Fluzone High Dose 2015-2016 Formula (Intradermal, Intramuscular)

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

There are many types of influenza viruses, but not all will be a problem each year. Before the influenza vaccine is made each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses are most likely to cause infections that year. The vaccine includes antigens, which are substances that trigger the production of protective antibodies, for these viruses. Typically, the U.S. and Canada use the same influenza vaccine, but they are not required to do so.

It is important to get an influenza vaccine injection each 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 viral infection of the throat, bronchial tubes, and lungs. It can cause fever, chills, cough, headache, muscle aches, and pain in your back, arms, and legs. Adults and children who are already weakened by other diseases or medical conditions, as well as people 50 years of age and older, even if they are healthy, may suffer a more serious illness that could require hospitalization. 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 of age and older, all children, and all adults (including those 65 years of age and older).

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

It is very important that your child goes back to your doctor’s office at the right time if they need a second dose of the vaccine. Be sure to inform your doctor about any side effects that happen after you or your child receive this vaccine.

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

Children who have received a certain brand of the influenza vaccine (Afluria®, Afluria® Quadrivalent) have developed a fever and in some cases a fever with seizures. Talk with your doctor if you are concerned about this.

If you are very sick and have a high fever, you will probably need to wait until you are well before you get this vaccine.

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 people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you receive this vaccine.

Tell your doctor if you or your child are using a medicine or treatment that weakens your immune system, including steroids, radiation, or cancer treatment. This vaccine may not work as well if you are also using these treatments. Your doctor may still want 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 and benefits. 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 enough studies on how Agriflu®, Flulaval™, Fluzone® High-Dose, Fluzone® Intradermal, or Fluzone® Intradermal Quadrivalent affect children. We do not know if they are safe or effective for this age group.

There have not been enough studies on how Fluvirin® affects children younger than 4 years of age. We do not know if it is safe or effective for this age group.

There have not been enough studies on how Fluarix® affects children younger than 3 years of age. We do not know if it is safe or effective for this age group.

There have not been enough studies on how Afluria®, Afluria® Quadrivalent, Fluarix® Quadrivalent, Flucelvax® Quadrivalent, Flulaval® Quadrivalent, Fluzone®, or Fluzone® Quadrivalent affect children younger than 6 months of age. We do not know if they are safe or effective for this age group.

Geriatric

So far, studies have not found any specific problems that would limit the use of the influenza virus vaccine in older adults.

There have not been enough studies on how Fluzone® Intradermal or Fluzone® Intradermal Quadrivalent affect older adults. We do not know if they are safe or effective for this age group.

Breast Feeding

There are not enough studies in women to determine any risks to infants when using this medication while breastfeeding. Consider the possible benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there is a chance of interaction. Your doctor may want to adjust the dose or take other precautions if you are getting this vaccine and also taking any of the medicines listed below. The following interactions are significant and may not be a complete list.

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

• Rituximab

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food as interactions may happen. Using alcohol or tobacco with some medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this vaccine. Be sure to inform 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, as there may be a higher risk of bleeding at the injection site.

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

• Moderate or severe illness with fever—You may need to wait until you are feeling better before getting the vaccine.

• Immune system problems due to a disease or medication—The vaccine may not work as well in these patients.

• History of allergy to kanamycin, neomycin, or polymyxin—Only certain brands of the influenza vaccine can be used. Talk with your doctor about this.

In 1976, some people who got the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), a disease that can cause paralysis. Most affected were over 25 years old. Although only 10 out of every one million vaccinated people developed GBS, this was 6 times more than expected. Most people with GBS recovered fully.

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

Along with its beneficial effects, a medicine may cause some unwanted effects. Not all side effects may occur, but if they do, they may need 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 occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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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