FluMist Quadrivalent 2015-2016 Formula (Nasal)

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

There are many types of influenza viruses, but not all will cause issues in any given year. Before the influenza vaccine is made each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services determine which viruses are most likely to cause influenza infections that year. The antigens, which are substances that trigger protective antibodies, for these viruses are included in the influenza vaccine. Usually, the U.S. and Canada use the same influenza vaccine; however, it is not required.

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

Influenza is a viral infection of the throat, bronchial tubes, and lungs. Influenza infection can cause 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, as well as people 50 years of age and older, even if they are healthy, may experience a much more serious illness that could require hospitalization. Each year, thousands of people die because of an influenza infection.

The best way to help prevent influenza infections is to get an influenza vaccination each year, typically 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 should only be given by or under the supervision of your doctor or other health care professional.

It is very important that your child returns to your doctor's office at the right time for the second dose. Be sure to inform your doctor of 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). Also, 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 of age are typically 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 known as anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Inform your doctor right away if you or your child experience 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 individuals or those at increased risk of getting the infection after you or your child receive this vaccine. Discuss any concerns with your doctor.

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

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.

In deciding to use a vaccine, it's important to consider the risks of taking the vaccine compared to the benefits it will provide. This decision will be made together with your doctor. For this vaccine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not shown 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 approved for children younger than 2 years of age.

Children younger than 5 years old who have had one or more episodes of wheezing in the past year may have a higher risk of wheezing after getting the vaccine.

Geriatric

Studies have not been conducted on how age affects the nasal influenza virus vaccine in adults 50 years of age and older. Safety and effectiveness have not been established.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together, even if an interaction might happen. In these situations, your doctor may adjust the dose, or other precautions may be needed. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below when you receive this vaccine. The following interactions are noted based on their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may choose not to use this vaccine or modify 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use 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 medications may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use 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

Some medicines should not be taken around the time of eating food or specific types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about taking your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how well this vaccine works. Be sure to inform 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 worsen these conditions.

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

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

• Severe illness with fever—Should not be given when a 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), a condition that can cause paralysis. Most of these individuals were over 25 years old. Although only 10 out of every one million people who got the vaccine actually developed GBS, this rate was 6 times higher than what was normally expected. Most people with GBS fully recovered.

It is believed that the "swine flu" virus in the 1976 vaccine caused the 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 reports of GBS linked to influenza vaccinations.

Like any medicine, this vaccine can cause some unwanted effects. Not all side effects will occur, but if they do, they may require medical attention.

Contact your doctor or nurse right away if you experience any of the following 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 typically do not require medical attention. These side effects might go away as your body gets used to the medicine. Your healthcare professional may also provide information on how to prevent or lessen some of these side effects. Consult your healthcare professional if any of the following side effects persist or are bothersome, or if you have 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, talk to 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.