Pronunciation:

in-floo-EN-za VYE-rus VAX-een ree-KOM-bi-nant

Brand Names:

• Flublok
• Flublok 2015-2016 Formula
• Flublok 2016-2017 Formula
• Flublok 2017-2018 Formula
• Flublok Quadrivalent 2016-2017 Formula
• Flublok Quadrivalent 2017-2018 Formula

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Influenza virus vaccine, recombinant is used to prevent infection caused by the influenza viruses in adults 18 years of age and older. The vaccine works by causing your body to produce its own protection (antibodies) against the disease. It is also known as a “flu shot”.

It is necessary to receive an influenza vaccine injection each year, since influenza infections are usually caused by different kinds of viruses and the protection gained by the vaccine lasts less than a year. The best way to help prevent influenza infections is to get an influenza vaccination each year, usually in early November.

This vaccine is to be given only by or under the supervision of your doctor or other health care professional.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Flublok® or Flublok® Quadrivalent in children 3 to 17 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Flublok® or Flublok® Quadrivalent in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy
• Warfarin

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Guillain-Barré syndrome (GBS, a severe nerve and muscle problem), history of—Use with caution. May cause the symptoms of this condition to return.

• Immune system problems from a disease or medicine—May not work as well in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this vaccine. This vaccine is given as a shot into one of your muscles, usually in the shoulder area.

You need to get the flu vaccine every year to protect you from the flu.

This medicine comes with a patient information sheet. It is very important that you read and understand this information. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or troubled breathing after you get the injection.

Influenza virus vaccine may not protect everyone who receives the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.

Make sure your doctor knows if you are using a medicine or treatment that weakens your immune system, such as a steroid, radiation, or cancer treatment. This vaccine may not work as well if you are also using these medicines. Your doctor may still want you to get the vaccine because it can give you some protection.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Cough

difficulty with swallowing

dizziness

fast heartbeat

hives, itching, or skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

tightness in the chest

unusual tiredness or weakness

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. Also, your health care professional may be able to tell you about 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 with moving

headache

joint pain

muscle aching or cramping

muscle pains or stiffness

nausea

pain at the injection site

swollen joints

Less common

Chills

redness, bruising, or swelling at the injection site

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.