influenza virus vaccine trivalent, recombinant (Rx)

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Brand and Other Names:Flublok

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IM solution

  • 0.5mL/vial
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Influenza Prophylaxis

Indicated for active immunization against influenza virus subtypes A and B contained in the vaccine for adults aged ≥18 yr

0.5 mL IM x1/season

Dosing Considerations

Contents for 2016-2017 northern hemisphere season:

  • A/California/7/2009 (H1N1)pdm09-like virus (same strain as was used for 2009 H1N1 monovalent vaccines)
  • A/Hong Kong/4801/2014 (H3N2)-like virus (new for 2016-2017)
  • B/Brisbane/60/2008-like virus (B/Victoria lineage vaccine virus) (new for the trivalent vaccine for 2016-2017)

Egg allergy

  • The Advisory Committee on Immunization Practices (ACIP) recommends FluBlok for vaccination of persons aged 18 through 49 years with egg allergy of any severity
  • FluBlok does not use the influenza virus or chicken eggs in its manufacturing process

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and influenza virus vaccine trivalent, recombinant

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            Adverse Effects

            >10%

            Injection site pain (37%)

            Headache (15%)

            Fatigue (15%)

            Muscle pain (11%)

            1-10%

            Nausea (6%)

            Joint pain (4%)

            Injection site redness (4%)

            Injection site swelling/bruising (3%)

            Chills (3%)

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            Warnings

            Contraindications

            Severe hypersensitivity (eg, anaphylaxis) to any component of the vaccine

            Cautions

            Expected immune response may not be obtained in immunocompromised individuals, including those receiving immunosuppressive therapy

            Influenza vaccine may not protect all susceptible individuals

            Guillain-Barre syndrome has been reported within 6 weeks of receipt of influenza vaccines

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            Pregnancy & Lactation

            Pregnancy Category: B

            CDC recommends Influenza vaccine be administered during pregnancy (all trimesters); vaccination during pregnancy shown to decrease risk of illness in the mother, as well as the risk of influenza and influenza hospitalization in their infants during the first 6 months of life (MMWR August 26, 2011;60[33]:1128-32)

            Lactation: Unknown if excreted in human breast milk; use with caution

            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

            Recombinant HA proteins of the 3 strains of influenza virus specified for annual seasonal vaccine; these proteins function as antigens which induce a humoral immune response

            Contains purified HA proteins produced in a continuous insect cell line (expresSF+) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda, and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts

            Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography; purified HAs are then blended and filled into single-dose vials that are standardized according to US Public Health Service (USPHS) requirements for each season viral subtypes

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            Administration

            Instructions

            Administer at beginning of influenza season

            Should not be mixed with any other vaccine in the same syringe or vial

            Shake well before administration

            For IM injection only

            Administer IM in deltoid muscle of upper arm

            Storage

            Store refrigerated between 2-8ºC (36-46ºF)

            Do not freeze and protect from light

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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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