Pronunciation:

in-floo-EN-za VYE-rus VAX-een, lyve

Brand Names:

• FluMist Quadrivalent
• FluMist Quadrivalent 2015-2016 Formula

Dosage Forms:

• Spray

Classifications:

Therapeutic—

Vaccine, Live

Uses of This Medicine:

Influenza virus vaccine is used to prevent infection by the influenza viruses. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

There are many kinds of influenza viruses, but not all will cause problems in any given year. Therefore, before the influenza vaccine is produced each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses will most likely cause influenza infections for that year. The antigens, which are substances that cause protective antibodies to be formed, for these viruses are included in the influenza vaccine. Usually, the U.S. and Canada use the same influenza vaccine; however, they are not required to do so.

It is necessary to receive an influenza vaccine each year, since influenza infections are usually caused by different kinds of viruses and the protection gained by the vaccine lasts less than a year.

Influenza is a virus infection of the throat, bronchial tubes, and lungs. Influenza infection causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. In addition, adults and children weakened by other diseases or medical conditions, and persons 50 years of age and over, even if they are healthy, may get a much more serious illness that may have to be treated in a hospital. Each year thousands of people die as a result of an influenza infection.

The best way to help prevent influenza infections is to get an influenza vaccination each year, usually in early November. Immunization (getting a vaccine) against influenza is approved for infants 6 months of age and over, all children, and all adults.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nasal influenza virus vaccine in children 2 years of age and older. However, this vaccine is not indicated for children younger than 2 years of age.

Children younger than 5 years of age with one or more episodes of wheezing in the past year may have an increased risk of wheezing after receiving the vaccination

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of nasal influenza virus vaccine in adults 50 years of age and older. Safety and efficacy have not been established.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

• Aspirin
• Deflazacort
• Thiotepa

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adalimumab
• Alemtuzumab
• Anifrolumab-fnia
• Ansuvimab-zykl
• Antithymocyte Globulin Rabbit
• Atoltivimab
• Axicabtagene Ciloleucel
• Azathioprine
• Baricitinib
• Belatacept
• Bendamustine
• Betibeglogene Autotemcel
• Bortezomib
• Bosutinib
• Brexucabtagene Autoleucel
• Brodalumab
• Cabazitaxel
• Canakinumab
• Capecitabine
• Carboplatin
• Carfilzomib
• Carmustine
• Certolizumab Pegol
• Chlorambucil
• Cisplatin
• Cladribine
• Clofarabine
• Cyclophosphamide
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dasatinib
• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Deucravacitinib
• Docetaxel
• Doxorubicin
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Emapalumab-lzsg
• Epirubicin
• Etanercept
• Etoposide
• Everolimus
• Fingolimod
• Fludarabine
• Fluorouracil
• Gemcitabine
• Gemtuzumab Ozogamicin
• Golimumab
• Guselkumab
• Hyaluronidase
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Imatinib
• Immune Globulin
• Inebilizumab-cdon
• Infliximab
• Interferon Alfa
• Irinotecan
• Irinotecan Liposome
• Ixekizumab
• Leflunomide
• Leniolisib
• Lomustine
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Methotrexate
• Mitomycin
• Mitoxantrone
• Mycophenolic Acid
• Nelarabine
• Nilotinib
• Ocrelizumab
• Ofatumumab
• Oxaliplatin
• Ozanimod
• Paclitaxel
• Paclitaxel Protein-Bound
• Pemetrexed
• Pentostatin
• Peramivir
• Ponatinib
• Ponesimod
• Procarbazine
• Rilonacept
• Risankizumab-rzaa
• Ritlecitinib
• Rituximab
• Rozanolixizumab-noli
• Sarilumab
• Satralizumab-mwge
• Secukinumab
• Siponimod
• Sirolimus
• Spesolimab-sbzo
• Tacrolimus
• Temozolomide
• Teniposide
• Teplizumab-mzwv
• Teriflunomide
• Tildrakizumab-asmn
• Tocilizumab
• Tofacitinib
• Topotecan
• Tositumomab
• Trabectedin
• Tralokinumab-ldrm
• Ublituximab-xiiy
• Upadacitinib
• Ustekinumab
• Valoctocogene Roxaparvovec-rvox
• Vinblastine
• Vinorelbine
• Voclosporin
• Warfarin

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Carbamazepine
• Cytomegalovirus Immune Globulin, Human
• Hepatitis B Immune Globulin
• Rabies Immune Globulin
• Respiratory Syncytial Virus Immune Globulin, Human
• Tetanus Immune Globulin
• Vaccinia Immune Globulin, Human
• Varicella-Zoster Immune Globulin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to eggs, egg products, gentamicin, gelatin, or arginine (an amino acid), history of—Should not be used in patients with severe allergic reactions to these substances.

• Asthma, or
• Diabetes or
• Heart disease or
• Kidney disease or
• Lung disease or
• Wheezing, history of—Use with caution. May make these conditions worse.

• Guillain-Barré syndrome (GBS, a severe nerve and muscle problem), history of—Use with caution. May cause the symptoms of this condition to return.

• Immune system problems (e.g., cancer, HIV)—This vaccine may not work as well if you have weak immune system.

• Severe illness with fever—Should not be given when a fever is present. Your doctor will decide when you are well enough to get your influenza virus vaccine.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a nasal spray.

Use the nasal spray 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 nasal spray, 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.

This vaccine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using This Medicine:

It is very important that your child return to your doctor's office at the right time for the second dose. Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

This vaccine should not be given to children and teenagers (2 to 17 years of age) who are also using aspirin or any medicine that contains aspirin (e.g., 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.

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 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 breathing after you receive the vaccine.

The nasal mist vaccine (FluMist® or FluMist® Quadrivalent) contains a live virus. Avoid contact with people who are sick or at increased risk of getting the infection after you or your child receive this vaccine. Talk to your doctor about this if you have concerns.

Influenza virus vaccine will not treat flu symptoms if you already have the virus. Also, this vaccine may not protect all persons given the vaccine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

In 1976, a number of people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), which is a disease that may cause paralysis. Most of these people were over 25 years of age. Although only 10 out of every one million people who received the vaccine actually developed GBS, this number was 6 times higher than would normally have been expected. Most of the people who got GBS recovered completely.

It is assumed that the “swine flu” virus included in the 1976 vaccine caused the problem, but this has not been proven. Since that time, the “swine flu” virus has not been used in influenza vaccines, and there has been no recurrence of GBS that was associated with influenza vaccinations.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Chills

cough

decreased appetite

fever

headache

muscle aches

sore throat

stuffy or runny nose

tiredness or weakness

Less common

Earache

pain or tenderness around the eyes and cheekbones

redness or swelling in the ear

shortness of breath or troubled breathing

sneezing

tightness of the chest or wheezing

Rare

Difficulty with breathing or swallowing

hives

itching, especially of the feet or hands

reddening of the skin, especially around the ears

swelling of the eyes, face, or inside of the nose

unusual tiredness or weakness (sudden and severe)

Incidence not known

Anxiety

bloody nose

blue or pale skin

chest pain, possibly moving to the left arm, neck, or shoulder

confusion

diarrhea

dizziness

drowsiness

fast heartbeat

general feeling of illness

hoarseness

inability to move the arms and legs

irritation

itching

joint pain, stiffness, or swelling

nausea

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

severe headache

skin rash

stiff neck and/or back

sudden numbness and weakness in the arms and legs

swelling or puffiness of the face

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual tiredness or weakness

vomiting

weakness of the muscles in your face

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain

irritability

loss of appetite

Incidence not known

Welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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