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

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Dosing & Administration

FLUARIX, 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 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

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

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 light¹

Coding

CPT, NDC, and ICD-10 Codes for FLUARIX

VACCINE	CPT CODE	2024-2025 NDC NUMBER	ICD-10 CODE
FLUARIX Package of 10 Prefilled syringes1	90656	Box NDC Code: 58160-884-52 Unit NDC Code: 58160-884-41	Z23

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

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

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 Local Adverse Reactions Within 7 Days^a After First Vaccination in Children Aged 6 Through 35 Months^b (Total Vaccinated Cohort)¹

	FLUARIX QUADRIVALENT %		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

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.

n=number of subjects with diary card completed.

^aSeven days included day of vaccination and the subsequent 6 days.
^bTrial 5: NCT01439360.
^cChildren younger than 12 months: pneumococcal 13-valent conjugate vaccine [Diphtheria CRM₁₉₇ Protein] (Wyeth Pharmaceuticals, Inc.).
^dChildren 12 months and older: HAVRIX (Hepatitis A Vaccine) for those with a history of influenza vaccination; or HAVRIX (Dose 1) and a varicella vaccine (US-licensed manufactured by Merck & Co., Inc. or non—US-licensed manufactured by GlaxoSmithKline Biologicals) (Dose 2) for those with no history of influenza vaccination.
^eGrade 3 pain: defined as cried when limb was moved/spontaneously painful.
Grade 3 swelling, redness: defined as >50 mm.
In children who received a second dose of FLUARIX QUADRIVALENT or the Non-Influenza Active Comparator vaccine, the incidences of solicited adverse reactions following the second dose were generally lower than those observed after the first dose.

Trial 5 Study Design

Trial 5: FLUARIX QUADRIVALENT: Incidence of Systemic Adverse Reactions Within 7 Days^a After First Vaccination in Children Aged 6 Through 35 Months^b (Total Vaccinated Cohort)¹

	FLUARIX QUADRIVALENT %		Non-Influenza Active Comparatorc,d %
	Any	Grade 3e	Any	Grade 3e
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

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.

n=number of subjects with diary card completed.

^aSeven days included day of vaccination and the subsequent 6 days.
^bTrial 5: NCT01439360.
^cChildren younger than 12 months: pneumococcal 13-valent conjugate vaccine [Diphtheria CRM ₁₉₇ Protein] (Wyeth Pharmaceuticals, Inc.).
^dChildren 12 months and older: HAVRIX (Hepatitis A Vaccine) for those with a history of influenza vaccination; or HAVRIX (Dose 1) and a varicella vaccine (US-licensed manufactured by Merck & Co., Inc. or non—US-licensed manufactured by GlaxoSmithKline Biologicals) (Dose 2) for those with no history of influenza vaccination.
^eGrade 3 pain: defined as cried when limb was moved/spontaneously painful.
Grade 3 swelling, redness: defined as >50 mm.
Grade 3 irritability: defined as crying that could not be comforted/prevented normal activity.
Grade 3 loss of appetite: defined as not eating at all.
Grade 3 drowsiness: defined as prevented normal activity.
Grade 3 fever: defined as >102.2°F (39.0°C).
^fFever: Defined as ≥100.4°F (38.0°C).
In children who received a second dose of FLUARIX QUADRIVALENT or the Non-Influenza Active Comparator vaccine, the incidences of solicited adverse reactions following the second dose were generally lower than those observed after the first dose.

Trial 5 Study Design

Children Aged 3 Through 17 Years

Trial 4: FLUARIX: Incidence of Solicited Local and Systemic Adverse Reactions Within 4 Days^a of First Vaccination in Children Aged 3 Through 17 Years^b (Total Vaccinated Cohort)¹

	Aged 3 Through 4 Years				Aged 5 Through 17 Years
	FLUARIX n=350 %		Comparator n=341 %		FLUARIX n=1348 %		Comparator n=451 %
	Any	Grade 3s	Any	Grade 3s	Any	Grade 3s	Any	Grade 3s
Local
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

Aged 3 Through 4 Years
	FLUARIX n=350 %		Comparator n=341 %
	Any	Grade 3c	Any	Grade 3c
Local
Pain	35	2	38	1
Redness	23	0.3	20	0
Swelling	14	0	13	0

Aged 5 Through 17 years
	FLUARIX n=1348 %		Comparator n=451 %
	Any	Grade 3c	Any	Grade 3c
Local
Pain	56	0.8	56	0.7
Redness	18	1	16	0.7
Swelling	14	2	13	0.7

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.

n=number of subjects with diary card completed.

^aFour days included day of vaccination and the subsequent 3 days.
^bTrial 4: NCT00383123. The active control was FLUZONE, a US-licensed trivalent, inactivated influenza vaccine (Sanofi Pasteur Inc.).
^cGrade 3 pain.
Grade 3 swelling, redness: defined as >50 mm.
In children who received a second dose of FLUARIX or the comparator vaccine, the incidences of adverse reactions following the second dose were similar to those observed after the first dose.

Trial 4 Study Design

Trial 4: FLUARIX: Incidence of Solicited Systemic Adverse Reactions Within 4 Days^a of First Vaccination in Children Aged 3 Through 17 Years^b (Total Vaccinated Cohort)¹

	Aged 3 Through 4 Years				Aged 5 Through 17 Years
	FLUARIX n=350 %		Comparator n=341 %		FLUARIX n=1348 %		Comparator n=451 %
	Any	Grade 3s	Any	Grade 3s	Any	Grade 3s	Any	Grade 3s
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	8	2	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 %		Comparator n=341 %
	Any	Grade 3s	Any	Grade 3s
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	8	2
Muscle aches	-	-	-	-
Fatigue	-	-	-	-
Headache	-	-	-	-
Arthralgia	-	-	-	-
Shivering	-	-	-	-

Aged 5 Through 17 Years
	FLUARIX n=1348 %		Comparator n=451 %
	Any	Grade 3s	Any	Grade 3s
Systemic
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

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.

n=number of subjects with diary card completed.

^aFour days included day of vaccination and the subsequent 3 days.
^bTrial 4: NCT00383123. The active control was FLUZONE, a US-licensed trivalent, inactivated influenza vaccine (Sanofi Pasteur Inc.).
^cGrade 3 irritability, loss of appetite, drowsiness, muscle aches, fatigue, headache, arthralgia, shivering: defined as prevented normal activity.
Grade 3 fever: defined as >102.2°F (39.0°C).
^dFever: defined as ≥99.5°F (37.5°C).
In children who received a second dose of FLUARIX or the comparator vaccine, the incidences of adverse reactions following the second dose were similar to those observed after the first dose.

Trial 4 Study Design

Adults Aged 18 Years and Older

Trial 1: FLUARIX: Incidence of Solicited Local and Systemic Adverse Reactions Within 4 Days^a of First Vaccination in Adults Aged 18 Through 64 Years^b (Total Vaccinated Cohort)¹

	FLUARIX n=760 %		Placebo n=192 %
	Any	Grade 3c	Any	Grade 3c
Local
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

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.

n=number of subjects with diary card completed.

^aFour days included day of vaccination and the subsequent 3 days.
^bTrial 1: NCT00100399.
^cGrade 3 pain, muscle aches, fatigue, headache, arthralgia, shivering: defined as prevented normal activity.
Grade 3 redness, swelling: defined as >50 mm.
Grade 3 fever: defined as >102.2°F (39.0°C).
^dFever: defined as ≥100.4°F (38.0°C).

Trial 1 Study Design

Trial 2: FLUARIX: Incidence of Solicited Local and Systemic Adverse Reactions Within 4 Days^a of Vaccination in Adults^b (Total Vaccinated Cohort)¹

	Aged 18 Through 64 Years				Aged 65 Years and Older
	FLUARIX n=315 %		Comparator n=314 %		FLUARIX n=601-602 %		Comparator n=596 %
	Any	Grade 3c	Any	Grade 3c	Any	Grade 3c	Any	Grade 3c
Local
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 %
	Any	Grade 3c	Any	Grade 3c
Local
Pain	48	0.3	53	0.3
Redness	13	0	16	1
Swelling	9	0	11	2
Systemic
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=601-602 %		Comparator n=596 %
	Any	Grade 3c	Any	Grade 3c
Local
Pain	19	0	18	0
Redness	11	0.2	13	0.7
Swelling	6	0	9	0.7
Systemic
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

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.

n=number of subjects with diary card completed.

^aFour days included day of vaccination and the subsequent 3 days.
^bTrial 2: NCT00197288. The active control was FLUZONE, a US-licensed trivalent, inactivated influenza vaccine (Sanofi Pasteur Inc.).
^cGrade 3 pain, muscle aches, fatigue, headache, arthralgia, shivering: defined as prevented normal activity.
Grade 3 redness, swelling: defined as >50 mm.
Grade 3 fever: defined as >102.2°F (39.0°C).
^dFever: defined as ≥99.5°F (37.5°C).

Trial 2 Study Design

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

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3 ways to order or prebook

Dosing & Administration

Vaccination Dose and Schedule by Age1

Administering FLUARIX

Storing FLUARIX

Coding

CPT, NDC, and ICD-10 Codes for FLUARIX

Prefilled syringe includes:

Safety Information

Children Aged 6 Through 35 Months

Trial 5: FLUARIX QUADRIVALENT: Incidence of Solicited Local Adverse Reactions Within 7 Daysa After First Vaccination in Children Aged 6 Through 35 Monthsb (Total Vaccinated Cohort)1

Trial 5: FLUARIX QUADRIVALENT: Incidence of Systemic Adverse Reactions Within 7 Daysa After First Vaccination in Children Aged 6 Through 35 Monthsb (Total Vaccinated Cohort)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

Trial 4: FLUARIX: Incidence of Solicited 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: 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

Trial 2: FLUARIX: Incidence of Solicited Local and Systemic Adverse Reactions Within 4 Daysa of Vaccination in Adultsb (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: FLUARIX QUADRIVALENT: Incidence of Solicited Local Adverse Reactions Within 7 Days^a After First Vaccination in Children Aged 6 Through 35 Months^b (Total Vaccinated Cohort)¹

Trial 5: FLUARIX QUADRIVALENT: Incidence of Systemic Adverse Reactions Within 7 Days^a After First Vaccination in Children Aged 6 Through 35 Months^b (Total Vaccinated Cohort)¹

Trial 4: FLUARIX: Incidence of Solicited Local and Systemic Adverse Reactions Within 4 Days^a of First Vaccination in Children Aged 3 Through 17 Years^b (Total Vaccinated Cohort)¹

Trial 4: FLUARIX: Incidence of Solicited Systemic Adverse Reactions Within 4 Days^a of First Vaccination in Children Aged 3 Through 17 Years^b (Total Vaccinated Cohort)¹

Trial 1: FLUARIX: Incidence of Solicited Local and Systemic Adverse Reactions Within 4 Days^a of First Vaccination in Adults Aged 18 Through 64 Years^b (Total Vaccinated Cohort)¹

Trial 2: FLUARIX: Incidence of Solicited Local and Systemic Adverse Reactions Within 4 Days^a of Vaccination in Adults^b (Total Vaccinated Cohort)¹