Influenza virus vaccine recombinant (Intramuscular)

Influenza virus vaccine recombinant is used to prevent infection from the influenza viruses in adults 18 years and older. The vaccine works by helping 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 often 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, usually 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 inform your doctor about any side effects you experience after receiving this vaccine.

This vaccine may trigger a severe allergic reaction known as anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Contact your doctor right away if you develop a rash, itching, swelling of the tongue or throat, or have difficulty breathing after the injection.

Influenza virus vaccine may not protect everyone who gets the vaccine. Additionally, this vaccine will not alleviate flu symptoms if you already have the virus.

Make sure your doctor is aware if you are taking any medicine or treatment that weakens your immune system, such as a steroid, radiation, or cancer treatment. This vaccine may be less effective if you are also using these medications. Your doctor may still recommend that you receive the vaccine because it can offer some protection.

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

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your health care professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. If you are using non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on the effects of Flublok® or Flublok® Quadrivalent in children aged 3 to 17 years. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not found any specific problems in older adults that would limit the usefulness of Flublok® or Flublok® Quadrivalent in the elderly.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the possible benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together, even if an interaction could happen. In these situations, your doctor may adjust the dose, or other precautions may be necessary. It is very important that your healthcare professional knows if you are taking any of the medicines listed below while receiving this vaccine. The interactions listed are based on their possible significance but may not include all potential interactions.

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, your doctor may adjust 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, your doctor may adjust 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 the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this vaccine. Be sure to inform your doctor about any other medical issues you have, especially:

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

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

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

Check with your doctor or nurse right away if any of these 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 happen that usually do not need medical attention. These side effects may go away as your body adjusts 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 these 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 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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