Influenza Virus Vaccine Live Intranasal

Class: Vaccines
VA Class: IM100
Brands: FluMist

Introduction

Live, attenuated virus vaccine.^{1 100} Seasonal influenza virus vaccine live intranasal contains live (cold-adapted) influenza virus types A and B and is used to stimulate active immunity to influenza virus strains contained in the vaccine.^{1 100}

Uses for Influenza Virus Vaccine Live Intranasal

Prevention of Seasonal Influenza A and B Virus Infections

Prevention of seasonal influenza virus infection in children ≥2 years of age, adolescents, and adults 18 through 49 years of age.^{1 100 105 539}

Influenza is an acute viral infection; influenza viruses spread from person to person mainly through large-particle respiratory droplet transmission.¹⁰⁰ In the US, epidemics of seasonal influenza occur annually, usually during late fall through early spring.¹⁰⁰ Influenza viruses can cause illness in any age group; children have highest rate of infection.¹⁰⁰ Influenza can exacerbate underlying medical conditions or lead to pneumonia in certain individuals.¹⁰⁰ Individuals ≥65 years of age, children <2 years of age, and individuals with chronic medical conditions have highest risk of influenza-related complications and death.¹⁰⁰

Annual vaccination is the most effective strategy for preventing seasonal influenza and its complications.¹⁰⁰

US Public Health Service Advisory Committee on Immunization Practices (ACIP) recommends routine influenza vaccination for all adults, adolescents, and infants and children ≥6 months of age using an age-appropriate seasonal influenza vaccine, unless contraindicated.^{100 199 200 539} Seasonal influenza vaccination efforts should continue to target individuals at higher risk of influenza or influenza-related complications and those who live with or care for such individuals (e.g., health-care personnel, household or other close contacts).¹⁰⁰

For prevention of seasonal influenza infection, 2 different types of influenza vaccine are commercially available in the US: intranasal vaccine containing live, attenuated virus^{1 100} and parenteral vaccine containing inactivated virus subunits.^{100 103 186 187 188 189} Both vaccine types contain influenza virus strains antigenically equivalent to the annually recommended seasonal influenza strains.¹⁰⁰ Possible advantages of the intranasal live vaccine include its potential to induce a broad mucosal and systemic immune response, ease of administration, and improved acceptance of intranasal rather than parenteral administration;¹⁰⁰ possible disadvantages include restrictions based on age or medical conditions and risk that the live vaccine virus could be transmitted from the vaccinee to close contacts who are severely immunocompromised.¹⁰⁰ (See Transmission of Vaccine Virus under Cautions.)

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ACIP, AAP, American Academy of Family Physicians (AAFP), and other experts state that either seasonal intranasal live influenza vaccine or age-appropriate seasonal parenteral inactivated vaccine can be used for prevention of seasonal influenza infection in healthy, nonpregnant individuals 2 through 49 years of age who do not have underlying medical conditions that put them at higher risk for influenza complications.^{100 105 199 200 336 539} This includes health-care personnel, household contacts, and other individuals (e.g., day-care providers) who are in close contact with individuals at high risk of influenza complications or in close contact with certain immunocompromised individuals (e.g., those not requiring a protective environment, those with diabetes or HIV infection, asthma patients taking corticosteroids).¹⁰⁰

Do not use seasonal intranasal live influenza vaccine in health-care workers, household members, or other individuals who have close contact with severely immunocompromised individuals who are hospitalized and require care in a protective environment (e.g., hematopoietic stem cell transplant [HSCT] recipients).^{100 336} (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.) Use the seasonal parenteral inactivated influenza vaccine in these individuals.¹⁰⁰

Travelers who want to reduce their risk for influenza infection should receive vaccination with seasonal influenza vaccine at least 2 weeks before departure.^{100 117} Risk for exposure to seasonal influenza during travel depends on the time of year and destination.^{100 117} In tropical and subtropical areas, influenza occurs throughout the year.^{100 117} In temperate regions, influenza activity generally occurs from October to May in the northern hemisphere and from April through September in the southern hemisphere.^{100 117} However, travelers may be exposed to influenza at any time of the year if they are traveling on a cruise or as part of a large tourist group that includes individuals from areas of the world where influenza is circulating.^{100 117} ACIP recommends that travelers (especially those at high risk for influenza complications) be vaccinated against seasonal influenza before travel if they were not vaccinated during the preceding fall or winter, will be traveling to the tropics, traveling with organized tourist groups at any time of year, or traveling to the southern hemisphere between April and September.¹⁰⁰

Safety and efficacy of seasonal intranasal live influenza vaccine not established in children <24 months of age or adults ≥50 years of age;¹ use an age-appropriate parenteral inactivated seasonal influenza vaccine in these age groups.¹⁰⁰

Safety of seasonal intranasal live influenza vaccine not established in individuals with underlying medical conditions that may predispose them to severe disease following influenza infection;^{1 100} use age-appropriate parenteral inactivated seasonal influenza vaccine in these individuals.¹⁰⁰

Seasonal influenza vaccines not effective against all strains of influenza, but may be effective against those strains (and closely related strains) represented in the vaccines.¹⁰⁰

The 2009 pandemic influenza A (H1N1) virus, previously referred to as the novel 2009 influenza A (H1N1) virus or swine-origin influenza A (H1N1) virus and now referred to as influenza A (H1N1)pdm09 (pH1N1), is likely to continue to circulate during the 2012–2013 season.^{105 539} Seasonal influenza vaccines for the 2012–2013 influenza season are expected to provide protection against the influenza A (pH1N1) virus and influenza A (H3N2) and influenza B viruses represented in the vaccines.^{105 539 544}

Seasonal influenza vaccines for the 2012–2013 influenza season do not provide protection against influenza A (H3N2) variant viruses (H3N2v).⁵⁵⁰

Seasonal influenza vaccines not expected to provide protection against infection with avian influenza A viruses, including avian influenza A (H5N1).¹⁰⁰

Information regarding influenza surveillance and updated recommendations for prevention and treatment of seasonal influenza is available from CDC at .

Influenza Virus Vaccine Live Intranasal Dosage and Administration

Administration

Intranasal Administration

Administer intranasally using prefilled, single-use sprayer supplied by the manufacturer.¹

Do not administer IM, IV, or intradermally.¹⁰⁰

Intranasal live influenza vaccine is a colorless to pale yellow suspension and is clear to slightly cloudy.¹ Do not mix with any other vaccine or solution.¹¹⁸

Administer every year before exposure to seasonal influenza.¹⁰⁰ Begin annual vaccination efforts by October (or as soon as the seasonal influenza vaccine is available); continue vaccination efforts throughout influenza season (even in December or after influenza activity has begun in the community).¹⁰⁰ In the US, localized outbreaks indicating start of the annual influenza season can occur as early as October; peak influenza activity often occurs in January or February, but has occurred as late as April or May.¹⁰⁰

Must be administered by a health-care provider.¹ Severely immunosuppressed individuals should not administer the vaccine.¹⁰⁰ (See Administration Precautions under Cautions.) Other individuals at high risk of influenza complications (e.g., those with underlying medical conditions, pregnant women, individuals with asthma, individuals >50 years of age) may administer the vaccine.¹⁰⁰

Place recipient in an upright position.¹ Administer approximately one-half the contents of the prefilled, single-use sprayer into each nostril.¹ Consult manufacturer’s labeling for specific information regarding use of the sprayer.¹

After administering vaccine, carefully dispose of the sprayer (i.e., discard using standard procedures for medical waste).^{1 119}

If vaccine recipient sneezes after receiving a dose, do not repeat the dose.¹⁰⁰

If nasal congestion might impede delivery of vaccine to nasopharyngeal mucosa, defer administration until symptoms subside.¹⁰⁰ Alternatively, use parenteral inactivated seasonal influenza vaccine.¹⁰⁰

May be given simultaneously with other age-appropriate vaccines during same health-care visit.^{100 105 118} (See Interactions.)

Dosage

Dosing schedule for prevention of seasonal influenza depends on individual’s age and vaccination history.^{1 100 105 539}

A single-dose regimen of seasonal influenza vaccine is used in children ≥9 years of age, adolescents, and adults 18 through 49 years of age.^{1 100 105}

A 2-dose regimen of seasonal influenza vaccine is necessary in children 2 through 8 years of age who have not previously received any doses of seasonal influenza vaccine or have an uncertain history regarding prior influenza vaccination.^{1 100 105 539} (See Pediatric Patients under Dosage and Administration.)

A single dose consists of the entire contents (0.2 mL) of the sprayer (0.1 mL in each nostril).¹

Pediatric Patients

Prevention of Seasonal Influenza A and B Virus Infections

Healthy Children 2 through 8 Years of Age

Intranasal

Has not previously received any doses of any type of seasonal influenza vaccine or has an uncertain history regarding influenza vaccination: 2 doses administered at least 1 month (4 weeks) apart.^{1 105 539} Each dose consists of 0.2 mL (0.1 mL in each nostril).¹

Received <2 doses of any seasonal influenza vaccine since July 1, 2010: ACIP and AAP recommend 2 doses administered at least 4 weeks apart.^{105 539} Each dose consists of 0.2 mL (0.1 mL in each nostril).¹

Received ≥2 doses of any seasonal influenza vaccine since July 1, 2010: ACIP and AAP recommend a single dose^{105 539} consisting of 0.2 mL (0.1 mL in each nostril).¹

Manufacturer states that a single dose can be used in those who previously received influenza vaccination.¹

Healthy Children and Adolescents 9 through 17 Years of Age

Intranasal

Single dose consisting of 0.2 mL (0.1 mL in each nostril).^{1 100 105}

Adults

Prevention of Seasonal Influenza A and B Virus Infections

Healthy Adults 18 through 49 Years of Age

Intranasal

Single dose consisting of 0.2 mL (0.1 mL in each nostril).^{1 100}

Special Populations

Hepatic Impairment

No specific dosage recommendations.¹

Renal Impairment

No specific dosage recommendations.¹

Geriatric Patients

Not indicated in adults ≥50 years of age, including geriatric adults.¹

Cautions for Influenza Virus Vaccine Live Intranasal

Contraindications

• Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, gentamicin, gelatin, or arginine.¹ (See Sensitivity Reactions under Cautions.)

• Severe allergic reaction (e.g., anaphylaxis) to previous dose of any influenza vaccine.¹

• Children and adolescents 2 through 17 years of age receiving aspirin or aspirin-containing therapy; possible association of Reye's syndrome with aspirin use and wild-type influenza infection.¹ (See Specific Drugs under Interactions.)

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity reactions (e.g., anaphylactic reaction, facial edema, urticaria) reported.¹

Appropriate medical treatment and supervision must be readily available in case anaphylaxis occurs.¹

Do not administer additional doses to any individual who had a severe allergic reaction to a previous dose.¹ (See Contraindications under Cautions.)

Egg Allergy

Seasonal intranasal live influenza vaccine is produced using eggs;^{1 100 105 539} contains residual egg protein (<24 mcg of ovalbumin per dose)¹ that may induce immediate hypersensitivity reactions, including anaphylaxis, in individuals with severe egg allergy.^{100 539}

ACIP states that individuals who are able to eat lightly cooked eggs (e.g., scrambled eggs) without reaction are unlikely to be allergic and may receive influenza vaccination per usual protocols.⁵³⁹ However, tolerance to egg-containing foods does not exclude the possibility of egg allergy since some egg-allergic individuals may tolerate egg in baked products (e.g., bread, cake).⁵³⁹ Egg allergy can be confirmed by a consistent history of adverse reactions to eggs and egg-containing foods in addition to skin and/or blood testing for immunoglobulin E antibodies to egg proteins.⁵³⁹

ACIP and AAP state that individuals who have less severe reactions (i.e., hives only) after eating eggs or egg-containing foods may receive influenza vaccine; however, parenteral inactivated influenza vaccine is preferred over intranasal live influenza vaccine since data are lacking regarding use of the live vaccine in individuals with egg allergy.^{105 539} Additionally, if influenza vaccine is used in such individuals, the vaccine should be administered by a health-care provider familiar with potential manifestations of egg allergy and recipients should be observed for at least 30 minutes following vaccination.^{105 539} Other measures, such as skin testing or administration of the vaccine in 2 steps (e.g., 10% of the dose initially, followed by remainder of dose if no reaction occurs during 30 minutes of observation), are not necessary in individuals with a history of less severe reactions (i.e., hives only) to eggs.^{105 539}

Individuals with a history of severe reaction to eggs, including angioedema, respiratory distress (e.g., wheezing, throat swelling), lightheadedness, cardiovascular changes (e.g., hypotension), or GI symptoms (e.g., nausea, vomiting), or any previous reaction requiring epinephrine or other emergency intervention (particularly reactions that occurred within minutes to hours following egg exposure) are more likely to have a serious systemic or anaphylactic reaction following reexposure to egg protein.^{105 539} ACIP and AAP recommend that such individuals be referred to a clinician with expertise in the management of allergic conditions for further risk assessment to determine whether the vaccine should be administered.^{105 539}

Infants <24 Months of Age

Do not use in infants <24 months of age; increased risk of wheezing and hospitalization reported in clinical trials in this age group.¹ (See Pediatric Use under Cautions.)

Individuals with Asthma or Recurrent Wheezing

Individuals of any age with asthma and children <5 years of age with history of recurrent wheezing or a recent wheezing episode (i.e., during the past 12 months) may be at increased risk of wheezing after receiving intranasal live influenza vaccine.^{1 100 105} The vaccine has not been studied in individuals with severe asthma or active wheezing.¹

ACIP and AAP state that intranasal live influenza vaccine should not be used in individuals with asthma or in children 24 through 59 months of age who have had a wheezing episode within the past 12 months.^{100 105} (See Pediatric Use under Cautions.)

Guillain-Barré Syndrome

Carefully consider possible benefits and potential risks of intranasal live influenza vaccine in individuals who experienced Guillain-Barré syndrome (GBS) within 6 weeks of previous influenza vaccination.¹

Unclear whether influenza vaccination increases risk of recurrence of GBS.¹⁰⁰ ACIP states that, as a precaution, individuals who are not at high risk for severe influenza complications and who developed GBS within 6 weeks of a previous dose of influenza vaccine generally should avoid influenza vaccination.¹⁰⁰ Although data are limited, ACIP states that use of influenza vaccine can be considered in individuals with a history of GBS who are at high risk for severe complications from influenza.¹⁰⁰

Individuals with Altered Immunocompetence and Their Close Contacts

Efficacy not studied in immunocompromised individuals.¹ Limited data in immunocompromised adults, adolescents, and children with HIV or cancer indicate adverse effects and frequency and duration of vaccine virus shedding in such individuals are similar to that reported in healthy individuals.¹

CDC, NIH, IDSA, AAP, and other experts state that HIV-infected children, adolescents, and adults should receive annual vaccination against seasonal influenza; however, the parenteral inactivated influenza vaccine (not the intranasal live vaccine) should be used for prevention of seasonal influenza in HIV-infected individuals.^{105 155 156}

ACIP states that live viral vaccines (including intranasal live influenza vaccine) usually should not be used in immunocompromised individuals, except in certain circumstances.¹¹⁸ These experts state that use of live virus vaccines can be considered in patients with leukemia, lymphoma, or other malignancies if the disease is in remission and chemotherapy was terminated at least 3 months prior to vaccination.¹¹⁸ (See Specific Drugs under Interactions.)

Because of possible transmission of live vaccine viruses, intranasal live influenza vaccine should not be administered to close contacts of severely immunocompromised individuals who are hospitalized and require care in a protective environment (e.g., HSCT recipients); the vaccine may be administered to close contacts of less severely immunocompromised individuals (e.g., those not requiring a protective environment).^{100 336}

In addition, because of possible transmission of live vaccine viruses, ACIP states that health-care workers who have received the intranasal vaccine should avoid contact with severely immunocompromised patients requiring a protective environment (e.g., HSCT recipients) for 7 days after vaccination.¹⁰⁰ Hospital visitors who have received the vaccine should avoid contact with severely immunosuppressed patients for 7 days after vaccination but may visit patients who are not severely immunosuppressed.¹⁰⁰

Individuals with Medical Conditions that Increase Risk of Influenza Complications

Safety not established in individuals with underlying medical conditions that increase risk for complications following wild-type influenza infection.^{1 100 105}

Individuals at increased risk of influenza complications include those with chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, neurologic, hematologic, or metabolic (including diabetes mellitus) disorders and those who are immunosuppressed (including immunosuppression caused by drug therapy or HIV infection).¹⁰⁰ (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.)

Transmission of Vaccine Virus

Intranasal influenza vaccine contains live, attenuated virus.^{1 100} Vaccine virus capable of infection and replication is present in nasal secretions of vaccine recipients¹ and viral shedding occurs in adults and children who have received the intranasal live vaccine.^{1 100}

Relationship between vaccine virus replication in vaccine recipients and transmission of vaccine virus to other individuals not established.¹ Transmission of vaccine virus has occurred rarely between recipients of intranasal influenza vaccine and their contacts.^{1 100}

Limitations of Vaccine Effectiveness

May require up to 2 weeks for protection to develop following seasonal influenza vaccination.¹⁰⁰

May not protect all vaccine recipients against influenza.¹

Seasonal influenza vaccine is formulated annually to contain influenza A and B antigens predicted to represent strains of influenza virus likely to circulate in the US during the upcoming influenza season.^{1 100} (See Actions.) Efficacy of the seasonal vaccine during any given year depends on how closely viral strains represented in the vaccine match viral strains circulating during the season.¹⁰⁰

Intranasal influenza vaccine for the 2012–2013 influenza season expected to provide protection against the influenza A (pH1N1) virus and influenza A (H3N2) and influenza B viruses represented in the vaccine.^{105 539 544}

Seasonal intranasal influenza vaccine for the 2012–2013 influenza season does not provide protection against influenza A (H3N2) variant viruses (H3N2v).⁵⁵⁰

Seasonal influenza vaccines not expected to provide protection against infection with avian influenza A viruses, including avian influenza A (H5N1).¹⁰⁰

Duration of Immunity

Immunity declines during the year after seasonal influenza vaccination.¹⁰⁰ In addition, circulating strains of seasonal influenza virus change from year to year.^{23 100} Annual vaccination is needed for prevention of seasonal influenza.¹⁰⁰

Do not administer influenza vaccine from a previous influenza season in an attempt to provide protection during a subsequent influenza season.¹⁰⁰

Concomitant Illness

ACIP states that minor acute illness, such as mild diarrhea or mild upper respiratory tract infection (with or without fever), generally does not preclude vaccination.^{100 118} If nasal congestion will impede delivery of the vaccine to the nasopharyngeal mucosa, defer administration until illness resolves.¹⁰⁰

Administration Precautions

Health-care personnel who are severely immunosuppressed should not administer intranasal live influenza vaccine to patients.¹⁰⁰ Small amounts of vaccine virus are likely to be introduced into the environment; the risk of acquiring vaccine virus from the environment is unknown, but presumed to be low.¹⁰⁰

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees.¹¹⁸

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.^{118 119 119}

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.^{1 118 119} (See Storage under Stability.) If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.^{118 119}

Specific Populations

Pregnancy

Category B.¹

Manufacturer states use in pregnant women only when clearly needed.¹

ACIP, American Congress of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), NIH, IDSA, and other experts state that parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) should be used for prevention of seasonal influenza in pregnant women.^{100 118 155 200}

Lactation

Not known whether influenza virus live is distributed into milk.¹ Manufacturer recommends caution.¹

ACIP states that either seasonal intranasal live influenza vaccine or seasonal parenteral inactivated influenza vaccine can be used for prevention of seasonal influenza in nursing women, unless contraindicated.¹⁰⁰

Pediatric Use

Safety and efficacy established only in children ≥2 years of age.¹

Not indicated in infants <24 months of age.¹ Increased incidence of wheezing and hospitalization reported in a clinical trial in infants 6 through 23 months of age† who received intranasal live influenza vaccine compared with those who received parenteral inactivated seasonal influenza vaccine.¹

ACIP and AAP recommend that intranasal live influenza vaccine not be used in children with asthma or children 24 through 59 months of age with a history of recurrent wheezing or recent wheezing episode (i.e., during the past 12 months).^{100 105}

When considering use in children 24 through 59 months of age, ACIP and AAP recommend that clinicians screen for possible reactive airways diseases by consulting the child's medical record and asking the child's parent or guardian if wheezing or asthma episodes were identified by a health-care provider within the past 12 months.^{100 105} Use age-appropriate seasonal parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in such children.^{100 105}

Protection of young infants against seasonal influenza virus depends on immunization of their close contacts.^{100 105} All household contacts, health-care and day-care providers, and other close contacts of young infants should receive seasonal influenza vaccination appropriate for their age and target group.^{100 105}

Adults 50–64 Years of Age

Not indicated for use in adults 50–64 years of age.¹ Efficacy not demonstrated in adults 50–64 years of age.¹ Use age-appropriate seasonal parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in this age group.¹⁰⁰

Geriatric Use

Not indicated for use in geriatric individuals ≥65 years of age.¹ Use age-appropriate seasonal parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in geriatric adults.¹⁰⁰

Common Adverse Effects

Children 2 through 6 years of age: Runny nose/nasal congestion, decreased appetite, irritability, lethargy, sore throat, fever, headache, muscle aches, chills.¹

Older children and adolescents through 17 years of age: Adverse effects similar to those reported in younger children; in addition, abdominal pain and decreased activity.¹

Adults 18 through 49 years of age: Runny nose, headache, sore throat, tiredness/weakness, muscle aches, cough, chills, nasal congestion, sinusitis.¹

Interactions for Influenza Virus Vaccine Live Intranasal

Inactivated Vaccines and Toxoids

Safety and immunogenicity of intranasal live influenza vaccine administered concomitantly with age-appropriate inactivated vaccines not specifically studied.¹

ACIP states that, in the absence of specific data indicating interference, inactivated vaccines or toxoids can be administered simultaneously with or at any interval before or after seasonal intranasal live influenza vaccine.¹⁰⁰

Live Vaccines

Intranasal influenza vaccine is a live, attenuated virus vaccine.^{1 100 105 118} ACIP states that influenza virus vaccine live intranasal and other live vaccines generally may be administered simultaneously on the same day.^{100 118}

ACIP states that some oral live vaccines (e.g., typhoid vaccine live oral) can be administered concomitantly with or at any interval before or after intranasal live influenza vaccine.¹¹⁸ However, because of theoretical concerns that the immune response to other live virus vaccines might be impaired if given within 30 days of another live virus vaccine, ACIP states that if intranasal live influenza vaccine and other live vaccines are not administered on the same day, they should be administered at least 4 weeks apart.^{100 118} (See Specific Drugs under Interactions.)

Specific Drugs

Drug	Interaction	Comments
Antiviral agents active against influenza (amantadine, rimantadine, oseltamivir, zanamivir)	Concomitant use of intranasal live influenza vaccine and antivirals used for treatment or prevention of influenza not studied; these antivirals potentially could decrease response to the live vaccine1 100	Do not administer intranasal live influenza vaccine until at least 48 hours after influenza antiviral agent discontinued; do not administer influenza antiviral agent until at least 2 weeks after the vaccine, unless medically necessary1 100 If influenza antiviral agent and intranasal live influenza vaccine are administered concomitantly, consider revaccination if appropriate;1 ACIP recommends revaccination if an influenza antiviral was given 2 days before to 14 days after intranasal live influenza vaccine100
Aspirin	Association of Reye's syndrome with aspirin and wild-type influenza infection 1 100	Contraindicated in children and adolescents 2–17 years of age receiving aspirin or aspirin-containing therapy;1 100 avoid aspirin-containing products in children and adolescents 2–17 years of age for 4 weeks following vaccination1
Blood products		May be administered simultaneously with or at any time before or after whole blood, packed red blood cells, plasma, and platelet products118
Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV]) or specific hyperimmune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG])		May be given simultaneously with or at any interval before or after immune globulin or specific hyperimmune globulin118
Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)	Potential for decreased antibody response to intranasal live influenza vaccine and increased risk of adverse reactions118	Should not be used in those receiving immunosuppressive therapy105 118 Optimum interval between discontinuance of immunosuppressive therapy and subsequent administration of a live viral vaccine has not been determined118 Live viral vaccines generally should not be administered for at least 3 months after immunosuppressive therapy is discontinued, including chemotherapy or radiation for leukemia, other hematopoietic malignancies, or solid tumors, or after solid organ transplant 118 Systemic corticosteroid therapy (prednisone or equivalent) in a dosage ≥2 mg/kg daily or ≥20 mg daily given for ≥2 weeks is considered immunosuppressive;118 delay administration of live vaccines for at least 1 month after such therapy is discontinued118 Corticosteroid therapy involving short-term (<2 weeks), low- to moderate-dose systemic therapy (<20 mg prednisone or equivalent daily); long-term, alternate-day systemic therapy using short-acting drugs; maintenance physiologic doses (replacement therapy); topical therapy (e.g., cutaneous, ophthalmic); inhalation; or intra-articular, bursal, or tendon injections does not contraindicate use of live vaccines118
Intranasal preparations (e.g., corticosteroids)	Concomitant administration not evaluated1
Measles, mumps, and rubella vaccine (MMR)	Simultaneous administration of intranasal live influenza vaccine with MMR and monovalent varicella vaccine in infants 12–15 months of age did not interfere with the immune response to any of the antigens and did not increase frequency of adverse effects;1 25 100 safety and immunogenicity of simultaneous administration not evaluated in infants >15 months of age1	If not given simultaneously, give at least 4 weeks apart whenever possible100 118
Rotavirus vaccine (RV)	Concomitant use not studied;26 rotavirus vaccine not indicated in children ≥2 years of age (the age group that can receive intranasal live influenza vaccine)26
Varicella vaccine (VAR)	Simultaneous administration of intranasal live influenza vaccine with monovalent varicella vaccine and MMR vaccine in infants 12–15 months of age did not interfere with the immune response to any of the antigens and did not increase frequency of adverse effects;1 25 100 safety and immunogenicity of concomitant administration not evaluated in infants >15 months of age1	If not given simultaneously, give at least 4 weeks apart whenever possible100 118

Stability

Storage

Intranasal Spray

Suspension

2–8°C; do not freeze.¹

Does not contain thimerosal or any other preservatives.¹

Actions

• Influenza virus vaccine live intranasal used for prevention of seasonal influenza contains live, attenuated (cold-adapted) influenza virus types A and B.¹

• Seasonal influenza vaccines are formulated annually to contain antigens representative of the influenza A (H1N1), influenza A (H3N2), and influenza B viruses likely to circulate in the US during the upcoming influenza season.^{1 544}

• Seasonal intranasal live influenza vaccine is considered antigenically equivalent to seasonal parenteral inactivated influenza vaccine.¹⁰⁰

• The 2012–2013 seasonal intranasal live influenza vaccine for the US is a trivalent vaccine containing 2 influenza type A antigens (H1N1 and H3N2) and a single influenza type B antigen.^{1 539 544} Quadrivalent seasonal intranasal live influenza vaccine containing 2 influenza B antigens in addition to the 2 influenza A antigens received FDA approval, but is not expected to be available in the US during the 2012–2013 influenza season.⁵³⁹

• The 2012–2013 seasonal intranasal live influenza vaccine for the US contains A/California/7/2009-like (pH1N1), A/Victoria/361/2011-like (H3N2), and B/Wisconsin/1/2010-like (B/Yamagata lineage) antigens.^{1 539 544} The influenza A (H1N1) antigen is derived from the influenza A (pH1N1) virus and was included in the vaccine used during the previous influenza season (2011–2012).^{105 539 544} The influenza A (H3N2) and influenza B antigens differ from those contained in the 2011–2012 vaccine.^{105 539 544}

• Influenza vaccines stimulate active immunity to influenza virus strains represented in the vaccines.^{1 100}

• Following administration of intranasal live influenza vaccine, vaccine virus replicates in cells lining the nasopharynx.^{1 100} Protective mechanism not completely understood; may involve serum antibodies, mucosal antibodies, and influenza-specific T-cells.^{1 100}

• Efficacy of seasonal influenza vaccine in preventing seasonal influenza virus infection depends on whether the virus strains represented in the vaccine are antigenically similar to influenza virus strains circulating during the influenza season.¹⁰⁰

• Seasonal influenza vaccines for the 2012–2013 influenza season are expected to provide protection against the influenza A (pH1N1) virus and influenza A (H3N2) and influenza B strains represented in the vaccines.^{105 539 544}

Advice to Patients

• Prior to administration of seasonal influenza virus vaccine live, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient's legal representative (VISs are available at ).^{1 20}

• Advise patient and/or patient's parent or guardian of the risks and benefits of vaccine administration.¹

• Advise patient and/or patient's parent or guardian that annual vaccination against seasonal influenza is necessary.¹⁰⁰

• Importance of receiving the 2012–2013 seasonal influenza vaccine, even if the individual received the 2011–2012 seasonal influenza vaccine.^{105 539}

• Advise patient and/or patient's parent or guardian that a single dose of seasonal influenza vaccine is necessary each year in adults, adolescents, and children ≥9 years of age, but that 2 doses of seasonal influenza vaccine may be necessary in some children 2 through 8 years of age.^{1 100 105} (See Pediatric Patients under Dosage and Administration.)

• Ask patient and/or patient's parent or guardian if vaccinee has a history of asthma or recurrent wheezing or has had a recent wheezing episode (within the past 12 months).^{1 100 105} Advise patient's parent or guardian that a history of recurrent wheezing may be an asthma equivalent in children <5 years of age and that individuals of any age with asthma and children <5 years of age with recurrent wheezing may be at increased risk for wheezing after receiving the intranasal vaccine.¹ (See Pediatric Use under Cautions.)

• Importance of informing clinicians of any severe or life-threatening allergies, including severe allergy to eggs, or any history of severe reaction after prior influenza vaccination.²⁰

• Advise patient and/or patient's parent or guardian that seasonal intranasal influenza vaccine is a live, attenuated virus vaccine and that vaccine virus can be transmitted to close contacts.^{1 100} Necessity of vaccine recipient avoiding close contact with severely immunocompromised individuals for 7 days following vaccination.¹⁰⁰ (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.)

• Importance of informing clinicians of adverse effects.¹ Clinicians or individuals can report any adverse reactions that occur following vaccination to the manufacturer at 877-633-4411 or Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or .^{1 100}

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant medical problems (i.e., asthma, recurrent wheezing, GBS).¹

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.¹

• Importance of informing patients of other precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Influenza Virus Vaccine Live Intranasal Trivalent Types A and B (2012–2013)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Nasal	Suspension	106.5-7.5 FFU (fluorescent focus units) each of A/California/7/2009 (pH1N1), A/Victoria/361/2011 (H3N2), and B/Wisconsin/1/2010 per 0.2 mL	FluMist (available in 0.2-mL prefilled single-use sprayers)	MedImmune

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.