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Influenza virus vaccine (LAIV4) (live attenuated): Drug information

Influenza virus vaccine (LAIV4) (live attenuated): Drug information
(For additional information see "Influenza virus vaccine (LAIV4) (live attenuated): Patient drug information" and see "Influenza virus vaccine (LAIV4) (live attenuated): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • FluMist Quadrivalent
Brand Names: Canada
  • FluMist Quadrivalent
Pharmacologic Category
  • Vaccine;
  • Vaccine, Live (Viral)
Dosing: Adult

Note: Influenza seasons vary in the timing and duration from year to year. In general, vaccination should preferably occur during September or October (in the United States) to ensure optimal immunity prior to onset and for the full duration of influenza activity in the community. Early vaccination (in July or August) for an upcoming influenza season has been associated with suboptimal immunity before the end of an influenza season, particularly in older adults. Vaccination should continue throughout the influenza season as long as vaccine is available. The CDC does not recommend revaccination later in the season for those persons who have already been fully vaccinated (CDC/ACIP [Grohskopf 2023]).

Immunization

Immunization:

US labeling: Adults ≤49 years of age: Intranasal: 0.2 mL/dose (0.1 mL per nostril) (1 dose per season).

Canadian labeling: Adults ≤59 years of age: Intranasal: 0.2 mL/dose (0.1 mL per nostril) (1 dose per season).

Not indicated for use in patients ≥50 years of age (US labeling) or ≥60 years of age (Canadian labeling).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Not indicated for use in patients ≥50 years (US labeling) or ≥60 years (Canadian labeling).

Dosing: Pediatric

(For additional information see "Influenza virus vaccine (LAIV4) (live attenuated): Pediatric drug information")

Immunization, annual

Immunization, annual: Note: Live attenuated influenza vaccine (LAIV4) is an option for the 2023–2024 influenza season in healthy persons aged 2 to 49 years. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Kroger 2023]).

Influenza seasons vary in their timing and duration from year to year. In general, vaccination should preferably occur by the end of October (in the United States) to ensure optimal immunity prior to onset and for the full duration of influenza activity in the community; patients who should receive 2 doses should begin vaccination as soon as vaccine is available so that the second dose can be given by the end of October. Vaccination should continue throughout the influenza season as long as vaccine is available (AAP 2023; CDC/ACIP [Grohskopf 2023]).

Children 2 to 8 years: Intranasal: 0.2 mL per dose (0.1 mL per nostril); 1 or 2 doses per season. The number of doses needed per flu season is dependent upon vaccination history; see the following criteria (CDC/ACIP [Grohskopf 2023]):

One dose: If the patient received ≥2 doses of trivalent or quadrivalent influenza vaccine prior to July 1 preceding the current flu season start. The 2 doses need not have been received during the same season or consecutive seasons.

Two doses (separated by ≥4 weeks): If any of the following:

• It is the patient's first season of vaccination.

• Patient received ≤1 dose of trivalent or quadrivalent influenza vaccine prior to July 1 preceding the current flu season start.

• If vaccination history cannot be determined.

Note: A child turning 9 years of age between the first and second dose should still receive 2 doses.

Children ≥9 years and Adolescents: Intranasal: 0.2 mL per dose (0.1 mL per nostril); 1 dose per season (CDC/ACIP [Grohskopf 2023]).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency of events reported within 10 days.

>10%:

Central nervous system: Headache (adults: 40%; children: 3% to 9%), irritability (children: 12% to 21%), lethargy (children: 7% to 14%)

Gastrointestinal: Sore throat (adults: 28%; children: 5% to 11%), decreased appetite (children: 13% to 21%), abdominal pain (children: 2% to 12%)

Neuromuscular & skeletal: Fatigue (adults: ≤26%), weakness (adults: ≤26%), myalgia (adults: 17%; children: 2% to 6%)

Respiratory: Nasal congestion (children: ≤58%; adults: ≤44%), rhinorrhea (children: ≤58%; adults: ≤44%), cough (adults: 14%)

1% to 10%:

Central nervous system: Chills (adults: 9%; children: 2% to 4%)

Otic: Otitis media (children: 3%)

Respiratory: Wheezing (children: 6 to 23 months: 6%; 24 to 59 months: 2%), sinusitis (adults: 4%), sneezing (children: 2%)

Miscellaneous: Fever (children: 100°F to 101°F: 6% to 9%; >101°F: 1% to 4%)

<1%, postmarketing, and/or case reports: Anaphylaxis, Bell's palsy, diarrhea, encephalitis (vaccine-associated), epistaxis, exacerbation of asthma, facial edema, Guillain-Barre syndrome, hypersensitivity reaction, meningitis (including eosinophilic meningitis), nausea, pericarditis, skin rash, subacute necrotizing encephalomyelopathy (Leigh syndrome exacerbation), urticaria, vomiting

Contraindications

Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine, including egg protein, or to previous influenza vaccination; children and adolescents (≤17 years of age) receiving aspirin or salicylate-containing therapy because of the association of Reye syndrome with aspirin and wild-type influenza infection.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Note: The Advisory Committee on Immunization Practices (ACIP) and Canadian National Advisory Committee on Immunization (NACI) do not consider an egg allergy to be a contraindication to influenza vaccination (CDC/ACIP [Grohskopf 2023]; NACI 2023a).

In addition, the ACIP also considers the following to be contraindications: Children 2 to 4 years of age with asthma or wheezing within past 12 months; immunocompromising conditions (including immunosuppressive therapy, HIV, and anatomic or functional asplenia [eg, due to sickle cell anemia); close contacts of severely immunosuppressed persons who require a protected environment; pregnancy; persons with active communication between the cerebrospinal fluid (CSF) and the oropharynx, nasopharynx, nose, or ear or any other cranial CSF leak; persons with cochlear implants; use of oseltamivir or zanamivir within past 48 hours, use of peramivir within past 5 days, or use of baloxavir within past 17 days (CDC/ACIP [Grohskopf 2023]).

In addition to ACIP contraindications, the NACI also considers the following to be contraindications to LAIV: Age <24 months; severe asthma, active wheezing, or wheezing requiring medical attention in the 7 days prior to vaccination (NACI 2023a).

Warnings/Precautions

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]).

• Asthma/wheezing: Children <24 months of age had increased wheezing and hospitalizations following administration in clinical trials of FluMist (trivalent); use of the nasal spray is not approved in this age group. The Advisory Committee on Immunization Practices (ACIP) considers LAIV contraindicated in children 2 to 4 years of age who have had asthma or wheezing episodes within the past year. Use with caution in patients ≥5 years of age who have asthma (CDC/ACIP [Grohskopf 2023]). Canadian National Advisory Committee on Immunization (NACI) considers LAIV contraindicated in patients with severe asthma, active wheezing, or wheezing requiring medical attention in the 7 days prior to vaccination (NACI 2023a). Risk of wheezing following vaccination is increased in children <5 years of age with a history of recurrent wheezing and in persons of any age with asthma. Patients with severe asthma or active wheezing were not included in clinical trials.

• Guillain-Barré syndrome: Use with caution in patients with history of Guillain-Barré syndrome (GBS); patients with history of GBS have a greater likelihood of developing GBS than those without. As a precaution, the ACIP recommends that patients with a history of GBS and who are not at higher risk for severe influenza complications and patients known to have experienced GBS within 6 weeks following previous influenza vaccination should generally not be vaccinated (consider influenza antiviral chemoprophylaxis in these patients). Based on limited data, the benefits of vaccinating persons with a history of GBS who are also at higher risk for severe complications of influenza, may outweigh the risks (CDC/ACIP [Grohskopf 2023]). Studies of patients who received the trivalent inactivated influenza vaccine (IIV3) or the monovalent H1N1 influenza vaccine have shown the risk of GBS is lower with vaccination than with influenza infection (Baxter 2013; Greene 2013; Kwong 2013).

• Medical conditions predisposing to influenza complications: Safety of LAIV in patients with medical conditions predisposing to influenza complications (eg, chronic pulmonary, cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders [including diabetes]) has not been established; use with caution (CDC/ACIP [Grohskopf 2023]).

• Nasal congestion: Use another influenza vaccine or defer immunization with LAIV if nasal congestion is present which may impede delivery of vaccine (CDC/ACIP [Grohskopf 2023]).

Concurrent drug therapy issues:

• Oral influenza antiviral medications: LAIV should not be given until 48 hours after the completion of oseltamivir or zanamivir, 5 days after completion of peramivir, or 17 days after completion of baloxavir. Influenza antiviral therapy (influenza A and B) should not be administered for 2 weeks after receiving LAIV. If influenza antiviral therapy (influenza A and B) and LAIV are administered concomitantly, revaccination with another appropriate vaccine (eg, IIV4 or RIV4) should be considered (CDC/ACIP [Grohskopf 2023]).

• Vaccines: In order to maximize vaccination rates, the ACIP and NACI recommend simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (ACIP [Kroger 2023]; NACI 2023a).

Special populations:

• Altered immunocompetence: Data on the use of LAIV in immunocompromised patients is limited. ACIP and NACI do not recommend the use of LAIV in immunosuppressed patients, including most patients with HIV (CDC/ACIP [Grohskopf 2023]; NACI 2023a). Children and adolescents with HIV who have stable disease, are receiving highly active antiretroviral therapy, and have stable immune function may receive LAIV per NACI (NACI 2023a). Avoid contact with severely immunocompromised individuals who require a protected environment for at least 7 days following vaccination per ACIP (at least 14 days for all severely immunocompromised persons per NACI). Persons who care for severely immunocompromised persons should receive either inactivated influenza vaccine (IIV) or recombinant influenza vaccine (RIV). (CDC/ACIP [Grohskopf 2023]; NACI 2023a). Live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible; live vaccines should not be administered for ≥3 months after immunosuppressive therapy (ACIP [Kroger 2023]; IDSA [Rubin 2014]).

• Pediatric: Due to association of Reye syndrome with aspirin, use of LAIV is contraindicated in pediatric patients on concurrent aspirin therapy; aspirin-containing products should be avoided for 4 weeks following vaccination in children and adolescents ≤17 years of age.

Dosage form specific issues:

• Arginine: Manufactured using arginine.

• Chicken egg protein: Manufactured with chicken egg protein. The ACIP no longer recommends additional safety monitoring for patients with a history of an allergic reaction related to egg (regardless of severity). Current recommendations state that patients may receive vaccination regardless of severity of egg allergy and no special precautions are required (AAP 2023; CDC/ACIP [Grohskopf 2023]; Greenhawt 2018; NACI 2023a).

• Gelatin: Manufactured using gelatin.

• Gentamicin: Manufactured with gentamicin.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen prior to vaccination to prevent fever decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Appropriate use: The safety of LAIV in individuals with underlying medical conditions that may predispose them to complications following wild-type influenza infection has not been established. Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to Centers for Disease Control and Prevention [CDC] schedule for detailed information). Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the Infectious Diseases Society of America (Rubin 2014).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).

• Other influenza vaccines: Influenza vaccines from previous seasons must not be used. Vaccines formulated for the Northern hemisphere may differ in composition from the southern hemisphere vaccine; consult CDC Yellow Book for more information regarding travel vaccines (CDC/ACIP [Grohskopf 2023]).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Nasal [preservative free]:

FluMist Quadrivalent: (1 ea [DSC]) [contains disodium edta, gelatin (pork)]

FluMist Quadrivalent: (1 ea) [contains edetic acid (edta), gelatin (pork)]

FluMist Quadrivalent: (1 ea [DSC]) [contains egg white (egg protein), gelatin (pork)]

FluMist Quadrivalent: (1 ea [DSC]) [contains gelatin (pork)]

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Nasal [preservative free]:

FluMist Quadrivalent: (1 ea) [contains gelatin (pork)]

Administration: Adult

Intranasal: For intranasal administration only; do not inject. Half the dose (0.1 mL) is administered into each nostril; patient should be in upright position. A dose divider clip is provided to allow administration of 0.1 mL into each nostril. Place the tip of the sprayer inside the nostril and depress plunger as rapidly as possible to deliver the dose. Remove dose divider clip and repeat into opposite nostril. The patient does not need to inhale during administration (may breathe normally). If recipient sneezes or coughs following administration, the dose should not be repeated (ACIP [Kroger 2023]). Defer immunization or use a different influenza vaccine if nasal congestion is present, which may impede delivery of vaccine (CDC/ACIP [Grohskopf 2023]; NACI 2023a).

US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

Administration: Pediatric

Intranasal: For intranasal administration only; do not inject. Administer 0.1 mL (half of the dose from a single sprayer) into each nostril while the recipient is in an upright position. Place the tip of the sprayer inside the nostril and depress plunger as rapidly as possible to deliver the dose. Remove dose divider clip and repeat into opposite nostril. The patient does not need to inhale during administration (may breathe normally). If recipient sneezes or coughs following administration, the dose should not be repeated (ACIP [Kroger 2023]). Defer immunization or use a different influenza vaccine if nasal congestion is present, which may impede delivery of vaccine (CDC/ACIP [Grohskopf 2023]).

US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

Medication Guide and/or Vaccine Information Statement (VIS)

In the US, the appropriate Centers for Disease Control and Prevention (CDC)-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/flulive.html.

Use: Labeled Indications

Influenza disease prevention:

US labeling: Active immunization of individuals 2 to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

Canadian labeling: Active immunization of individuals 2 to 59 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

Recommendations for annual seasonal influenza prevention:

The Advisory Committee on Immunization Practices (ACIP) recommends routine annual vaccination with seasonal influenza vaccine for all persons ≥6 months of age who do not otherwise have contraindications to vaccination. Live attenuated influenza vaccine (LAIV4) is an option for the upcoming influenza season in healthy, nonpregnant persons aged 2 to 49 years (CDC/ACIP [Grohskopf 2023]). ACIP and American Academy of Pediatrics (AAP) recommend use of any age- and risk factor–appropriate product and do not have a preferential recommendation for an influenza vaccine product for persons 6 months to <65 years of age. For persons ≥65 years of age, the ACIP recommends a higher dose or adjuvanted influenza vaccine (ie, HD-IIV4, RIV4, or aIIV4). If one of these vaccines is not available, then any other age-appropriate vaccine may be used. In addition to LAIV4, the inactivated influenza vaccines may be used for persons ≥6 months of age and recombinant influenza vaccine (RIV) can be used in persons ≥18 years of age (AAP 2023; CDC/ACIP [Grohskopf 2023]).

The Canadian National Advisory Committee on Immunization (NACI) recommends annual vaccination with seasonal influenza vaccine for all persons ≥6 months of age who do not otherwise have contraindications to the vaccine. Healthy, nonpregnant persons aged 2 to 59 years may receive vaccination with the seasonal live, attenuated influenza vaccine (LAIV) (nasal spray). The following influenza vaccine preferences should be considered. (Note: Trivalent inactivated influenza vaccines [IIV3] will not be available in Canada during the 2023-2024 influenza season.)

• Persons 6 months to 23 months of age: Quadrivalent inactivated influenza vaccine (IIV4) is preferred; use trivalent inactivated influenza vaccine (IIV3) if IIV4 is not available.

• Persons 2 to 17 years of age: Either IIV4-SD, LAIV4 (if appropriate), or IIV4-cc is preferred; use IIV3-SD if the other options are not available.

• Persons 18 to 64 years of age: Any age– and risk factor–appropriate product may be used.

• Persons ≥65 years of age: IIV-HD (high dose) is preferred over IIV-SD (standard dose); however, any available influenza vaccine may be used for public health program-level decision making.

• Health care workers: Either IIV4 or IIV3 are recommended; LAIV should not be used.

Prioritization when vaccine supply is limited:

When vaccine supply is limited, target groups for vaccination (those at higher risk of complications from influenza infection and their close contacts) include the following; see guidelines for details (CDC/ACIP [Grohskopf 2023]; NACI 2023a): Note: Only use LAIV if appropriate:

• All infants and children 6 to 59 months of age

• Persons ≥50 years of age (≥65 years of age in Canada)

• Infants, children, and adolescents (6 months to 18 years of age) who are receiving aspirin or salicylate therapy, and therefore, may be at risk for developing Reye syndrome after influenza

• Persons who are or will be pregnant during the influenza season

• Persons with chronic pulmonary disorders (including asthma) or cardiovascular systems disorders (except isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus). Note: The Canadian NACI excludes persons with isolated migraine or psychiatric conditions.

• Persons who have immunosuppression due to any cause (including immunosuppression caused by medications or HIV)

• Residents of nursing homes and other long-term care facilities

• Indigenous peoples (including American Indians/Alaska Natives)

• Persons with extreme obesity (BMI ≥40 for adults)

• Health care personnel, including students in these professions and other persons not directly involved in patient care who may be exposed to patients or to infectious agents (eg, clerical, housekeeping, volunteers)

• Household contacts (≥6 months of age) and caregivers of neonates, infants, and children <5 years of age (particularly neonates and infants <6 months of age) and adults ≥50 years of age

• Household contacts (≥6 months of age) and caregivers of persons with medical conditions which put them at higher risk of complications from influenza infection

• In addition, the NACI includes the following: persons who provide services within closed or relatively closed settings to persons at high risk; persons who provide essential community services; and persons in direct contact with poultry infected with avian influenza during culling operations

Medication Safety Issues
Sound-alike/look-alike issues:

FluMist may be confused with flumazenil

Influenza virus vaccine may be confused with flumazenil, perflutren lipid microspheres

Influenza virus vaccine may be confused with tetanus toxoid and tuberculin products. Medication errors have occurred when tuberculin skin tests (PPD) have been inadvertently administered instead of tetanus toxoid products and influenza virus vaccine. These products are refrigerated and often stored in close proximity to each other.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Anti-CD20 B-Cell Depleting Therapies: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Antiviral Agents (Influenza A and B): May diminish the therapeutic effect of Influenza Virus Vaccine (Live/Attenuated). Management: Avoid administration of live influenza virus vaccine (LAIV) within 2 weeks before or 48 hours after administration of antiviral agents. Consider avoiding LAIV if peramivir was given within the last 5 days or baloxavir was given within the last 17 days. Risk D: Consider therapy modification

Cladribine: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Cladribine may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines 4 weeks prior to therapy if possible. Risk D: Consider therapy modification

Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Risk C: Monitor therapy

Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination

Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination

Etrasimod: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Etrasimod may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Immunosuppressants (Cytotoxic Chemotherapy): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Leniolisib: May diminish the therapeutic effect of Vaccines (Live). Risk C: Monitor therapy

Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided. Risk D: Consider therapy modification

Methotrexate: May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating methotrexate if possible. If vaccination occurs less than 2 weeks prior to or during methotrexate therapy, revaccinate 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Salicylates: Influenza Virus Vaccine (Live/Attenuated) may enhance the adverse/toxic effect of Salicylates. Specifically, Reye's syndrome may develop. Risk X: Avoid combination

Teplizumab: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccines-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Tezepelumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination

Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Tralokinumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination

Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: Consider therapy modification

Vaccines (Live): May diminish the therapeutic effect of other Vaccines (Live). Management: Two or more injectable or nasally administered live vaccines not administered on the same day should be separated by at least 28 days (ie, 4 weeks). If not, the vaccine administered second should be repeated at least 4 week later. Risk C: Monitor therapy

Reproductive Considerations

Using data prospectively collected from the Pregnancy Study Online (PRESTO), an internet-based preconception cohort study of patients planning to become pregnant, use of the seasonal influenza vaccine by either partner did not adversely affect the probability of conceiving (time and date of influenza vaccination in proximity to pregnancy was self-reported) (Orta 2020).

Influenza vaccination with any licensed, recommended, age-appropriate vaccine is recommended for all patients who may become pregnant during the influenza season and who do not otherwise have contraindications to the vaccine. The Advisory Committee on Immunization Practices contraindicates use of the live attenuated influenza vaccine during pregnancy (CDC/ACIP [Grohskopf 2023]).

Pregnancy Considerations

This vaccine is not systemically absorbed following maternal nasal administration and is not expected to result in exposure to the fetus. Data related to the use of influenza virus vaccine (live/attenuated) in pregnancy are limited (Haber 2015; Moro 2013; Moro 2017; Toback 2012).

The Advisory Committee on Immunization Practices contraindicates use of live attenuated influenza vaccine during pregnancy (CDC/ACIP [Grohskopf 2023]).

Breastfeeding Considerations

This vaccine is not systemically absorbed following maternal nasal administration and is not expected to result in exposure to an infant via breast milk.

Anti-influenza IgA antibodies can be detected in breast milk following maternal vaccination with the influenza virus vaccine (live/attenuated) (Brady 2018).

The risk for severe illness and complications from influenza infection is increased postpartum and influenza vaccination decreases the risk for respiratory illness and influenza in postpartum patients. When vaccine supply is limited, focus on delivering the vaccine should be given to patients who are pregnant or who may become pregnant during the flu season, as well as contacts or caregivers of children <5 years of age (particularly contacts of neonates and infants <6 months of age) (CDC/ACIP [Grohskopf 2023]). Postpartum patients who are breastfeeding and did not receive the influenza vaccine during pregnancy may be vaccinated (ACOG 2018). The live attenuated influenza vaccine may be used postpartum (CDC/ACIP [Grohskopf 2023]).

Mechanism of Action

The vaccine contains live attenuated viruses which infect and replicate within the cells lining the nasopharynx. Promotes immunity to seasonal influenza virus by inducing specific antibody production. Preparations from previous seasons must not be used.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Most adults have antibody protection within 2 weeks of vaccination (CDC/ACIP [Grohskopf 2023]).

Duration: Vaccine effectiveness declines at a variable rate, depending on virus subtypes, patient age, and other confounding factors (CDC/ACIP [Grohskopf 2023]).

Distribution: Following nasal administration, vaccine is distributed in the nasal cavity (~90%), stomach (~3%), brain (~2%), and lung (0.4%).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Fluenz tetra;
  • (BE) Belgium: Fluenz tetra;
  • (BG) Bulgaria: Fluenz tetra;
  • (CZ) Czech Republic: Fluenz tetra;
  • (EE) Estonia: Fluenz tetra;
  • (ES) Spain: Fluenz tetra;
  • (FI) Finland: Fluenz tetra;
  • (FR) France: Fluenz tetra;
  • (GB) United Kingdom: Fluenz tetra;
  • (GR) Greece: Fluenz tetra;
  • (HU) Hungary: Fluenz tetra;
  • (IE) Ireland: Fluenz tetra;
  • (IT) Italy: Fluenz tetra;
  • (LT) Lithuania: Fluenz tetra;
  • (LU) Luxembourg: Fluenz tetra;
  • (LV) Latvia: Fluenz tetra;
  • (NO) Norway: Fluenz tetra;
  • (PL) Poland: Fluenz tetra;
  • (RO) Romania: Fluenz tetra;
  • (SE) Sweden: Fluenz tetra;
  • (SK) Slovakia: Fluenz tetra
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