Amyvid belongs to a group of drugs called diagnostic radiopharmaceuticals. Amyvid allows images of specific organs in the body to be detected by a PET (Positron Emission Tomography) scan.

Amyvid is used together with a PET scan to detect the amount of plaque in the brain. Plaque is a build-up of certain proteins and diseased nerve cells that is often found in the brain of a person who has signs of Alzheimer's disease or other causes of dementia.

Amyvid is supplied in multiple doses vials enclosed in a shielded container to minimize external radiation exposure.

Receiving a radioactive agent such as Amyvid may increase your long-term risk of developing cancer. Talk with your doctor about your specific risk.

To make sure you can safely receive Amyvid, tell your doctor about all of your medical conditions.

Do not breast-feed within 24 hours after receiving Amyvid. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby. Receiving a radioactive agent such as Amyvid may increase your long-term risk of developing cancer. Talk with your doctor about your specific risk.

Before taking this medicine

Tell your doctor about all of your medical conditions.

Tell your doctor if you are pregnant. There is no information available on the use of Amyvid in pregnant women. All radiopharmaceuticals, including Amyvid, have a potential to cause harm to the unborn baby depending on the stage of pregnancy and the size of the florbetapir F 18 dose.

Do not breastfeed within 24 hours after receiving Amyvid. If you use a breast pump during this time, throw out the milk and do not feed it to your baby.

Amyvid is injected into a vein by a healthcare provider.

This medicine is usually given 30 to 50 minutes before your PET scan.

Usual Adult Dose for Positron Emission Tomography Imaging:

370 MBq (10 mCi), maximum 50 microgram mass dose, intravenously as a single bolus in a total volume of 10 mL or less

Comments: The injection should be followed with an intravenous flush of 0.9% sterile sodium chloride.

Use: PET imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.

Tell your doctor about all of your medical conditions.

Tell your doctor if you are pregnant. There is no information available on the use of Amyvid in pregnant women. All radiopharmaceuticals, including Amyvid, have a potential to cause harm to the unborn baby depending on the stage of pregnancy and the size of the florbetapir F 18 dose.

Do not breastfeed within 24 hours after receiving Amyvid. If you use a breast pump during this time, throw out the milk and do not feed it to your baby.

Amyvid is used as a single dose and does not have a daily dosing schedule.

In a medical setting an overdose would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Amyvid: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common Amyvid side effects may include:

• pain, bruising, swelling, or irritation where the medicine was injected;

• headache;

• joint or muscle pain;

• increased blood pressure;

• nausea; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.