/nasal congestion on the same or consecutive days.

In the primary efficacy analysis, FluMist (influenza virus vaccine) demonstrated a 44.5% (95% Cl: 22.4, 60.6) reduction in influenza rate compared to active control as measured by culture-confirmed modified CDC-ILI caused by wild-type strains antigenically similar to those contained in the vaccine. See Table 3 for a description of the results by strain and antigenic similarity.

Tables 3: Comparative Efficacy against Culture-Confirmed Modified CDC-ILIa Caused by Wild-Type Strains in Children < 5 Years of Age


Study D153-P501: Pediatric Study

A randomized, double-blind, placebo-controlled trial (D153-P501) was performed to evaluate the efficacy of FluMist (influenza virus vaccine) in children 12 to 35 months of age without high-risk medical conditions against culture-confirmed influenza illness, using the refrigerated formulation. A total of 3174 children were randomized 3:2 (vaccine: placebo) to receive 2 doses of study vaccine or placebo at least 28 days apart in Year 1. See Table 4 for a description of the results.

Study AV006: Pediatric Study

AV006 was a multi-center, randomized, double-blind, placebo-controlled trial performed in U.S. children without high-risk medical conditions to evaluate the efficacy of FluMist (influenza virus vaccine) against culture-confirmed influenza over two successive seasons using the frozen formulation. The primary endpoint of the trial was the prevention of culture-confirmed influenza illness due to antigenically matched wild-type influenza in children, who received two doses of vaccine in the first year and a single revaccination dose in the second year. During the first year of the study 1602 children 15-71 months of age were randomized 2:1 (vaccine: placebo). Approximately 85% of the participants in the first year returned for the second year of the study. In Year 2, children remained in the same treatment group as in year one and received a single dose of FluMist (influenza virus vaccine) or placebo. See Table 4 for a description of the results.

Table 4: Efficacya of FluMist (influenza virus vaccine) vs. Placebo against Culture-Confirmed Influenza Illness due to Antigenically Matched Wild-Type Strains (D153-P501 & AV006, Year 1)


During the second year of Study AV006, the primary circulating strain was the A/Sydney/05/97 H3N2 strain, which was antigenically dissimilar from the H3N2 strain represented in the vaccine, A/Wuhan/359/95; FluMist (influenza virus vaccine) demonstrated 87.0% (95% Cl: 77.0, 92.6) efficacy against culture-confirmed influenza illness.

Study in Adults

AV009 was a multi-center, randomized, double-blind, placebo-controlled trial to evaluate effectiveness in adults 18-64 years of age without high-risk medical conditions. Participants were randomized 2:1 (vaccine: placebo). Cultures for influenza virus were not obtained from subjects in the trial, so that the efficacy against culture-confirmed influenza was not assessed. The A/Wuhan/359/95 (H3N2) strain, which was contained in FluMist (influenza virus vaccine) , was antigenically distinct from the predominant circulating strain of influenza virus during the trial period, A/Sydney/05/97 (H3N2). Type A/Wuhan (H3N2) and Type B strains also circulated in the U.S. during the study period. The primary endpoint of the trial was the reduction in the proportion of participants with one or more episodes of any febrile illness, and prospective secondary endpoints were severe febrile illness and febrile upper respiratory illness. Effectiveness for any of the three endpoints was not demonstrated in a subgroup of adults 50-64 years of age. Primary and secondary effectiveness endpoints from the age group 18-49 years of age are presented in Table 5. Effectiveness was not demonstrated for the primary endpoint in adults 18-49 years of age.

Tables 5: Effectiveness of FluMist (influenza virus vaccine) a in Adults 18-49 Years of Age Durina the 7-week Site-Specific Outbreak Period

Endpoint FluMist (influenza virus vaccine)
N=2411b
n (%)
Placebo
N=1226b
n (%)
Percent Reduction (95% Cl)
Participants with one or more events of:c
Primary Endpoint:
Any febrile illness 331 (13.73) 189 (15.42) 10.9 (-5.1,24.4)
Secondary Endpoints:
Severe febrile illness 250 (10.37) 158 (12.89) 19.5 (3.0, 33.2)
Febrile upper respiratory illness 213 (8.83) 142 (11.58) 23.7 (6.7, 37.5)
a Frozen formulation used.
b Number of evaluable subjects (92.7% and 93.0% of FluMist (influenza virus vaccine) and placebo recipients, respectively).
c The predominantly circulating virus during the trial period was A/Sydney/05/97 (H3N2), an antigenic variant not included in the vaccine.

Effectiveness was shown in a post-hoc analysis using CDC-ILI in the age group 18-49 years.

Study in Adults with Human Immunodeficiency Virus (HIV) Infection

Safety and shedding of vaccine virus following FluMist (influenza virus vaccine) administration were evaluated in 57 HIV-infected [median CD4 cell count of 541 cells/mm3] and 54 HIV-negative adults 18-58 years of age in a randomized, double-blind, placebo-controlled trial using the frozen formulation. No serious adverse events were reported during the one-month follow-up period. Vaccine strain (type B) virus was detected in 1 of 28 HIV-infected subjects on Day 5 only and none of the HIV-negative FluMist (influenza virus vaccine) recipients. No adverse effects on HIV viral load or CD4 counts were identified following FluMist (influenza virus vaccine) . The effectiveness of FluMist (influenza virus vaccine) in preventing influenza illness in HIV-infected individuals has not been evaluated.

Refrigerated Formulation Study

A double-blind, randomized, multi-center trial was conducted to evaluate the comparative immunogenicity and safety of refrigerated and frozen formulations of FluMist (influenza virus vaccine) in individuals 5 to 49 years of age without high-risk medical conditions. Nine hundred and eighty-one subjects were randomized at a 1:1 ratio to receive either vaccine formulation. Subjects 5-8 years of age received two doses of study vaccine 46-60 days apart; subjects 9-49 years of age received one dose of study vaccine. The study met its primary endpoint. The GMT ratios of refrigerated and frozen formulations (adjusted for baseline serostatus) for H1N1, H3N2, and B strains, respectively, were 1.24,1.02, and 1.00 in the two dose group and 1.14,1.12, and 0.96 in the one dose group.

Transmission Study

FluMist (influenza virus vaccine) contains live attenuated influenza viruses that must infect and replicate in cells lining the nasopharynx of the recipient to induce immunity. Vaccine viruses capable of infection and replication can be cultured from nasal secretions obtained from vaccine recipients.

The relationship of viral replication in a vaccine recipient and transmission of vaccine viruses to other individuals has not been established.

Using the frozen formulation, a prospective, randomized, double-blind, placebo-controlled trial was performed in a daycare setting in children < 3 years of age to assess the transmission of vaccine viruses from a vaccinated individual to a non-vaccinated individual. A total of 197 children 8-36 months of age were randomized to receive one dose of FluMist (influenza virus vaccine) (n = 98) or placebo (n = 99). Virus shedding was evaluated for 21 days by culture of nasal swab specimens. Wild-type A (H3N2) influenza virus was documented to have circulated in the community and in the study population during the trial, whereas Type A (H1N1) and Type B strains did not.

At least one vaccine strain was isolated from 80% of FluMist (influenza virus vaccine) recipients; strains were recovered from 1-21 days post vaccination (mean duration of 7.6 days ± 3.4 days). The cold-adapted (ca) and temperature-sensitive (ts) phenotypes were preserved in 135 tested of 250 strains isolated at the local laboratory. Ten influenza isolates (9 influenza A, 1 influenza B) were cultured from a total of seven placebo subjects. One placebo subject had mild symptomatic Type B virus infection confirmed as a transmitted vaccine virus by a FluMist (influenza virus vaccine) recipient in the same playgroup. This Type B isolate retained the ca, ts, and att phenotypes of the vaccine strain, and had the same genetic sequence when compared to a Type B virus cultured from a vaccine recipient within the same playgroup. Four of the influenza Type A isolates were confirmed as wild-type A/Panama (H3N2). The remaining isolates could not be further characterized.

Assuming a single transmission event (isolation of the Type B vaccine strain), the probability of a young child acquiring vaccine virus following close contact with a single FluMist (influenza virus vaccine) vaccinee in this daycare setting was 0.58% (95% Cl: 0,1.7) based on the Reed-Frost model. With documented transmission of one Type B in one placebo subject and possible transmission of Type A viruses in four placebo subjects, the probability of acquiring a transmitted vaccine virus was estimated to be 2.4% (95% Cl: 0.13, 4.6), using the Reed-Frost model.

REFERENCES

1. Centers for Disease Control and Prevention. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR2009; 58(RR-8): 1-52.

 

 

FluMist


FluMist Medication Guide


PATIENT INFORMATION

Vaccine recipients or their parents/guardians should be informed by the health care provider of the potential benefits and risks of FluMist (influenza virus vaccine) , 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 (influenza virus vaccine) 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.

 

FluMist

FluMist Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

INFLUENZA VIRUS VACCINE LIVE - NASAL

 

(IN-floo-EN-za)

 

COMMON BRAND NAME(S): FluMist

 

USES: This medication is a vaccine against influenza (flu) virus. It is also called the seasonal flu vaccine. The vaccine works by helping the body produce immunity (protection) that will prevent you from getting the flu or lessen the seriousness of the infection. As with any vaccine, it may not fully protect everyone who receives it. Since different types of flu viruses cause infection every flu season, usually a new vaccine is produced and given for each flu season.

The 2010-2011 flu vaccine provides protection against H1N1 (pandemic) influenza. A separate vaccine is not needed this year. People who received the 2009 H1N1 pandemic vaccine shot should still get the regular seasonal flu vaccine.

This form of the vaccine is given through the nose and is recommended for healthy children and adults, aged 2 to 49 years.

This form of the vaccine is not recommended for children younger than 2 years old, or for children aged 2 to 4 years with a history of repeated wheezing. A flu vaccine that is given by injection is recommended for these children and for adults older than 49. Consult your doctor for more details.

 

HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.

If this vaccine is the first flu vaccination of a child aged 2 through 8 years, the child should receive a second dose (usually at least 1 month after the first dose). If a child in this age group has received this vaccine in a previous flu season, only one dose is given. Patients aged 9 years and older (including adults) should receive only one dose for each flu season.

To receive this vaccine, sit or stand upright with your head tilted back. A health care professional will spray the medication into each nostril, one at a time.

 

FluMist


FluMist Consumer (continued)

SIDE EFFECTS: Cough, runny nose, sneezing, sore throat, fever, headache, chills, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to receive this vaccine, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

 

PRECAUTIONS: Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to eggs; or if you have previously had a severe allergic reaction to flu vaccine; or if you have any other allergies. This product may contain inactive ingredients (such as gentamicin, gelatin, arginine), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccine, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, wheezing, chronic lung disease), current infection/fever, diabetes, history of Guillain-Barre syndrome, immune system problems (e.g., due to cancer treatment, HIV infection), kidney disease.

This vaccine contains a weakened form of the flu virus. After receiving the vaccine, you may be able to infect others with flu for up to 3 weeks. Rarely, infections may occur in people in close contact with someone who has received this vaccine. Caution is advised if you have regular close contact with family/household members with weakened immune systems (e.g., due to cancer).

Children aged 2 to 17 years who are taking aspirin should not receive this vaccine due to the risk for developing Reye's syndrome, a rare but serious condition. Also, children in this age group should not use products containing aspirin for 4 weeks after receiving this vaccine unless directed by the doctor. Consult the doctor for details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

 

FluMist

FluMist Consumer (continued)

DRUG INTERACTIONS: See also Precautions section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Avoid taking certain drugs that fight flu virus (e.g., amantadine, oseltamivir, rimantadine) when receiving this vaccine. If you are currently taking any of these drugs, you should not receive this vaccine until at least 48 hours after stopping treatment. Do not take any of these drugs until at least 2 weeks after receiving this vaccine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: other vaccines, other products applied in the nose, drugs that weaken the immune system (e.g., cyclosporine, tacrolimus, certain anti-cancer drugs, corticosteroids such as prednisone).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Keep all medical and laboratory appointments.

 

MISSED DOSE: This vaccine is usually given once for each flu season. If the doctor prescribes a second dose (for a first vaccination in a child aged 2 through 8 years), and the child misses the second dose, contact the doctor to set up a new appointment.

 

STORAGE: Not applicable. This vaccine is given in a doctor's office or clinic and will not be stored at home.

 

FluMist


FluMist Patient Information Including Side Effects

Brand Names: FluMist

Generic Name: influenza virus vaccine (nasal) (Pronunciation: in floo ENZ a VYE rus VAK seen)

 

  • What is influenza virus nasal vaccine (FluMist)?
  • What are the possible side effects of influenza virus nasal vaccine (FluMist)?
  • What is the most important information I should know about this vaccine (FluMist)?
  • What should I discuss with my healthcare provider before receiving this vaccine (FluMist)?
  • How is this vaccine given (FluMist)?
  • What happens if I miss a dose (FluMist)?
  • What happens if I overdose (FluMist)?
  • What should I avoid before or after receiving this vaccine (FluMist)?
  • What other drugs will affect influenza virus nasal vaccine (FluMist)?
  • Where can I get more information?

 

What is influenza virus nasal vaccine (FluMist)?

Influenza virus (commonly known as "the flu") is a serious disease caused by a virus. Influenza virus can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The virus can also be passed through contact with objects the infected person has touched, such as a door handle or other surfaces.

Nasal influenza virus vaccine is used to prevent infection caused by influenza virus. The vaccine is redeveloped each year to contain specific strains of activated (live) flu virus that are recommended by public health officials for that year.

The nasal influenza virus vaccine is a "live virus" vaccine. Influenza virus vaccine is also available in an injectable form, which is a "killed virus" vaccine.

Influenza virus vaccine works by exposing you to a small dose of the virus, which helps your body to develop immunity to the disease. Influenza virus vaccine will not treat an active infection that has already developed in the body.

Nasal influenza virus vaccine is for use in children and adults, between the ages of 2 and 49 years old.

Becoming infected with influenza (commonly known as "the flu") is much more dangerous to your health than receiving the vaccine to protect against it. Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

What are the possible side effects of influenza virus nasal vaccine (FluMist)?

Nasal influenza virus (live virus) vaccine may cause you to have mild flu-like symptoms. However, you may have flu-like symptoms at any time during flu season that may be caused by strains of influenza virus that are not contained in the vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first dose.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another nasal influenza virus vaccine in the future, you will need to tell the doctor if the first vaccine caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine); or
  • high fever, chills, body aches, flu symptoms.

Less serious side effects include:

  • low fever, chills;
  • runny or stuffy nose;
  • sore throat, cough;
  • headache;
  • feeling tired or irritable;
  • vomiting; or
  • muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What is the most important information I should know about this vaccine (FluMist)?

The nasal influenza virus vaccine is a "live virus" vaccine. Influenza virus vaccine is also available in an injectable form, which is a "killed virus" vaccine. This medication guide addresses only the nasal spray form of this vaccine.

For at least 21 days after receiving nasal influenza virus vaccine, avoid close contact with anyone who has a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by certain medicines such as steroids, cancer chemotherapy, or radiation treatment. A person with a weak immune system can become ill if they have close contact with you after you have recently received a an influenza vaccine.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another influenza virus vaccine in the future, you will need to tell the doctor if the first vaccine caused any side effects.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

Becoming infected with influenza (commonly known as "the flu") is much more dangerous to your health than receiving the vaccine to protect against it. Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Related Drug Centers
  • FluMist

 

FluMist


FluMist Patient Information including How Should I Take

In this Article

  • What is influenza virus nasal vaccine (FluMist)?
  • What are the possible side effects of influenza virus nasal vaccine (FluMist)?
  • What is the most important information I should know about this vaccine (FluMist)?
  • What should I discuss with my healthcare provider before receiving this vaccine (FluMist)?
  • How is this vaccine given (FluMist)?
  • What happens if I miss a dose (FluMist)?
  • What happens if I overdose (FluMist)?
  • What should I avoid before or after receiving this vaccine (FluMist)?
  • What other drugs will affect influenza virus nasal vaccine (FluMist)?
  • Where can I get more information?

What should I discuss with my healthcare provider before receiving this vaccine (FluMist)?

Do not receive this vaccine if you have ever had an allergic reaction to a flu vaccine, or if you have:

  • a history of Guillain-Barré syndrome (especially if you had it within 6 weeks after having a flu vaccine);
  • a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by taking certain medicines such as steroids;
  • if someone in your household has a weak immune system;
  • if you are under 18 years old and have recently taken aspirin or other similar medicines such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others; or
  • if you are allergic to chicken or egg products.

Before receiving nasal influenza virus vaccine, tell your doctor if you are allergic to any drugs, or:

  • asthma or other lung disorder;
  • a history of seizures;
  • a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);
  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or
  • if you have used a flu medication such as oseltamivir (Tamiflu) or zanamivir (Relenza) within the past 48 hours.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with influenza.

It is not known whether nasal influenza virus vaccine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

This vaccine should not be given to anyone younger than 2 or older than 49 years of age.

How is this vaccine given (FluMist)?

This vaccine is given as a nasal spray into each nostril. Your doctor, nurse, or other healthcare provider will give you this vaccine.

You should receive a flu vaccine every year. Your immunity will gradually decrease over the 12 months after you receive the influenza virus vaccine. Children receiving this vaccine may need a repeat dose two months after receiving the first vaccine.

The influenza virus vaccine is usually given in October or November. Some people may need to have their vaccines earlier or later. Follow your doctor's instructions.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the vaccine is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

Related Drug Centers
  • FluMist

FluMist

FluMist Patient Information including If I Miss a Dose

In this Article

  • What is influenza virus nasal vaccine (FluMist)?
  • What are the possible side effects of influenza virus nasal vaccine (FluMist)?
  • What is the most important information I should know about this vaccine (FluMist)?
  • What should I discuss with my healthcare provider before receiving this vaccine (FluMist)?
  • How is this vaccine given (FluMist)?
  • What happens if I miss a dose (FluMist)?
  • What happens if I overdose (FluMist)?
  • What should I avoid before or after receiving this vaccine (FluMist)?
  • What other drugs will affect influenza virus nasal vaccine (FluMist)?
  • Where can I get more information?

What happens if I miss a dose (FluMist)?

Since influenza virus vaccine is usually given only one time per year, you will most likely not be on a dosing schedule. Call your doctor if you forget to receive your yearly vaccination in October or November.

If your child misses a booster dose of this vaccine, call your doctor for instructions.

What happens if I overdose (FluMist)?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine (FluMist)?

For at least 21 days after receiving nasal influenza virus vaccine, avoid close contact with anyone who has a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by certain medicines such as steroids, cancer chemotherapy, or radiation treatment. A person with a weak immune system can become ill if they have close contact with you after you have recently received a an influenza vaccine.

For at least 2 weeks after receiving this vaccine, avoid using antiviral medications that are normally used to treat flu symptoms, such as oseltamivir (Tamiflu) or zanamivir (Relenza).

What other drugs will affect influenza virus nasal vaccine (FluMist)?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and there may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about nasal influenza virus vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.


 

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2010 Cerner Multum, Inc. Version: 2.02. Revision date: 11/17/2009.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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  • FluMist
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