Flublok Quadrivalent 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 make 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 each year, typically in early November.

This vaccine must be given only 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 have a rash, itching, swelling of the tongue and throat, or trouble breathing after getting the injection.

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

Make sure your doctor knows if you are taking any 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 might still recommend that you get the vaccine because it can offer some protection.

In deciding to use a vaccine, you need to consider the risks of the vaccine against the benefits it provides. This is a decision to make together with your doctor. 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 any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have 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

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of Flublok® or Flublok® Quadrivalent.

Breast Feeding

There are no sufficient 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 during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might happen. In such cases, your doctor may adjust 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 chosen based on their potential significance and may not include all possibilities.

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

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

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

• Carbamazepine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods because of potential interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this vaccine. Be sure to inform your doctor if you have any other medical problems, 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 caused by a disease or medication—This vaccine may not work as well for patients with this condition.

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

Check with your doctor or nurse right away if you notice 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 require medical attention. These side effects might go away as your body adjusts to the medicine. Your health care professional may also have tips on how 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 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.

• 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?
• How can I get a flu vaccine without a needle?
• What is the difference between Flublok and Flublok Quadrivalent?
• Which flu vaccines are available this year?
• Where Can I Get a Flu Shot Near Me?
• How well does the flu vaccine work?

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