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Agriflu

Generic Name: influenza virus vaccine
Date of Approval: November 27, 2009
Company: Novartis Vaccines and Diagnostics, Inc.
Treatment for: Prevention of Influenza

FDA Approves Agriflu

The U.S. Food and Drug Administration has approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

What is Agriflu (influenza virus vaccine)?

Influenza virus (commonly known as "the flu") is a serious disease caused by a virus. Influenza virus can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The virus can also be passed through contact with objects the infected person has touched, such as a door handle or other surfaces.

Agriflu is used to prevent infection caused by influenza virus. The influenza virus vaccine is redeveloped each year to contain specific strains of inactivated (killed) flu virus that are recommended by public health officials for that year.

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The Agriflu injectable influenza virus vaccine (flu shot) is a "killed virus" vaccine. Influenza virus vaccine is also available in a nasal spray form, which is a "live virus" vaccine.

Agriflu works by exposing you to a small dose of the virus, which helps your body to develop immunity to the disease. Agriflu will not treat an active infection that has already developed in the body.

Agriflu is for use in adults 18 years of age and older.

Becoming infected with influenza (commonly known as "the flu") is much more dangerous to your health than receiving the vaccine to protect against it. Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Like any vaccine, Agriflu may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

What is the most important information I should know about Agriflu?

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another influenza virus vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

Becoming infected with influenza (commonly known as "the flu") is much more dangerous to your health than receiving the vaccine to protect against it. Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving Agriflu?

Do not receive Agriflu if you have ever had an allergic reaction to a flu vaccine, or if you have:

  • a history of Guillain-BarrĂ© syndrome (especially if you had it within 6 weeks after having a flu vaccine); or
  • if you are allergic to chicken or egg products, kanamycin or neomycin, or any other constituent of the vaccine.

Before receiving influenza virus vaccine, tell your doctor if you are allergic to any drugs, or if you have:

  • a bleeding or blood clotting disorder such as hemophilia or easy bruising;
  • a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);
  • an allergy to latex rubber;
  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or
  • if you are taking a blood thinner such as warfarin (Coumadin).

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Pregnancy Category B. Your doctor will decide whether you should receive Agriflu if you are pregnant, especially if you have a high risk of infection with influenza.

It is not known whether influenza virus vaccine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is Agriflu given?

Agriflu is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.

You should receive a flu vaccine every year. Your immunity will gradually decrease over the 12 months after you receive the influenza virus vaccine.

The influenza virus vaccine is usually given in October or November. Some people may need to have their vaccines earlier or later. Follow your doctor's instructions.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

What happens if I miss a dose?

Since flu shots are usually given only one time per year, you will most likely not be on a dosing schedule. Call your doctor if you forget to receive your yearly flu shot in October or November.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you receive this vaccine.

Agriflu side effects

Agriflu will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another influenza virus vaccine in the future, you will need to tell the doctor if the first shot caused any side effects. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);
  • high fever; or
  • unusual bleeding.

Less serious side effects may include:

  • low fever, chills;
  • redness, bruising, pain, swelling, or a lump where the vaccine was injected;
  • headache, tired feeling; or
  • joint or muscle pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Agriflu dosing information

Usual Adult Dose for Influenza Prophylaxis:

0.5 mL once by intramuscular injection

What other drugs will affect Agriflu?

Before receiving this vaccine, tell your doctor if you are using phenytoin (Dilantin), theophylline (Respbid, Slo-Bid, Theodur, Uniphyl), or a blood thinner (warfarin, Coumadin).

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and there may be other drugs that can interact with this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about Agriflu written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

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