Influenza A (H5N1) Vaccine

Influenza A (H5N1) vaccine is used for active immunization to prevent disease caused by the influenza A virus H5N1 subtype in patients over 6 months of age at increased risk of exposure.

Influenza A (H5N1) vaccine is available under the following different brand names: Audenz.

Dosages of Influenza A (H5N1) Vaccine:

Dosage Forms and 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

Dosage Considerations – Should be Given as Follows:

H5N1 Influenza (Avian Flu) Immunization

• Indicated for active immunization to prevent disease caused by the influenza A virus H5N1 subtype in patients over 6 months of age at increased risk of exposure
• Adults and Children 6 months through 17 years:
• MF59 adjuvant (Audenz): 2-dose series: 0.5 mL intramuscularly (IM) administered 21 days apart
• Children 6 months through 17 years
• AS03 adjuvant: 2-dose series: 0.25 mL IM administered 21 days apart
• Children under 6 months: Safety and efficacy not established

Common side effects of influenza A (H5N1) vaccine include:

Adults aged 18-64 years

• Injection site pain
• Fatigue
• Headache
• Feeling unwell (malaise)
• Muscle pain
• Joint pain
• Nausea

Adults aged 65 years or older

• Injection site pain
• Fatigue
• Feeling unwell (malaise)
• Headache
• Joint pain

Children aged 6-17 years

• Injection site pain (may be severe)
• Muscle pain
• Fatigue (may be severe)
• Feeling unwell (malaise) (may be severe)
• Headache
• Loss of appetite (may be severe)
• Nausea (may be severe)
• Joint pain
• Fever
• Injection site hard lump
• Injection site redness

Infants and children aged 6 months through 5 years

• Injection site tenderness
• Irritability (may be severe)
• Sleepiness
• Change in eating habits
• Fever
• Injection site redness
• Injection site tenderness
• Injection site hard lump
• Postmarketing side effects of influenza A (H5N1) vaccine reported include:
• 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, fainting
• Skin and subcutaneous tissue disorders: Hives, itching, nonspecific rash
• Musculoskeletal and connective tissue disorders: Muscular weakness

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of influenza A (H5N1) vaccine include:
  • belimumab
• Serious interactions of influenza A (H5N1) vaccine include:
  • ocrelizumab
  • secukinumab
  • siponimod
• Influenza A (H5N1) vaccine has moderate interactions with at least 52 different drugs.
• Influenza A (H5N1) vaccine has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains the influenza A (H5N1) vaccine. Do not take Audenz if you are allergic to the influenza A (H5N1) vaccine or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• History of a severe allergic reaction (e.g., anaphylaxis) to any vaccine component or after a previous dose of any influenza vaccine

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Influenza A (H5N1) Vaccine?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Influenza A (H5N1) 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 the immune response to the vaccine

Pregnancy and Lactation

• Data are insufficient to inform of influenza A (H5N1) vaccine-associated risks during pregnancy. There is limited information on the 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. Consult your doctor.
• It is unknown if the influenza A (H5N1) vaccine is excreted in human milk. Data are not available to assess the effects of the influenza A (H5N1) vaccine on breastfed infants or milk production/excretion. Consult your doctor before breastfeeding.