Influenza Virus Vaccine Live, Intranasal

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KEY POINTS

• This medicine is sprayed in the nose to provide protection against the flu. The nasal spray flu vaccine is not recommended for the 2016-2017 flu season.
• For 1 month after getting this vaccine, avoid close contact with people with HIV infection, cancer, leukemia, or lymphoma, and do not have any other vaccines without your healthcare provider's approval.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: vaccine

Generic and brand names: influenza virus vaccine live, intranasal; FluMist Quadrivalent

What is this medicine used for?

This medicine is sprayed in the nose to provide protection against the flu virus for children and adults between the ages of 2 and 49.

Everyone 6 months and older should receive the flu vaccine each year. It is very important for these people to get the flu vaccine:

• Adults 50 years of age and older
• Children younger than 5 years of age
• Children and teens on long-term aspirin therapy
• People who work in healthcare
• People who live in nursing homes, dormitories, or other facilities
• Women who are pregnant or will be pregnant during the flu season
• People with chronic medical problems or whose immune systems may be impaired
• School teachers and other community workers with close, daily contact with the public
• Household contacts or caregivers of children less than 5 years of age (especially contacts of children less than 6 months of age), adults over 50 years of age, or people who are at high risk for complications from the flu
• People who are morbidly obese

Some people should get the flu shot rather than the nasal spray:

• Adults 50 years of age and older or children between 6 months and 2 years of age
• Children younger than 5 years of age with asthma or one or more episodes of wheezing within the past year
• People with chronic medical problems, such as asthma, blood disorders, heart disease, lung disease, kidney disease, liver disease, and diabetes
• People with spinal cord injuries, or nerve or muscle disorders that affect breathing
• People whose immune systems may be impaired, such as by certain medicines, HIV, cancer, or an organ transplant
• People with close contact with someone who has a weakened immune system
• Children and teens on long-term aspirin therapy
• Pregnant women

What should my healthcare provider know before I take this medicine?

Before receiving this medicine, tell your healthcare provider if you have ever had:

• An allergy to any medicine or vaccine, or to eggs, gelatin, or arginine
• Asthma or any other lung disease
• Diabetes
• Guillain-Barré syndrome
• Heart problems
• Kidney or liver problems

Tell your healthcare provider if you currently have a fever or infection of any kind, or any sinus problems or a stuffy nose. Also talk with the provider if the you have a weakened immune system from diseases such as HIV/AIDS or from cancer chemotherapy, radiation therapy, or taking steroid medicine.

Also, tell your healthcare provider if you have received any other vaccine within the past 4 weeks, or taken flu medicine in the past 2 days.

Children and teens from 2 through 17 years of age who are taking aspirin or products that contain aspirin should not receive the nasal spray vaccine. They should receive the flu shot. Talk with your healthcare provider about this.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Your healthcare provider may advise a flu shot rather than the nasal spray as a safer way to protect you from the flu. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while receiving this medicine without your healthcare provider's approval.

How do I use it?

This medicine must be given by a healthcare provider. You can get vaccinated any time during flu season. It is best to get the flu vaccine in October of each year for full protection.

This flu vaccine is sprayed into your nose. You can breathe normally while getting vaccine. You do not need to inhale or “sniff” it.

Children aged 2 years through 8 years of age may need 2 doses of this flu vaccine at least 4 weeks apart if they have not been vaccinated before. Your healthcare provider will decide if your child needs to come back for a second dose. Keep all appointments.

People aged 9 to 49 years old need 1 dose per flu season.

What should I watch out for?

This vaccine contains live virus. Avoid close contact with people with conditions such as HIV infection, cancer, leukemia, or lymphoma. Also, do not have any other vaccines for 1 month after getting this vaccine without getting your healthcare provider's approval first.

The flu vaccine reduces your risk of getting the flu, but may not completely protect you. You still have a small chance of getting the flu even after a flu vaccine. If you do get the flu, your symptoms should be less severe, and you are less likely to develop complications. The flu vaccine will not protect against colds or viruses other than the flu.

Do not use any other nasal sprays unless your healthcare provider approves. This includes nonprescription products.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness in your chest, swelling of your lips, tongue or throat, trouble breathing).

Serious (Report these to your healthcare provider right away.): High fever, chest congestion, wheezing.

Other: Fever, runny nose, stuffy nose, sore throat, cough, irritability, headache, chills, vomiting, loss of appetite, muscle aches, tiredness, earache.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antiviral medicines to treat influenza such as amantadine, oseltamivir (Tamiflu), and rimantadine (Flumadine)
• Aspirin and medicines that contain aspirin (Do not take any aspirin for at least 4 weeks after this vaccine unless your healthcare provider tells you otherwise. Children 18 years or younger should not be given aspirin in any form for any reason unless told by your healthcare provider.)
• Cancer medicines such as cisplatin, doxorubicin (Doxil), hydroxyurea (Droxia, Hydrea), vinblastine, and vincristine (Marqibo)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Everolimus (Afinitor, Zortress)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), tacrolimus (Astagraf, Prograf, Protopic), and temsirolimus (Torisel)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), belimumab (Benlysta), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), and leflunomide (Arava)
• Other vaccines

Keep a record of all vaccines received and when you received them.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.