- Covered by Medicare Part B and by most Medicare Advantage Plans with no copay*
- CPT reimbursement code
- Single-dose syringe: 90694
INDICATION AND IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Do not administer FLUAD QUADRIVALENT or AFLURIA QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine.
Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reactions (e.g. anaphylaxis) to any component of the vaccine.
WARNINGS AND PRECAUTIONS
If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT should be based on careful consideration of the potential benefits and risks.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
Syncope (fainting) may occur in association with administration of injectable vaccines. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Ensure procedures are in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.
The immune response to FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals.
Vaccination with FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT may not protect all vaccine recipients against influenza disease.
ADVERSE REACTIONS
FLUAD QUADRIVALENT:
The most common (≥ 10%) local and systemic reactions with FLUAD QUADRIVALENT in elderly subjects 65 years of age and older were injection site pain (16.3%), headache (10.8%) and fatigue (10.5%). Other adverse events may occur.
FLUCELVAX QUADRIVALENT:
In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (27.9%), erythema (25.8%), induration (17.3%) and ecchymosis (10.7%). The most common systemic adverse reactions were irritability (27.9%), sleepiness (26.9%), diarrhea (17.9%) and change of eating habits (17.4%).
In children 2 through 8 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28.7%), pain (27.9%) and erythema (21.3%), induration (14.9%) and ecchymosis (10.0%). The most common systemic adverse reactions were sleepiness (14.9%), headache (13.8%), fatigue (13.8%), irritability (13.8%) and loss of appetite (10.6%).
In children and adolescents 9 through 17 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were injection site pain (21.7%), erythema (17.2%) and induration (10.5%). The most common systemic adverse reactions were headache (18.1%) and fatigue (17.0%).
In adults 18 through 64 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (45.4%), erythema (13.4%) and induration (11.6%). The most common systemic adverse reactions were headache (18.7%), fatigue (17.8%) and myalgia (15.4%).
In adults ≥65 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (21.6%) and erythema (11.9%).
Other adverse events may occur.
AFLURIA QUADRIVALENT:
AFLURIA QUADRIVALENT administered by needle and syringe:
In children 6 months through 35 months of age, the most frequently reported injection site reactions in the clinical study with AFLURIA QUADRIVALENT administered by needle and syringe were pain and redness (≥ 20%). The most common systemic adverse events were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%).
In children 36 through 59 months of age, the most commonly reported injection site reactions in the clinical study with AFLURIA QUADRIVALENT administered by needle and syringe were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse events were malaise and fatigue, and diarrhea (≥ 10%).
In children 5 through 8 years, the most commonly reported injection-site adverse reactions when AFLURIA QUADRIVALENT was administered by needle and syringe were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse event was headache (≥ 10%).
In children 9 through 17 years, the most commonly reported injection-site adverse reactions when AFLURIA QUADRIVALENT was administered by needle and syringe were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥ 10%).
In adults 18 through 64 years of age, the most commonly reported injection-site adverse reaction observed in clinical studies with AFLURIA QUADRIVALENT administered by needle and syringe was pain (≥ 40%). The most common systemic adverse events observed were myalgia and headache (≥ 20%).
In adults 65 years of age and older, the most commonly reported injection-site adverse reaction observed in clinical studies with AFLURIA QUADRIVALENT administered by needle and syringe was pain (≥ 20%). The most common systemic adverse event observed was myalgia (≥ 10%).
AFLURIA (trivalent formulation) administered by PharmaJet Stratis Needle-Free Injection System:
The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions.
In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions observed in a clinical study with AFLURIA (trivalent formulation) using the PharmaJet Stratis Needle-Free Injection System were tenderness (≥ 80%), swelling, pain, redness (≥ 60%), itching (≥ 20%) and bruising (≥ 10%). The most common systemic adverse events were myalgia, malaise (≥ 30%) and headache (≥ 20%).
Other adverse events may occur.
To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Before administration, please see the full US Prescribing Information for FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT and AFLURIA QUADRIVALENT.
FLUAD® QUADRIVALENT, FLUCELVAX® QUADRIVALENT, AFLURIA® and AFLURIA® QUADRIVALENT are registered trademarks of Seqirus UK Limited or its affiliates.
PharmaJet® and STRATIS® are registered trademarks of PharmaJet.
References: 1. Grohskopf LA, Blanton LH, Ferdinands JM, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices — United States, 2022-23 influenza season. MMWR Recomm Rep. 2022;71(1):1-28. doi:10.15585/mmwr.rr7101a1 2. Centers for Disease Control and Prevention. Flu & people 65 years and older. Accessed April 21, 2023. https://www.cdc.gov/flu/highrisk/65over.htm 3. Monto AS, Ansaldi F, Aspinall R, et al. Influenza control in the 21st century: optimizing protection of older adults. Vaccine. 2009;27(37):5043-5053. doi:10.1016/j.vaccine.2009.06.032 4. Paules CI, Sullivan SG, Subbarao K, Fauci AS. Chasing seasonal influenza - the need for a universal influenza vaccine. N Engl J Med. 2018;378(1):7-9. doi:10.1056/NEJMp1714916 5. Zost SJ, Parkhouse K, Gumina ME, et al. Contemporary H3N2 influenza viruses have a glycosylation site that alters binding of antibodies elicited by egg-adapted vaccine strains. Proc Natl Acad Sci USA. 2017;114(47):12578-12583. doi:10.1073/pnas.1712377114 6. McLean HQ, Thompson MG, Sundaram ME, et al. Influenza vaccine effectiveness in the United States during 2012-2013: variable protection by age and virus type. J Infect Dis. 2015;211(10):1529-1540. doi:10.1093/infdis/jiu647 7. Gaglani M, Pruszynski J, Murthy K, et al. Influenza vaccine effectiveness against 2009 pandemic influenza A(H1N1) virus differed by vaccine type during 2013-2014 in the United States. J Infect Dis. 2016;213(10):1546-1556. doi:10.1093/infdis/jiv577 8. Zimmerman RK, Nowalk MP, Chung J, et al. 2014-2015 influenza vaccine effectiveness in the United States by vaccine type. Clin Infect Dis. 2016;63(12):1564-1573. doi:10.1093/cid/ciw635. 9. Jackson ML, Chung JR, Jackson LA, et al. Influenza vaccine effectiveness in the United States during the 2015-2016 season. N Engl J Med. 2017;377(6):534-543. doi:10.1056/NEJMoa1700153 10. Flannery B, Chung JR, Belongia EA, et al. Interim estimates of 2017-18 seasonal influenza vaccine effectiveness—United States, February 2018. MMWR Morb Mortal Wkly Rep. 2018;67(6):180-185. doi:10.15585/mmwr.mm6706a2 11. Flannery B, Kondor RJG, Chung JR, et al. Spread of antigenically drifted influenza A(H3N2) viruses and vaccine effectiveness in the United States during the 2018-2019 season. J Infect Dis. 2020;221(1):8-15. doi:10.1093/infdis/jiz543 12. Tenforde MW, Garten Kondor RJ, Chung JR, et al. Effect of antigenic drift on influenza vaccine effectiveness in the United States—2019-2020. Clin Infect Dis. 2021;73(11):e4244-e4250. doi:10.1093/cid/ciaa1884 13. Skowronski DM, Janjua NZ, De Serres G, et al. Low 2012-13 influenza vaccine effectiveness associated with mutation in the egg-adapted H3N2 vaccine strain not antigenic drift in circulating viruses. PLoS One. 2014;9(3):e92153. doi:10.1371/journal.pone.0092153. 14. Centers for Disease Control and Prevention. Update: Influenza activity—United States, 2010-11 season, and composition of the 2011-12 influenza vaccine. MMWR Morb Mortal Wkly Rep. 2011;60(21):705-712. 15. Ohmit SE, Thompson MG, Petrie JG, et al. Influenza vaccine effectiveness in the 2011-2012 season: protection against each circulating virus and the effect of prior vaccination on estimates. Clin Infect Dis. 2014;58(3):319-327. doi:10.1093/cid/cit736 16. FLUAD QUADRIVALENT. Package insert. Seqirus Inc. 17. O’Hagan DT, Ott GS, De Gregorio E, Seubert A. The mechanism of action of MF59—an innately attractive adjuvant formulation. Vaccine. 2012;30(29):4341-4348. doi:10.1016/j.vaccine.2011.09.061 18. O’Hagan DT, Ott GS, Nest GV, Rappuoli R, Giudice GD. The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines. 2013;12(1):13-30. doi:10.1586/erv.12.140 19. Banzhoff A, Pellegrini M, Del Giudice G, Fragapane E, Groth N, Podda A. MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respir Viruses. 2008;2(6):243-249. doi:10.1111/j.1750-2659.2008.00059.x 20. Izurieta HS, Lu M, Kelman J, et al. Comparative effectiveness of influenza vaccines among U.S. Medicare beneficiaries ages 65 years and older during the 2019-20 season. Clin Infect Dis. 2021;73(11):e4251-e4259. 21. Izurieta HS, Chillarige Y, Kelman J, et al. Relative effectiveness of influenza vaccines among the United States elderly, 2018-2019. J Infect Dis. 2020;222(2):278-287. doi:10.1093/infdis/jiaa080 22. Boikos C, Fischer L, O’Brien D, Vasey J, Sylvester GC, Mansi JA. Relative effectiveness of adjuvanted trivalent inactivated influenza vaccine versus egg-derived quadrivalent inactivated influenza vaccines and high-dose trivalent influenza vaccine in preventing influenza-related medical encounters in US adults ≥65 years during the 2017–2018 and 2018–2019 influenza seasons. Clin Infect Dis. 2021;ciab152. doi:10.1093/cid/ciab152 23. Izurieta HS, Chillarige Y, Kelman J, et al. Relative effectiveness of cell-cultured and egg-based influenza vaccines among elderly persons in the United States, 2017-18. J Infect Dis. 2019;220(8):1255-1264. doi:10.1093/infdis/jiy716 24. Pelton SI, Divino V, Shah D, et al. Evaluating the relative vaccine effectiveness of adjuvanted trivalent influenza vaccine compared to high-dose trivalent and other egg-based influenza vaccines among older adults in the US during the 2017-2018 influenza season. Vaccines (Basel). 2020;8(3):E446. doi:10.3390/vaccines8030446 25. McConeghy KW, Davidson HE, Canaday DH, et al. Cluster-randomized trial of adjuvanted vs. nonadjuvanted trivalent influenza vaccine in 823 U.S. nursing homes. Clin Infect Dis. 2020;ciaa1233. doi:10.1093/cid/ciaa1233 26. Cocchio S, Gallo T, Del Zotto S, et al. Preventing the risk of hospitalization for respiratory complications of influenza among the elderly: is there a better influenza vaccination strategy? A retrospective population study. Vaccines (Basel). 2020;8(3):344. doi:10.3390/vaccines8030344 27. Van Buynder PG, Konrad S, Van Buynder JL, et al. The comparative effectiveness of adjuvanted and unadjuvanted trivalent inactivated influenza vaccine (TIV) in the elderly. Vaccines (Basel). 2013;31(51):6122-6128. doi:10.1016/j.vaccine.2013.07.059 28. Mannino S, Villa M, Apolone G, et al. Effectiveness of adjuvanted influenza vaccination in elderly subjects in northern Italy. Am J Epidemiol. 2012;176(6):527-533. doi:10.1093/aje/kws313 29. Lapi F, Marconi E, Simonetti M, et al. Adjuvanted versus nonadjuvanted influenza vaccines and risk of hospitalizations for pneumonia and cerebro/cardiovascular events in the elderly. Expert Rev Vaccines. 2019;18(6):663-670. doi:10.1080/14760584.2019.1622418 30. Pelton SI, Divino V, Postma MJ, et al. A retrospective cohort study assessing relative effectiveness of adjuvanted versus high-dose trivalent influenza vaccines among older adults in the United States during the 2018–19 influenza season. Vaccine. 2021;39(17):2396-2407. doi:10.1016/j.vaccine.2021.03.054 31. van Aalst R, Gravenstein S, Mor V, et al. Comparative effectiveness of high dose versus adjuvanted influenza vaccine: A retrospective cohort study. Vaccine. 2020;38(2):372-379. doi:10.1016/j.vaccine.2019.09.105 32. Data on file. Seqirus Inc; 2022