Influenza Virus Vaccine, Live (n-floo-EN-za VYE-rus VAX-een, lyve)

Keeps you from getting sick with an influenza virus ("catching the flu").

Brand Name(s):

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• A nurse or other trained health professional will give you this medicine.
• This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
• Before using the medicine, gently blow your nose to clear the nostrils.
• Children 2 to 8 years of age who have not received the nasal vaccine before should receive 2 doses at least 1 month apart.
• The influenza vaccine must be repeated each year to protect you from the flu.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• Most people need only one dose of this medicine.
• If your child needs a second dose of this medicine, it is very important for your child to receive the second dose on schedule. If you must cancel the appointment, make another appointment as close to that date as possible.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using any other medicines given through your nose, or any medicine that weakens the immune system (such as steroids, radiation, or cancer treatment). This vaccine may not work as well if you are also using these medicines. Your doctor may still want you to get the vaccine because it can give you some protection.
• Make sure you doctor knows if you are also using medicine to treat influenza virus infections (such as amantadine, oseltamivir, rimantadine, zanamivir, Flumadine®, Relenza®, Symmetrel®, or Tamiflu®). Wait at least 48 hours after your last dose of antiviral medicine before receiving FluMist®. It is best to wait at least 2 weeks after receiving FluMist® before using any antiviral medicines. Talk with your doctor if you are concerned about this.
• You should not receive any other vaccines at the same time that you receive FluMist®.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have severe asthma or other breathing problems. Tell your doctor if you have kidney disease, heart disease, cancer, diabetes, HIV or AIDS, lung disease, problems with your immune system, or a history of Guillain-Barré syndrome (a severe nerve and muscle problem).
• This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble with breathing after you receive the vaccine.
• Tell your doctor about any health problems or illnesses you have had recently, especially if you have a fever. This vaccine is for use by healthy adults younger than 50 years of age and children 2 years of age and older.
• Tell your doctor if you spend time with a person who has health problems, such as someone you live with. This is especially important if you are often with a person who has problems with his or her immune system. Try to avoid being with anyone who has immune system problems for at least 21 days after you receive this vaccine.
• Children younger than 2 years of age are usually not given the flu vaccine nasal spray. Young children who need the flu vaccine are usually given the flu vaccine injection (a shot).
• This vaccine will not treat flu symptoms if you already have the virus. Also, this vaccine may not protect all persons given the vaccine.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Ear pain or discharge.
• Fever, chills, cough, sore throat, and body aches.
• Troubled breathing.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Headache, or pain around the eyes and cheekbones.
• Irritability.
• Loss of appetite.
• Muscle aches or pain.
• Skin rash.
• Sneezing, or stuffy or runny nose.
• Stomach pain.
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088