FluMist Quadrivalent 2015-2016 Formula

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.

Pediatric

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

Geriatric

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.

Pregnancy

Breast Feeding

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

Interactions with 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
• Antithymocyte Globulin Rabbit
• Azathioprine
• Bendamustine
• Bortezomib
• Bosutinib
• Brodalumab
• Cabazitaxel
• Capecitabine
• Carboplatin
• Carfilzomib
• Carmustine
• Certolizumab Pegol
• Chlorambucil
• Cisplatin
• Cladribine
• Clofarabine
• Cyclophosphamide
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dasatinib
• Daunorubicin
• Daunorubicin Citrate Liposome
• Docetaxel
• Doxorubicin
• Dupilumab
• Epirubicin
• Etanercept
• Etoposide
• Everolimus
• Fingolimod
• Fludarabine
• Fluorouracil
• Gemcitabine
• Gemtuzumab Ozogamicin
• Golimumab
• Guselkumab
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Imatinib
• Immune Globulin
• Infliximab
• Interferon Alfa
• Irinotecan
• Irinotecan Liposome
• Leflunomide
• Lomustine
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Methotrexate
• Mitomycin
• Mitoxantrone
• Mycophenolic Acid
• Nelarabine
• Nilotinib
• Ofatumumab
• Oxaliplatin
• Paclitaxel
• Paclitaxel Protein-Bound
• Pemetrexed
• Pentostatin
• Peramivir
• Ponatinib
• Procarbazine
• Rilonacept
• Rituximab
• Sarilumab
• Secukinumab
• Sirolimus
• Temozolomide
• Teniposide
• Teriflunomide
• Tocilizumab
• Topotecan
• Tositumomab
• Trabectedin
• Ustekinumab
• Vinblastine
• Vinorelbine
• 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
• Vaccinia Immune Globulin, Human

Interactions with Food/Tobacco/Alcohol

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.

This section provides information on the proper use of a number of products that contain influenza virus vaccine, live. It may not be specific to FluMist Quadrivalent 2015-2016 Formula. Please read with care.

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.

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.