Flublok 2016-2017 Formula (Intramuscular)

Influenza virus vaccine, recombinant is used to prevent infection from influenza viruses in adults 18 years of age and older. The vaccine helps your body create its own protection (antibodies) against the disease. It is also called a “flu shot.”

You need to get an influenza vaccine injection every year because influenza infections are usually caused by different types of viruses, and the protection from the vaccine lasts less than a year. The best way to help prevent influenza infections is to get an influenza vaccination every year, typically in early November.

This vaccine should only be given by or under the supervision of your doctor or another health care professional.

Be sure to tell your doctor about any side effects that happen after you get this vaccine.

This vaccine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Contact your doctor right away if you experience a rash, itching, swelling of the tongue and throat, or trouble breathing after the injection.

The influenza virus vaccine may not protect everyone who gets it. Also, this vaccine will not help if you already have flu symptoms.

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

In deciding to use a vaccine, you need to think about the risks of the vaccine compared to the benefits it can provide. This choice is something you and your doctor will make together. For this vaccine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, check the label or package ingredients carefully.

Pediatric

Research has not been done to determine how Flublok® or Flublok® Quadrivalent affects children aged 3 to 17 years. 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 use of Flublok® or Flublok® Quadrivalent.

Breast Feeding

There are not enough studies to assess the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together, while others can be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose or take other precautions. When you receive this vaccine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and do not include every possible interaction.

Receiving this vaccine with any of the following medicines is generally not recommended but may be necessary in some cases. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

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

Receiving this vaccine with any of the following medicines may raise the risk of certain side effects, but taking both may be the best treatment option for you. If both are prescribed together, your doctor may change the dose or how often you take one or both medicines.

• Carbamazepine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtimes or with certain foods because interactions may happen. Drinking alcohol or using tobacco with some medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Guillain-Barré syndrome (GBS, a serious nerve and muscle condition), history of—Use with caution. This may cause the symptoms of this condition to come back.

• Immune system problems from a disease or medicine—This vaccine may not be as effective for patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if you have any of the following side effects:

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 happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also have ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

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

Available Dosage Forms:

• Solution

Therapeutic Class: Vaccine

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.

• 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 can I get a flu vaccine without a needle?
• What is the difference between Flublok and Flublok Quadrivalent?

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