FluMist

DRUG DESCRIPTION

FluMist (Influenza Vaccine Live, Intranasal) is a live trivalent vaccine for administration by intranasal spray. The influenza virus strains in FluMist are (a) cold-adapted (ca) (i.e., they replicate efficiently at 25C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperaturesensitive (ts) (i.e., they are restricted in replication at 37C (Type B strains) or 39C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (they do not produce classic influenza-like illness in the ferret model of human influenza infection). The cumulative effect of the antigenic properties and the ca, ts, and att phenotypes is that the attenuated vaccine viruses replicate in the nasopharynx to induce protective immunity.

No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) [see Clinical Studies]. For each of the three reassortant strains in FluMist, the six internal gene segments responsible for ca, ts, and att phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses that have been recommended by the USPHS for inclusion in the annual vaccine formulation. Thus, the three viruses contained in FluMist maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses that are related to strains expected to circulate during the 2011-2012 influenza season. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the ts and att phenotypes. For the Type BMDV, at least three genetic loci in two different internal gene segments contribute to both the ts and att properties; five genetic loci in three gene segments control the ca property.

Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled, and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. Ethylene diamine tetraacetic acid (EDTA) is added to the dilution buffer for H3N2 strains. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the three strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration.

Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU of live attenuated influenza virus reassortants of each of the three strains: A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68mg/dose sucrose, 2.26mg/dose dibasic potassiumphosphate, 0.96mg/dosemonobasic potassium phosphate, and < 0.015 mcg/mL gentamicin sulfate. FluMist contains no preservatives.

The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist is a colorless to pale yellow liquid and is clear to slightly cloudy.

What are the possible side effects of influenza virus nasal vaccine (FluMist)?

Nasal influenza virus (live virus) vaccine may cause you to have mild flu-like symptoms. However, you may have flu-like symptoms at any time during flu season that may be caused by strains of influenza virus that are not contained in the vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first dose.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another nasal influenza virus vaccine in the future, you...

Read All Potential Side Effects and See Pictures of FluMist

What are the precautions when taking influenza virus vaccine (FluMist)?

Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to eggs; or if you have previously had a severe allergic reaction to flu vaccine; or if you have any other allergies. This product may contain inactive ingredients (such as gentamicin, gelatin, arginine), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccine, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, wheezing, chronic lung disease), current infection/fever, diabetes, history of Guillain-Barre syndrome, immune system problems (e.g., due to cancer treatment, HIV infection), kidney disease.

This vaccine contains a weakened form of the flu virus. After receiving the...

Read All Potential Precautions of FluMist


FluMist Consumer (continued)

SIDE EFFECTS: Cough, runny nose, sneezing, sore throat, fever, headache, chills, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to receive this vaccine, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to eggs; or if you have previously had a severe allergic reaction to flu vaccine; or if you have any other allergies. This product may contain inactive ingredients (such as gentamicin, gelatin, arginine), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccine, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, wheezing, chronic lung disease), current infection/fever, diabetes, history of Guillain-Barre syndrome, immune system problems (e.g., due to cancer treatment, HIV infection), kidney disease.

This vaccine contains a weakened form of the flu virus. After receiving the vaccine, you may be able to infect others with flu for up to 3 weeks. Rarely, infections may occur in people in close contact with someone who has received this vaccine. Caution is advised if you have regular close contact with family/household members with weakened immune systems (e.g., due to cancer).

Children aged 2 to 17 years who are taking aspirin should not receive this vaccine due to the risk for developing Reye's syndrome, a rare but serious condition. Also, children in this age group should not use products containing aspirin for 4 weeks after receiving this vaccine unless directed by the doctor. Consult the doctor for details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


FluMist Patient Information Including Side Effects

Brand Names: FluMist

Generic Name: influenza virus vaccine (nasal) (Pronunciation: in floo ENZ a VYE rus VAK seen)

  • What is influenza virus nasal vaccine (FluMist)?
  • What are the possible side effects of influenza virus nasal vaccine (FluMist)?
  • What is the most important information I should know about this vaccine (FluMist)?
  • What should I discuss with my healthcare provider before receiving this vaccine (FluMist)?
  • How is this vaccine given (FluMist)?
  • What happens if I miss a dose (FluMist)?
  • What happens if I overdose (FluMist)?
  • What should I avoid before or after receiving this vaccine (FluMist)?
  • What other drugs will affect influenza virus nasal vaccine (FluMist)?
  • Where can I get more information?

What is influenza virus nasal vaccine (FluMist)?

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.

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

The nasal influenza virus vaccine is a "live virus" vaccine. Influenza virus vaccine is also available in an injectable form, which is a "killed virus" vaccine.

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

Nasal influenza virus vaccine is for use in children and adults, between the ages of 2 and 49 years old.

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

What are the possible side effects of influenza virus nasal vaccine (FluMist)?

Nasal influenza virus (live virus) vaccine may cause you to have mild flu-like symptoms. However, you may have flu-like symptoms at any time during flu season that may be caused by strains of influenza virus that are not contained in the vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first dose.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another nasal influenza virus vaccine in the future, you will need to tell the doctor if the first vaccine 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); or
  • high fever, chills, body aches, flu symptoms.

Less serious side effects include:

  • low fever, chills;
  • runny or stuffy nose;
  • sore throat, cough;
  • headache;
  • feeling tired or irritable;
  • vomiting; or
  • muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What is the most important information I should know about this vaccine (FluMist)?

The nasal influenza virus vaccine is a "live virus" vaccine. Influenza virus vaccine is also available in an injectable form, which is a "killed virus" vaccine. This medication guide addresses only the nasal spray form of this vaccine.

For at least 21 days after receiving nasal influenza virus vaccine, avoid close contact with anyone who has a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by certain medicines such as steroids, cancer chemotherapy, or radiation treatment. A person with a weak immune system can become ill if they have close contact with you after you have recently received a an influenza vaccine.

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 vaccine 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.

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