FluLaval Quadrivalent 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 known as a “flu shot.”

There are many types of influenza viruses, but not all will cause problems each year. Before the influenza vaccine is made every 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 antigens, which are substances that trigger protective antibodies, for these viruses are included in the influenza vaccine. 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 each year because influenza infections are typically 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 causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. Additionally, adults and children with other diseases or medical conditions, as well as people 50 years of age and older, even if they are healthy, may experience a more serious illness that might require hospital treatment. Each 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. Immunization (getting a vaccine) against influenza is approved for infants 6 months old and older, all children, and all adults (including those 65 years of age 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 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 needs immediate medical attention. Contact your doctor right away if you or your child experience a rash, itching, hoarseness, difficulty breathing, difficulty swallowing, or any swelling of the hands, face, or mouth after the injection.

Children who have received a specific 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 getting this vaccine.

The influenza virus vaccine may not protect everyone who receives it. It 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.

Let your doctor know if you or your child are using any medicine or treatment that weakens your immune system, including steroids, radiation, or cancer treatments. This vaccine may not be as effective if you are also using these treatments. Your doctor may still recommend getting the vaccine because it can provide some protection.

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

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 efficacy have not been established.

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

There have not been appropriate studies on the effects of Fluarix® in children younger than 3 years old. Safety and efficacy 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 younger than 6 months old. Safety and efficacy have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients 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 elderly patients. Safety and efficacy 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 using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction could happen. In such cases, your doctor may change the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this vaccine. The following interactions have been highlighted for their potential significance but are not necessarily complete.

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

• Rituximab

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around 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 other medical problems, especially:

• Allergy to eggs, egg products, or chicken proteins—This vaccine 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 (a severe nerve and muscle condition), history of—Use with caution. It may cause the symptoms of this condition to return.

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

• Immune system problems due to a disease or medication—This vaccine may not work as well in patients with this condition.

• 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 condition that can lead to paralysis. Most of these individuals were over 25 years old. Although only 10 out of every one million vaccinated people developed GBS, this rate was six times higher than what was typically expected. Most people who got GBS recovered completely.

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

While a medicine can help in many ways, it can also cause some unwanted effects. Not all side effects may happen, but if they do, you may need to seek medical help.

Contact your doctor or nurse right away if any of these 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
• 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
• Changes in voice
• 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 healthcare professional may also provide information on how to prevent or lessen some of these side effects. Contact your healthcare 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 listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice regarding 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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