Fluarix Quadrivalent 2013-2014 Formula (Intradermal, Intramuscular)

Influenza virus vaccine is used to prevent infections caused by 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 cause issues each year. Before producing the influenza vaccine every 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 help your body form protective antibodies, for these viruses. Usually, the U.S. and Canada use the same influenza vaccine, but they are not required to.

You need to get an influenza vaccine injection every year because influenza infections are typically caused by different 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, muscle aches, and pain in your back, arms, and legs. Additionally, adults and children with other diseases or medical conditions, as well as people 50 years and older, even if they are healthy, may experience more severe illness that could 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, typically in early November. Vaccination against influenza is approved for infants 6 months and older, all children, and all adults (including those 65 years 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 scheduled time if a second dose of the vaccine is needed. Make sure to inform your doctor about any side effects that happen after you or your child get this vaccine.

This vaccine may cause a serious allergic reaction called 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 any swelling of the hands, face, or mouth after 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. 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 better before you receive 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 people 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 a medicine or treatment that weakens your immune system, such as 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 and your doctor need to consider the risks of the vaccine against the benefits it provides. The following points should be taken into account for this vaccine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare provider know if you have any other types of allergies, like those 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 affect children. Safety and effectiveness have not been established for these vaccines in the pediatric population.

There have not been enough studies on the effects of Fluvirin® in children younger than 4 years old. Safety and effectiveness have not been established for this age group.

There have not been enough studies on the effects of Fluarix® in children younger than 3 years old. Safety and effectiveness have not been established for this age group.

There have not been enough studies on the effects of Afluria®, Afluria® Quadrivalent, Fluarix® Quadrivalent, Flucelvax® Quadrivalent, Flulaval® Quadrivalent, Fluzone®, or Fluzone® Quadrivalent in children younger than 6 months old. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of the influenza virus vaccine in this population.

There have not been enough studies to determine how Fluzone® Intradermal or Fluzone® Intradermal Quadrivalent affect older adults. Safety and effectiveness have not been established for this age group.

Breast Feeding

There are no adequate studies on the effects of this medication during 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, while others may be used together even if there is a risk of interaction. In these cases, your doctor may want to adjust the dosage or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the following medicines while receiving this vaccine. The following interactions are notable but not all-inclusive.

Using this vaccine with any of the following medicines may increase the risk of certain side effects. However, using both medicines may be necessary for your treatment. If prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Rituximab

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating certain foods, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare provider about taking your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this vaccine works. Be sure to tell your doctor if you have any other medical conditions, particularly:

• 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 an increased 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 receiving the vaccine.

• Immune system problems due to a disease or medicine—The vaccine 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), which can cause paralysis. Most of these individuals were over 25 years old. Although only 10 out of every one million vaccine recipients developed GBS, this was 6 times higher than what would normally be expected. Most people 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, research has shown that the risk of getting GBS from an influenza vaccine is very low (one out of every million people).

Along with its required effects, a medicine may cause some unwanted effects. Not all side effects occur, 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 may go away during treatment as your body adjusts to the medicine. Your health care professional might also be able to tell you how 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 happen 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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