Injectable Emulsion, for Intramuscular Use, 2024-2025 Formula, Pre-filled Syringes, 0.5 ML, Rx Only, No Preservatives
Features
Adjuvant Technology - Designed to strengthen, broaden, and lengthen immune response35-37
Boosted Response - Helps address weakened immune systems and strain mismatch in adults 65+35-37
Clinically Effective - Backed by 20+ years of real-world evidence2-20
References:
1. Grohskopf LA, et al. MMWR Recomm Rep. 2023;72(2)1-25.
2. Domnich A, et al. Int J Infect Dis. 2022;125:164-169.
3. Izurieta HS, et al. Clin Infect Dis. 2020;ciaa1727.
4. Izurieta HS, et al. J Infect Dis. 2020;222(2):278-287.
5. Izurieta HS, et al. J Infect Dis. 2019;220(8):1255-1264.
6. Pelton SI, et al. Vaccines (Basel). 2020;8(3):E446.
7. Machado MAA, et al. NPJ Vaccines. 2021;6(1):108.
8. Lapi F, et al. Expert Rev Vaccines. 2022;21(3):377-384.
9. Cocchio S, et al. Vaccines (Basel). 2020;8(3):E344.
10. Lapi F, et al. Expert Rev Vaccines. 2019;18(6):663-670.
11. Mannino S, et al. Am J Epidemiol. 2012;176(6):527-533.
12. Imran M, et al. Open Forum Infect Dis. 2022;9(5):ofac167.
13. Boikos C, et al. Clin Infect Dis. 2021;73(5):816-823.
14. Boikos C, et al. Vaccines (Basel). 2021;9(8):862.
15. Van Buynder PG, et al. Vaccine. 2013;31(51):6122–6128.
16. Gravenstein S, et al. Clin Infect Dis. 2021;ciaa1916.
17. McConeghy KW, et al. Clin Infect Dis. 2020;ciaa1233.
18. Levin MJ, et al. Vaccines. 2021;9(10):1146.
19. Pelton SI, et al. Vaccine. 2021;39(17):2396-2407.
20. Van Aalst VR. Vaccine. 2020;38(2):372-379.
35. O’Hagan DT, et al. Vaccine. 2012;30(29):4341-4348.
36. O’Hagan DT, et al. Expert Rev Vaccines. 2013;12(1):13-30.
37. Banzhoff A, et al. Influenza Other Respir Viruses. 2008;2(6):243-249.
FLUAD is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in adults 65 years of age and older.
This indication is approved under accelerated approval based on the immune response elicited by FLUAD. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
This product contains ten 0.5 mL pre-filled single-dose syringes. Needles are not supplied.
Warning: Do not administer FLUAD to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine.
Reimbursement for this product may be possible depending on various factors including current law and medicare payment policy. Rally Inc. does not handle these reimbursements. Please contact the
manufacturer
for more information on this product's reimbursement eligibility and procedures.
Important Note: Product is Perishable and Non-Returnable. This product requires Refrigeration for storage. DO NOT FREEZE.
Due to safety and perishability precautions, product will not be shipped on Fridays. Please take all necessary precautions before ordering this product. As this product is non-returnable, please confirm it is the right product before ordering.
Please see Education and Documents section for Prescribing Information.
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Rally #
200-7-2424
NDC #
70461-024-03
Manufacturer
Seqirus USA Inc
Country of Origin
United States
Application
Flu Vaccine, Adjuvanted
Route Of Administration
Intramuscular
Container Type
Prefilled Syringe
Dosage Form
Injectable Emulsion
Strength
0.5 mL per pre-filled syringes
User
Indicated for People 65 Years of Age and Older
Sterility
Sterile
Volume
0.5 mL
Preservative
No
Initial U.S. Approval
2015
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These highlights do not include all the information needed to use FLUAD® safely and effectively.
See full prescribing information for FLUAD
here.
FLUAD (Influenza Vaccine, Adjuvanted)
Injectable Emulsion for Intramuscular Use
2024-2025 Formula
Initial U.S. Approval: 2015
FLUAD is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in adults 65 years of age and older.
This indication is approved under accelerated approval based on the immune response elicited by FLUAD. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
For Intramuscular Use:
A single 0.5 mL dose for intramuscular injection.
FLUAD is an injectable emulsion. A single dose is 0.5 mL.
Do not administer FLUAD to anyone with a history of a severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine.
If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks.
The most common (≥10%) local and systemic adverse reactions in adults 65 years of age and older who received FLUAD were injection site pain (25%), injection site tenderness (21%), myalgia (15%), fatigue (13%) and headache (13%).
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus USA Inc. at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Pregnancy - Risk Summary:
FLUAD is not approved for use in persons < 65 years of age.
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general
population, the estimated background risk of major birth defects and miscarriage in clinically
recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The data are insufficient to
establish if there is vaccine-associated risk with FLUAD in pregnant women.
Pediatric Use
The safety and effectiveness of FLUAD in infants less than 6 months of age and in children older than 72 months of age have not been evaluated.
Geriatric Use
Safety and immunogenicity of FLUAD have been evaluated in adults 65 years of age and older.
FLUAD (Influenza Vaccine, Adjuvanted), a sterile injectable emulsion for intramuscular use, is a trivalent inactivated influenza vaccine prepared from virus propagated in the allantoic cavity of embryonated hens' eggs inoculated with a specific type of influenza virus.
FLUAD is standardized according to United States Public Health Service requirements and each 0.5 mL dose is formulated to contain 15 mcg of hemagglutinin (HA) from each of the following influenza strains recommended for the 2024-2025 influenza season: A/Victoria/4897/2022 IVR-238 (an A/Victoria/4897/2022 (H1N1)pdm09-like virus), A/Thailand/8/2022 IVR-237 (an A/Thailand/8/2022 (H3N2)-like virus), B/Austria/1359417/2021 BVR-26 (a B/Austria/1359417/2021-like virus). FLUAD also contains MF59C.1 adjuvant (MF59®), a squalene based oil-in-water emulsion. Each of the strains is harvested and clarified separately by centrifugation and filtration prior to inactivation with formaldehyde. The inactivated virus is concentrated and purified by zonal centrifugation. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of cetyltrimethylammonium bromide (CTAB). The antigen preparation is further purified.
FLUAD is prepared by combining the three virus antigens with the MF59C.1 adjuvant. After combining, FLUAD is a sterile, milky-white injectable emulsion supplied in single-dose pre-filled syringes containing 0.5 mL dose. Each 0.5 mL dose contains 15 mcg of hemagglutinin (HA) from each of the three recommended influenza strains and MF59C.1 adjuvant (9.75 mg squalene, 1.175 mg of polysorbate 80, 1.175 mg of sorbitan trioleate, 0.66 mg of sodium citrate dihydrate and 0.04 mg of citric acid monohydrate) at pH 6.9-7.7.
FLUAD may contain trace amounts of neomycin (≤ 0.02 mcg by calculation), kanamycin (≤ 0.03 mcg by calculation) and hydrocortisone (≤ 0.005 ng by calculation) which are used during the initial stages of manufacture, as well as residual egg protein (ovalbumin) (≤ 0.4 mcg), formaldehyde (≤ 10 mcg) or CTAB (≤ 12 mcg).
FLUAD does not contain a preservative. The syringe, syringe plunger stopper and tip caps are not made with natural rubber latex.
FLUCELVAX Product Presentations
Presentation
Carton NDC Number
Components
Pre-Filled Syringe
70461-024-03
0.5 mL dose in a pre-filled syringe (needle not supplied), package of 10 syringes per carton [NDC 70461-024-04]
The syringe, syringe plunger stopper and tip cap are not made with natural rubber latex.
Store FLUAD refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date.
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The CSL Seqirus Portfolio Of Influenza Vaccines — 2024-2025 Season
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