influenza virus vaccine (H5N1), adjuvanted (Rx)

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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

emulsion for IM injection

  • 3.75mcg/0.5mL; contains hemagglutinin (HA) of the influenza virus strain within the vaccine

H5N1 Influenza (Avian Flu)

Indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype (ie, A/Indonesia/05/2005)

2-dose immunization series

3.75 mcg (0.5 mL) IM once; administer second 0.5 mL dose 21 days later

Dosing Considerations

Contains AS03 adjuvant; in clinical studies, the adjuvanted formulation stimulated the required immune response while using a smaller amount of antigen as compared to a formulation without adjuvant

Specific strain: A/Indonesia/05/2005

Also contains thimerosal, chicken egg protein

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

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            Adverse Effects

            >10%

            Injection site pain (83%)

            Myalgia (45%)

            Headache (35%)

            Fatigue (34%)

            Arthralgia (25%)

            Shivering (17%)

            Sweating (11%)

            1-10%

            Swelling (10%)

            Injection site erythema (9%)

            Fever (5%)

            Postmarketing Reports

            Immune system disorders: Anaphylaxis, allergic reactions

            Nervous system disorders: Febrile convulsions, Guillain-Barré syndrome, narcolepsy, somnolence

            Skin and subcutaneous tissue disorders: Angioedema, generalized skin reactions, urticaria

            General disorders and administration site conditions: Injection site reactions (including inflammation, mass, necrosis, and ulcer)

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            Warnings

            Contraindications

            Known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or after a previous dose of an influenza vaccine

            Cautions

            Hypersensitivity may occur; appropriate medical treatment, including epinephrine, and supervision should be available to manage possible anaphylactic

            History of Guillain-Barre syndrome following prior vaccine

            Syncope can occur with administration of injectable vaccines

            May not be effective in preventing disease caused by influenza A (H5N1) virus in immunosuppressed persons, including individuals receiving immunosuppressive therapy

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: Distributed 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

            Influenza vaccines induce antibodies against the viral hemagglutinin antigen in the vaccine, which then blocks viral attachment to human respiratory cells

            The mechanism of action of type A (H5N1) influenza virus is not well understood; promotes active immunity to avian influenza

            Pharmacokinetics

            In clinical trials, a 4-fold increase in antibody titers was seen in up to ≥70% of patients aged 18-64 years, and ≥60% aged ≥65 years

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            Administration

            IM Preparation

            Emulsion for injection supplied as 2 separate vials, a vial of H5N1 antigen and a vial of AS03 adjuvant

            The 2 vials must be combined before use

            Once combined, the resulting volume provides 10 doses (0.5 mL each) in a multi-dose vial

            Administer vaccine within 24 hr after combining H5N1 antigen and AS03 adjuvant

            Do not mix with any other vaccine

            IM Administration

            If after mixing, the vaccine is stored refrigerated, place the vaccine at room temperature for a minimum of 15 minutes prior to administration

            Mix the vaccine thoroughly by inversion before each administration

            Inspected visually for particulate matter and discoloration prior to administration

            Use a sterile needle (23-gauge is recommended) and sterile syringe for each dose withdrawal from the multi-dose vial and for vaccine administration

            Preferred site for IM injection is the deltoid muscle of the upper arm

            Storage

            Do not freeze; discard if frozen

            Protect from light

            Before mixing vials: Refrigerate between 2-8°C (36-46°F)

            After mixing vials

            • Use within 24 hr
            • Store either refrigerated between 2-8°C (36-46°F) or at room temperature 30°C (86°F) for up to 24 hr
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            Formulary

            FormularyPatient Discounts

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            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
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.