Fluzone Intradermal Quadrivalent 2015-2016 Formula (Intradermal, Intramuscular)

Influenza virus vaccine is used to prevent infections caused 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 each year. Before making the influenza vaccine 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 the antigens, which are substances that stimulate the formation of protective antibodies, for these viruses. 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 typically 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 can cause fever, chills, cough, headache, and muscle aches, as well as pain in your back, arms, and legs. Additionally, adults and children with other diseases or medical conditions, and people aged 50 and older, even if healthy, may face 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 receive an influenza vaccination each year, typically in early November. Immunization 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 for your child to return to the 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 can cause a serious allergic reaction called anaphylaxis, which can be life-threatening and needs immediate medical help. Tell your doctor right away if you or your child experience 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 specific brand of the influenza vaccine (Afluria®, Afluria® Quadrivalent) have had a fever, and in some cases, a fever with seizures. Discuss any concerns you have with your doctor.

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

Influenza virus vaccine may not protect everyone who gets it. It will also 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.

Tell your doctor 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 also receiving 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 weigh the risks of the vaccine against its benefits. Consider the following for this vaccine:

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 allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to assess how age affects the use of Agriflu®, Flulaval™, Fluzone® High-Dose, Fluzone® Intradermal, or Fluzone® Intradermal Quadrivalent in children. Safety and efficacy have not been established.

Studies have not been done to assess how age affects the use of Fluvirin® in children younger than 4 years. Safety and efficacy have not been established.

Studies have not been done to assess how age affects the use of Fluarix® in children younger than 3 years. Safety and efficacy have not been established.

Studies have not been done to assess how age affects the use of Afluria®, Afluria® Quadrivalent, Fluarix® Quadrivalent, Flucelvax® Quadrivalent, Flulaval® Quadrivalent, Fluzone®, or Fluzone® Quadrivalent in children younger than 6 months. Safety and efficacy have not been established.

Geriatric

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

Studies have not been done to assess how age affects the use of Fluzone® Intradermal or Fluzone® Intradermal Quadrivalent in older adults. Safety and efficacy have not been established.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential 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 interactions may happen. In these situations, your doctor may adjust the dose, or other precautions may be needed. It is very important that your healthcare professional knows if you are taking any of the medicines listed below while receiving this vaccine. The following interactions are important but not 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 the best treatment for you. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Rituximab

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at mealtime or with certain foods 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 issues may affect the use of this vaccine. Be sure to inform your doctor if you have any of the following conditions:

• 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 (a severe nerve and muscle issue), history of—Use with caution. This may cause the symptoms to return.

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

• Immune system issues from a disease or medicine—The vaccine may not work as well in patients with this condition.

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

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

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 benefits, a medicine can cause some unwanted effects. Not everyone will experience these side effects, but if they do occur, they may require medical attention.

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

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 breathing
• earache
• ear congestion
• loss of voice
• shivering
• swelling or puffiness of the face
• unusual tiredness or weakness

Rare

• Difficulty 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 sometimes, 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 as your body adjusts to the medicine. Your healthcare professional can also provide information on ways to prevent or reduce some of these side effects. Contact 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, check with your healthcare professional.

Call 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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