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.

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.

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.

Before receiving Fluzone High Dose, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to eggs, any inactive ingredients in the vaccine or previous allergies to vaccines
• Have or have had an episode of Guillain-Barre Syndrome
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed
• A weakened immune system due to a current condition or medication therapy

Tell your doctor about all of the medications you take, including all prescription and non-prescription medicine, vitamins, minerals and herbal supplements.

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A burning, numbness, or tingling feeling that is not normal.
• Not able to move face muscles as much.
• Trouble controlling body movements.
• Very bad dizziness or passing out.
• Muscle weakness.
• Seizures.
• Very bad headache.
• Change in eyesight.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Fluzone High-Dose, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Fluzone High-Dose. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Fluzone High-Dose.

Review Date: October 4, 2017