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Drug overview for FLUAD 2025-2026 (influenza vaccine tvs 2025-26 (65 yr up)/adjuvant mf59c.1/pf):
Generic name: INFLUENZA VACCINE TVS 2025-26 (65 YR UP)/ADJUVANT MF59C.1/PF (IN-floo-EN-za)
Drug class: Influenza Vaccine
Therapeutic class: Biologicals
Influenza vaccine inactivated (IIV3) stimulates active immunity to influenza virus infection. Influenza virus vaccine inactivated contains noninfectious, suitably inactivated influenza virus types A and B subunits representing influenza strains likely to circulate in the US during the upcoming influenza season.
No enhanced Uses information available for this drug.
Generic name: INFLUENZA VACCINE TVS 2025-26 (65 YR UP)/ADJUVANT MF59C.1/PF (IN-floo-EN-za)
Drug class: Influenza Vaccine
Therapeutic class: Biologicals
Influenza vaccine inactivated (IIV3) stimulates active immunity to influenza virus infection. Influenza virus vaccine inactivated contains noninfectious, suitably inactivated influenza virus types A and B subunits representing influenza strains likely to circulate in the US during the upcoming influenza season.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for FLUAD 2025-2026 (influenza vaccine tvs 2025-26 (65 yr up)/adjuvant mf59c.1/pf) have been approved by the FDA:
Indications:
Influenza vaccination
Professional Synonyms:
Vaccination to prevent influenza
Indications:
Influenza vaccination
Professional Synonyms:
Vaccination to prevent influenza
The following dosing information is available for FLUAD 2025-2026 (influenza vaccine tvs 2025-26 (65 yr up)/adjuvant mf59c.1/pf):
Dose and dosing schedule (i.e., number of doses) of influenza virus vaccine inactivated for prevention of seasonal influenza depend on the individual's age, vaccination history, and specific product administered.
The usual dosage of Fluad(R) standard-dose adjuvant-containing vaccine for prevention of seasonal influenza infection in adults 65 years of age or older is 0.5 mL administered IM as a single dose.
The usual dosage of Fluzone(R) High-Dose for prevention of seasonal influenza infection in adults 65 years of age or older is 0.5 mL administered IM as a single dose.
In adults >=65 years of age, the most common (>10%) injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were myalgia, malaise, and headache.
The usual dosage of Fluad(R) standard-dose adjuvant-containing vaccine for prevention of seasonal influenza infection in adults 65 years of age or older is 0.5 mL administered IM as a single dose.
The usual dosage of Fluzone(R) High-Dose for prevention of seasonal influenza infection in adults 65 years of age or older is 0.5 mL administered IM as a single dose.
In adults >=65 years of age, the most common (>10%) injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were myalgia, malaise, and headache.
Inactivated influenza vaccines are administered by IM injection; do not administer intradermally or subcutaneously. As an alternative to IM injection using a needle and syringe, Afluria(R) may be administered IM using a PharmaJet(R) Stratis(R) needle-free injection system only in adults 18 through 64 years of age. Other commercially available inactivated influenza vaccines should not be administered IM using a jet injector.
The vaccine product should be inspected visually for particulate matter and discoloration prior to administration. Discard the vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation. Influenza vaccine inactivated should not be mixed with any other vaccine or solution.
Influenza vaccine inactivated should be stored at 2-8degreesC; do not freeze (if freezing occurs, discard vaccine). Multiple-dose vials should be returned to 2-8oC between uses. The manufacturer of Afluria(R) states to discard any vaccine remaining in multiple-dose vials after a total of 20 doses has been removed from the vial and discard the multiple-dose vial if not used within 28 days after first entry.
The vaccine should be protected from light. Single-dose vials are preservative-free. Multiple-dose vials contain thimerosal as a preservative.
Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination; such reactions occur most frequently in adolescents and young adults. Take appropriate measures to decrease the risk of injury if a vaccine recipient becomes weak or dizzy or loses consciousness (e.g., vaccine recipients should sit or lie down during and for 15 minutes after vaccination). If syncope occurs, observe the individual until symptoms resolve.
Influenza vaccine inactivated may be administered concurrently with other vaccines during the same health-care visit. When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given using separate syringes and at different injection sites. Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.
The vaccine product should be inspected visually for particulate matter and discoloration prior to administration. Discard the vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation. Influenza vaccine inactivated should not be mixed with any other vaccine or solution.
Influenza vaccine inactivated should be stored at 2-8degreesC; do not freeze (if freezing occurs, discard vaccine). Multiple-dose vials should be returned to 2-8oC between uses. The manufacturer of Afluria(R) states to discard any vaccine remaining in multiple-dose vials after a total of 20 doses has been removed from the vial and discard the multiple-dose vial if not used within 28 days after first entry.
The vaccine should be protected from light. Single-dose vials are preservative-free. Multiple-dose vials contain thimerosal as a preservative.
Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination; such reactions occur most frequently in adolescents and young adults. Take appropriate measures to decrease the risk of injury if a vaccine recipient becomes weak or dizzy or loses consciousness (e.g., vaccine recipients should sit or lie down during and for 15 minutes after vaccination). If syncope occurs, observe the individual until symptoms resolve.
Influenza vaccine inactivated may be administered concurrently with other vaccines during the same health-care visit. When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given using separate syringes and at different injection sites. Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for FLUAD 2025-2026 (influenza vaccine tvs 2025-26 (65 yr up)/adjuvant mf59c.1/pf):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for FLUAD 2025-2026 (influenza vaccine tvs 2025-26 (65 yr up)/adjuvant mf59c.1/pf):
Drug contraindication overview.
*History of severe hypersensitivity (e.g., anaphylaxis) to previous dose of any influenza vaccine. *Egg-based influenza vaccine inactivated: History of severe hypersensitivity (e.g., anaphylaxis) to any component of the vaccine, including egg protein. *Cell culture-based influenza vaccine inactivated: History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine.
*History of severe hypersensitivity (e.g., anaphylaxis) to previous dose of any influenza vaccine. *Egg-based influenza vaccine inactivated: History of severe hypersensitivity (e.g., anaphylaxis) to any component of the vaccine, including egg protein. *Cell culture-based influenza vaccine inactivated: History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Guillain-barre syndrome |
There are 0 moderate contraindications.
The following adverse reaction information is available for FLUAD 2025-2026 (influenza vaccine tvs 2025-26 (65 yr up)/adjuvant mf59c.1/pf):
Adverse reaction overview.
The most common adverse effects of influenza vaccine inactivated are listed below for individual vaccine preparations.
The most common adverse effects of influenza vaccine inactivated are listed below for individual vaccine preparations.
There are 15 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Bell's palsy Brachial plexus disorder Cellulitis Dyspnea Encephalopathy Guillain-barre syndrome Hypersensitivity drug reaction Myelitis Optic neuritis Serum sickness Stevens-johnson syndrome Thrombocytopenic disorder Vasculitis |
There are 34 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bruising Chills Erythema Fatigue Headache disorder Induration of skin Injection site pain Injection site sequelae Malaise Myalgia Pruritus of skin |
Appetite changes Arthralgia Cough Diarrhea Ecchymosis Fever Injection site erythema Injection site inflammation Nausea Pharyngitis Vomiting |
| Rare/Very Rare |
|---|
|
Back pain Dizziness Extensive limb swelling after injection Flushing Lymphadenopathy Neuralgia Pain in oropharynx Paresthesia Seizure disorder Skin rash Syncope Urticaria |
The following precautions are available for FLUAD 2025-2026 (influenza vaccine tvs 2025-26 (65 yr up)/adjuvant mf59c.1/pf):
Afluria(R), Fluarix(R), Flulaval(R), Fluzone(R), Flucelvax(R): Safety and efficacy not established in infants <6 months of age. Fluad(R) adjuvant-containing: Safety and efficacy not established in pediatric patients. Fluzone(R) High-Dose: Safety and efficacy not established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Data collected in a prospective pregnancy exposure registry from women vaccinated with influenza virus vaccine inactivated quadrivalent (Afluria(R), Fluarix(R), Flucelvax(R)) found no evidence of a vaccine-associated increase in the risk of major birth defects and miscarriages when administered during any trimester of pregnancy. Data for quadrivalent vaccines are relevant to trivalent products because both vaccines are manufactured using the same process and have overlapping compositions. Data are insufficient to assess the risk of use during pregnancy for other inactivated influenza vaccines (Fluzone(R), Fluad(R), Flulaval(R)).
Animal reproduction studies have not revealed evidence of harm to a fetus. Pregnant and postpartum women are at higher risk for severe influenza and influenza-related complications, particularly during the second and third trimesters, which may lead to adverse pregnancy outcomes including preterm labor and delivery. To monitor pregnancy outcomes and newborn health status following influenza vaccination of pregnant women, some manufacturers have established pregnancy registries.
Animal reproduction studies have not revealed evidence of harm to a fetus. Pregnant and postpartum women are at higher risk for severe influenza and influenza-related complications, particularly during the second and third trimesters, which may lead to adverse pregnancy outcomes including preterm labor and delivery. To monitor pregnancy outcomes and newborn health status following influenza vaccination of pregnant women, some manufacturers have established pregnancy registries.
It is not known whether influenza vaccine inactivated is distributed into human milk. Data are insufficient to assess effects on the breast-fed infant or on milk production. Consider the benefits of breast-feeding and importance of the vaccine to the woman; also consider potential adverse effects on the breast-fed child from the vaccine or underlying maternal condition (i.e., susceptibility to influenza infection). ACIP states that breast-feeding is not a contraindication to influenza vaccine inactivated; the vaccines do not pose any unusual risks for the mother or her nursing infant.
Afluria(R), Fluarix(R), Flucelvax(R), Flulaval(R), Fluzone(R): No overall differences in safety relative to younger adults; may be less immunogenic in geriatric individuals. Fluad(R) adjuvant-containing: Use only in adults >=65 years of age. Fluzone(R) High-Dose: Use in adults >=65 years of age.
Each 0.5 mL of Fluzone(R) High-Dose contains 4 times the amount of antigen contained in standard-dose Fluzone(R). In adults >=65 years of age, higher incidence of injection site reactions and systemic adverse effects reported with Fluzone(R) High-Dose compared with standard-dose Fluzone(R).
Some evidence that the high-dose formulation elicits higher antibody titers and higher seroconversion rates than the standard-dose formulation in adults >=65 years of age and may be more effective in preventing laboratory-confirmed influenza in this age group. ACIP states that all adults >=65 years of age should be vaccinated against influenza using influenza virus vaccine inactivated or influenza vaccine recombinant. ACIP states a preference for Fluzone(R) High-Dose, Flublok(R) recombinant influenza vaccine, or the standard-dose adjuvant-containing vaccine (Fluad(R)), but if none of these 3 vaccines is available at the time of vaccine administration, then adults >=65 years may receive a standard-dose preparation.
Each 0.5 mL of Fluzone(R) High-Dose contains 4 times the amount of antigen contained in standard-dose Fluzone(R). In adults >=65 years of age, higher incidence of injection site reactions and systemic adverse effects reported with Fluzone(R) High-Dose compared with standard-dose Fluzone(R).
Some evidence that the high-dose formulation elicits higher antibody titers and higher seroconversion rates than the standard-dose formulation in adults >=65 years of age and may be more effective in preventing laboratory-confirmed influenza in this age group. ACIP states that all adults >=65 years of age should be vaccinated against influenza using influenza virus vaccine inactivated or influenza vaccine recombinant. ACIP states a preference for Fluzone(R) High-Dose, Flublok(R) recombinant influenza vaccine, or the standard-dose adjuvant-containing vaccine (Fluad(R)), but if none of these 3 vaccines is available at the time of vaccine administration, then adults >=65 years may receive a standard-dose preparation.
The following prioritized warning is available for FLUAD 2025-2026 (influenza vaccine tvs 2025-26 (65 yr up)/adjuvant mf59c.1/pf):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for FLUAD 2025-2026 (influenza vaccine tvs 2025-26 (65 yr up)/adjuvant mf59c.1/pf)'s list of indications:
| Influenza vaccination | |
| Z23 | Encounter for immunization |
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