Fluzone 2015-2016 Formula (Intradermal, Intramuscular)

Influenza virus vaccine is used to prevent infection by the influenza viruses. The vaccine helps your body make its own protection (antibodies) against the disease. It is also known as a "flu shot."

There are many types of influenza viruses, but not all will cause problems each year. Before making the influenza vaccine each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses are most likely to cause influenza infections that year. The antigens, which help your body make 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 do so.

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

Influenza is a virus infection of the throat, bronchial tubes, and lungs. It causes fever, chills, cough, headache, muscle aches, and pain in your back, arms, and legs. Adults and children who are weakened by other diseases or medical conditions, as well as people 50 years and older, 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 (including those 65 years of age and older).

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

It is very important for your child to return to your doctor’s office at the appropriate time if a second dose of the vaccine is needed. Make sure to inform your doctor about any side effects that occur after you or your child receive this vaccine.

This vaccine may cause a serious allergic reaction known as anaphylaxis, which can be life-threatening and requires immediate medical attention. Contact your doctor right away if you or your child experience a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of the hands, face, or mouth after the injection.

Children who received a specific brand of the influenza vaccine (Afluria®, Afluria® Quadrivalent) have experienced fever, and in some instances, fever with seizures. Discuss any concerns with your doctor.

If you are very sick and have a high fever, you will likely need to wait until you are feeling better before receiving this vaccine.

The influenza virus vaccine may not protect everyone who receives it. It also will not treat flu symptoms if you already have the virus.

The tip cap of the prefilled syringe for certain brands of the injection (Agriflu®, Flucelvax®, Fluvirin®, Fluzone®, Fluzone® High-Dose) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals who are sensitive to latex. Inform your doctor if you or your child have a latex allergy before receiving this vaccine.

Let your doctor know if you or your child are taking any medicine or treatment that weakens your immune system, including steroids, radiation, or cancer treatment. This vaccine may not work as effectively if you are undergoing these treatments. Your doctor may still recommend the vaccine because it can provide some protection.

In deciding to use a vaccine, you must consider the risks of taking the vaccine against the benefits it will provide. This is a decision to be made with your doctor. For this vaccine, the following should be kept in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies to determine how Agriflu®, Flulaval™, Fluzone® High-Dose, Fluzone® Intradermal, or Fluzone® Intradermal Quadrivalent affects children. Safety and effectiveness are not known.

There have not been enough studies to determine how Fluvirin® affects children younger than 4 years old. Safety and effectiveness are not known.

There have not been enough studies to determine how Fluarix® affects children younger than 3 years old. Safety and effectiveness are not known.

There have not been enough studies to determine how Afluria®, Afluria® Quadrivalent, Fluarix® Quadrivalent, Flucelvax® Quadrivalent, Flulaval® Quadrivalent, Fluzone®, or Fluzone® Quadrivalent affects children younger than 6 months old. Safety and effectiveness are not known.

Geriatric

Studies to date have not shown any problems specific to older adults that would limit the use of the influenza virus vaccine in this age group.

There have not been enough studies to determine how Fluzone® Intradermal or Fluzone® Intradermal Quadrivalent affects older adults. Safety and effectiveness are not known.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In these cases, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this vaccine. The following interactions have been highlighted because of their potential importance, but they may not include all possible interactions.

Receiving this vaccine with any of the following medicines may lead to a higher risk of certain side effects, but using both may be the best option for you. If both medicines are prescribed together, your doctor might adjust the dose or frequency of one or both medicines.

• Rituximab

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at the same time as eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines might also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this vaccine. Make sure to inform your doctor if you have any other medical problems, especially:

• Allergy to eggs, egg products, or chicken proteins, history of—Should not be used in patients with this condition.

• Bleeding problems (e.g., hemophilia, thrombocytopenia)—Use with caution. May have a higher risk of bleeding at the injection site.

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

• Illness with fever, moderate or severe—You may need to wait until you feel better before receiving the vaccine.

• Immune system problems from a disease or medicine—May not work as well in patients with this condition.

• Kanamycin, neomycin, or polymyxin allergy, history of—Only certain brands of the influenza vaccine can be used. Discuss this with your doctor.

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 expected. Most people who experienced GBS recovered fully.

It is believed that the “swine flu” virus in the 1976 vaccine caused this issue, but this has not been confirmed. Since then, studies have indicated that the risk of getting GBS from an influenza vaccine is very low (one out of every million people).

Along with its necessary effects, a medicine may also cause some unwanted effects. Not all side effects may happen, but if they do, they may require medical attention.

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

More common

• Bruising, hard lump, redness, or pain at the injection site
• cough
• diarrhea
• fever
• headache
• irritability
• large, flat, blue or purplish patches in the skin
• loss of appetite
• muscle aches
• redness of the eyes
• sneezing
• sore throat
• stuffy or runny nose
• vomiting

Less common

• Body aches or pain
• chest tightness
• chills
• difficulty with breathing
• earache
• ear congestion
• loss of voice
• shivering
• swelling or puffiness of the face
• unusual tiredness or weakness

Rare

• Difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, lips, or tongue

Incidence not known

• Agitation
• back pain, sudden and severe
• back, leg, or stomach pains
• blistering, peeling, or loosening of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• chest pain
• clumsiness or unsteadiness
• confusion
• drowsiness
• dryness of the throat
• fainting
• feeling hot
• increased sensitivity of the eyes to sunlight
• inflammation, rash, swelling, or tenderness at the injection site
• lightheadedness
• nosebleeds
• pain, redness, soreness, swelling, tenderness, or warmth on the skin
• pinpoint red spots on the skin
• redness of the face, neck, arms, and occasionally, upper chest
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• sores, ulcers, or white spots in the mouth or on the lips
• sores, welts, or blisters
• stomach pain, soreness, or discomfort
• sweating
• trouble sleeping
• unusual bleeding or bruising
• voice changes
• weakness of the muscles in your face
• yellowing of the eyes or skin

Some side effects may happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also have ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Difficulty in moving
• joint pain
• muscle aches, cramping, pains, or stiffness
• swollen joints

Incidence not known

• Sleepiness or unusual drowsiness

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.

In the U.S.

• Afluria 2015-2016 Formula
• Fluarix Quadrivalent 2013-2014 Formula
• Fluarix Quadrivalent 2015-2016 Formula
• Flucelvax 2015-2016 Formula
• Flulaval Quadravalent 2013-2014 Season
• FluLaval Quadrivalent 2015-2016 Formula
• Fluvirin 2015-2016 Formula
• Fluzone 2013-2014 Formula
• Fluzone 2015-2016 Formula
• Fluzone High Dose 2015-2016 Formula
• Fluzone Intradermal Quadrivalent 2014-2015 Formula
• Fluzone Intradermal Quadrivalent 2015-2016 Formula

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

A nurse or other trained health professional will give you or your child this vaccine. It is given as a shot into one of your muscles or into your skin, usually in the upper arm.

Sometimes there is not enough flu vaccine for everyone. If this happens and you are a healthy adult, you might need to wait until later in the flu season before getting your vaccination.

You need to get the flu vaccine every year to protect you from the flu.

Some children may need a second dose of the vaccine. If your child needs a second dose of the vaccine, it is very important for your child to receive the second dose on schedule. If you must cancel the appointment, make another appointment as soon as possible.

Fluzone® Intradermal Quadrivalent and Fluzone® Quadrivalent come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

• How and where is a flu shot injection given?
• Flu Vaccines and Egg Allergy: Which Are Safe?
• Which flu vaccines are available this year?
• Where Can I Get a Flu Shot Near Me?
• How well does the flu vaccine work?
• How can I get a flu vaccine without a needle?
• What is the difference between Flublok and Flublok Quadrivalent?

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