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  • CLASSES

    Influenza Vaccines

    DEA CLASS

    Rx

    DESCRIPTION

    Inactivated influenza vaccine (IIV)
    Used to confer immunity against 3 (2 type A and 1 type B) or 4 (2 type A and 2 type B) strains likely to circulate during annual flu season
    Annual immunizations required; recommended for all people at least 6 months of age

    COMMON BRAND NAMES

    Afluria Quadrivalent, FLUAD, Fluarix Quadrivalent, Flublok Quadrivalent, FLUCELVAX, Flulaval, Fluzone

    HOW SUPPLIED

    Alfuria/FLUAD/Fluarix Quadrivalent/Flublok Quadrivalent/FLUCELVAX/Flulaval/Fluvirin/Fluzone/Fluzone High-Dose/Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Iowa/06/2017 Antigen (MDCK Cell Derived, Propiolactone Inactivated), Influenza B Virus Phuket 3073/2013 antigen/Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated)/Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen/Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Maryland/15/2016 Antigen (Propiolactone Inactivated), Influenza B Virus Phuket 3073/2013 antigen Intramuscular Inj Susp: 0.5mL, 15-15-15mcg, 60-60-60mcg
    Flublok Intramuscular Inj Sol: 0.5mL, 45-45-45mcg
    Fluzone Intradermal Intradermal Inj Susp

    DOSAGE & INDICATIONS

    For annual seasonal influenza prophylaxis.
    Intramuscular dosage (Fluzone Quadrivalent High-Dose)
    Geriatric 65 years and older

    0.7 mL IM as a single dose.

    Intramuscular dosage (Fluzone Quadrivalent)
    Adults

    0.5 mL IM as a single dose.

    Children and Adolescents 9 years and older

    0.5 mL IM as a single dose.

    Children 3 to 8 years

    0.5 mL IM. For children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[54943] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Infants and Children 6 to 35 months

    0.25 mL or 0.5 mL IM. For infants and children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.25 mL or 0.5 mL IM at least 4 weeks after the initial dose.[54943] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Intramuscular dosage (Fluad Quadrivalent)
    Geriatric 65 years and older

    0.5 mL IM as a single dose.

    Intramuscular dosage (Fluarix Quadrivalent)
    Adults

    0.5 mL IM as a single dose.

    Children and Adolescents 9 years and older

    0.5 mL IM as a single dose. 

    Infants and Children 6 months to 8 years

    0.5 mL IM. For infants and children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[52652] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Intramuscular dosage (Flulaval Quadrivalent)
    Adults

    0.5 mL IM as a single dose.

    Children and Adolescents 9 years and older

    0.5 mL IM as a single dose.

    Infants and Children 6 months to 8 years

    0.5 mL IM. For infants and children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[55717] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Intramuscular dosage (Afluria Quadrivalent)
    Adults

    0.5 mL IM as a single dose.

    Children and Adolescents 9 years and older

    0.5 mL IM as a single dose.

    Children 3 to 8 years

    0.5 mL IM. For children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[61129] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Infants and Children 6 to 35 months

    0.25 mL IM. For infants and children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.25 mL IM at least 4 weeks after the initial dose.[61129] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Intramuscular dosage (Flucelvax Quadrivalent)
    Adults

    0.5 mL IM as a single dose.

    Children and Adolescents 9 years and older

    0.5 mL IM as a single dose.

    Infants and Children 6 months to 8 years

    0.5 mL IM. For children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[60831] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Intramuscular dosage (Flublok Quadrivalent)
    Adults

    0.5 mL IM as a single dose.

    Intradermal dosage (Fluzone Intradermal)
    Adults 18 to 64 years

    0.1 mL intradermally as a single dose.

    MAXIMUM DOSAGE

    Adults

    0.5 mL/dose IM; 0.1 mL/dose intradermal (Fluzone Intradermal only). Safety and efficacy of Fluad and Fluzone High-Dose have not been established.

    Geriatric

    0.5 mL/dose IM; 0.7 mL/dose IM (Fluzone High-Dose only). Safety and efficacy of intradermal administration have not been established.

    Adolescents

    0.5 mL/dose IM for Fluzone, Fluarix, FluLaval, Afluria (excluding the needle-free injection system), and Flucelvax. Safety and efficacy of Fluzone High-Dose, Flublok, Fluad, and intradermal administration have not been established.

    Children

    3 to 12 years: 0.5 mL/dose IM for Fluzone, Fluarix, FluLaval, Afluria (excluding the needle-free injection system), and Flucelvax. Safety and efficacy of Fluzone High-Dose, Flublok, Fluad, and intradermal administration have not been established.
    1 to 2 years: 0.25 mL/dose IM for Afluria (excluding the needle-free injection system); 0.5 mL/dose IM for FluLaval, Fluarix, Fluzone, and Flucelvax. Safety and efficacy of Fluzone High-Dose, Flublok, Fluad, and intradermal administration have not been established.

    Infants

    6 to 11 months: 0.25 mL/dose IM for Afluria (excluding the needle-free injection system); 0.5 mL/dose IM for Flulaval, Fluarix, Fluzone, and Flucelvax. Safety and efficacy of Fluzone High-Dose, Flublok, Fluad, and intradermal administration have not been established.
    1 to 5 months: Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    For storage information, see the specific product information within the How supplied section.
     
    NOTE: According to U.S. federal laws, the healthcare provider must record in the patient's permanent record: the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine.
    Obtain a patient's current health status and immunization history to determine vaccine adverse reactions. Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1-800-822-7967. Depending on the adverse reaction, subsequent vaccination, if needed, may be contraindicated.
    The health care professional should have immediate availability of epinephrine injection and other agents used in the treatment of anaphylaxis in the event of a serious allergic reaction.
    Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. The vaccine cannot cause influenza.
    Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization; materials are free of charge from the Centers for Disease Control. Provision of the Vaccine Information Statements is required by the National Childhood Vaccine Injury Act of 1986.

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
    Do not mix with any other vaccine.
    When concomitant administration of other vaccines is required, they should be given with different syringes and at different injection sites.

    Intramuscular Administration

    Before administration, clean skin over the injection site with a suitable cleansing agent.
    For products supplied as a suspension, shake well immediately before use.
    For vials, use a sterile syringe and needle to withdraw vaccine from vial. It is recommended that small syringes (0.5 mL) be used to minimize product loss. For prefilled syringes, attach a sterile needle.[41686]
    For adults and older children, a needle length of at least 1 inch can be considered; needles less than 1 inch might be of insufficient length to penetrate muscle tissue in certain adults and children.[28647]
    For children 3 years and older, the needle size required for deltoid injection ranges from 5/8- to 1-inch.
    For children 1 to 2 years, a needle at least 1 inch long is preferred for administration into the thigh; a 5/8 inch needle is sufficient for administration into the deltoid if the skin is stretched flat and the needle is inserted at a 90 degree angle.
    For the majority of infants younger than 1 year, a 1-inch, 22- to 25-gauge needle is sufficient to penetrate thigh muscle.[43236]
    Inject into the anterolateral aspect of the mid-thigh (for infants younger than 1 year of age) or the deltoid muscle of the upper arm (for children and adults). Do NOT administer in the gluteal muscle.[41686] [43236]
    Doses from Afluria vials may be administered to adults (18 to 64 years) using the PharmaJet Stratis needle-free injection system. This spring-loaded device delivers a single IM dose by creating a narrow fluid stream that rapidly penetrates the skin. Safety and efficacy of needless injectors have not been established in geriatric (older than 64 years) nor pediatric (less than 18 years) patients.[41448]
    Storage of opened vials: Acceptable storage varies depending on vaccine formulation and brand. See How Supplied section or directly contact the manufacturer for specific vaccine being used.

    Other Injectable Administration

    Intradermal administration (Fluzone Intradermal only):
    Gently shake the device and remove the needle cap.
    Insert the needle perpendicular to the skin in the region of the deltoid. Maintain light pressure on the surface of the skin and push the plunger to inject the dose. Do not aspirate.
    After needle removal from the skin, firmly push the plunger to activate the needle shield.

    STORAGE

    Afluria :
    - Discard entered multi-dose vial after 28 days
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Protect from light
    - Refrigerate (between 36 and 46 degrees F)
    Afluria Quadrivalent:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Protect from light
    - Refrigerate (between 36 and 46 degrees F)
    Agriflu:
    - Do not freeze
    - Protect from light
    - Store between 36 to 46 degrees F
    Alfuria:
    - Discard entered multi-dose vial after 28 days
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Protect from light
    - Store between 36 to 46 degrees F
    FLUAD:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Protect from light
    - Refrigerate (between 36 and 46 degrees F)
    - Store in original package until time of use
    Fluarix:
    - Discard if product has been frozen
    - Do not freeze
    - Protect from light
    - Refrigerate (between 36 and 46 degrees F)
    - Store in original container
    Fluarix Quadrivalent:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Protect from light
    - Store between 36 to 46 degrees F
    - Store in original package until time of use
    Flublok:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Protect from light
    - Store between 36 to 46 degrees F
    Flublok Quadrivalent:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Protect from light
    - Refrigerate (between 36 and 46 degrees F)
    FLUCELVAX:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Protect from light
    - Refrigerate (between 36 and 46 degrees F)
    - Store in outer carton when not in use
    Flulaval:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Protect from light
    - Store between 36 to 46 degrees F
    - Store in original package until time of use
    Fluvirin:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Protect from light
    - Refrigerate (between 36 and 46 degrees F)
    - Store in original package until time of use
    Fluzone:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Store between 35 to 46 degrees F
    Fluzone High-Dose:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Store between 35 to 46 degrees F
    Fluzone Intradermal:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Store between 35 to 46 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986. If a dose of influenza virus vaccine, inactivated has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.

    Intravenous administration, subcutaneous administration

    Influenza virus vaccine should not be given via intravenous administration or subcutaneous administration, it is for intramuscular (IM) administration only, with the exception of the intradermal Fluzone products. All other formulations should not be given by intradermal administration. Incorrect administration may result in inadequate immunity.

    Fever

    The decision to administer or to delay vaccination with the influenza virus vaccine because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. Consider delaying vaccinations during the course of a moderate or severe acute illness with or without fever and administer after the acute phase of illness has resolved. All vaccines can be administered to persons with mild illnesses. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness.[65107]

    Egg hypersensitivity

    All inactivated influenza vaccines (IIVs), with the exception of Flucelvax and Flublok, are contraindicated in persons with a known history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine or any of its components or persons who have had a life-threatening reaction to any previous influenza vaccination.[51849] [52652] [54943] [55717] Most of the vaccines available are contraindicated by the manufacturers in patients with egg hypersensitivity because these vaccines are prepared using embryonated chicken eggs. These vaccines contain only minimal amounts of egg protein; however, anaphylactic reactions can occur in individuals with severe egg allergies.[52652] [54943] [55717] [60831] Due to differences in manufacturing processes, Flucelvax and Flublok do not use eggs to propagate the virus; thus, they are only contraindicated in persons with a known history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine or any of its components. Flucelvax, however, cannot be considered 100% egg-free because the initial seed virus is created using reference virus stains from the World Health Organization, which have been passaged in eggs. For patients with a history of severe allergic reaction (e.g. anaphylaxis) to an influenza vaccine, the Advisory Committee on Immunization Practices (ACIP) has specific recommendations for vaccine receipt. A history of a severe allergic reaction to a previous dose of any egg-based IIV, recombinant influenza vaccine (RIV), or live-attenuated influenza vaccine (LAIV) is a precaution to use of the cell culture-based inactivated influenza vaccine (ccIIV, Flucelvax). A history of a severe allergic reaction to a previous dose of any egg-based IIV, ccIIV, or LAIV is a precaution to use of the RIV (Flublok). Patients who have had symptoms other than urticaria after egg exposure (i.e., angioedema or swelling, respiratory distress, lightheadedness, or recurrent emesis) or required emergency medical intervention, should be vaccinated in an inpatient or outpatient medical setting by a health care provider experienced in the recognition and management of severe allergic conditions if a vaccine other than ccIIV or RIV is used. Providers can consider consulting an allergist to assist in identification of the component responsible for the allergic reaction. Severe allergic reactions to vaccines can occur in patients without a history of previous allergic reaction. Although no specific observation time is recommended for egg-allergic patients, ACIP recommends patients be observed for syncope for 15 minutes after vaccination. [63436] The American Academy of Pediatrics (AAP), the American Academy of Allergy, Asthma, and Immunology (AAAAI), and the American College of Allergy, Asthma, and Immunology (ACAAI) do not recommend any special precautions for egg-allergic recipients, regardless of severity. The AAAAI and ACAAI consider any special precautions (i.e., special observation periods or administration in a specialized medical setting) unnecessary due to the extremely rare risk of anaphylactic reactions after vaccination. They recommend that providers and screening questionnaires not ask about the egg allergy status of the influenza virus vaccine recipient.[62809] [63520] As with any biologic product, the prescriber or health care professional should have procedures in place to manage allergic reactions. The health care professional should have immediate availability of epinephrine (1 mg/mL) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the influenza virus vaccine.[51849] [52652] [54943] [55717]

    Guillain-Barre syndrome

    Carefully consider the potential benefits and risks of the inactivated influenza vaccine (IIV) for patients who have developed Guillain-Barre syndrome (GBS) within 6 weeks of a previous influenza vaccination. Influenza immunization is generally not recommended in patients who have developed GBS within 6 weeks of a previous influenza vaccination. However, for most persons with a history of GBS who are at high risk for severe complications from influenza, many experts believe the benefits of the influenza virus vaccine justify yearly vaccination.

    Geriatric

    Geriatric persons may develop lower postvaccination antibody titers than healthy young adults and, thus, may remain susceptible to influenza-related upper respiratory tract infection (see Pharmacokinetics). However, even if such persons develop influenza illness despite vaccination, the vaccine can be effective in preventing lower respiratory tract infection or other secondary complications, thereby reducing the risk for hospitalization and death. In a retrospective study of data from 1990—2000, influenza vaccination was associated with significant reductions in the risk of hospitalization for pneumonia or influenza and in the risk of death among community-dwelling patients at least 65 years of age as compared with unvaccinated patients. Specifically, vaccination was associated with a 27% reduction in the risk of hospitalization for pneumonia or influenza and a 48% reduction in the risk of death. Statistically significant reductions in the risk of both hospitalization and death were also found by sensitivity analyses, which modeled the effect of a hypothetical unmeasured confounder that would have caused overestimation of vaccine effectiveness. In elderly nursing home residents, administration of the flu vaccine annually prior to October should generally be avoided because antibody concentrations can decrease within a few months of immunization.

    Pregnancy

    No adequate and well-controlled studies have been conducted in pregnant women, and the ability of the vaccine to cause fetal harm or to affect reproductive capacity is unknown. During animal studies, no evidence of impaired fertility or fetal harm was noted with Afluria, Agriflu, Fluarix, Flublok, Flucelvax, FluLaval, Fluvirin, or Fluzone Quadrivalent or Intradermal. Pregnancy may increase the risk of serious medical complications from influenza. Therefore, the Advisory Committee on Immunization Practices (ACIP) recommends that all women who are or will be pregnant (in any trimester) during the influenza season be routinely vaccinated with an inactivated influenza vaccine (vs. live-attenuated influenza vaccine).[63436] Although more data are needed, studies of more than 2,000 pregnant women have demonstrated no adverse fetal effects associated with influenza virus vaccine. Many experts consider influenza vaccination safe during any stage of pregnancy. However, because spontaneous abortion is common in the first trimester and unnecessary drug-exposures have traditionally been avoided during this time, some experts prefer waiting until the second trimester of pregnancy to vaccinate. In addition to benefits to the mother, influenza vaccine administration during pregnancy appears to help protect newborns and infants. Fewer cases of laboratory-confirmed influenza occurred during the first 6 months of life among infants of the 159 mothers who received the inactivated influenza vaccine (6 cases) as compared with infants of 157 mothers who received the pneumococcal polysaccharide vaccine (16 cases). The clinical judgment of the physician is paramount in the determination of whether to vaccinate a pregnant woman. Some manufacturers have established pregnancy registries to monitor pregnancy outcomes and newborn health after vaccination. Patients who receive these vaccines during pregnancy are encouraged to enroll in these registries. For GlaxoSmithKline (GSK) influenza vaccines (e.g., FluLaval and Fluarix), patients are encouraged to contact GSK by telephone at 888-452-9622. For Sanofi Pasteur influenza vaccines (e.g., Fluzone and Flublok), patients are encouraged to contact Sanofi Pasteur at 800-822-2463. For Seqirus influenza vaccines (e.g., Afluria and Afluria Quadrivalent), patients are encouraged to contact Seqirus at 855-358-8966 or us.medical information@seqirus.com.[28647] [30823] [34402] [41448] [41684] [41685] [41686] [47301] [52415] [52652] [52915] [54943] [55717] [65107]

    Breast-feeding

    Data are limited regarding use of the influenza virus vaccine during breast-feeding, and its' excretion in human breast milk is unknown. The Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) state inactivated virus vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[41686] [30823] [41685] [41448] [41684] [47301] [52652] [63520] [65107]

    Anticoagulant therapy, coagulopathy, hemophilia, thrombocytopenia, vitamin K deficiency

    Patients with thrombocytopenia or a coagulopathy (e.g., hemophilia), vitamin K deficiency, or who are on anticoagulant therapy should be monitored closely when given influenza virus vaccine because bleeding can occur at the IM injection site.

    Acquired immunodeficiency syndrome (AIDS), human immunodeficiency virus (HIV) infection

    Although patients with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) could have a diminished response, the inactivated influenza vaccine (IIV) or recombinant influenza vaccine (RIV) should be offered to these patients. The CDC recommends immunization of patients with HIV with the IIV, as this measure is safe and may confer protection against influenza. One randomized, placebo-controlled trial noted that the administration of IIV was highly effective in preventing hospitalization due to influenza in patients with HIV infection and was not associated with changes in viral load or CD4 counts (mean count 400 cells/mm3).

    Syncope

    Injectable vaccines, including influenza virus vaccine, have been associated with episodes of syncope and fainting. These events may be accompanied by transient tonic-clonic limb movements, visual disturbances, and paresthesias. Prior to administration, ensure procedures are in place to prevent falls and restore cerebral perfusion. Monitor vaccine recipients after administration of the dose. If syncope occurs, place the patient in a supine or Trendelenburg position to restore cerebral perfusion.

    Agammaglobulinemia, hypogammaglobulinemia, immunosuppression, severe combined immunodeficiency (SCID)

    Patients with significant immunosuppression may not have an adequate antibody response to the inactivated influenza vaccine (IIV).[41448] Immunosuppressed persons may include patients with severe combined immunodeficiency (SCID), hypogammaglobulinemia, agammaglobulinemia, or an immune system compromised by drug therapy (i.e., corticosteroid therapy with greater than physiologic doses). Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. Patients vaccinated with IIV within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. IIV can be administered to patients with major antibody deficiencies and some residual antibody production.[65107]

    Neoplastic disease, organ transplant, radiation therapy

    Patients with altered immune states due to generalized neoplastic disease or an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses) may not have an adequate antibody response to the inactivated influenza vaccine (IIV).[41448] Patients with hematological malignancies or solid tumor malignancies, except those receiving anti-B-cell antibodies or intensive chemotherapy (i.e., induction or consolidation chemotherapy for acute leukemia), should receive IIV annually. Patients vaccinated with IIV within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored.[60092] [65107] IIV should not be administered to solid organ transplant (SOT) recipients during intensified immunosuppression, including the first 2 months post-transplant, because of the likelihood of inadequate response. However, IIV can be administered beginning 1 month after transplant during a community influenza outbreak and should be administered 2 to 6 months after SOT. Concerns have been raised that vaccination may trigger rejection; however, clinical evidence indicates that vaccines are not important triggers of rejection episodes and should not be withheld for that reason.[60092]

    ADVERSE REACTIONS

    Severe

    erythema multiforme / Delayed / Incidence not known
    anaphylactic shock / Rapid / Incidence not known
    bronchospasm / Rapid / Incidence not known
    Stevens-Johnson syndrome / Delayed / Incidence not known
    angioedema / Rapid / Incidence not known
    Guillain-Barre syndrome / Delayed / Incidence not known
    muscle paralysis / Delayed / Incidence not known
    myelitis / Delayed / Incidence not known
    optic neuritis / Delayed / Incidence not known
    vasculitis / Delayed / Incidence not known
    seizures / Delayed / Incidence not known

    Moderate

    erythema / Early / 1.0-76.4
    migraine / Early / 1.0-1.0
    wheezing / Rapid / 1.0-1.0
    dysphonia / Delayed / Incidence not known
    neuropathic pain / Delayed / Incidence not known
    encephalopathy / Delayed / Incidence not known
    confusion / Early / Incidence not known
    dysphagia / Delayed / Incidence not known
    dyspnea / Early / Incidence not known
    lymphadenopathy / Delayed / Incidence not known
    thrombocytopenia / Delayed / Incidence not known
    conjunctivitis / Delayed / Incidence not known
    photophobia / Early / Incidence not known
    sinus tachycardia / Rapid / Incidence not known

    Mild

    injection site reaction / Rapid / 1.0-89.0
    pruritus / Rapid / 0.2-52.1
    irritability / Delayed / 1.7-42.9
    malaise / Early / 1.0-38.1
    drowsiness / Early / 13.0-37.7
    myalgia / Early / 1.0-36.4
    anorexia / Delayed / 1.0-32.3
    headache / Early / 1.0-24.7
    diarrhea / Early / 1.0-24.2
    fatigue / Early / 1.0-20.0
    fever / Early / 0-16.0
    ecchymosis / Delayed / 0.5-15.2
    arthralgia / Delayed / 0.3-15.0
    vomiting / Early / 1.4-14.8
    shivering / Rapid / 2.6-12.1
    nausea / Early / 0.4-12.0
    rhinorrhea / Early / 2.7-11.2
    diaphoresis / Early / 1.0-10.0
    rhinitis / Early / 1.0-10.0
    chills / Rapid / 2.0-7.3
    nasal congestion / Early / 1.0-7.0
    back pain / Delayed / 1.5-1.5
    abdominal pain / Early / 1.4-1.4
    dysmenorrhea / Delayed / 1.3-1.3
    cough / Delayed / 1.0
    pharyngitis / Delayed / 1.0
    infection / Delayed / 1.0
    rash / Early / Incidence not known
    urticaria / Rapid / Incidence not known
    throat irritation / Early / Incidence not known
    hypoesthesia / Delayed / Incidence not known
    paresthesias / Delayed / Incidence not known
    insomnia / Early / Incidence not known
    tremor / Early / Incidence not known
    laryngitis / Delayed / Incidence not known
    vertigo / Early / Incidence not known
    dizziness / Early / Incidence not known
    pallor / Early / Incidence not known
    flushing / Rapid / Incidence not known
    syncope / Early / Incidence not known
    chest pain (unspecified) / Early / Incidence not known

    DRUG INTERACTIONS

    Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
    Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
    Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
    Siponimod: (Moderate) Administer all non-live vaccines at least 4 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment and for 1 month after discontinuation of siponimod treatment.

    PREGNANCY AND LACTATION

    Pregnancy

    No adequate and well-controlled studies have been conducted in pregnant women, and the ability of the vaccine to cause fetal harm or to affect reproductive capacity is unknown. During animal studies, no evidence of impaired fertility or fetal harm was noted with Afluria, Agriflu, Fluarix, Flublok, Flucelvax, FluLaval, Fluvirin, or Fluzone Quadrivalent or Intradermal. Pregnancy may increase the risk of serious medical complications from influenza. Therefore, the Advisory Committee on Immunization Practices (ACIP) recommends that all women who are or will be pregnant (in any trimester) during the influenza season be routinely vaccinated with an inactivated influenza vaccine (vs. live-attenuated influenza vaccine).[63436] Although more data are needed, studies of more than 2,000 pregnant women have demonstrated no adverse fetal effects associated with influenza virus vaccine. Many experts consider influenza vaccination safe during any stage of pregnancy. However, because spontaneous abortion is common in the first trimester and unnecessary drug-exposures have traditionally been avoided during this time, some experts prefer waiting until the second trimester of pregnancy to vaccinate. In addition to benefits to the mother, influenza vaccine administration during pregnancy appears to help protect newborns and infants. Fewer cases of laboratory-confirmed influenza occurred during the first 6 months of life among infants of the 159 mothers who received the inactivated influenza vaccine (6 cases) as compared with infants of 157 mothers who received the pneumococcal polysaccharide vaccine (16 cases). The clinical judgment of the physician is paramount in the determination of whether to vaccinate a pregnant woman. Some manufacturers have established pregnancy registries to monitor pregnancy outcomes and newborn health after vaccination. Patients who receive these vaccines during pregnancy are encouraged to enroll in these registries. For GlaxoSmithKline (GSK) influenza vaccines (e.g., FluLaval and Fluarix), patients are encouraged to contact GSK by telephone at 888-452-9622. For Sanofi Pasteur influenza vaccines (e.g., Fluzone and Flublok), patients are encouraged to contact Sanofi Pasteur at 800-822-2463. For Seqirus influenza vaccines (e.g., Afluria and Afluria Quadrivalent), patients are encouraged to contact Seqirus at 855-358-8966 or us.medical information@seqirus.com.[28647] [30823] [34402] [41448] [41684] [41685] [41686] [47301] [52415] [52652] [52915] [54943] [55717] [65107]

    Data are limited regarding use of the influenza virus vaccine during breast-feeding, and its' excretion in human breast milk is unknown. The Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) state inactivated virus vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[41686] [30823] [41685] [41448] [41684] [47301] [52652] [63520] [65107]

    MECHANISM OF ACTION

    Influenza virus vaccine imparts immunity against the influenza virus by stimulating production of antibodies that are specific to the disease. Vaccine recipients develop immunity only to those strains of the virus from which the vaccine was prepared. Influenza viruses are recognized by the surface antigens they carry, and two such antigens, hemagglutinin (H) and neuraminidase (N) have been identified and are used to classify the various viruses. Subtypes of these strains (H1, H2, H3, N1, N2) are associated with influenza A virus and have been recognized to cause disease in humans. Immunity to these surface antigens increases resistance to infection and decreases the severity of the disease if infection occurs. Eventually, antigenic variation can occur, and immunity to one strain may no longer impart immunity to distantly related subtypes of the virus. Influenza B viruses also exhibit antigenic variation, and new variants of both types of viruses continue to cause widespread epidemics of respiratory disease.

    PHARMACOKINETICS

    The inactivated influenza virus vaccine (IIV) is usually administered intramuscularly; intradermal vaccines are also available. The vaccine usually imparts a protective effect within 10 to 14 days of administration. Post-vaccine antibody titers are generally high enough in healthy young adults and children to provide resistance against infection by strains found in the vaccine as well as related strains. A hemagglutination-inhibiting antibody titer of at least 1:40 may be protective against influenza infection in up to 50% of people. Among 1007 patients 18 to 64 years of age who got Afluria, 94.2 to 99.9% had a postvaccination titer of at least 1:40. The duration of immunity imparted by the influenza vaccine generally lasts 6 to 12 months.