Influenza virus vaccine, live (Into the nose)

Introduction

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

This vaccine is for adults younger than 50 years and children older than 2 years to prevent influenza virus (the flu).

Brand Name(s)

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

Do not receive this vaccine if you have had an allergic reaction to influenza vaccine (a flu shot), eggs, egg products, gentamicin (Garamycin®), gelatin, or arginine (an amino acid). This vaccine should not be given to a person younger than 17 years of age who is also taking aspirin or any medicine that contains aspirin (such as Aggrenox®, Ecotrin®, Excedrin®, Soma® Compound, and many cold medicines). Also, children and teenagers should not be given aspirin for 4 weeks after getting FluMist® or FluMist® Quadrivalent, unless your doctor tells you otherwise.

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.
• Children 2 to 8 years of age who have not received the nasal vaccine before should receive 2 doses at least 1 month apart. If your child needs a second dose of this vaccine, it is very important for him to receive the second dose on schedule. If you must cancel the appointment, make another appointment as close to that date as possible.
• 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 1 dose of this vaccine.

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 you receive FluMist®. Wait at least 2 weeks after you receive FluMist® or FluMist® Quadrivalent before you use any antiviral medicines. Talk with your doctor if you are concerned about this.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have 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).
• Tell your doctor about any health problems or illnesses you have had recently, especially if you have a fever.
• Tell your doctor if you live with or spend time with a person who has a weak immune system.
• Children younger than 2 years 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).
• Children younger than 5 years with a history of wheezing may experience wheezing after receiving the vaccine. Persons of any age with asthma may experience wheezing after receiving the vaccine.
• This vaccine will not treat flu symptoms if you already have the virus. Also, this vaccine may not protect all persons who receive it.

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
• Fever, chills, cough, and body aches
• Trouble breathing
• Unusual muscle weakness

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

• Headache
• Sneezing, or stuffy or runny nose
• Sore throat
• Tiredness or weakness

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