influenza A (H5N1) vaccine (Rx)

Brand and Other Names:Audenz

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
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Interactions

Interaction Checker

and influenza A (H5N1) vaccine

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            Contraindicated (1)

            • belimumab

              belimumab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.

            Serious - Use Alternative (6)

            • elivaldogene autotemcel

              elivaldogene autotemcel, influenza A (H5N1) vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .

            • ocrelizumab

              ocrelizumab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.

            • ofatumumab SC

              ofatumumab SC decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 2 weeks before initiating ofatumumab SC for inactivated vaccines, and whenever possible.

            • secukinumab

              secukinumab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating secukinumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with secukinumab may not elicit an immune response sufficient to prevent disease.

            • siponimod

              siponimod decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.

            • teplizumab

              teplizumab decreases effects of influenza A (H5N1) vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

            Monitor Closely (58)

            • belatacept

              belatacept decreases effects of influenza A (H5N1) vaccine by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.

            • bendamustine

              bendamustine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • betamethasone

              betamethasone decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

            • busulfan

              busulfan decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • capecitabine

              capecitabine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • carboplatin

              carboplatin decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • carmustine

              carmustine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • certolizumab pegol

              certolizumab pegol decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor.

            • chlorambucil

              chlorambucil decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • cisplatin

              cisplatin decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • cladribine

              cladribine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • clofarabine

              clofarabine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • corticotropin

              corticotropin decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

            • cortisone

              cortisone decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

            • cyclophosphamide

              cyclophosphamide decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • cyclosporine

              cyclosporine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. If possible, complete all age-appropriate vaccinations at least 2 weeks before initiating immunosuppressant therapy. Patients vaccinated <14 days before starting immunosuppressive therapy or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. Longer waiting periods may be required for drugs that maintain their immunosuppressive effects for more than 3 months after discontinuation (eg, ocrelizumab). .

            • cytarabine

              cytarabine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • dacarbazine

              dacarbazine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • dexamethasone

              dexamethasone decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

            • floxuridine

              floxuridine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • fludarabine

              fludarabine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • fludrocortisone

              fludrocortisone decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

            • fluorouracil

              fluorouracil decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • gemcitabine

              gemcitabine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • hydrocortisone

              hydrocortisone decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

            • ibrutinib

              ibrutinib decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • ifosfamide

              ifosfamide decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              ifosfamide decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • lomustine

              lomustine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • mechlorethamine

              mechlorethamine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

              mechlorethamine decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • mechlorethamine topical

              mechlorethamine topical decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • melphalan

              melphalan decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • mercaptopurine

              mercaptopurine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • methotrexate

              methotrexate decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • methylprednisolone

              methylprednisolone decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

            • nelarabine

              nelarabine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • onasemnogene abeparvovec

              onasemnogene abeparvovec decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

            • oxaliplatin

              oxaliplatin decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • pemetrexed

              pemetrexed decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • pentostatin

              pentostatin decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • ponesimod

              ponesimod decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. If possible, complete all age-appropriate vaccinations at least 4 weeks before initiating ponesimod.

            • pralatrexate

              pralatrexate decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • prednisolone

              prednisolone decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

            • prednisone

              prednisone decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

            • rituximab

              rituximab, influenza A (H5N1) vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

            • rituximab-hyaluronidase

              rituximab-hyaluronidase, influenza A (H5N1) vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

            • satralizumab

              satralizumab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

            • streptozocin

              streptozocin decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • temozolomide

              temozolomide decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • thioguanine

              thioguanine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • thiotepa

              thiotepa decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • tralokinumab

              tralokinumab will decrease the level or effect of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

            • triamcinolone acetonide injectable suspension

              triamcinolone acetonide injectable suspension decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

            • ublituximab

              ublituximab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.

            • vinblastine

              vinblastine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • vincristine

              vincristine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • vincristine liposomal

              vincristine liposomal decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • vinorelbine

              vinorelbine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

            • voclosporin

              voclosporin decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment.

            Minor (1)

            • ozanimod

              ozanimod decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Minor/Significance Unknown. No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. Vaccinations may be less effective if coadministered with ozanimod.

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            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

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            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
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            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.

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            Pharmacology

            Mechanism of Action

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

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            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
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            Images

            No images available for this drug.
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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            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.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
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