INFLUENZA VACCINE1

FLULAVAL

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

ORDER FLULAVAL
FLULAVAL (Influenza Vaccine)

Dosing & Administration of FLULAVAL

FLULAVAL 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. FLULAVAL is approved for use in persons aged 6 months and older.

 

  • 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.

Administration

Administering FLULAVAL (Influenza Vaccine)

Administering FLULAVAL

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

See safety profile for FLULAVAL
Storing FLULAVAL (Influenza Vaccine)

Storing FLULAVAL

FLULAVAL 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 FLULAVAL

 

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CPT, NDC, and ICD-10 Codes for FLULAVAL

Vaccine CPT Code 2025-2026 NDC Number ICD-10 Code
FLULAVAL Package of 10 Prefilled syringes1 90656 Carton NDC code: 19515-904-52
PFS NDC code: 19515-904-41		 Z23
Vaccine
FLULAVAL Package of 10 Prefilled syringes1
CPT Code
90656
2025-2026 NDC Number
Carton NDC code: 19515-904-52
PFS NDC code: 19515-904-41
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 FLULAVAL codes

See codes for FLUARIX

FLULAVAL safety information

 

In clinical trials, FLULAVAL 0.5 mL demonstrated a safety profile comparable to another trivalent influenza vaccine.1

Children aged 6 through 35 months

 

Safety data were obtained with FLULAVAL QUADRIVALENT in children aged 6 through 35 months. Data with FLULAVAL QUADRIVALENT are relevant to FLULAVAL because both vaccines are manufactured using the same process and have overlapping compositions.1

 

FLULAVAL QUADRIVALENT demonstrated a safety profile comparable to Fluzone Quadrivalent (Influenza Vaccine) in a clinical trial.

 

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

  FLULAVAL Active comparatorc
Adverse reactions Any Grade 3d Any Grade 3d
Local (%) n=1151 n=1146
Pain 40 2 37 1
Swelling 1 0 0.4 0
Redness 1 0 1 0
Systemic (%) n=1155 n=1148
Irritability 49 4 46 3
Drowsiness 37 3 37 3
Loss of appetite 29 2 29 1
Fevere 6 1 6 1

    Children aged 3 through 17 years

     

    FLULAVAL demonstrated a safety profile comparable to a trivalent inactivated influenza vaccine in a clinical trial.1

     

    Trial 4: FLULAVAL: 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
     

      FLULAVAL Active comparatorc
    Adverse reactions Any Grade 3d Any Grade 3d
    Aged 3 through 17 years
    Local (%) n=1042 n=1026
    Pain 56 2 53 2
    Redness 4 0.2 5 0
    Swelling 4 0.1 5 0
    Aged 3 through 4 years
    Systemic (%) n=293 n=279
    Irritability 25 2 27 1
    Drowsiness 19 1 19 0.4
    Loss of appetite 16 2 13 0.4
    Fevere 5 1 3 0.4
    Aged 5 through 17 years
    Systemic (%) n=750 n=747
    Muscle aches 24 1 23 1
    Headache 17 1 15 1
    Fatigue 17 1 17 1
    Arthralgia 8 0.3 10 0.3
    Shivering 6 0.1 5 0.4
    Fevere 5 2 4 2

      Adults aged 18 years and older

       

      FLULAVAL demonstrated a safety profile comparable to a trivalent inactivated influenza vaccine and placebo in 3 clinical trials.1

       

      Trial 1, 2 & 3: FLULAVAL: Incidence of solicited local and systemic adverse reactions within 4 daysa of first vaccination in adults aged 18 years and older (total vaccinated cohort)1
       

        Trial 1b
      Aged 18 Through 64 Years      		 Trial 2b
      Aged 50 Years and Older      		 Trial 3b
      Aged 18 Through 49 Years
        FLULAVAL Comparatorc FLULAVAL Comparatorc FLULAVAL Placebo
      Adverse reactions Any Grade 3d Any Grade 3d Any Grade 3d Any Grade 3d Any Grade 3d Any Grade 3d
      Local (%) n=721 n=279 n=610 n=615 n=3783 n=3828
      Pain 24 0 31 0.4 25 0 32 0 51 0.2 14 <0.1
      Redness 11 0.1 10 0 10 0.2 11 0.2 13 0.3 6 0.1
      Swelling 10 0.1 10 0.4 7 0.3 9 1 11 0.3 3 0
      Systemic (%)
      Headache 18 0.4 17 0 11 0.2 12 0.3 18 1 19 1
      Fatigue 17 0.3 15 0 12 0.2 13 1 20 1 18 0.4
      Muscle achese 13 0.4 16 0 11 0.2 10 0 18 0.2 10 0.2
      Feverf 11 0 10 0.4 1 0 2 0 3 <0.1 1 0.1
      Malaise 10 0.4 10 0.4 6 0.3 7 0 9 0.3 6 0.4
      Sore throat 9 0.4 9 0 5 0.2 6 0 9 0.3 9 0.4
      Reddened eyes
      		 6 0.3 5 0 4 0 7 0 7 <0.1 6 <0.1
      Cough 6 0.3 7 0 5 0.2 6 0 8 0.1 7 0.1
      Chills 5 0.3 2 0 3 0.2 6 0 4 0.2 4 0.2
      Chest tightness 3 0 1 0 3 0.3 2 0 3 <0.1 3 0.1
      Facial swelling 1 0 0.4 0 1 0 2 0 1 0 1 0
      Trial 1b
      Aged 18 Through 64 Years
        FLULAVAL Comparatorc
      Adverse reactions Any Grade 3d Any Grade 3d
      Local (%) n=721 n=279
      Pain 24 0 31 0.4
      Redness 11 0.1 10 0
      Swelling 10 0.1 10 0.4
      Systemic (%)
      Headache 18 0.4 17 0
      Fatigue 17 0.3 15 0
      Muscle achese 13 0.4 16 0
      Feverf 11 0 10 0.4
      Malaise 10 0.4 10 0.4
      Sore throat 9 0.4 9 0
      Reddened eyes
      		 6 0.3 5 0
      Cough 6 0.3 7 0
      Chills 5 0.3 2 0
      Chest tightness 3 0 1 0
      Facial swelling 1 0 0.4 0
      Trial 2b
      Aged 50 Years and Older
        FLULAVAL Comparatorc
      Adverse reactions Any Grade 3d Any Grade 3d
      Local (%) n=610 n=615
      Pain 25 0 32 0
      Redness 10 0.2 11 0.2
      Swelling 7 0.3 9 1
      Systemic (%)
      Headache 11 0.2 12 0.3
      Fatigue 12 0.2 13 1
      Muscle achese 11 0.2 10 0
      Feverf 1 0 2 0
      Malaise 6 0.3 7 0
      Sore throat 5 0.2 6 0
      Reddened eyes
      		 4 0 7 0
      Cough 5 0.2 6 0
      Chills 3 0.2 6 0
      Chest tightness 3 0.3 2 0
      Facial swelling 1 0 2 0
      Trial 3b
      Aged 18 Through 49 Years
        FLULAVAL Placebo
      Adverse reactions Any Grade 3d Any Grade 3d
      Local (%) n=3783 n=3828
      Pain 51 0.2 14 <0.1
      Redness 13 0.3 6 0.1
      Swelling 11 0.3 3 0
      Systemic (%)
      Headache 18 1 19 1
      Fatigue 20 1 18 0.4
      Muscle achese 18 0.2 10 0.2
      Feverf 3 <0.1 1 0.1
      Malaise 9 0.3 6 0.4
      Sore throat 9 0.3 9 0.4
      Reddened eyes
      		 7 <0.1 6 <0.1
      Cough 8 0.1 7 0.1
      Chills 4 0.2 4 0.2
      Chest tightness 3 <0.1 3 0.1
      Facial swelling 1 0 1 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 FLULAVAL.

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