Injectable Suspension, for Intramuscular Use, 2024-2025 Formula, Pre-filled Syringes, 0.5 ML, Rx Only, No Preservatives
Features
Produced in mammalian cells to avoid egg adaptation.2
May improve vaccine effectiveness and reduce hospitalizations vs egg-based vaccines, based on real-world evidence.*†17-19
Provides an exact antigenic match to the WHO-selected flu strains.2,14-16
Supported by randomized clinical trials, including data featured in The New England Journal of Medicine and Pediatrics.*20-23
Clinical effectiveness in reducing flu-related hospitalizations shown in 11.7 million patients across 3 consecutive influenza seasons.*‡17-19
Notes:
† 2017-2018 through 2019-2020 US influenza seasons.
* The data of FLUCELVAX QUADRIVALENT are relevant to FLUCELVAX, as both vaccines are manufactured using the same process and have overlapping compositions.
‡ The data being shown are based on peer-reviewed RWE studies assessing influenza-related hospitalizations in persons 4 through 64 years of age. This is not inclusive of all peer-reviewed RWE studies, which include different outcomes and age groups.
References:
2. Rajaram S, et al. Ther Adv Vaccines Immunother. 2020;8:2515135520908121.
14. Rockman S, et al. Vaccines (Basel). 2022;11(1):52.
15. CDC. Cell-based flu vaccines. Accessed February 15, 2024. https://www.cdc.gov/flu/prevent/cell-based.htm
16. Data on file. Seqirus Inc; 2024.
17. Divino V, et al. Vaccine. 2020;38(40):6334-6343.
18. Krishnarajah G, et al. Vaccines (Basel). 2021;9(2):80.
19. Divino V, et al. Open Forum Infect Dis. 2021;9(1):ofab604.
20. Nolan T, et al. N Engl J Med. 2021;385(16):1485-1495.
21. Essink BJ, et al. Pediatrics. 2022;150(5):e2022057509.
22. Bart S, et al. Hum Vaccin Immunother. 2016;12(9):2278-2288.
23. Frey S, et al. Clin Infect Dis. 2010;51(9):997-1004.
FLUCELVAX is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
FLUCELVAX is approved for use in persons 6 months of age and older.
This product contains ten 0.5 mL pre-filled single-dose syringes.
Warning: Do not administer FLUCELVAX to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the 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 #
200-7-6544
NDC#
70461-654-03
Manufacturer
Seqirus Inc.
Country of Origin
United States
Application
Flu Vaccine
Route Of Administration
Intramuscular
Container Type
Pre-filled Syringes
Dosage Form
Injectable Suspension
Dosage Strength
0.5 mL per pre-filled syringes
User
Indicated for People 6 Months of Age and Older
Sterility
Sterile
Storage Temperature
2-8°C (36-46°F)
Initial U.S. Approval
2012
Volume
0.5 ML
Preservatives
No
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These highlights do not include all the information needed to use FLUCELVAX® safely and effectively.
See full prescribing information for FLUCELVAX®
here.
FLUCELVAX (Influenza Vaccine)
Injectable Suspension, for Intramuscular Use
2024-2025 Formula
Initial U.S. Approval: 2012
FLUCELVAX is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
FLUCELVAX is approved for use in persons 6 months of age and older.
For Intramuscular Use:
Age
Dose
Schedule
6 months through 8 years of age
One or two dosesa, 0.5 mL each
If 2 doses, administer at least 4 weeks apart
9 years of age and older
One doses, 0.5 mL each
Not Applicable
a 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.
FLUCELVAX is an injectable suspension. A single dose is 0.5 mL.
Do not administer FLUCELVAX to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX should be based on careful consideration of the potential benefits and risks.
Note: Adverse Reaction Data for FLUCELVAX QUADRIVALENT are relevant to FLUCELVAX because both vaccines are manufactured using the same process and have overlapping compositions.
In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28%), erythema (26%), induration (17%) and ecchymosis (11%). The most common systemic adverse reactions were irritability (28%), sleepiness (27%), diarrhea (18%) and change of eating habits (17%).
In children 4 through 8 years of age who received FLUCELVAX, the most commonly reported local injection-site adverse reactions were pain (29%) and erythema (11%). The most common systemic adverse reaction was fatigue (10%).
In children and adolescents 9 through 17 years of age who received FLUCELVAX, the most commonly reported injection-site adverse reactions were pain (34%) and erythema (14%). The most common systemic adverse reactions were myalgia (15%) and headache (14%).
In adults 18 through 64 years of age who received FLUCELVAX, the most commonly reported injection-site adverse reactions were pain (28%) and erythema (13%). The most common systemic adverse reactions were headache (16%), fatigue (12%), myalgia (11%) and malaise (10%).
In adults ≥ 65 years who received FLUCELVAX the most commonly reported injection-site reaction was erythema (10%). The most common systemic adverse reactions were fatigue (11%), headache (10%) and malaise (10%).
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:
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US 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. Data collected in a prospective Pregnancy Exposure Registry from 665 women vaccinated with FLUCELVAX QUADRIVALENT showed no evidence of a vaccine-associated increase in the risk of major birth defects and miscarriages when FLUCELVAX QUADRIVALENT is administered during any trimester of pregnancy. Data for FLUCELVAX QUADRIVALENT are relevant to FLUCELVAX because both vaccines are manufactured using the same process and have overlapping compositions.
Geriatric:
Antibody responses were lower in adults 65 years and older than in younger adults.
FLUCELVAX (Influenza Vaccine) is a trivalent subunit influenza vaccine manufactured using cell derived candidate vaccine viruses (CVV) that are propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line. These cells were adapted to grow freely in suspension in culture medium. The virus is inactivated with β-propiolactone, disrupted by the detergent cetyltrimethylammonium bromide and purified through several process steps. Each of the virus strains are produced and purified separately then pooled to formulate the vaccine.
FLUCELVAX is a sterile, slightly opalescent injectable suspension in phosphate buffered saline. FLUCELVAX is standardized according to United States Public Health Service requirements for the 2024-2025 influenza season and is formulated to contain a total of 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA of each of the following influenza strains:
B/Singapore/WUH4618/2021 (a B/Austria/1359417/2021-like virus).
Each dose of FLUCELVAX may contain residual amounts of MDCK cell protein (≤ 21.6 mcg), protein other than HA (≤ 225 mcg), MDCK cell DNA (≤ 10 ng), polysorbate 80 (≤ 1125 mcg), cetyltrimethylammonium bromide (≤ 13.5 mcg), and β-propiolactone (< 0.5 mcg), which are used in the manufacturing process.
FLUCELVAX contains no egg protein or antibiotics.
FLUCELVAX 0.5 mL pre-filled syringes contain no preservative.
FLUCELVAX 5 mL multi-dose vials contain thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury.
The tip caps and plungers of the pre-filled syringes and the multi-dose vial stopper are not made with natural rubber latex.
FLUCELVAX Product Presentations
Presentation
Carton NDC Number
Components
Pre-Filled Syringe
70461-654-03
0.5 mL single dose pre-filled syringe, package of 10 syringes per carton [NDC 70461-654-04]
Multi-Dose Vial
70461-554-10
5 mL multi-dose vial, individually packaged in a carton [NDC 70461-554-11]
Store this product refrigerated at 2°C to 8°C (36ºF to 46ºF). Between uses, return the multi-dose vial to the recommended storage conditions. Do not freeze. Protect from light. Do not use after the expiration date.
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The CSL Seqirus Portfolio Of Influenza Vaccines — 2024-2025 Season
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