Influenza Virus Vaccine Trivalent, Adjuvanted

Influenza virus vaccine trivalent, adjuvanted is used for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine for adults aged 65 years and older.

Influenza virus vaccine trivalent, adjuvanted is available under the following different brand names: Fluad.

Dosage Forms and Strengths

Suspension for IM Injection

• 0.5mL/prefilled syringe

Dosage Considerations – Should be Given as Follows:

• Influenza
• Indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine for adults aged 65 years and older
• 0.5 mL intramuscular (IM) for 1 dose

Dosing Considerations

• Contains the following 3 viral strains for the 2019-2020 northern hemisphere season:
• A/Brisbane/02/2018 (H1N1)pdm09-like virus (New for 2019-2020)
• A/Kansas/14/2017 (H3N2)-like virus (New for 2019-2020)
• B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage) (no change from last season)
• Not indicated for adults under 65 years or children

Common side effects of influenza virus vaccine trivalent, adjuvanted include:

• Injection site pain
• Injection site tenderness
• Muscle pain
• Headache
• Fatigue
• Joint pain
• Diarrhea
• Fever
• Nausea
• Vomiting
• Injection site redness, hard lump, swelling

Postmarketing side effects of influenza virus vaccine trivalent, adjuvanted reported include:

• Blood and lymphatic system disorders: Low blood platelets (thrombocytopenia), some cases were severe with platelet counts less than 5000/mm³, lymphadenopathy
• General disorders and administration site conditions: Extensive swelling of injected limb lasting more than 1 week, injection site cellulitis-like reactions (some cases of swelling, pain, and redness extending greater than 10 cm and lasting more than 1 week)
• Immune system disorders: Allergic reactions, including anaphylactic shock, anaphylaxis, and angioedema
• Musculoskeletal and connective-tissue disorders: Muscular weakness
• Nervous system disorders: Encephalomyelitis, Guillain-Barré syndrome, convulsions, neuritis, neuralgia, numbness and tingling, lightheadedness and fainting
• Skin and subcutaneous tissue disorders: Generalized skin reactions, including erythema multiforme, hives, itching, or nonspecific rash
• Vascular disorders: Vasculitis with transient renal involvement

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe interactions of influenza virus vaccine trivalent, adjuvanted include:

• ustekinumab

Influenza virus vaccine trivalent, adjuvanted has serious interactions with at least 93different drugs.

Moderate interactions of influenza virus vaccine trivalent, adjuvanted include:

• ibrutinib
• ifosfamide
• lomustine
• mechlorethamine
• melphalan
• onasemnogene abeparvovec
• oseltamivir
• oxaliplatin
• procarbazine
• rituximab

Influenza virus vaccine trivalent, adjuvanted has no listed mild interactions with other drugs.
 

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings
 

This medication contains the influenza virus vaccine trivalent, adjuvanted. Do not Fluad if you are allergic to influenza virus vaccine trivalent, adjuvanted or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or a previous influenza vaccine

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Influenza Virus Vaccine Trivalent, Adjuvanted?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Influenza Virus Vaccine Trivalent, Adjuvanted?”

Cautions

• If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give the vaccine should be based on careful consideration of the potential benefits and risks; the 1976 swine influenza vaccine was associated with an elevated risk of GBS, although evidence for a causal relationship of GBS with other influenza vaccines is inconclusive
• Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine
• The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals
• The immune response in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals
• Fainting (syncope) may occur in association with the administration of injectable vaccines
• May not protect all vaccine recipients against influenza disease
• Drug interaction overview
• Data are not available to assess concomitant administration with other vaccines; if co-administered with other injectable vaccines, administered at different injection sites
• Immunosuppressive or corticosteroid therapies may reduce the immune response to the vaccine

Pregnancy and Lactation

Influenza virus vaccine trivalent, adjuvanted is not approved for persons under 65 years of age. Data are insufficient to establish risk with the use of influenza virus vaccine trivalent, adjuvanted during pregnancy or to assess effects on breastfed infants or milk production in breastfeeding women.