You are using an unsupported browser.
Some features of this site may not function properly. For optimal user experience, please view this site in Chrome, Firefox, Safari, or Edge.

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

ORDER GSK FLU VACCINES

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

3 ways to order or prebook

Call 1-855-475-4748

Online at GSKDirect.com

Contact your GSK Vaccines
Sales Representative

Dosing & Administration

FLULAVAL, an influenza vaccine¹:

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 Age¹

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)

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

Administering FLULAVAL

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

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 light¹

Coding

CPT, NDC, and ICD-10 Codes for FLULAVAL

VACCINE	CPT CODE	2024-2025 NDC CODE	ICD-10 CODE
FLULAVAL Package of 10 – Prefilled syringes1	90656	Box NDC Code: 19515-810-52 Unit NDC Code: 19515-810-41	Z23

See CPT, NDC, and ICD-10 codes for FLUARIX.

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 information about coding

Safety Information

In clinical trials, FLULAVAL QUADRIVALENT 0.5 mL demonstrated a safety profile comparable to both quadrivalent and trivalent flu vaccines and placebo, across a broad age range of patients.¹

Children Aged 6 Through 35 Months

Children Aged 3 Through 17 Years

Adults Aged 18 Years and Older

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.¹

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 %
	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

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available (ie, diary card completed for solicited symptoms). n=number of subjects with diary card completed. Values ≥0.5 have been rounded to the nearest integer.

^aSeven days included day of vaccination and the subsequent 6 days.
^b Trial 5: NCT02242643.
^c US-licensed quadrivalent, inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc.).
^dGrade 3 pain: defined as cried when limb was moved/spontaneously painful.
Grade 3 swelling, redness: defined as >100 mm.
Grade 3 irritability: defined as crying that could not be comforted/prevented normal activity.
Grade 3 drowsiness: defined as prevented normal activity.
Grade 3 loss of appetite: defined as not eating at all.
Grade 3 (or higher) fever: defined as >102.2°F (39.0°C).
^eFever: defined as ≥100.4°F (38.0°C).

Trial 5 Study Design

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 %
	Any	Grade 3d	Any	Grade 3d
Aged 3 Through 4 Years
Local	n=1042		n=1026
Pain	56	2	53	2
Swelling	4	0.2	5	0
Redness	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

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n=number of subjects with diary card completed. Values ≥0.5 have been rounded to the nearest integer.

^aFour days included day of vaccination and the subsequent 3 days.
^bTrial 4: NCT00980005.
^cUS-licensed trivalent, inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc.).
^dGrade 3 pain: defined as cried when limb was moved/spontaneously painful (children <5 years), or pain that prevented normal activity (children ≥5 years).
Grade 3 swelling, redness: defined as >100 mm.
Grade 3 irritability, drowsiness, muscle aches, headache, fatigue, arthralgia, shivering: Defined as prevented normal activity.
Grade 3 loss of appetite: defined as not eating at all.
Grade 3 (or higher) fever: defined as ≥102.2°F (39.0°C).
^eFever: defined as ≥100.4°F (38.0°C).

Trial 4 Study Design

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 Days^a 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 n=721 %		Comparatorc n=279 %		FLULAVAL n=610 %		Comparatorc n=615 %		FLULAVAL n=3783 %		Placebo n=3828 %
	Any	Grade 3d	Any	Grade 3d	Any	Grade 3d	Any	Grade 3d	Any	Grade 3d	Any	Grade 3d
Local
Pain	24	0	31	0.4	25	0	32	0	51	0.2	14	<0.1
Swelling	11	0.1	10	0	10	0.2	11	0.2	13	0.3	6	0.1
Redness	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 n=721 %		Comparatorc n=279 %
	Any	Grade 3d	Any	Grade 3d
Local
Pain	24	0	31	0.4
Swelling	11	0.1	10	0
Redness	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 n=610 %		Comparatorc n=615 %
	Any	Grade 3d	Any	Grade 3d
Local
Pain	25	0	32	0
Swelling	10	0.2	11	0.2
Redness	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 n=3783 %		Placebo n=3828 %
	Any	Grade 3d	Any	Grade 3d
Local
Pain	51	0.2	14	<0.1
Swelling	13	0.3	6	0.1
Redness	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

^aFour days included day of vaccination and the subsequent 3 days.
^b Trial 1: NCT01389479; Trial 2: NCT00232947; Trial 3: NCT00216242.
^cUS-licensed trivalent, inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc.).
^dGrade 3 pain, headache, fatigue, muscle aches, malaise, sore throat, cough, chills, chest tightness: defined as prevented work/school/normal activities.
Grade 3 redness, swelling: defined as >50 mm.
Grade 3 fever: defined as >103.1°F (39.5°C).
Grade 3 reddened eyes: defined as very reddened, interfered with vision or caused a doctor’s visit.
Grade 3 facial swelling: defined as very swollen, prevented work/school/normal activities or caused a doctor’s visit.
^e For Trial 2 and Trial 3, includes muscle aches and arthralgia.
^fFever: defined as ≥99.5°F (37.5°C).

Trial 1, 2, & 3 Study Designs

Indication & Important Safety Info

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 for FLUARIX and FLULAVAL

Do not administer FLUARIX or FLULAVAL to anyone

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

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.

View References

Chat with GSK

GSK Vaccines Access Program

Help provide eligible patients with access to GSK vaccines through the GSK Vaccines Access Program.

Trademarks are owned by or licensed to the GSK group of companies.

3 ways to order or prebook

Dosing & Administration

Vaccination Dose and Schedule by Age1

Administering FLULAVAL

Storing FLULAVAL

Coding

CPT, NDC, and ICD-10 Codes for FLULAVAL

Prefilled syringe includes:

Safety Information

Children Aged 6 Through 35 Months

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

Children Aged 3 Through 17 Years

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

Adults Aged 18 Years and Older

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

Indication for FLUARIX and FLULAVAL

Important Safety Information for FLUARIX and FLULAVAL

GSK Vaccines Access Program

Vaccination Dose and Schedule by Age¹

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

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

Trial 1, 2, & 3: FLULAVAL: Incidence of Solicited Local and Systemic Adverse Reactions Within 4 Days^a of First Vaccination in Adults Aged 18 Years and Older (Total Vaccinated Cohort)¹