Fluzone Intradermal Quadrivalent 2014-2015 Formula (Intradermal, Intramuscular)

Influenza virus vaccine is used to prevent infection by influenza viruses. The vaccine helps your body create its own defense (antibodies) against the disease. It is also called a “flu shot.”

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 infections that year. The vaccine includes antigens, which are substances that trigger the formation of protective antibodies, for these viruses. Generally, 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 usually caused by different types of viruses, and the protection from the vaccine lasts less than a year.

Influenza is a viral infection affecting the throat, bronchial tubes, and lungs. It leads to fever, chills, cough, headache, muscle aches, and pain in your back, arms, and legs. Additionally, adults and children with other diseases or medical conditions, as well as people aged 50 and older, even if they are healthy, may experience a much more serious illness that might require hospital treatment. Every year, thousands of people die from influenza infections.

The best way to help prevent influenza infections is to get an influenza vaccination each year, usually in early November. Immunization (getting a vaccine) against influenza is approved for infants 6 months and older, all children, and all adults (including those 65 years and older).

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

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

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

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

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

The influenza virus vaccine may not protect everyone who gets 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 people who are sensitive to latex. Inform your doctor if you or your child have a latex allergy before receiving this vaccine.

Notify your doctor if you or your child are using a medicine or treatment that weakens your immune system, like steroids, radiation, or cancer treatment. This vaccine may not be as effective if you are using these treatments. However, your doctor may still advise you to get the vaccine because it can provide some protection.

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine against the benefits it provides. Here are some important points to think about:

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 if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on the effects of Agriflu®, Flulaval™, Fluzone® High-Dose, Fluzone® Intradermal, or Fluzone® Intradermal Quadrivalent in children. Safety and effectiveness have not been established.

There have not been appropriate studies on the effects of Fluvirin® in children under 4 years old. Safety and effectiveness have not been established.

There have not been appropriate studies on the effects of Fluarix® in children under 3 years old. Safety and effectiveness have not been established.

There have not been appropriate studies on the effects of Afluria®, Afluria® Quadrivalent, Fluarix® Quadrivalent, Flucelvax® Quadrivalent, Flulaval® Quadrivalent, Fluzone®, or Fluzone® Quadrivalent in children under 6 months old. Safety and effectiveness have not been established.

Geriatric

Studies so far have not found any specific problems in older adults that would limit the usefulness of the influenza virus vaccine.

There have not been appropriate studies on the effects of Fluzone® Intradermal or Fluzone® Intradermal Quadrivalent in older adults. Safety and effectiveness have not been established.

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 while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if there might be an interaction. If you are receiving this vaccine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not all-inclusive.

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 medicines are prescribed together, your doctor may adjust the dose or how often you take one or both.

• Rituximab

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this vaccine. Be sure to tell your doctor if you have any other medical issues, 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. There may be a higher risk of bleeding at the injection site.

• Guillain-Barré syndrome (severe nerve and muscle problem), history of—Use with caution. This 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 getting the vaccine.

• Immune system problems from a disease or medicine—It 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. Talk with your doctor about this.

In 1976, some people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), 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 actually developed GBS, this number was 6 times higher than expected. Most people who had GBS fully recovered.

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

Like any medication, a vaccine can cause some unwanted effects. While not everyone experiences these side effects, if they do happen, they might require medical attention.

Contact your doctor or nurse right away if you experience any of the following side effects:

More common

• Bruising, hard lump, redness, or pain at the injection site
• cough
• diarrhea
• fever
• headache
• irritability
• large, flat, blue or purplish patches on 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
• sudden and severe back pain
• back, leg, or stomach pains
• blistering, peeling, or loosening of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling sensations
• 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 might happen but usually do not need medical care. These side effects may go away as your body adjusts to the vaccine. Additionally, your healthcare professional may have suggestions to help prevent or lessen some of these side effects. Speak with your healthcare professional if any of the following side effects persist, are bothersome, or if you have any questions about them:

More common

• Difficulty 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, consult with your healthcare professional.

Contact 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.

• 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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