Fluzone High Dose

Fluzone High Dose is an inactivated influenza vaccine used to prevent infection with the influenza virus in persons aged 65 years and over.

It is available as an injection and is injected into the muscle once per year by a healthcare professional. 

Common side effects include mild hypersensitivity reactions such as rash, local reactions at the injection site, and mild and temporary influenza-like symptoms such as fever, muscle aches, tiredness, headache, and chills.

Fluzone High Dose is an inactivated influenza virus vaccine for persons aged 65 years and over and is used to prevent influenza virus infection. Fluzone High Dose is designed to help protect against 2 different strains of the flu: influenza A and influenza B.

This vaccine may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Fluzone High Dose is administered as a single 0.5 mL injection given into the deltoid muscle by a healthcare professional in adults 65 years of age and older.

Serious side effects have been reported with Fluzone High Dose, including the following:

• Guillain-Barré Syndrome (GBS). Tell your healthcare provider immediately if you have a history of GBS or any neurologic disorder including seizures. If Guillain-Barré syndrome has occurred within 6 weeks of receiving an influenza vaccine in the past, your doctor will determine if you should receive Fluzone High Dose.
• Altered Immunity. Tell your healthcare provider immediately if you have a suppressed immune system due to a current condition or medication therapy. If Fluzone High Dose is administered to a person with a suppressed immune system, including individuals receiving immunosuppressive therapy, you may not have the best immune response. Tell your doctor if you are receiving immunosuppressive therapies such as prednisone, auto-Immune treatments such as etanercept (Enbrel), and chemotherapy such as capecitabine (Xeloda).
• Allergic Reactions: Tell your doctor if you are allergic to eggs or latex. Tell your doctor right away if you experience:
  • Swelling of the face, tongue, or throat
  • Trouble breathing
  • Hives or bad rash

Do not receive Fluzone High Dose vaccine if you:

• ever had a severe allergic reaction to eggs or egg products.
• ever had a severe allergic reaction after getting any flu vaccine.
• are younger than 65 years of age.

Serious side effects have been associated with Fluzone High Dose. See the "Fluzone High Dose Precautions" section.

Common side effects of Fluzone High Dose include the following:

• Injection site reactions (redness, tenderness, swelling, etc.)
• Influenza type symptoms (fever, muscle aches, headache, tiredness, chills)

This is not a complete list of Fluzone High Dose side effects. Ask your doctor or pharmacist for more information.

Inform your doctor if you have any side effects that bother you and do not go away.

Call your doctor about medical advice related to side effects. You may report side effects to VAERS at 1-800-822-7967.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Irradiation therapy (radiation treatments)
• Any other live or inactive vaccine given in separate vial or syringe
• Immunosuppressive therapies such as prednisone, auto-Immune treatments such as etanercept (Enbrel), and chemotherapy such as capecitabine (Xeloda)

This is not a complete list of Fluzone High Dose drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fluzone High Dose falls into category C. There are no well-controlled studies that have been done in animals.  Fluzone High-Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone High Dose should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Fluzone High Dose crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Fluzone High Dose.