Influenza virus vaccine (nasal)

Influenza virus ("the flu") is a contagious illness caused by a virus that spreads easily from person to person through the air or on surfaces. Symptoms of the flu include fever, chills, tiredness, body aches, sore throat, cough, vomiting, and diarrhea. The flu can also lead to sinus infections, ear infections, bronchitis, or serious complications like pneumonia.

Influenza results in thousands of deaths each year and hundreds of thousands of hospital visits. It is especially dangerous for children, pregnant women, older adults, and people with weakened immune systems or health issues such as diabetes, heart disease, or cancer.

Influenza virus nasal vaccine (nasal flu vaccine) is intended for people aged 2 to 49 years to help prevent infection caused by the influenza virus. This vaccine helps your body build immunity to the flu but will not treat an active infection you may already have.

The influenza virus vaccine is updated each year to include the specific strains of the flu virus recommended by public health officials for that year.

The nasal influenza virus vaccine is made from "live viruses." The influenza virus vaccine is also available as an injection (flu shot), which is a "killed virus" vaccine. This medication guide focuses only on the nasal form of the vaccine.

Like any vaccine, the nasal flu vaccine may not protect every person from the disease.

Read all vaccine information sheets provided to you.

A healthcare provider may give you this vaccine or may teach you how to use it yourself.

Do not use in the eyes, mouth, or on your skin.

This vaccine is given as a nasal spray into each nostril.

Read and follow all Instructions for Use. Call your pharmacist if the vaccine looks cloudy, has changed colors, or has particles in it. Ask your doctor or pharmacist if you do not understand how to give the vaccine.

This vaccine should not be given to anyone younger than 17 years of age.

Children ages 2 to 8 years old may need a second dose, at least 1 month after the first nasal vaccine.

The influenza vaccine is usually given in September or October for most people who need only one dose during the season. Follow your doctor's instructions or the schedule recommended by your local health department.

Since the influenza virus vaccine is redeveloped each year for specific strains of influenza, you should receive a flu vaccine every year.

Read and carefully follow the instructions provided with this vaccine about how to safely dispose of the vaccine. Do not reuse the nasal spray.

Store in the original container in the refrigerator, do not freeze. Protect from light.

The vaccine may also be stored at room temperature away from moisture and heat. Do not leave the vaccine out for longer than 12 hours.

This vaccine is made from "live viruses" and may cause mild flu-like symptoms.

You should not get this vaccine if you are allergic to eggs, or if you have:

• a history of severe allergic reaction to any flu vaccine; or
• if you are between 2 and 17 years old and have recently taken aspirin or medicines that contain aspirin.

The nasal flu vaccine is not approved for use by children younger than 2 years or adults older than 49 years.

You should not receive a nasal flu vaccine if you have used:

• oseltamivir (Tamiflu) or zanamivir (Relenza) in the past 48 hours or 2 weeks after your vaccine;
• peramivir (Rapivab) in the past 5 days; or
• baloxavir (Xofluza) in the past 17 days.

You may not be able to receive this vaccine if you have certain medical conditions. Tell the vaccination provider if you have:

• a fever;
• asthma, wheezing, or other breathing or lung problems;
• (for children younger than 5 years) a history of wheezing;
• a history of Guillain-Barré syndrome within 6 weeks after receiving a flu vaccine;
• a weak immune system (or if someone in your household has a weak immune system);
• heart problems;
• a neurologic disorder;
• a nerve-muscle disorder, such as myasthenia gravis, ALS (Lou Gehrig's disease), multiple sclerosis, or muscular dystrophy;
• no spleen or a spleen that doesn't work;
• a cochlear implant;
• a cerebrospinal fluid (CSF) leak (a leak of the fluid around the brain);
• diabetes; or
• liver or kidney disease.

If you cannot get a nasal influenza vaccine due to a medical condition, you may be able to receive an injectable influenza vaccine (flu shot) instead.

You can still receive a vaccine if you have a minor cold. If you have a more severe illness with a fever or any type of infection, wait until you feel better before getting this vaccine.

Tell your vaccination provider if you are pregnant or breastfeeding.

The nasal flu vaccine is not recommended for use in pregnant women. However, the Centers for Disease Control and Prevention recommends that pregnant women get a flu shot during any trimester of pregnancy to protect themselves and their newborn babies from the flu.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

The vaccination provider may want to monitor you for a short period after giving the vaccine to ensure you do not have an allergic reaction. You will be treated quickly if there is a reaction right after you receive the vaccine.

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

Keep a record of any and all side effects you experience. If you receive a nasal flu vaccine in the future, you need to inform the vaccination provider if the previous shot caused any side effects.

Nasal flu vaccine is made from "live viruses" and may lead to mild flu-like symptoms. You might have flu-like symptoms during flu season that could be due to other strains of the influenza virus.

Call a doctor immediately or seek emergency medical help if the person who received this vaccine has:

• wheezing or trouble breathing; or
• feels dizzy, has vision changes, or has ringing in the ears after receiving the vaccine.

Common side effects of influenza virus vaccine may include:

• fever over 100 degrees F;
• chills;
• runny or stuffy nose;
• sore throat, cough;
• loss of appetite;
• muscle pain;
• headache; or
• feeling tired or irritable.

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

Usual Adult Dose for Influenza Prophylaxis:

PATIENTS UP TO 49 YEARS: 0.2 mL intranasally onceComments:-The dose should be administered as a 0.1 mL dose per nostril.-Active inhalation (sniffing) is not needed during administration.Use: Active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine

Usual Pediatric Dose for Influenza Prophylaxis:

PATIENTS 2 TO 8 YEARS: 0.2 mL intranasally once OR in two-0.2 mL separate dosesPATIENTS 9 YEARS AND OLDER: 0.2 mL intranasally onceComments:-The dose should be administered as a 0.1 mL dose per nostril.-If administering 2 doses, doses should be given at least 1 month apart.-The Advisory Committee on Immunization Practices (ACIP) should be consulted regarding annual recommendations to determine the number of doses.-Active inhalation (sniffing) is not needed during administration.Use: Active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine

Call your doctor if you forget to get your yearly influenza virus vaccine (nasal), or if your child misses a booster dose.

An overdose of this vaccine is unlikely to happen.

For at least 2 weeks after getting this vaccine, do not use antiviral flu medications (like amantadine, oseltamivir, rimantadine, zanamivir, Flumadine, Tamiflu, Relenza).

For at least 7 days after receiving a nasal flu vaccine, do not have close contact with anyone who has a weak immune system due to conditions like cancer or HIV, or because they are using steroids, chemotherapy, radiation, or other treatments that can weaken the immune system. People with weak immune systems can get sick if they are close to you after you have recently received a live vaccine.

Anyone aged 2 to 17 years who gets a nasal flu vaccine should not take aspirin for at least 4 weeks after the vaccine. Taking aspirin with the nasal flu vaccine may lead to a serious or fatal condition known as Reye's syndrome.

Before you get this vaccine, inform your vaccination provider about any other vaccines you have recently had.

Other medications may impact the influenza virus nasal vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.