Influenza virus vaccine, adjuvanted (Intramuscular)

Influenza virus vaccine, adjuvanted is used to prevent infections from influenza virus subtypes A and types B in elderly patients who are 65 years old and older. This vaccine helps your body make its own defense (antibodies) against the disease.

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

Be sure to tell your doctor about any side effects that happen after you receive 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 difficulty breathing after the injection.

Fluad® Quadrivalent may not protect everyone who receives the vaccine. Additionally, this vaccine will not treat flu symptoms if you already have the virus.

Inform your doctor 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 taking these medicines. However, your doctor may still recommend that you get the vaccine because it can provide some protection.

In deciding to use a vaccine, you and your doctor will need to consider the risks of the vaccine versus the benefits it may provide. 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 other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how Fluad® Quadrivalent affects children. Safety and effectiveness have not been established for this age group.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause 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 if you have any other medical issues, especially:

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

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

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

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

Less common

• Fever or chills

Incidence not known

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• cough
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, or rash
• inability to move the arms and legs
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sudden numbness and weakness in the arms and legs
• tightness in the chest
• unusual bleeding or bruising
• 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 gets used to the medicine. Also, your health care professional may be able to tell you how 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

• Headache
• joint or muscle pain
• pain at the injection site

Less common

• Diarrhea
• loss of appetite
• nausea or vomiting
• redness 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.

In the U.S.

• Fluad
• Fluad 2017-2018 Formula

Available Dosage Forms:

• Emulsion

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 upper arm.

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