Flulaval Quadravalent 2013-2014 Season (Intradermal, Intramuscular)

Influenza virus vaccine is used to prevent infection from influenza viruses. The vaccine helps your body make its own defenses (antibodies) against the disease. It is commonly referred to as 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 likely to cause influenza infections that year. The vaccine includes antigens, which are substances that help form protective antibodies, for these viruses. Typically, 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 viral infection that affects 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 who have other diseases or medical conditions, as well as people aged 50 and older, even if they are healthy, may experience a more serious illness that could require hospital treatment. Every year, thousands of people die due to influenza infections.

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

This vaccine must 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 your doctor’s office at the right time if they need a second dose of the vaccine. Make 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 attention. Contact your doctor right away if you or your child experience a rash, itching, hoarseness, difficulty breathing, trouble swallowing, or any swelling of the hands, face, or mouth after receiving 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 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 receiving 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 using 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 should consider the risks and benefits. For this vaccine, keep the following in mind:

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

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 Fluvirin® in children younger than 4 years. Safety and effectiveness have not been established.

There have not been appropriate studies on Fluarix® in children younger than 3 years. Safety and effectiveness have not been established.

There have not been appropriate studies on Afluria®, Afluria® Quadrivalent, Fluarix® Quadrivalent, Flucelvax® Quadrivalent, Flulaval® Quadrivalent, Fluzone®, or Fluzone® Quadrivalent in children younger than 6 months. Safety and effectiveness have not been established.

Geriatric

There have not been studies showing problems specific to older adults that would limit the usefulness of the influenza virus vaccine in this population.

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, while others may be used together even if there might be interactions. In these cases, your doctor may adjust the dose or take other precautions. It is important for your healthcare professional to know if you are taking any of the following medicines when receiving this vaccine. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this vaccine with any of the following medicines may increase the risk of certain side effects, but taking both may be the best option for you. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both.

• Rituximab

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause 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. Make sure to inform your doctor about 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. Symptoms of this condition may 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—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. 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 lead to 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 rate was 6 times higher than expected. Most people who got GBS recovered fully.

It is thought 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).

Like all medicines, vaccines can cause unwanted effects. Not everyone will experience side effects, but if they do happen, they might need medical attention.

Contact your doctor or nurse right away if you have any of these 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 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 might go away as your body adjusts to the vaccine. Your health care professional may also have suggestions to prevent or lessen some of these side effects. Speak with your health care professional if any of the following side effects persist 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 mentioned may also occur in some patients. If you notice any other effects, consult 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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