influenza virus vaccine quadrivalent (Rx)

Brand and Other Names:Fluarix Quadrivalent, Fluzone Quadrivalent, more...Fluzone Intradermal Quadrivalent, FluLaval Quadrivalent, Afluria Quadrivalent, Fluzone High-Dose Quadrivalent
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

IM suspension

  • 0.5mL/prefilled syringe (Afluria Quadrivalent, Fluzone Quadrivalent, FluLaval Quadrivalent, Fluarix Quadrivalent)
  • 0.5mL/vial (Fluzone Quadrivalent)
  • 5mL/vial (Afluria Quadrivalent, Fluzone Quadrivalent, FluLaval Quadrivalent)

intradermal suspension

  • 0.1mL/microinjection system (Fluzone Intradermal Quadrivalent)

IM suspension injection, high-dose

  • 240mcg/0.7mL (Fluzone High-dose Quadrivalent)

Influenza Prophylaxis

CDC's ACIP recommends that everyone aged 6 months and older receive an annual influenza vaccination

0.5 mL IM x1 dose/season

For more vaccine information see http://www.cdc.gov/vaccines/

Intradermal

  • Fluzone Intradermal Quadrivalent only
  • 18-64 yr: 0.1 mL ID x1 dose at beginning of flu season

Dosing Considerations

Contains the following 4 viral strains for 2021-2022 Northern Hemisphere season

  • A/Victoria/2570/2019 (H1N1)pdm09-like virus (new for 2021-2022)
  • A/Cambodia/30826360/2020 (H3N2)-like virus (new for 2021-2022)
  • B/Washington/02/2019 (B/Victoria lineage)-like virus (no change from last season)
  • B/Phuket/3073/2013-like virus (B/Yamagata lineage) (no change from last season)

Dosage Forms & Strengths

IM suspension

  • 0.25mL/prefilled syringe (Fluzone Quadrivalent)
  • 0.5mL/prefilled syringe (Afluria Quadrivalent, Fluzone Quadrivalent, FluLaval Quadrivalent, Fluarix Quadrivalent)
  • 0.5mL/vial (Fluzone Quadrivalent)
  • 5mL/vial (Afluria Quadrivalent, Fluzone Quadrivalent, FluLaval Quadrivalent)

Influenza Prophylaxis

CDC's ACIP recommends that everyone aged 6 months and older receive an annual influenza vaccinationFor more vaccine information see http://www.cdc.gov/vaccines/

Safety and efficacy not established

Fluarix Quadrivalent, Afluria Quadrivalent, FluLaval Quadrivalent, or Fluzone Quadrivalent: <6 months

6 months to <9 years

  • Fluarix Quadrivalent
    • Not previously vaccinated: 0.5 mL IM x 2 doses
    • Previously vaccinated in a previous season: 0.5 mL IM x 1-2 doses
Afluria Quadrivalent, FluLaval Quadrivalent, or Fluzone Quadrivalent
  • 6 to <36 months and not previously vaccinated: 0.25 mL or 0.5 IM x 2 doses
  • 6 to <36 months and previously vaccinated in a previous season: 0.5 mL IM x 1-2 doses
  • ≥36 months to <9 years and not previously vaccinated: 0.5 mL IM x 2 doses
  • ≥36 months to <9 years and previously vaccinated in a previous season: 0.5 mL IM x 1-2 doses
  • Flucelvax Quadrivalent
    • ≥4 to <9 years: 0.5 mL 1-2 doses

≥9 years

  • For all formulations
  • 0.5 mL IM x 1 dose

Dosing Considerations

Contains the following 4 viral strains for 2021-2022 Northern Hemisphere season

  • A/Victoria/2570/2019 (H1N1)pdm09-like virus (new for 2021-2022)
  • A/Cambodia/30826360/2020 (H3N2)-like virus (new for 2021-2022)
  • B/Washington/02/2019 (B/Victoria lineage)-like virus (no change from last season)
  • B/Phuket/3073/2013-like virus (B/Yamagata lineage) (no change from last season)

Influenza Prophylaxis

CDC's ACIP recommends that everyone aged 6 months and older receive an annual influenza vaccination

Afluria Quadrivalent, Fluzone Quadrivalent, FluLaval Quadrivalent

  • 0.5 mL IM x1 dose/season

Fluzone High-Dose Quadrivalent

  • Indicated for use in patients ≥65 years
  • 0.7 mL IM x1 dose/season
  • For more vaccine information see http://www.cdc.gov/vaccines/
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Interactions

Interaction Checker

and influenza virus vaccine quadrivalent

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      Serious - Use Alternative

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            Contraindicated (1)

            • ifosfamide

              ifosfamide decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            Serious - Use Alternative (36)

            • adalimumab

              adalimumab decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • alefacept

              alefacept decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • anakinra

              anakinra decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • antithymocyte globulin equine

              antithymocyte globulin equine decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • antithymocyte globulin rabbit

              antithymocyte globulin rabbit decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • azathioprine

              azathioprine decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • basiliximab

              basiliximab decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • budesonide

              budesonide decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • canakinumab

              canakinumab decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • cortisone

              cortisone decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • deflazacort

              deflazacort decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • dexamethasone

              dexamethasone decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • etanercept

              etanercept decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • everolimus

              everolimus decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • fludrocortisone

              fludrocortisone decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • glatiramer

              glatiramer decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • golimumab

              golimumab decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hydrocortisone

              hydrocortisone decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • infliximab

              infliximab decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • leflunomide

              leflunomide decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • methylprednisolone

              methylprednisolone decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • muromonab CD3

              muromonab CD3 decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • mycophenolate

              mycophenolate decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ocrelizumab

              ocrelizumab decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.

            • ofatumumab SC

              ofatumumab SC decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 2 weeks before initiating ofatumumab SC for inactivated vaccines, and whenever possible.

            • prednisolone

              prednisolone decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • prednisone

              prednisone decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • rilonacept

              rilonacept decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • secukinumab

              secukinumab decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating secukinumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with secukinumab may not elicit an immune response sufficient to prevent disease.

            • siponimod

              siponimod decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.

            • sirolimus

              sirolimus decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tacrolimus

              tacrolimus decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • temsirolimus

              temsirolimus decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tocilizumab

              tocilizumab decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • triamcinolone acetonide injectable suspension

              triamcinolone acetonide injectable suspension decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            Monitor Closely (17)

            • certolizumab pegol

              certolizumab pegol decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Use Caution/Monitor.

            • cyclosporine

              cyclosporine decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. If possible, complete all age-appropriate vaccinations at least 2 weeks before initiating immunosuppressant therapy. Patients vaccinated <14 days before starting immunosuppressive therapy or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. Longer waiting periods may be required for drugs that maintain their immunosuppressive effects for more than 3 months after discontinuation (eg, ocrelizumab). .

            • dengue vaccine

              dengue vaccine, influenza virus vaccine quadrivalent. unspecified interaction mechanism. Use Caution/Monitor. Data are not available to establish safety and immunogenicity of coadministration of dengue vaccine with recommended adolescent vaccines.

            • ibrutinib

              ibrutinib decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • ifosfamide

              ifosfamide decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • lomustine

              lomustine decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • mechlorethamine

              mechlorethamine decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • melphalan

              melphalan decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • mercaptopurine

              mercaptopurine decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • methotrexate

              methotrexate decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Use Caution/Monitor. Concomitant administration of methotrexate can decrease the immunological response of vaccines.

            • onasemnogene abeparvovec

              onasemnogene abeparvovec decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

            • oseltamivir

              oseltamivir decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Use Caution/Monitor. Avoid administration of live attenuated influenza vaccine intranasal within 2 weeks before or 48 hours after administration of oseltamivir, unless medically indicated.

            • oxaliplatin

              oxaliplatin decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • ponesimod

              ponesimod decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. If possible, complete all age-appropriate vaccinations at least 4 weeks before initiating ponesimod.

            • procarbazine

              procarbazine decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • rituximab

              rituximab, influenza virus vaccine quadrivalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

            • rituximab-hyaluronidase

              rituximab-hyaluronidase, influenza virus vaccine quadrivalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

            Minor (6)

            • amantadine

              amantadine decreases effects of influenza virus vaccine quadrivalent by Other (see comment). Minor/Significance Unknown. Comment: Because of its antiviral properties, amantadine may interfere with the efficacy of live attenuated influenza vaccines (LAIV). Coadministration of LAIV and amantadine is not recommended. Inactivated influenza vaccines may be used, as appropriate.

            • chloroquine

              chloroquine decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Minor/Significance Unknown.

            • ethotoin

              influenza virus vaccine quadrivalent, ethotoin. Mechanism: unknown. Minor/Significance Unknown. Vaccine administration may incr or decr phenytoin levels.

            • fosphenytoin

              influenza virus vaccine quadrivalent, fosphenytoin. Mechanism: unknown. Minor/Significance Unknown. Vaccine administration may incr or decr phenytoin levels.

            • ozanimod

              ozanimod decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Minor/Significance Unknown. No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. Vaccinations may be less effective if coadministered with ozanimod.

            • phenytoin

              influenza virus vaccine quadrivalent, phenytoin. Mechanism: unknown. Minor/Significance Unknown. Vaccine administration may incr or decr phenytoin levels.

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            Adverse Effects

            >10%

            Afluria Quadrivalent

            • Pain (61-68%)
            • Myalgia (8-40%)
            • Headache (10-27%)
            • Redness (17-24%)
            • Malaise (8-24%)
            • Irritability (16-18%)
            • Induration (15-17%)
            • Swelling (13-17%)
            • Any fever (5-16%)
            • Nausea/vomiting (3-12%)

            Fluarix Quadrivalent

            • Pain (43.7%)
            • Redness (23%)
            • Fatigue (19.7%)
            • Swelling (18.5%)
            • Muscle aches (17.5%)
            • Drowsiness (17.2%)
            • Irritability (16.8%)
            • Headache (16.3%)
            • Loss of appetite (15.5%)

            Flucelvax Quadrivalent

            • Injection site erythema (11.9-13.4%)
            • Injection site induration (8.7-11.6%)

            FluLaval Quadrivalent

            • Pain (59.5%)
            • Muscle aches (26.3%)
            • Headaches (21.5%)
            • Fatigue (21.5%)
            • Arthralgia (14.8%)

            Fluzone High-Dose Quadrivalent

            • Injection site pain (41.3%)
            • Myalgia (22.7%)
            • Headache (14.4%)
            • Malaise (13.2%)

            1-10%

            Afluria Quadrivalent

            • Diarrhea (2-8%)
            • Loss of appetite (4-5%)

            Fluarix Quadrivalent

            • Arthralgia (9.8%)
            • Gastrointestinal symptoms (9.8%)
            • Fever (8.9%)
            • Shivering (6.4%)
            • Fever (6%)
            • Pain, Grade 3 (1.6%)
            • Fatigue, Grade 3 (1.5%)
            • Headache, Grade 3 (1.3%)
            • Fever, Grade 3 (1.1%)
            • Redness, Grade 3 (1%)
            • Drowsiness, Grade 3 (1%)
            • Gastrointestinal symptoms, Grade 3 (1%)

            FluLaval Quadrivalent

            • Gastrointestinal symptoms (9.3%)
            • Shivering (8.8%)
            • Pain, Grade 3 (1.7%)
            • Fever (1.3%)

            <1%

            Fluarix Quadrivalent

            • Swelling, Grade 3 (0.8%)
            • Irritability, Grade 3 (0.7%)
            • Muscle aches, Grade 3 (0.7%)
            • Shivering, Grade 3 (0.5%)
            • Loss of appetite (0.3%)
            • Fever (0.3%)

            Flucelvax Quadrivalent

            • Headache (0.3-0.9%)
            • Fatigue (0.6-0.8%)
            • Myalgia (0.3-0.8%)
            • Diarrhea (0.5-0.6%)
            • Arthralgia (0.3-0.5%)
            • Injection site pain (0.5%)
            • Chills (0.2-0.3%)
            • Nausea (0.2-0.3%)
            • Loss of appetite (0.2-0.3%)
            • Vomiting (0.2%)

            FluLaval Quadrivalent

            • Headache, Grade 3 (0.9%)
            • Muscle aches, Grade 3 (0.8%)
            • Fatigue, Grade 3 (0.8%)
            • Arthralgia, Grade 3 (0.8%)
            • Gastrointestinal symptoms, Grade 3 (0.8%)
            • Shivering, Grade 3 (0.6%)
            • Fever, Grade 3 (0.4%)

            Postmarketing Reports

            Afluria Quadrivalent

            • Blood and lymphatic disorders: Thrombocytopenia
            • Immune system disorders: Allergic or immediate hypersensitivity reactions, including anaphylactic shock and serum sickness
            • Nervous system disorders: Neuralgia, paresthesia, convulsions (eg, febrile seizures), encephalomyelitis, encephalopathy, neuritis or neuropathy, transverse myelitis, and Guillain-Barré syndrome
            • Vascular disorders: Vasculitis
            • Skin and subcutaneous tissue disorders: Pruritus, urticaria, and rash
            • General disorders and administration site conditions: Cellulitis, large injection site swelling, influenzalike illness

            Fluarix Quadrivalent

            • Blood and lymphatic disorders: Lymphadenopathy
            • Cardiac disorders: Tachycardia
            • Ear and labyrinth disorders: Vertigo
            • Eye disorders: Conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling
            • Gastrointestinal disorders: Abdominal pain or discomfort; swelling of the mouth, throat, and/or tongue
            • General disorders and administration site conditions: Asthenia, chest pain, feeling hot, injection site mass, injection site reaction, injection site warmth, body aches
            • Immune system disorders: Anaphylactic reaction (eg, shock), anaphylactoid reaction, hypersensitivity, serum sickness
            • Infections and infestations: Injection site abscess, injection site cellulitis, pharyngitis, rhinitis, tonsillitis
            • Nervous system disorders: Convulsion, encephalomyelitis, facial palsy, facial paresis, Guillain-Barré syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia, syncope
            • Respiratory, thoracic, and mediastinal disorders: Asthma, bronchospasm, dyspnea, respiratory distress, stridor
            • Skin and subcutaneous tissue disorders: Angioedema, erythema, erythema multiforme, facial swelling, pruritus, Stevens-Johnson syndrome, sweating, urticaria
            • Vascular disorders: Henoch-Schönlein purpura, vasculitis

            Flucelvax Quadrivalent

            • Immune system disorders: Allergic or immediate hypersensitivity reactions (eg, anaphylactic shock)
            • Nervous systems disorders: Syncope, presyncope, paresthesia
            • Skin and subcutaneous tissue disorders: Generalized skin reactions (eg, pruritus, urticaria, nonspecific rash)
            • General disorders and administration site conditions: Extensive swelling of injected limb

            FluLaval Quadrivalent

            • Blood and lymphatic disorders: Lymphadenopathy
            • Eye disorders: Eye pain, photophobia
            • Gastrointestinal disorders: Dysphagia, vomiting
            • General disorders and administration site conditions: Chest pain, injection site inflammation, asthenia, injection site rash, influenzalike symptoms, abnormal gait, injection site bruising, injection site sterile abscess
            • Immune system disorders: Allergic reactions (including anaphylaxis), angioedema
            • Infections and infestations: Rhinitis, laryngitis, cellulitis
            • Musculoskeletal and connective-tissue disorders: Muscle weakness, arthritis
            • Nervous system disorders: Dizziness, paresthesia, hypoesthesia, hypokinesia, tremor, somnolence, syncope, Guillain-Barré syndrome, convulsions/seizures, facial or cranial nerve paralysis, encephalopathy, limb paralysis
            • Psychiatric disorders: Insomnia
            • Respiratory, thoracic, and mediastinal disorders: Dyspnea, dysphonia, bronchospasm, throat tightness
            • Skin and subcutaneous tissue disorders: Urticaria, localized or generalized rash, pruritus, sweating
            • Vascular disorders: Flushing, pallor
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            Warnings

            Contraindications

            Severe hypersensitivity (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous administration of any influenza vaccine

            Cautions

            Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of vaccine

            Use split or purified surface antigen in children

            Defer vaccine with febrile illnesses until illness is resolved; may administer vaccine with minor illnesses without fever (eg, upper respiratory tract infections)

            Expected immune response may not be obtained in immunocompromised individuals, including those receiving immunosuppressive therapy

            Guillain-Barré syndrome has been reported within 6 weeks of receipt of influenza vaccines

            Tip of syringe may contain natural rubber latex

            Syncope reported with injectable vaccines

            IM injections may cause hematoma in individuals with bleeding disorders (eg, hemophilia, anticoagulant therapy)

            Before administration, review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions

            Vaccination may not protect all susceptible individuals

            Drug interaction overview

            Coadministration with other vaccines
            • Do not mix with any other vaccine in the same syringe or vial
            • There are insufficient data to assess the coadministration of influenza vaccine with other vaccines
            • When concomitant administration of other vaccines is required, administer at different injection sites
            Immunosuppressive therapies
            • Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to influenza vaccine
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            Pregnancy & Lactation

            Pregnancy

            There are insufficient data on influenza vaccine in pregnant women to inform vaccine-associated risk

            Pregnancy exposure registry

            • Monitors pregnancy outcomes in women exposed to influenza vaccine during pregnancy
            • Healthcare providers are encouraged to register women by calling the following: H5
            • FluLaval Quadrivalent, Fluarix Quadrivalent: 1-888-452-9622
            • Afluria Quadrivalent: 1-855-358-8966 or sending an email to Seqirus at us.medicalinformation@seqirus.com
            • Fluzone Intradermal Quadrivalent or Fluzone Quadrivalent: 1-800-822-2463

            Animal data

            • No adverse effects observed on preweaning or vaccine-related fetal malformations when administered to female rabbits before pregnancy or during pregnancy

            Clinical considerations

            • Pregnant women are at increased risk of complications associated with influenza infection compared with nonpregnant women
            • The CDC recommends pregnant women be immunized with influenza vaccine by injection and not the live-attenuated influenza vaccine (LAIV; intranasal influenza vaccine)
            • Vaccination has been shown to reduce the risk of flu-associated acute respiratory infection in pregnant women by up to 50%; immunization also confers some immunity to infants for the first several months after their birth, when they are too young to be vaccinated

            Lactation

            Unknown if distributed in human breast milk

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Inactivated influenza virus types A & B subunits

            Conveys active immunity via stimulation of production of endogenously produced antibodies

            Pharmacokinetics

            Onset: ~2 weeks

            Duration: Several months

            Effectiveness: Varies seasonally, depending on viral strain and mutations; lower antibody response in patients aged >65 yr or immunosuppressed individuals

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            Administration

            IM Administration

            Do not administer IV, intradermally (ID), or SC

            Visually inspect for particulate matter and discoloration before administration; if either condition exists, discard vaccine

            Fluzone High Dose Quadrivalent: Deltoid muscle of the upper arm; do not inject into the gluteal area or areas where there may be a major nerve trunk

            Fluzone Quadrivalent, FluLaval Quadrivalent, Fluarix Quadrivalent, Afluria Quadrivalent

            • 6-11 months: Anterolateral aspect of the thighs
            • 12-35 months: Anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate)
            • ≥36 months: Deltoid muscle
            • Do not inject into the gluteal area or areas where there may be a major nerve trunk

            ID Administration

            Fluzone Intradermal Quadrivalent only

            Preferred site of injection: Skin in the deltoid region

            Shake prefilled syringe

            Visually inspect for particulate matter and discoloration before administration

            Gently pierce the skin over the deltoid region; a wheal (superficial bump) and/or redness may be visible at injection site

            Do not aspirate

            Discard syringe after administration

            Storage

            Single-dose vials and prefilled syringes

            • Refrigerate at 2-8ºC (35-46ºF)
            • Do not freeze; discard if vaccine has been frozen
            • Do not use after expiration date shown on the label
            • Protect from light

            Multidose vials

            • Unopened vials: Refrigerate at 2-8ºC (35-46ºF)
            • Open vials: Refrigerate at 2-8ºC (35-46ºF) for up to 28 days
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.