Dosing & Uses
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)
IM suspension injection, high-dose
- 0.5mL/prefilled syringe (Fluzone High-dose Quadrivalent) for aged ≥65 years
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/
Dosing Considerations
Contains the following 4 viral strains for 2023-2024 Northern Hemisphere season
- A/Victoria/4897/2022 (H1N1)pdm09-like virus (new for 2023-2024)
- A/Darwin/9/2021 (H3N2)-like virus (no change from last season)
- B/Austria/1359417/2021 (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 2023-2024 Northern Hemisphere season
- A/Victoria/4897/2022 (H1N1)pdm09-like virus (new for 2023-2024)
- A/Darwin/9/2021 (H3N2)-like virus (no change from last season)
- B/Austria/1359417/2021 (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
- 0.5 mL IM x1 dose/season
- For more vaccine information see http://www.cdc.gov/vaccines/
Dosing Considerations
Contains the following 4 viral strains for 2023-2024 Northern Hemisphere season
- A/Victoria/4897/2022 (H1N1)pdm09-like virus (new for 2023-2024)
- A/Darwin/9/2021 (H3N2)-like virus (no change from last season)
- B/Austria/1359417/2021 (B/Victoria lineage)-like virus (no change from last season)
- B/Phuket/3073/2013-like virus (B/Yamagata lineage) (no change from last season)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (37)
- 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.
- elivaldogene autotemcel
elivaldogene autotemcel, influenza virus vaccine quadrivalent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- 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.
- 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.
- teplizumab
teplizumab decreases effects of influenza virus vaccine quadrivalent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.
- 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 (22)
- 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). .
- delandistrogene moxeparvovec
delandistrogene moxeparvovec, influenza virus vaccine quadrivalent. Other (see comment). Use Caution/Monitor. Comment: Consider patient vaccination status before initiating corticosteroid regimen required before delandistrogene moxeparvovec administration. If possible, ensure patients are current with all immunizations according to immunization guidelines. Complete vaccinations at least 4 weeks before starting corticosteroid regimen. High-dose or long-term corticosteroids may decrease immungenicity of vaccines.
- 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.
- satralizumab
satralizumab decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .
- tralokinumab
tralokinumab will decrease the level or effect of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.
- ublituximab
ublituximab decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.
- voclosporin
voclosporin decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment.
Minor (5)
- 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.
- 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.
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
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
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.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
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
Images
Formulary
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.
