FluMist: Package Insert and Label Information

FLUMIST- influenza a virus a/california/7/2009 (h1n1) live(attenuated) antigen, influenza a virus a/victoria/361/2011 (h3n2) live(attenuated) antigen and influenza b virus b/wisconsin/1/2010 live(attenuated) antigen spray
MedImmune, LLC

1 INDICATIONS AND USAGE

FluMist® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and the type B virus contained in the vaccine [see Description ( 11) ].

FluMist is approved for use in persons 2 through 49 years of age.

2 DOSAGE AND ADMINISTRATION

FOR INTRANASAL ADMINISTRATION BY A HEALTH CARE PROVIDER.

2.1 Dosing Information

Administer FluMist according to the following schedule:

*
Administer as 0.1 mL per nostril.
Age Group Vaccination Status Dosage Schedule
Children age 2 years through8 years Not previously vaccinated with influenza vaccine 2 doses (0.2 mL * each,at least 1 month apart)
Children age 2 years through8 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 *)

2.2 Administration Instructions

Each sprayer contains a single dose (0.2 mL) of FluMist; administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril (each sprayer contains 0.2 mL of vaccine). Refer to Figure 1 for step-by-step administration instructions. Following administration, dispose of the sprayer according to the standard procedures for medical waste (e.g., sharps container or biohazard container).

Figure 1
(click image for full-size original)

Figure 1

3 DOSAGE FORMS AND STRENGTHS

Each 0.2 mL dose is a suspension supplied in a single-dose pre-filled intranasal sprayer.

4 CONTRAINDICATIONS

4.1 Severe Allergic Reaction

Do not administer FluMist to persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description ( 11) ] including egg protein, gentamicin, gelatin, and arginine, or after a previous dose of any influenza vaccine.

4.2 Concomitant Aspirin Therapy and Reye’s Syndrome in Children and Adolescents

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 infection [see Drug Interactions ( 7.1) ].

5 WARNINGS AND PRECAUTIONS

5.1 Risks of Hospitalization and Wheezing in Children Younger than 24 Months of Age

In clinical trials, risks of hospitalization and wheezing were increased in children younger than 2 years of age who received FluMist [see Adverse Reactions ( 6.1) ].

5.2 Asthma, Recurrent Wheezing, and Active Wheezing

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.

5.3 Guillain-Barré Syndrome

The 1976 swine influenza vaccine (inactivated) was associated with an elevated risk of Guillain-Barré syndrome (GBS). Evidence for causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, based on data for inactivated influenza vaccines, it is probably slightly more that 1 additional case per 1 million persons vaccinated [1]. If GBS has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist should be based on careful consideration of the potential benefits and potential risks.

5.4 Altered Immunocompetence

The effectiveness of FluMist has not been studied in immunocompromised persons. Data on safety and shedding of vaccine virus after administration of FluMist in immunocompromised persons are limited to 174 individuals with HIV infection and 10 mild to moderately immunocompromised children and adolescents with cancer [see Clinical Pharmacology ( 12.2) ].

5.5 Medical Conditions Predisposing to Influenza Complications

The safety of FluMist in individuals with underlying medical conditions that may predispose them to complications following wild-type influenza infection has not been established.

5.6 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 ( 4.1) ].

5.7 Limitations of Vaccine Effectiveness

FluMist may not protect all individuals receiving the vaccine.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

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

A total of 9537 children and adolescents 1 through 17 years of age and 3041 adults 18 through 64 years of age received FluMist in randomized, placebo-controlled Studies D153-P501, AV006, D153-P526, AV019, and AV009 [3 used Allantoic Fluid containing Sucrose-Phosphate-Glutamate (AF-SPG) placebo, and 2 used saline placebo] described below. In addition, 4179 children 6 through 59 months of age received FluMist in Study MI-CP111, a randomized, active-controlled trial. Among pediatric FluMist recipients 6 months through 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

The safety of FluMist was evaluated in an AF-SPG placebo-controlled study (AV019) conducted in a Health Maintenance Organization (HMO) in children 1 through 17 years of age (FluMist = 6473, placebo = 3216). An increase in asthma events, captured by review of diagnostic codes, was observed in children younger than 5 years of age who received FluMist compared to those who received placebo (Relative Risk 3.53, 90% CI: 1.1, 15.7).

In Study MI-CP111, children 6 through 59 months of age were randomized to receive FluMist or inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. Wheezing requiring bronchodilator therapy or accompanied by respiratory distress or hypoxia was prospectively monitored from randomization through 42 days post last vaccination. Hospitalization due to all causes was prospectively monitored from randomization through 180 days post last vaccination. Increases in wheezing and hospitalization (for any cause) were observed in children 6 months through 23 months of age who received FluMist compared to those who received inactivated Influenza Virus Vaccine, as shown in Table 1.

Table 1: Percentages of Children with Hospitalizations and Wheezing from Study MI-CP111*
*
NCT00128167; see www.clinicaltrials.gov
Inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc., administered intramuscularly.
Hospitalization due to any cause from randomization through 180 days post last vaccination.
§
Wheezing requiring bronchodilator therapy or accompanied by respiratory distress or hypoxia evaluated from randomization through 42 days post last vaccination.
Adverse Reaction Age Group FluMist (n/N) Active Control (n/N)
Hospitalizations 6-23 months 4.2%(84/1992) 3.2%(63/1975)
24-59 months 2.1%(46/2187) 2.5%(56/2198)
Wheezing § 6-23 months 5.9%(117/1992) 3.8%(75/1975)
24-59 months 2.1%(47/2187) 2.5%(56/2198)

Most hospitalizations observed were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. In post-hoc analysis, rates of hospitalization in children 6 through 11 months of age were 6.1% (42/684) in FluMist recipients and 2.6% (18/683) in inactivated Influenza Virus Vaccine recipients.

Table 2 shows pooled solicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (≥ 1% rate difference after rounding) compared to placebo post Dose 1 for Studies D153-P501 and AV006, and solicited adverse reactions post Dose 1 for Study MI-CP111. Solicited adverse reactions were those about which parents/guardians were specifically queried after receipt of FluMist, placebo, or control vaccine. In these studies, solicited reactions were documented for 10 days post vaccination. Solicited reactions following the second dose of FluMist were similar to those following the first dose and were generally observed at a lower frequency.

Table 2: Summary of Solicited Adverse Reactions Observed Within 10 Days after Dose 1 for FluMist and Either Placebo or Active Control Recipients in Children 2 through 6 Years of Age
*
NCT00192244; see www.clinicaltrials.gov
NCT00128167; see www.clinicaltrials.gov
Study D153-P501 used saline placebo; Study AV006 used AF-SPG placebo.
§
Inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc., administered intramuscularly.
Number of evaluable subjects (those who returned diary cards) for each reaction. Range reflects differences in data collection between the 2 pooled studies.
Studies D153-P501 * & AV006 Study MI-CP111
FluMist Placebo FluMist Active Control §
N = 876-1759 N = 424-1034 N = 2170 N = 2165
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°F Oral 16 11 13 11
> 100 — ≤ 101°F Oral 9 6 6 4
> 101 — ≤ 102°F Oral 4 3 4 3

In clinical studies D153-P501 and AV006, unsolicited adverse reactions in children occurring in at least 1% of FluMist recipients and at a higher rate (≥ 1% rate difference after rounding) compared to placebo were abdominal pain (2% FluMist vs. 0% placebo) and otitis media (3% FluMist vs. 1% placebo). An additional adverse reaction identified in the active-controlled trial MI-CP111 occurring in at least 1% of FluMist recipients and at a higher rate (≥ 1% rate difference after rounding) compared to active control was sneezing (2% FluMist vs. 1% active control).

In a separate saline placebo-controlled trial (D153-P526) in a subset of older children and adolescents 9 through 17 years of age who received one dose of FluMist, the solicited adverse reactions as well as unsolicited adverse reactions reported were generally consistent with observations from the trials in Table 2.Abdominal pain was reported in 12% of FluMist recipients compared to 4% of placebo recipients and decreased activity was reported in 6% of FluMist recipients compared to 0% of placebo recipients.

In Study AV018, in which FluMist was concomitantly administered with Measles, Mumps, and Rubella Virus Vaccine Live (MMR, manufactured by Merck & Co., Inc.) and Varicella Virus Vaccine Live (manufactured by Merck & Co., Inc.) to children 12 through 15 months of age, adverse reactions were similar to those seen in other clinical trials of FluMist.

Adverse Reactions in Adults

In adults 18 through 49 years of age in Study AV009, solicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (≥ 1% rate difference after rounding) compared to AF-SPG placebo include runny nose (44% FluMist vs. 27% placebo), headache (40% FluMist vs. 38% placebo), sore throat (28% FluMist vs. 17% placebo), tiredness/weakness (26% FluMist vs. 22% placebo), muscle aches (17% FluMist vs. 15% placebo), cough (14% FluMist vs. 11% placebo), and chills (9% FluMist vs. 6% placebo).

In Study AV009, unsolicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (≥ 1% rate difference after rounding) compared to placebo were nasal congestion (9% FluMist vs. 2% placebo) and sinusitis (4% FluMist vs. 2% placebo).

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