influenza A (H5N1) vaccine (Rx)

Brand and Other Names:Audenz
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Supplied only to government agencies and for stockpiles

injection, emulsion AS03 adjuvant

  • 3.75mcg/mL hemagglutinin (HA) of the H5N1 influenza virus strain 364 A/Indonesia/05/2005

injection, emulsion MF59 adjuvant (Audenz)

  • 7.5mcg/0.5mL HA of the H5N1 influenza virus strain A/turkey/Turkey/1/2005

H5N1 Influenza (Avian Flu) Immunization

Indicated for active immunization to prevent disease caused by the influenza A virus H5N1 subtype in patients aged >6 months at increased risk of exposure

2-dose series: 0.5 mL IM administered 21 days apart

Dosage Forms & Strengths

Supplied only to government agencies and for stockpiles

injection, emulsion AS03 adjuvant

  • 3.75mcg/0.5mL hemagglutinin (HA) of the H5N1 influenza virus strain 364 A/Indonesia/05/2005

injection, emulsion MF59 adjuvant (Audenz)

  • 7.5mcg/0.5mL HA of the H5N1 influenza virus strain A/turkey/Turkey/1/2005

H5N1 Influenza (Avian Flu) Immunization

Indicated for active immunization to prevent disease caused by the influenza A virus H5N1 subtype in patients aged >6 months at increased risk of exposure

<6 months: Safety and efficacy not established

6 months through 17 years

  • AS03 adjuvant
    • 2-dose series: 0.25 mL IM administered 21 days apart
  • MF59 adjuvant (Audenz)
    • 2-dose series: 0.5 mL IM administered 21 days apart
Next:

Interactions

Interaction Checker

and influenza A (H5N1) vaccine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10% (Audenz)

            Adults aged 18-64 yr

            • Injection site pain (64%)
            • Fatigue (25%)
            • Headache (25%)
            • Malaise (22%)
            • Myalgia (14%)

            Adults aged 65 yr or older

            • Injection site pain (36%)
            • Fatigue (20%)
            • Malaise (16%)
            • Headache (16%)

            Children aged 6-17 yr

            • Injection site pain (68%)
            • Myalgia (30%)
            • Fatigue (27%)
            • Malaise (25%)
            • Headache (22%)
            • Loss of appetite (14%)
            • Nausea (13%)
            • Arthralgia (13%)

            Infants and children aged 6 mo through 5 yr

            • Injection site tenderness (56%)
            • Irritability (30%)
            • Sleepiness (25%)
            • Change in eating habits (18%)
            • Fever ≥100.4ºF (16%)

            1-10% (Audenz)

            Adults aged 18-64 yr

            • Arthralgia (10%)
            • Nausea (10%)

            Adults aged 65 yr or older

            • Arthralgia (10%)

            Children aged 6-17 yr

            • Fever ≥100.4ºF (4%)
            • Injection site induration (2%)
            • Injection site pain, severe (1%)
            • Injection site erythema (1%)
            • Fatigue, severe (1%)
            • Malaise, severe (1%)
            • Loss of appetite, severe (1%)
            • Nausea, severe (1%)
            • Fever ≥102.1ºF (1%)

            Infants and children aged 6 mo through 5 yr

            • Injection site erythema (3%)
            • Fever ≥102.1ºF (2%)
            • Injection site tenderness (1%)
            • Injection site induration (1%)
            • Severe irritability (1%)

            Postmarketing Reports (Audenz)

            Blood and lymphatic system disorders: Lymphadenopathy

            Immune system disorders: Hypersensitivity reactions including angioedema and anaphylaxis

            Nervous system disorders: Bell Palsy, convulsions, including febrile convulsion, demyelination, encephalitis, Guillain-Barre Syndrome, neuritis, paresthesia, syncope

            Skin and subcutaneous tissue disorders: Urticaria, pruritus, nonspecific rash

            Musculoskeletal and connective tissue disorders: Muscular weakness

            Previous
            Next:

            Warnings

            Contraindications

            History of a severe allergic reaction (eg, anaphylaxis) to any vaccine component or after previous dose of an influenza vaccine

            Cautions

            Hypersensitivity reactions reported; appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions after vaccine administration

            If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give influenza A (H5N1) vaccine should be based on careful consideration of potential benefits and risks

            Vaccination may not protect all recipients; immunocompromised individuals may have a diminished immune response

            Drug interaction overview

            • No data are available to evaluate concomitant administration with other vaccines
            • Immunosuppressive or corticosteroid therapies may reduce immune response to vaccine
            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy

            Data are insufficient to inform of vaccine-associated risks during pregnancy

            Animal data

            • Female rabbits were administered MF59 adjuvant vaccine 1 and 3 weeks before mating, and on gestation days 7 and 20
            • No vaccine-related fetal malformations or variations and no adverse effects on preweaning development were observed

            Clinical considerations

            • Limited information on risk of influenza A (H5N1) infection in pregnant women
            • However, pregnant women infected with pandemic H1N1 or with seasonal influenza are at increased risk of severe illness associated with influenza infection compared to non-pregnant women
            • Pregnant women with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery

            Lactation

            Unknown if excreted in human milk; data are not available to assess effects on breastfed infants or on milk production/excretion

            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.

            Previous
            Next:

            Pharmacology

            Mechanism of Action

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

            Previous
            Next:

            Administration

            IM Preparation

            AS03 adjuvant vaccine

            • Supplied as 2 separate vials that must be combined before administration: a vial of H5N1 antigen and a vial of AS03 adjuvant
            • Place 1 vial of H5N1 antigen and 1 vial of AS03 adjuvant at room temperature for minimum of 15 minutes
            • Mix each vial by inversion and inspect visually for particulate matter and discoloration
            • Cleanse both vial stoppers and withdraw the entire contents of the AS03 adjuvant vial using a sterile syringe with a 23-gauge sterile needle and add it to the H5N1 antigen vial to formulate the vaccine (may substitute 22-gauge or 21-gauge needle if 23-gauge needle not available)
            • Mix vaccine thoroughly by inversion; after mixing, label the H5N1 antigen vial (now containing the vaccine) with the date and time mixed in the designated area on the vial label
            • Withdraw 0.5 mL for an adult dose or 0.25 mL for a pediatric dose
            • If stored in refrigerator after mixing, place vaccine at room temperature for minimum of 15 minutes before administration
            • Mix the vaccine thoroughly by inversion before each administration

            Prefilled syringe (Audenz)

            • Gently shake syringe emulsion

            IM Administration

            Aged ≥12 months: Administer preferably in lateral aspect of deltoid muscle of upper arm

            Aged 6-11 months: Administer in the anterolateral thigh; do not inject gluteal region or areas where a major nerve trunk might be present

            Storage

            Unopened AS03 adjuvant vials and MF59 adjuvant (Audenz) prefilled syringes

            • Refrigerate at 2-8ºC (35-46ºF)
            • Do not freeze (discard if frozen)
            • Protect from light

            AS03 adjuvant storage after mixing

            • Administered within 24 hr of combining
            • Once combined, may refrigerate at 2-8ºC (36-46ºF) or at room temperature up to 30ºC (86ºF) for up to 24 hr
            • Do not freeze (discard if frozen)
            • Protect from light
            Previous
            Next:

            Images

            Previous
            Next:

            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.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.