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Influenza Virus Vaccine (Inactivated)

Pronunciation

(in floo EN za VYE rus vak SEEN, in ak ti VAY ted)

Index Terms

  • ccIIV4 [Flucelvax Quadrivalent]
  • Cell Culture Inactivated Influenza Vaccine, Quadrivalent [Flucelvax Quadrivalent]
  • H1N1 Influenza Vaccine
  • IIV
  • IIV3
  • IIV4
  • Inactivated Influenza Vaccine, Quadrivalent
  • Inactivated Influenza Vaccine, Trivalent
  • Influenza Vaccine
  • Influenza Virus Vaccine (Purified Surface Antigen)
  • Influenza Virus Vaccine (Split-Virus)
  • TIV (Trivalent Inactivated Influenza Vaccine)

Dosage Forms

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

Suspension, Intramuscular:

Afluria: (5 mL) [contains egg white (egg protein), neomycin sulfate, polymyxin b, thimerosal]

FluLaval Quadrivalent: (5 mL) [contains egg white (egg protein), formaldehyde solution, polysorbate 80, thimerosal]

Fluvirin: (5 mL) [contains egg white (egg protein), neomycin, polymyxin, thimerosal]

Fluzone: (5 mL [DSC]) [contains egg white (egg protein), formaldehyde solution, gelatin (pork), thimerosal]

Fluzone Quadrivalent: (5 mL) [contains egg white (egg protein), formaldehyde solution, thimerosal]

Suspension, Intramuscular [preservative free]:

Fluzone Quadrivalent: (0.5 mL) [contains egg white (egg protein), formaldehyde solution]

Suspension Pen-injector, Intradermal [preservative free]:

Fluzone Intradermal Quadrivalent: 9 mcg/strain (0.1 mL) [contains egg white (egg protein), formaldehyde solution]

Suspension Prefilled Syringe, Intramuscular [preservative free]:

Afluria: (0.5 mL) [contains egg white (egg protein), neomycin sulfate, polymyxin b]

Fluad: (0.5 mL) [contains egg white (egg protein), formaldehyde solution, neomycin, polysorbate 80]

Fluarix Quadrivalent: (0.5 mL) [contains egg white (egg protein), formaldehyde solution, gentamicin, polysorbate 80]

Flucelvax: (0.5 mL [DSC]) [contains polysorbate 80]

Flucelvax Quadrivalent: (0.5 mL) [contains polysorbate 80]

FluLaval Quadrivalent: (0.5 mL) [contains egg white (egg protein), polysorbate 80, formaldehyde solution]

Fluvirin: (0.5 mL) [contains egg white (egg protein), neomycin, polymyxin]

Fluzone High-Dose: (0.5 mL) [contains egg white (egg protein), formaldehyde solution]

Fluzone Quadrivalent: (0.25 mL, 0.5 mL) [contains egg white (egg protein), formaldehyde solution]

Brand Names: U.S.

  • Afluria
  • Afluria Quadrivalent
  • Fluad
  • Fluarix Quadrivalent
  • Flucelvax Quadrivalent
  • Flucelvax [DSC]
  • FluLaval Quadrivalent
  • Fluvirin
  • Fluzone High-Dose
  • Fluzone Intradermal Quadrivalent
  • Fluzone Quadrivalent
  • Fluzone [DSC]

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Viral)

Pharmacology

Promotes immunity to seasonal influenza virus by inducing specific antibody production. Each year the formulation is standardized according to the US Public Health Service. Preparations from previous seasons must not be used.

Onset of Action

Most adults have antibody protection within 2 weeks of vaccination (CDC/ACIP [Grohskopf 2016])

Duration of Action

≥6 to 8 months when vaccine is antigenically similar to circulating virus (CDC/ACIP [Grohskopf 2016]); response may be diminished in persons ≥65 years and limited evidence suggests titers may decline significantly 6 months following vaccination in this population (CDC/ACIP [Grohskopf 2016]).

Use: Labeled Indications

Influenza disease prevention: Active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine in the following persons:

US labeling:

• 6 months and older (Fluzone Quadrivalent)

• 3 years and older (Fluarix Quadrivalent, FluLaval Quadrivalent)

• 4 years and older (Flucelvax Quadrivalent, Fluvirin)

• 5 years and older (Afluria)

• 18 years and older (Afluria Quadrivalent)

• 18 through 64 years of age (Fluzone Intradermal Quadrivalent)

• 65 years and older (Fluad, Fluzone High-Dose)

Canadian labeling:

• 6 months to <2 years (Fluad Pediatric)

• 6 months and older (Agriflu, FluLaval Tetra, Fluviral, Fluzone Quadrivalent)

• 18 years and older (Influvac)

• 65 years and older (Fluad, Fluzone High-Dose)

The Advisory Committee on Immunization Practices (ACIP) recommends routine annual vaccination with the seasonal influenza vaccine for all persons ≥6 months of age who do not otherwise have contraindications to the vaccine (ACIP [Grohskopf 2016]).

The ACIP recommends use of any age and risk factor appropriate product and does not have a preferential recommendation for use of the trivalent inactivated influenza vaccine (IIV3) or the quadrivalent inactivated influenza vaccine (IIV4). In addition to the IIV products, other alternative products are available for certain patient populations: Persons 18 years and older may receive vaccination with the recombinant influenza vaccine (RIV). Although live attenuated influenza vaccine (LAIV4) is FDA approved for healthy nonpregnant persons aged 2 to 49 years, the ACIP has made the interim recommendation that LAIV4 should not be used for any population for the 2016-17 season due to concerns regarding low effectiveness during the 2013-14 and 2015-16 seasons (ACIP [Grohskopf 2016]).

The Canadian National Advisory Committee on Immunization (NACI) recommends annual vaccination with seasonal influenza vaccine for all persons ≥6 months 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). When readily available and no contraindications exist, NACI prefers use of LAIV (nasal spray) in healthy persons 2 to 17 years of age. LAIV is not recommended in patients with severe asthma or wheezing requiring medical attention in the 7 days prior to vaccination, adults with chronic health conditions, and children and adults who are immunocompromised. Where LAIV is not recommended, use of quadrivalent inactivated influenza vaccine (QIV) or trivalent inactivated influenza vaccine (TIV) if QIV is not available, is recommended (NACI 2016).

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 (CDC/ACIP [Grohskopf 2016]):

• Infants and children 6 to 59 months of age

• Persons ≥50 years of age

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

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

• Patients with chronic pulmonary disorders (including asthma) or cardiovascular systems disorders (except hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus)

• Persons who have immunosuppression (including immunosuppression caused by medications or HIV)

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

• American Indians/Alaska Natives

• Morbidly obese (BMI ≥40)

• Healthcare personnel

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

• Household contacts (including children) and caregivers of persons with medical conditions which put them at high risk of complications from influenza infection

Contraindications

Severe allergic reaction (eg, anaphylaxis) to a previous influenza vaccination or to any component of the formulation

Additional manufacturer contraindications for Afluria, Afluria Quadrivalent, Fluad, Fluarix Quadrivalent, FluLaval Quadrivalent, Fluvirin, Fluzone High-Dose, Fluzone Intradermal Quadrivalent, Fluzone Quadrivalent: History of severe allergic reaction (eg, anaphylaxis) to egg protein

Additional manufacturer contraindications for Canadian products: Agriflu, Fluad, Fluad Pediatric, FluLaval Tetra, Fluviral: Hypersensitivity to egg protein.

Note: Both ACIP and NACI do not consider egg allergy a contraindication to influenza vaccination (CDC/ACIP [Grohskopf 2016]; NACI 2016).

Dosing: Adult

It is important to note that influenza seasons vary in their timing and duration from year to year. In general, vaccination should begin soon after the vaccine becomes available (and, if possible, by the end of October) and prior to onset of influenza activity in the community. However, vaccination should continue throughout the influenza season as long as vaccine is available. Unless noted, the ACIP does not have a preference for any given inactivated influenza vaccine (IIV) formulation when used within their specified age indications.

Immunization:

Afluria, Afluria Quadrivalent:

Adults ≤64 years: IM or via PharmaJet Stratis Needle-Free Injection System: 0.5 mL per dose as a single dose (1 dose per season)

Adults >64 years: IM: 0.5 mL per dose as a single dose (1 dose per season)

Fluarix Quadrivalent, Flucelvax Quadrivalent, FluLaval Quadrivalent, Fluvirin, Fluzone Quadrivalent: IM: 0.5 mL/dose (1 dose per season)

Fluzone Intradermal Quadrivalent: Adults 18 to 64 years: Intradermal: 0.1 mL/dose (1 dose per season)

Canadian labeling:

Agriflu, FluLaval Tetra, Fluviral, Fluzone Quadrivalent: IM: 0.5 mL/dose (1 dose per season)

Influvac: IM, SubQ: 0.5 mL/dose (1 per season)

Dosing: Geriatric

It is important to note that influenza seasons vary in their timing and duration from year to year. In general, vaccination should begin soon after the vaccine becomes available (and, if possible, by October) and prior to onset of influenza activity in the community. However, vaccination should continue throughout the influenza season as long as vaccine is available. Unless noted, the ACIP does not have a preference for any given inactivated influenza vaccine (IIV) formulation when used within their specified age indications.

Immunization: Adults ≥65 years:

Afluria, Afluria Quadrivalent, Fluad, Fluarix Quadrivalent, Flucelvax Quadrivalent, FluLaval Quadrivalent, Fluvirin, Fluzone High-Dose, Fluzone Quadrivalent: IM: 0.5 mL/dose (1 dose per season).

Canadian labeling:

Agriflu, Fluad, FluLaval Tetra, Fluviral, Fluzone Quadrivalent, Fluzone High-Dose: IM: 0.5 mL/dose (1 dose per season)

Influvac: IM, SubQ: 0.5 mL/dose (1 per season)

Dosing: Pediatric

It is important to note that influenza seasons vary in their timing and duration from year to year. In general, vaccination should begin soon after the vaccine becomes available (and, if possible, by the end of October) and prior to onset of influenza activity in the community. However, vaccination should continue throughout the influenza season as long as vaccine is available. Unless noted, the ACIP does not have a preference for any given inactivated influenza vaccine (IIV) formulation when used within their specified age indications.

Immunization: IM:

Afluria:

Children 5 to 8 years: 0.5 mL/dose (1 or 2 doses per season; see "Note"): Although FDA-approved for use in children ≥5 years of age, the ACIP does not recommend use of Afluria in children <9 years due to an increased incidence of fever and febrile seizures observed with use of the 2010 Southern Hemisphere formulation of Afluria in this age group. However, if other age-appropriate vaccines are not available, children 5 to 8 years of age who are also considered at risk for influenza complications may be given Afluria. The benefits and risks of this vaccine should be discussed with parents or caregivers prior to administration (CDC/ACIP [Grohskopf 2016]).

Children ≥9 years and Adolescents: 0.5 mL per dose as a single dose (1 dose per season).

Fluarix Quadrivalent, FluLaval Quadrivalent:

Children 3 to 8 years: 0.5 mL/dose (1 or 2 doses per season; see "Note")

Children ≥9 years and Adolescents: Refer to adult dosing.

Flucelvax Quadrivalent, Fluvirin:

Children 4 to 8 years: 0.5 mL/dose (1 or 2 doses per season; see "Note")

Children ≥9 years and Adolescents: Refer to adult dosing.

Fluzone Quadrivalent:

Infants and Children 6 to 35 months: 0.25 mL/dose (1 or 2 doses per season; see "Note")

Children 3 to 8 years: 0.5 mL/dose (1 or 2 doses per season; see "Note")

Children ≥9 years and Adolescents: Refer to adult dosing.

Note: Infants and children 6 months to <9 years who received at least 2 doses of trivalent or quadrivalent influenza vaccine prior to July 1, 2016 need only 1 dose of the 2016 to 2017 seasonal influenza vaccine. The 2 doses need not have been received during the same season or consecutive seasons. All other children <9 years (including those whose vaccination status cannot be determined) should receive 2 doses separated by ≥4 weeks in order to achieve satisfactory antibody response (ACIP [Grohskopf 2016]).

Canadian labeling:

Agriflu, Fluzone Quadrivalent: IM:

Infants and Children 6 to 35 months: Manufacturer labeling: 0.25 mL/dose; NACI recommendation: 0.5 mL/dose (NACI 2016) (1 dose per season); a second dose should be administered 4 weeks after the first in previously unvaccinated patients

Children 3 to 8 years: 0.5 mL/dose (1 dose per season); a second dose should be administered 4 weeks after the first in previously unvaccinated patients

Children ≥9 years and Adolescents: Refer to adult dosing.

Fluad Pediatric: IM: Infants and Children 6 months to < 2 years: 0.25 mL/dose (1 dose per season); a second dose should be administered 4 weeks after the first in previously unvaccinated patients and in patients who were vaccinated for the first time last season and only one dose was received.

FluLaval Tetra, Fluviral: IM:

Infants ≥6 months and Children <9 years: 0.5 mL/dose (1 dose per season); a second dose should be administered 4 weeks after the first in previously unvaccinated patients

Children ≥9 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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

Administration

Fluzone Intradermal Quadrivalent: For intradermal administration, preferably into the skin over the deltoid muscle only. Gently shake gently prior to use. Hold system using the thumb and middle finger (do not place fingers on windows). Insert needle perpendicular to the skin; inject using index finger to push on plunger. Do not aspirate.

Afluria, Afluria Quadrivalent, Fluad, Fluarix Quadrivalent, Flucelvax Quadrivalent, FluLaval Quadrivalent, Fluvirin, Fluzone High-Dose, Fluzone Quadrivalent, Agriflu [Canadian product], Fluad, Fluad Pediatric [Canadian product], FluLaval Tetra [Canadian product], Fluviral [Canadian product]: For IM administration only. Suspensions should be shaken well prior to use. Inspect for particulate matter and discoloration prior to administration. Some manufacturers recommend avoiding use if visible particles are present in the suspension after shaking. See manufacturer labeling for specific recommendations. Adults and older children should be vaccinated in the deltoid muscle using a ≥1 inch needle length. Infants and young children should be vaccinated in the anterolateral aspect of the thigh using a 1 inch needle length. Children ≥1 years with adequate deltoid muscle mass should be vaccinated using a 1 inch needle. A ⅝-inch needle may be adequate in younger children (refer to guidelines) (NCIRD/ACIP 2011). Do not inject into the gluteal region or areas where there may be a major nerve trunk.

Afluria and Afluria Quadrivalent via PharmaJet Stratis Needle-free Injection System: For IM administration in adults 18 to 64 years of age only. For detailed instructions on preparation and administration of a dose, refer to the information available online at www.pharmajet.com.

Influvac [Canadian product]: May be administered by IM or deep subcutaneous injection. Shake well prior to use. Allow to warm to room temperature prior to use.

Unless otherwise indicated in product labeling, jet injectors should not be used to administer inactivated influenza vaccines. Currently, Afluria and Afluria Quadrivalent are the only influenza vaccines licensed in the United States that can be given IM by a jet-injector device.

To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

If a pediatric vaccine (0.25 mL) is inadvertently administered to an adult, an additional 0.25 mL should be administered to provide the full adult dose (0.5 mL). If the error is discovered after the patient has left, an adult dose should be given as soon as the patient can return. If an adult vaccine (0.5 mL) is inadvertently given to a child, no action needs to be taken (CDC/ACIP [Grohskopf 2016]). Agriflu [Canadian product]: If 0.25 mL dose is to be given, discard half the contained syringe volume prior to administration.

Note: For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (NCIRD/ACIP 2011).

Compatibility

Do not mix with other vaccines or injections. Separate needles and syringes should be used for each injection.

Storage

Store all products between 2°C to 8°C (36°F to 46°F). Potency is destroyed by freezing; do not use if product has been frozen.

Afluria, Afluria Quadrivalent: Protect from light. Discard multiple dose vials 28 days after initial entry. Between uses, the multiple dose vial should be stored at 2°C to 8°C (36°F to 46°F).

Agriflu [Canadian product]: Protect from light. May be used if exposed to temperatures between 8°C to 25°C for less than 2 hours. Between uses, the multiple-dose vial should be stored at 2°C to 8°C (36°F to 46°F). The number of needle punctures should not exceed 10 per multi-dose vial.

Fluad, Fluarix Quadrivalent, Flucelvax Quadrivalent, Fluzone High-Dose (Canadian labeling), Fluzone Quadrivalent (Canadian labeling), Influvac: Protect from light.

Fluad (Canadian labeling), Fluad Pediatric [Canadian product]: Protect from light. May be used if exposed to temperatures between 8°C to 25°C for less than 2 hours.

Fluviral [Canadian product]: Discard multiple dose vials 28 days after initial entry. Protect from light.

FluLaval Quadrivalent, FluLaval Tetra [Canadian product]: Between uses, the multiple dose vial should be stored at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Discard multiple dose vials 28 days after initial entry.

Fluvirin: Between uses, the multiple dose vial should be stored at 2°C to 8°C (36°F to 46°F). Protect from light.

Drug Interactions

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

Doxofylline: Influenza Virus Vaccine (Inactivated) may increase the serum concentration of Doxofylline. Monitor therapy

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Pneumococcal Conjugate Vaccine (13-Valent): May diminish the therapeutic effect of Influenza Virus Vaccine (Inactivated). Influenza Virus Vaccine (Inactivated) may diminish the therapeutic effect of Pneumococcal Conjugate Vaccine (13-Valent). Monitor therapy

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

Frequency not defined. Adverse reactions in adults ≥65 years of age may be greater using the high-dose vaccine, but are typically mild and transient.

Cardiovascular: Chest tightness, hypertension

Central nervous system: Chills, drowsiness, fatigue, headache, irritability, malaise, migraine, shivering

Dermatologic: Diaphoresis, ecchymoses

Gastrointestinal: Decreased appetite, diarrhea, gastroenteritis, nausea, sore throat, upper abdominal pain, vomiting

Infection: Infection, varicella

Local: Injection site reactions (including bruising, erythema, hematoma at injection site, induration, inflammation, itching at injection site, pain, soreness, swelling at injection site, tenderness at injection site)

Neuromuscular & skeletal: Arthralgia, back pain, myalgia (may start within 6 to 12 hours and last 1 to 2 days; incidence generally equal to placebo in adults; occurs more frequently than placebo in children)

Ophthalmic: Eye redness

Respiratory: Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngolaryngeal pain, respiratory congestion (upper), rhinitis, rhinorrhea, upper respiratory tract infection, wheezing

Miscellaneous: Crying (infants and children 6 to 35 months), fever

Postmarketing and/or case reports (limited to important or life-threatening): Bell's palsy, erythema multiforme, febrile seizures, Guillain-Barre syndrome, hypersensitivity reaction (including oculorespiratory syndrome, an acute, self-limited reaction with ocular and respiratory symptoms) (CDC/ACIP [Grohskopf 2013]), IgA vasculitis, limb paralysis, lymphadenopathy, maculopapular rash, microscopic polyangiitis (vasculitis), myelitis (including encephalomyelitis), neuralgia, optic neuritis, optic neuropathy, paralysis (including limb), photophobia, seizure, serum sickness, Stevens-Johnson syndrome, swelling of injected limb (lasting >1 week), syncope, tachycardia, thrombocytopenia, transverse myelitis, vasculitis (including transient renal involvement), vesicobullous rash

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (NCIRD/ACIP 2011).

• Oculorespiratory syndrome: Oculorespiratory syndrome (ORS) is an acute, self-limiting reaction to IIV with one or more of the following symptoms appearing within 2-24 hours after the dose: Chest tightness, cough, difficulty breathing, facial swelling, red eyes, sore throat, or wheezing. Symptoms resolve within 48 hours of onset. The cause of ORS has not been established, but studies have suggested that it is not IgE-mediated. However, because ORS symptoms may be similar to those of an IgE-mediated hypersensitivity reaction, health care providers unsure of etiology of symptoms should seek advice from an allergist/immunologist when determining whether a patient may be revaccinated in subsequent seasons (CDC/ACIP [Grohskopf 2016]).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (NCIRD/ACIP 2011).

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. Consider deferring 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).

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (NCIRD/ACIP 2011).

• Febrile seizures: Postmarketing reports of increased incidence of fever and febrile seizures in children <5 years of age has been observed with the use of the 2010 Southern Hemisphere formulation of the Afluria vaccine. Febrile events have also been reported in children 5 to <9 years of age. Based on information from the CDC, an increased rate of febrile seizures has been reported in young children 6 months to 4 years who received vaccination with inactivated influenza vaccine (IIV) and the 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously. However, due to the risks associated with delaying either vaccine, administering them at separate visits or deviating from the recommended vaccine schedule is not currently recommended. The ACIP does not recommend use of Afluria in children <9 years of age (ACIP [Grohskopf 2016]). Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• 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 at low risk for severe influenza complications, and patients known to have experienced GBS within 6 weeks following previous vaccination should generally not be vaccinated (consider influenza antiviral chemoprophylaxis in these patients). The benefits of vaccination may outweigh the potential risks in persons with a history of GBS who are also at high risk for complications of influenza (CDC/ACIP [Grohskopf 2016]). Recent studies of patients who received the trivalent inactivated influenza vaccine 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).

• HIV: Antigenic response may not be adequate in HIV-infected persons with CD4 cells <100/mm3 and viral copies of HIV type 1 >30,000/mL, and a second dose does not improve immune response in these persons (CDC/ACIP [Grohskopf 2016]).

• Neurologic disorders: Some Canadian product labeling recommends delaying therapy in patients with active neurologic disorders.

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the ACIP, as well as the Canadian National Advisory Committee on Immunization (NACI), recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (NACI 2016; NCIRD/ACIP 2011).

Special populations:

• Altered immunocompetence: Use with caution in severely-immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroid]); may have a reduced response to vaccination. Inactivated vaccine (IIV or RIV) is preferred over live virus vaccine for household members, healthcare workers and others coming in close contact with severely-immunosuppressed persons requiring care in a protected environment (CDC/ACIP [Grohskopf 2016]; NCIRD/ACIP 2011). In general, inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).

• Elderly: Antibody responses may be lower and decline faster in older adults ≥65 years compared to younger adults, especially by 6 months postvaccination; however, deferral to later in the season may result in missed vaccination opportunities or early season infection (ACIP [Grohskopf 2016]).

• Oncology patients: Seasonal influenza immunization (with inactivated vaccine) is recommended for all patients receiving chemotherapy for malignancy, and for all family and household contacts (Flowers 2013). Lifelong seasonal influenza immunization (with inactivated vaccine) is also recommended for hematopoietic cell transplant candidates and recipients; vaccination of family members and close or household contacts is strongly recommended during each flu season and continuing annually as long the recipient is immunocompromised, even if beyond 24 months after transplant (CIBMTR [Tomblyn 2009]).

Dosage form specific issues:

• Chicken egg protein: Most products are manufactured with chicken egg protein (expressed as ovalbumin content when content is disclosed on prescribing information). The ovalbumin content may vary from season to season and lot to lot of vaccine. Allergy to eggs must be distinguished from allergy to the vaccine. Recommendations are available from the ACIP and NACI regarding influenza vaccination to persons who report egg allergies; however, ACIP states a prior severe allergic reaction to influenza vaccine, regardless of the component suspected, is a contraindication to vaccination. Per ACIP, patients with a history of egg allergy who have experienced only hives following egg exposure should receive influenza vaccine if otherwise appropriate. Patients with a history of egg allergy other than hives (eg, angioedema, respiratory distress) should receive influenza vaccine if otherwise appropriate and administered in an inpatient or outpatient medical setting with health care supervision able to recognize and manage severe allergic conditions (CDC/ACIP [Grohskopf 2016]). NACI does not consider an egg allergy as a contraindication to vaccination (NACI 2016). Flucelvax Quadrivalent (ccIIV4) is an inactivated influenza vaccine manufactured using cell culture technology and provides an alternative to vaccines cultured with chicken egg protein but should not be considered egg free (ACIP [Grohskopf 2016]).

• Gentamicin: Some products are manufactured with gentamicin.

• Kanamycin: Some products are manufactured with kanamycin.

• Latex: Packaging may contain natural latex rubber.

• Neomycin: Some products are manufactured with neomycin.

• Polymyxin: Some products are manufactured with polymyxin.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

• Thimerosal: Some products contain thimerosal; hypersensitivity reactions may occur.

Other warnings/precautions:

• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the ACIP Recommended Adult Immunization Schedule (ACIP [Kim 2016]). 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 are available from the IDSA (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. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011).

• Previous season vaccines: Influenza vaccines from previous seasons must not be used (CDC/ACIP [Grohskopf 2016]).

Monitoring Parameters

Monitor for syncope for 15 minutes following administration (CDC/ACIP [Grohskopf 2016]; NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Risk Factor

B/C (manufacturer specific)

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Inactivated influenza vaccine has not been shown to cause fetal harm when given to pregnant women, although information related to use in the first trimester is limited (CDC/ACIP [Grohskopf 2016]). Following maternal immunization with the inactivated influenza virus vaccine, vaccine specific antibodies are observed in the newborn (Englund 1993; Steinhoff 2010; Zaman 2008; Zuccotti 2010). Vaccination of pregnant women protects infants from influenza infection, including infants <6 months of age who are not able to be vaccinated (CDC/ACIP [Grohskopf 2016]).

Pregnant women are at an increased risk of complications from influenza infection (Rasmussen 2008). Influenza vaccination with the inactivated influenza vaccine (IIV) is recommended for all women who are or will become pregnant during the influenza season and who do not otherwise have contraindications to the vaccine (CDC/ACIP [Grohskopf 2016]). Pregnant women should observe the same precautions as nonpregnant women to reduce the risk of exposure to influenza and other respiratory infections (CDC/HHS 2016). When vaccine supply is limited, focus on delivering the vaccine should be given to women who are pregnant or will be pregnant during the flu season, as well as mothers of newborns and contacts or caregivers of children <5 years of age (CDC/ACIP [Grohskopf 2016]). Vaccination may be done at any time during pregnancy (ACOG 2014; CDC/ACIP [Grohskopf 2016]).

Health care providers are encouraged to refer women exposed to the influenza vaccine during pregnancy to the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) by contacting The Organization of Teratology Information Specialists (OTIS) at (877) 311-8972.

Women exposed to FluLaval Quadrivalent, or Fluarix Quadrivalent vaccine during pregnancy or their healthcare provider may also contact the GlaxoSmithKline registry at 888-452-9622.

Health care providers may enroll women exposed to Fluzone Intradermal Quadrivalent or Fluzone Quadrivalent during pregnancy in the Sanofi Pasteur vaccination registry at 800-822-2463.

Patient Education

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site pain or irritation, muscle pain, loss of strength and energy, nausea (children), vomiting (children), diarrhea (children), lack of appetite (children), fatigue (children), or irritability (children). Have patient report immediately to prescriber burning or numbness feeling, facial paralysis, abnormal movements, severe dizziness, passing out, muscle weakness, seizures, severe headache, or vision changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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