Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (4)
- 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.
Monitor Closely (56)
- 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.
- 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.
- 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.
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
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
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.Pharmacology
Mechanism of Action
Influenza vaccines induce antibodies against the viral HA in the vaccine, which then blocks viral attachment to human respiratory cells
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
Images
Formulary
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