Influenza virus vaccine, live (Nasal)

Influenza virus vaccine is used to prevent infection from influenza viruses. The vaccine helps your body make its own protection (antibodies) against the disease.

There are many types of influenza viruses, but not all cause problems each year. Before the influenza vaccine is made each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses are most likely to cause infections that year. The antigens, which are substances that help form protective antibodies, for these viruses are included in the influenza vaccine. Usually, the U.S. and Canada use the same influenza vaccine, but they are not required to.

You need to get an influenza vaccine every year because influenza infections are often caused by different viruses, and the protection from the vaccine lasts less than a year.

Influenza is a viral infection that affects the throat, bronchial tubes, and lungs. It causes symptoms like fever, chills, cough, headache, muscle aches, and pain in your back, arms, and legs. Additionally, adults and children who are weakened by other diseases or medical conditions, and people aged 50 and over, even if they are healthy, may experience a much more serious illness that could require hospital treatment. Each year, thousands of people die from influenza infections.

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

This vaccine must be given only by or under the supervision of your doctor or another health care professional.

It is very important that your child returns to your doctor's office at the correct time for the second dose. Be sure to let your doctor know about any side effects that happen after receiving this vaccine.

This vaccine should not be given to children and teenagers (2 to 17 years of age) who are taking aspirin or any medicine that contains aspirin (e.g., Aggrenox®, Ecotrin®, Excedrin®, Soma® Compound, and many cold medicines). Additionally, children and teenagers should not be given aspirin for 4 weeks after getting FluMist® or FluMist® Quadrivalent unless your doctor advises otherwise.

Children younger than 2 years old are generally not given the flu vaccine nasal spray. Young children who need the flu vaccine usually receive the flu vaccine injection (a shot).

This vaccine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble breathing after receiving the vaccine.

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

Influenza virus vaccine will not treat flu symptoms if you already have the virus. Also, this vaccine may not protect everyone who receives it.

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

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine versus the benefits it provides.

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this vaccine or any other medications. Also, let your healthcare provider know about any other allergies, including allergies to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not found any specific problems that would limit the use of the nasal influenza virus vaccine in children 2 years of age and older. However, this vaccine is not for children younger than 2 years old.

Children under 5 years old who have had wheezing episodes in the past year may be at a higher risk of wheezing after getting the vaccine.

Geriatric

There have not been studies on how the nasal influenza virus vaccine affects adults aged 50 years and older. The safety and effectiveness of this vaccine in this age group have not been established.

Breast Feeding

Research indicates that this vaccine poses minimal risk to infants when used by breastfeeding mothers.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a risk of interaction. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the medicines listed below when you receive this vaccine. The following interactions are significant but may not include all possibilities.

It is not recommended to receive this vaccine with the following medicines. Your doctor may choose not to administer this vaccine or adjust your other medications.

• Aspirin
• Deflazacort
• Thiotepa

It is usually not recommended to receive this vaccine with the following medicines, but it may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both medicines.

• Adalimumab
• Alemtuzumab
• Anifrolumab-fnia
• Ansuvimab-zykl
• Antithymocyte Globulin Rabbit
• Atoltivimab
• Axicabtagene Ciloleucel
• Azathioprine
• Baricitinib
• Belatacept
• Bendamustine
• Betibeglogene Autotemcel
• Bimekizumab-bkzx
• 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
• Etrasimod
• 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
• Mirikizumab-mrkz
• 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
• Vamorolone
• Vinblastine
• Vinorelbine
• Voclosporin
• Warfarin

Receiving this vaccine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both are prescribed, your doctor may adjust the dose or frequency for one or both 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtimes or with specific foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare provider about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this vaccine. Be sure to inform your doctor about any other medical problems you have, 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 worsen these conditions.

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

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

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

In 1976, some people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), which is a condition that can lead to paralysis. Most of these individuals were over 25 years old. Although only 10 out of every one million people who got the vaccine developed GBS, this rate was 6 times higher than what was usually expected. Most people who experienced GBS made a full recovery.

It is believed that the “swine flu” virus in the 1976 vaccine caused this issue, but this has not been confirmed. Since then, the “swine flu” virus has not been included in influenza vaccines, and there have been no cases of GBS linked to influenza vaccinations since that time.

Like all medicines, this vaccine may cause some side effects, and while not everyone experiences them, those that do may require medical attention.

Contact your doctor or nurse right away if you notice any of these side effects:

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 vaccine. Your healthcare professional may also provide information on how to prevent or reduce some of these side effects. Contact your healthcare professional if any of the following side effects persist 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 happen in some patients. If you notice any other effects, consult your healthcare professional.

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

In the U.S.

• FluMist Quadrivalent
• FluMist Quadrivalent 2015-2016 Formula

Available Dosage Forms:

• Spray

Therapeutic Class: Vaccine, Live

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.