Influenza Virus Vaccine, Inactivated

Some brands of this vaccine are made for use in adults and not in children. Your child's doctor can recommend the best influenza virus vaccine for your child.

This vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.

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

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

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

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

An overdose of this vaccine is unlikely to occur.

Since flu shots are usually given only one time per year, you will most likely not be on a dosing schedule. Call your doctor if you forget to receive your yearly flu shot in October or November.

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

• If you have an allergy to any part of influenza virus vaccine (inactivated).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take influenza virus vaccine. This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor.
• This medicine may not protect all people who use it. Talk with the doctor.
• This medicine is a vaccine with a virus that is not active. It cannot cause the disease.
• This medicine is not a cure for the flu. It must be given before you are exposed to the flu in order to work. Most of the time, it takes a few weeks for this medicine to work.
• This medicine only protects you for 1 flu season. You will need to get the flu vaccine each year.
• Not all brands of vaccines are for all children. Talk with your child's doctor.
• Some children may need to have more than 1 dose of this vaccine. Talk with your child's doctor.
• Some children have had a fever and seizures caused by fevers with some flu vaccines. Most of the time, this happened in children younger than 5 years of age. Fever has also been seen in children 5 to younger than 9 years of age. Talk with your child's doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using influenza virus vaccine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• 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)

• Vaccine
• Vaccine, Inactivated (Viral)

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).

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:

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.

FluLaval Quadrivalent:

Infants and Children 6 months 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.

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. Maternal influenza infection may be associated with adverse fetal events. Following maternal immunization with the inactivated influenza virus vaccine, vaccine specific antibodies are observed in the newborn (CDC/ACIP [Grohskopf 2016]).

Pregnant women are at an increased risk of complications from influenza infection. The inactivated influenza vaccine provides protective concentrations of antibodies in pregnant women and does not increase the risk for adverse maternal outcomes (CDC/ACIP [Grohskopf 2016]). 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).

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 health care 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.

Administration

Afluria, Fluad, Fluarix, Flucelvax, Flulaval, Fluvirin, Fluzone, Fluzone High-Dose: Administer only by IM injection.104 106 107 160 170 186 189 190

As an alternative to IM injection using a needle and syringe, Afluria may be administered IM using a PharmaJet Stratis needle-free injection system only in adults 18 through 64 years of age.189 Do not administer other commercially available parenteral inactivated influenza vaccines using a jet injector.543

Fluzone Intradermal: Administer intradermally.161

Do not mix with any other vaccine or solution.104 134 160 161 186 189 190

Discard vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation.104 106 107 160 161 186 189 190

Administer seasonal influenza vaccine every year before exposure to seasonal influenza.100 112 In the US, localized influenza outbreaks indicating start of annual influenza season can occur as early as October;100 112 peak influenza activity (which often is close to the midpoint of influenza activity for the season) usually occurs in January through March;100 112 and influenza activity can continue until late spring (end of May).100 112

Offer influenza vaccination by the end of October, if possible, and continue to offer vaccination as long as influenza viruses are circulating and unexpired vaccine is available.100

May be given simultaneously with other age-appropriate vaccines during same health-care visit.100 134 (See Interactions.) When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given with a different syringe and at different injection sites.134 Separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.134

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination; such reactions occur most frequently in adolescents and young adults.134 Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination.134 If syncope occurs, observe patient until symptoms resolve.134

IM Administration

Shake vaccine vial before withdrawing a dose.104 107 186 189 Shake prefilled syringe before administering a dose.104 106 107 160 170 186 189 190

To ensure delivery into muscle, make IM injections at a 90° angle to the skin using a needle length appropriate for individual's age and body mass.134

In infants and children 6 months to 2 years of age, make IM injections into the anterolateral thigh;100 104 134 alternatively, deltoid muscle can be used in those 1–2 years of age if muscle mass is adequate.134 In adults, adolescents, and children ≥3 years of age, make IM injections into the deltoid muscle.104 106 107 134 160 186 189 190

Do not administer into gluteal region104 106 107 134 160 170 186 190 or any area where there may be a major nerve trunk.104 106 107 160 170 186 190 If the gluteal muscle is chosen for infants <12 months of age because of special circumstance (e.g., physical obstruction of other sites), it is essential to identify anatomical landmarks prior to injection.134

Afluria may be administered IM using a PharmaJet Stratis needle-free injection system in adults 18 through 64 years of age.189 Do not use jet injector to administer Afluria in children and adolescents <18 years of age or geriatric adults ≥65 years of age.189

Consult manufacturer's information for the jet injector for specific information on how to administer Afluria using the PharmaJet Stratis needle-free injection system.189

Intradermal Administration

Fluzone Intradermal is the only commercially available influenza vaccine for intradermal use.161

Gently shake the prefilled microinjection system prior to administration.161

Administer intradermal injections into the region of deltoid muscle with the needle at a 90° angle to the skin.161 Consult manufacturer's labeling for more detailed administration instructions.161

Dosage

Dose and dosing schedule for prevention of seasonal influenza depend on individual’s age, vaccination history, and specific product administered.100 104 106 107 112 160 161 170 186 189 190

Dosage of standard-dose preparations of inactivated influenza vaccine is identical regardless of whether a trivalent or quadrivalent vaccine is used.100 104 106 107

Fluzone (quadrivalent): Use in adults, adolescents, and infants and children ≥6 months of age.104

Fluarix (quadrivalent) and Flulaval (quadrivalent): Use in adults, adolescents, and children ≥3 years of age.106 107

Flucelvax (quadrivalent) and Fluvirin (trivalent): Use in adults, adolescents, and children ≥4 years of age.186 190

Afluria (trivalent): Although labeled by FDA for use in adults, adolescents, and children ≥5 years of age,189 ACIP and AAP recommend use only in adults, adolescents, and children ≥9 years of age.100 112 534 (See Pediatric Use under Cautions.)

Fluzone Intradermal (quadrivalent): Use only in adults 18 through 64 years of age.161

Fluad adjuvant-containing (trivalent): Use only in adults ≥65 years of age.170 (See Geriatric Use under Cautions.)

Fluzone High-Dose (trivalent): Use only in adults ≥65 years of age.160 (See Geriatric Use under Cautions.)

Pediatric Patients

Has not previously received any doses of any seasonal influenza vaccine or has an uncertain history regarding influenza vaccination: Two 0.25-mL doses administered at least 1 month (4 weeks) apart.100 104 112

Did not receive a total of ≥2 doses of any seasonal influenza vaccine before July 1, 2016: ACIP and AAP recommend two 0.25-mL doses administered at least 4 weeks apart.100 112

Received a total of ≥2 doses of any seasonal influenza vaccine before July 1, 2016: ACIP and AAP recommend a single 0.25-mL dose.100 112

Has not previously received any doses of any seasonal influenza vaccine or has an uncertain history regarding influenza vaccination: Two 0.5-mL doses administered at least 1 month (4 weeks) apart.100 104 106 107 112 186 190

Did not receive a total of ≥2 doses of any seasonal influenza vaccine before July 1, 2016: ACIP and AAP recommend two 0.5-mL doses administered at least 4 weeks apart.100 112

Received a total of ≥2 doses of any seasonal influenza vaccine before July 1, 2016: ACIP and AAP recommend a single 0.5-mL dose.100 112

Has not previously received any doses of any seasonal influenza vaccine or has an uncertain history of influenza vaccination: Two 0.5-mL doses administered approximately 1 month (4 weeks apart).100 112 189

Did not receive a total of ≥2 doses of any seasonal influenza vaccine before July 1, 2016: Two 0.5-mL doses administered at least 4 weeks apart.100 112

Received a total of ≥2 doses of any seasonal influenza vaccine before July 1, 2016: A single 0.5-mL dose.100 189 112

Not recommended by ACIP and AAP for use in children <9 years of age.100 112 (See Pediatric Use under Cautions.)

Single 0.5-mL dose.100 112 186 189 190

Adults

Single 0.5-mL dose.100 104 106 107 186 189 190 (See Geriatric Use under Cautions.)

Single 0.1-mL dose.161

Special Populations

Hepatic Impairment

No specific dosage recommendations.104 106 107 186 189 190

Renal Impairment

No specific dosage recommendations.104 106 107 186 189 190

Geriatric Patients

A standard-dose IM preparation or IM Fluzone High-Dose may be used.100 (See Geriatric Use under Cautions.)

Geriatric adults ≥65 years of age: Single 0.5-mL IM dose.104 106 107 186 189 190

Geriatric adults ≥65 years of age: Single 0.5-mL IM dose.170

Geriatric adults ≥65 years of age: Single 0.5-mL IM dose.160

• Prior to administration of seasonal parenteral inactivated influenza vaccine, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient's legal representative (VISs are available at ).104 106 107 160 161 170 186 189 190 477

• Advise patients that parenteral inactivated influenza vaccine contains noninfectious killed viruses and cannot cause influenza.100 104 106 107 160 161 170 186 189 190

• Advise patients that parenteral inactivated influenza vaccine provides protection against illness due to influenza viruses represented in the vaccine and cannot provide protection against all respiratory illness.104 106 107 160 170 161 186 186 189 190

• Advise patient and/or patient's parent or guardian of the risks and benefits of vaccine administration.104 106 107 160 161 170 186 189 190

• Advise patient and/or patient's parent or guardian that annual vaccination against seasonal influenza is necessary.104 106 107 160 161 170 186 186 189 190

• Importance of receiving a 2016–2017 seasonal influenza vaccine, even if the individual received a 2015–2016 seasonal influenza vaccine.100 112

• 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 infants and children 6 months through 8 years of age.100 112 (See Pediatric Patients under Dosage and Administration.)

• Importance of informing clinicians of severe or unusual adverse effects.104 106 107 160 161 170 186 189 190 Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or .104 106 107 160 161 170 186 189 190

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses (e.g., GBS).104 106 107 160 161 170 186 189 190

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.104 106 107 160 161 170 186 189 190

• Importance of informing patients of other important precautionary information.104 106 107 160 161 170 186 189 190 (See Cautions.)