INFLUENZA VACCINE1

FLUARIX

Rely on the same dose (0.5 mL) for a broad age range of patients, aged 6 months and older.1

ORDER FLUARIX
FLUARIX (Influenza Vaccine)

Dosing and administration for FLUARIX

FLUARIX is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLUARIX is approved for use in persons aged 6 months and older1:

 

  • 0.5-mL single-dose prefilled syringes (package of 10)
  • Not made with thimerosal
  • Disposable
  • Packaged without needles
  • CPT code 90656

Vaccination dose and schedule by age

  Aged 6 months through 8 years Aged 9 years and older
Vaccination status Not previously vaccinated
with influenza vaccine		 Vaccinated with influenza vaccine
in a previous season		 Not applicable
Dose and schedule 2 doses (0.5 mL each)
at least 4 weeks apart		 1 or 2 dosesa (0.5 mL each) 1 dosea (0.5 mL each)

Aged 6 months through 8 years

Vaccination status Dose and schedule
Not previously vaccinated
with influenza vaccine		 2 doses (0.5 mL each)
at least 4 weeks apart
Vaccinated with influenza vaccine in a previous season 1 or 2 dosesa 

(0.5 mL each)

Aged 9 years and older

Vaccination status Dose and schedule
Not applicable 1 dosea 

(0.5 mL each)
  • a

    One dose or 2 doses (0.5 mL each) depending on vaccination history as per the annual Advisory Committee on Immunization Practices (ACIP) recommendation on prevention and control of influenza with vaccines. If 2 doses, administer each 0.5-mL dose at least 4 weeks apart.

Administering FLUARIX

Administering FLUARIX (Influenza Vaccine)

Administering FLUARIX

Shake well before administration. Attach a sterile needle to the prefilled syringe and administer intramuscularly1

See safety profile for FLUARIX
Storing FLUARIX (Influenza Vaccine)

Storing FLUARIX

FLUARIX should be refrigerated between 36°F and 46°F (2°C and 8°C). Do not freeze. Discard if the vaccine has been frozen. Store in the original package to protect from light.1

Coding information for FLUARIX

 

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CPT, NDC, and ICD-10 Codes for FLUARIX

Vaccine CPT Code 2025-2026 NDC Number ICD-10 Code
FLUARIX Package of 10 Prefilled syringes1 90656

Carton NDC code: 58160-912-52

PFS NDC code: 58160-912-41

 Z23

Vaccine

FLUARIX Package of 10 Prefilled syringes1

CPT Code

90656

2025-2026 NDC Number

Carton NDC code: 58160-912-52

PFS NDC code: 58160-912-41

ICD-10 Code

Z23

Please refer to your most up-to-date Current Procedural Terminology (CPT) and International Classification of Diseases (ICD) manuals for appropriate coding.

Administration codes will vary based on the service provided.

 

Prefilled syringe includes:

  • Color coding and color band for easy and quick identification
  • 2-D bar code with the NDC numbers, lot number, and expiration date to help simplify the documentation process

 

More FLUARIX codes

See codes for FLULAVAL

FLUARIX safety profile

 

In clinical trials, FLUARIX 0.5 mL demonstrated a safety profile comparable to other trivalent influenza vaccines and to placebo.1

Children aged 6 through 35 months

 

The safety experience with FLUARIX QUADRIVALENT is relevant to FLUARIX because both vaccines are manufactured using the same process and have overlapping compositions.1

 

Trial 5: FLUARIX QUADRIVALENT: Incidence of solicited adverse reactions within 7 daysa after first vaccination in children aged 6 through 35 monthsb (total vaccinated cohort)1

  FLUARIX TRIVALENT Non-Influenza Active comparatorc,d
  Any Grade 3e Any Grade 3e
Local (%) n=5899 n=5896
Pain 17 0.4 18 0.5
Redness 13 0 14 0
Swelling 8 0 9 0
Systemic (%) n=5898 n=5896
Irritability 16 0.7 18 1
Loss of appetite 14 1 15 1
Drowsiness 13 0.7 14 0.9
Feverf 6 1 7 1

    Children aged 3 through 17 years

     

    Trial 4: FLUARIX: Incidence of solicited local and systemic adverse reactions within 4 daysa of first vaccination in children aged 3 through 17 yearsb (total vaccinated cohort)1

      Aged 3 through 4 years
    		 Aged 5 through 17 years
      FLUARIX
    n=350    		 Comparatorc,d
    n=341
    		 FLUARIX
    n=1348
    		 Comparator
    n=451
    Local (%) Any Grade 3c
    		 Any Grade 3c
    		 Any Grade 3c
    		 Any Grade 3c
    Pain 35 2 38 1 56 0.8 56 0.7
    Redness 23 0.3 20 0 18 1 16 0.7
    Swelling 14 0 13 0 14 2 13 0.7
    Systemic (%)
    Irritability 21 0.9 22 0 - - - -
    Loss of appetite 13 0.9 15 0.9 - - - -
    Drowsiness 13 0.6 20 0.9 - - - -
    Feverd 7 1 2 8 4 0.3 3 0.2
    Muscle aches - - - - 29 0.4 29 0.4
    Fatigue - - - - 20 1 19 1
    Headache - - - - 15 0.5 16 0.9
    Arthralgia - - - - 6 0.1 6 0.2
    Shivering - - - - 3 0.1 4 0.2
      Aged 3 through 4 years
      FLUARIX
    n=350    		 Comparatorc,d
    n=341
    Local (%) Any Grade 3c
    		 Any Grade 3c
    Pain 35 2 38 1
    Redness 23 0.3 20 0
    Swelling 14 0 13 0
    Systemic (%) Any Grade 3c Any Grade 3c
    Irritability 21 0.9 22 0
    Loss of Appetite 13 0.9 15 0.9
    Drowsiness 13 0.6 20 0.9
    Feverd 7 1 2 8
    Muscle aches - - - -
    Fatigue - - - -
    Headache - - - -
    Arthralgia - - - -
    Shivering - - - -
      Aged 5 through 17 years
      FLUARIX
    n=1348
    		 Comparator
    n=451
    Local (%) Any Grade 3c
    		 Any Grade 3c
    Pain 56 0.8 56 0.7
    Redness 18 1 16 0.7
    Swelling 14 2 13 0.7
    Systemic (%) Any Grade 3c Any Grade 3c
    Irritability - - - -
    Loss of appetite - - - -
    Drowsiness - - - -
    Feverd 4 0.3 3 0.2
    Muscle aches 29 0.4 29 0.4
    Fatigue 20 1 19 1
    Headache 15 0.5 16 0.9
    Arthralgia 6 0.1 6 0.2
    Shivering 3 0.1 4 0.2

      Adults aged 18 Years and older

       

      Trial 1: FLUARIX: Incidence of solicited local and systemic adverse reactions within 4 daysa of first vaccination in adults aged 18 through 64 yearsb (total vaccinated cohort)1

        FLUARIX
      n=760      		 Placebo
      n=192
      Local (%) Any Grade 3c
      		 Any Grade 3c
      Pain 55 0.1 12 0
      Redness 18 0 10 0
      Swelling 9 0.1 6 0
      Systemic (%)  
      Muscle aches 23 0.4 12 0.5
      Fatigue 20 0.4 18 1
      Headache 19 0.1 21 1
      Arthralgia 6 0.1 6 0.5
      Shivering 3 0.1 3 0
      Feverd 2 0 2 0
        FLUARIX
      n=760      		 Placebo
      n=192
      Local (%) Any Grade 3c
      		 Any Grade 3c
      Pain 55 0.1 12 0
      Redness 18 0 10 0
      Swelling 9 0.1 6 0
      Systemic (%) Any Grade 3c Any Grade 3c
      Muscle aches 23 0.4 12 0.5
      Fatigue 20 0.4 18 1
      Headache 19 0.1 21 1
      Arthralgia 6 0.1 6 0.5
      Shivering 3 0.1 3 0
      Feverd 2 0 2 0

        Trial 2: FLUARIX: Incidence of solicited local and systemic adverse reactions within 4 daysa of first vaccination in adultsb (total vaccinated cohort)1

          Aged 18 through 64 years
        		 Aged 65 years and older
          FLUARIX
        n=315        		 Comparator
        n=314
        		 FLUARIX
        n=601-2
        		 Comparator
        n=596
        Local (%) Any Grade 3c
        		 Any Grade 3c
        		 Any Grade 3c
        		 Any Grade 3c
        Pain 48 0.3 53 0.3 19 0 18 0
        Redness 13 0 16 1 11 0.2 13 0.7
        Swelling 9 0 11 2 6 0 9 0.7
        Systemic (%)
        Fatigue
        		 21 0.3 18 0.6 9 0.3 10 0.7
        Headache 20 0.3 21 1 8 0.3 8 0.3
        Muscle aches 16 0 13 1 7 0.3 7 0
        Arthralgia 9 0 9 0.6 6 0.5 5 0.2
        Shivering 3 0 5 0 2 0.2 2 0
        Feverd 3 0 1 0 2 0 0.5 0
          Aged 18 through 64 years
          FLUARIX
        n=315        		 Comparator
        n=314
        Local (%) Any Grade 3c
        		 Any Grade 3c
        Pain 48 0.3 53 0.3
        Redness 13 0 16 1
        Swelling 9 0 11 2
        Systemic (%) Any Grade 3c Any Grade 3c
        Fatigue 21 0.3 18 0.6
        Headache 20 0.3 21 1
        Muscle aches 16 0 13 1
        Arthralgia 9 0 9 0.6
        Shivering 3 0 5 0
        Feverd 3 0 1 0
          Aged 65 years and older
          FLUARIX
        n=601-2        		 Comparator
        n=596
        Local (%) Any Grade 3c
        		 Any Grade 3c
        Pain 19 0 18 0
        Redness 11 0.2 13 0.7
        Swelling 6 0 9 0.7
        Systemic (%) Any Grade 3c Any Grade 3c
        Fatigue 9 0.3 10 0.7
        Headache 8 0.3 8 0.3
        Muscle aches 7 0.3 7 0
        Arthralgia 6 0.5 5 0.2
        Shivering 2 0.2 2 0
        Feverd 2 0 0.5 0

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          Indication for FLUARIX and FLULAVAL & Important Safety Info

          Indication for FLUARIX and FLULAVAL

          Important Safety Information

          Indication for FLUARIX and FLULAVAL

          FLUARIX and FLULAVAL are vaccines indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccines. FLUARIX and FLULAVAL are approved for use in persons aged 6 months and older.

          Important Safety Information

          • Do not administer FLUARIX or FLULAVAL to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine
          • If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX or FLULAVAL should be based on careful consideration of the potential benefits and risks
          • Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX and FLULAVAL. Procedures should be in place to avoid injury from fainting
          • Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of FLUARIX and FLULAVAL
          • If FLUARIX or FLULAVAL is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons
          • The most common (≥10%) solicited local adverse reactions with FLUARIX in adults were pain (55%) and redness (18%), and the most common systemic adverse reactions were muscle aches (23%), fatigue (20%), and headache (19%). In children aged 5 through 17 years, the most common (≥10%) solicited local adverse reactions were pain (56%), redness (18%), and swelling (14%), and the most common systemic adverse reactions were muscle aches (29%), fatigue (20%), and headache (15%). In children aged 3 through 4 years, the most common (≥10%) solicited local adverse reactions were pain (35%), redness (23%), and swelling (14%), and the most common systemic adverse reactions were irritability (21%), loss of appetite (13%), and drowsiness (13%). In children aged 6 through 35 months who received FLUARIX QUADRIVALENT, the most common (≥10%) solicited local adverse reactions were pain (17%) and redness (13%), and the most common systemic adverse reactions were irritability (16%), loss of appetite (14%), and drowsiness (13%)
          • The most common (≥10%) solicited local adverse reactions with FLULAVAL in adults were pain (51%), redness (13%), and swelling (11%), and the most common solicited systemic adverse reactions were fatigue (20%), headache (18%), and muscle aches/arthralgia (18%). In children aged 3 through 17 years, the most common (≥10%) solicited local adverse reaction was pain (56%). In children aged 3 through 4 years, the most common (≥10%) solicited systemic adverse reactions were irritability (25%), drowsiness (19%), and loss of appetite (16%). In children aged 5 through 17 years, the most common (≥10%) solicited systemic adverse reactions were muscle aches (24%), headache (17%), and fatigue (17%). In children aged 6 through 35 months who received FLULAVAL QUADRIVALENT, the most common (≥10%) solicited local adverse reaction was pain (40%), and the most common solicited systemic adverse reactions were irritability (49%), drowsiness (37%), and loss of appetite (29%)
          • Vaccination with FLUARIX or FLULAVAL may not result in protection of all vaccine recipients


          Please see full Prescribing Information
for FLUARIX.

          Please see full Prescribing Information for FLULAVAL.

          To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or
          1-888-825-5249, or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

          References

          1. Prescribing information for FLUARIX.

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