influenza virus vaccine trivalent, adjuvanted (Rx)

Brand and Other Names:Fluad
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Dosing & Uses

AdultPediatricGeriatric

Not indicated (see Geriatric Dosing)

Not indicated

Dosage Forms and Strengths

suspension for IM injection

0.5mL/prefilled syringe

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 yr

0.5 mL IM x1 dose

Dosing Considerations

Contains the following 3 viral strains for 2017-2018 northern hemisphere season:

A/Michigan/45/2015 (H1N1)pdm09-like virus (new for 2017-2018)

A/Hong Kong/4801/2014 (H3N2)-like virus (no change from last season)

B/Brisbane/60/2008-like virus (B/Victoria lineage vaccine virus) (no change from last season)

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Interactions

Interaction Checker

and influenza virus vaccine trivalent, adjuvanted

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            Adverse Effects

            >10%

            Injection site pain (25%)

            Injection site tenderness (21%)

            Myalgia (15%)

            Headache (13%)

            Fatigue (13%)

            1-10%

            Arthralgia (8.5%)

            Diarrhea (5%)

            Fever (3.6%)

            Nausea (3%)

            Vomiting (1.4%)

            Injection site erythema, induration, swelling (~1%)

            Postmarketing Reports

            Blood and lymphatic system disorders: Thrombocytopenia, some cases were severe with platelet counts <5,000 per mm³, lymphadenopathy

            General disorders and administration site conditions: Extensive swelling of injected limb lasting more than 1 week, injection site cellulitislike reactions (some cases of swelling, pain, and redness extending >10 cm and lasting >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, paraesthesia, syncope, presyncope

            Skin and subcutaneous tissue disorders: Generalized skin reactions including erythema multiforme, urticaria, pruritus, or nonspecific rash

            Vascular disorders: Vasculitis with transient renal involvement

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            Warnings

            Contraindications

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

            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

            Syncope may occur in association with 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 coadministered with other injectable vaccines, administer at different injection sites
            • Immunosuppressive or corticosteroid therapies may reduce the immune response to the vaccine
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            Pregnancy & Lactation

            Not applicable

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Vaccine contains inactivated influenza viruses (2 subtypes for A and 1 subtype for B) that are determined annually

            Conveys active immunity via stimulation of production of endogenously produced antibodies

            Manufactured using an egg-based process

            It is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oil

            Squalene, a naturally occurring substance found in humans, animals, and plants, is highly purified for the vaccine manufacturing process

            Adjuvants are incorporated into some vaccine formulations to enhance or direct the immune response of the vaccinated individual

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            Administration

            IM Administration

            Gently shake each syringe (vaccine is a milky-white suspension)

            Inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit; if either condition exists, do not administer

            Administer by IM injection, preferably in the region of the deltoid muscle of the upper arm

            Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk

            Storage

            Refrigerate at 2-8°C (36-46°F)

            Protect from light

            Do not freeze; discard if the vaccine has been frozen

            Do not use after expiration date

            The tip caps of prefilled syringes contain natural rubber latex

            The syringe and syringe plunger stopper are not made with natural rubber latex

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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