Florbetapir F 18

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

Less serious side effects may include:

• headache;
• joint or muscle pain;
• 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.

Florbetapir F 18 is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. It is usually given within 30 to 50 minutes before your radiologic test.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Since florbetapir F 18 is used as a single dose, it does not have a daily dosing schedule.

Contraindications

None

Cautions

Risk for image misinterpretation

• Errors may occur in the estimation of brain neuritic plaque density during image interpretation; perform image interpretation independently of the patient’s clinical information
• Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the scan as well as motion artifacts that distort the image

Radiation risk

• Similar to other radiopharmaceuticals, florbetapir F 18 contributes to a patient’s overall long-term cumulative radiation exposure; long-term cumulative radiation exposure is associated with an increased risk of cancer
• Ensure safe handling to protect patients and health care workers from unintentional radiation exposure

Pregnancy Category: C; should be administered to a pregnant woman only if clearly needed; all radiopharmaceuticals have potential to cause fetal harm

The likelihood of fetal harm depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose

Assess pregnancy status before administering to a female of reproductive potential

Lactation: Unknown whether distributed in breast milk; avoid use in breastfeeding women or temporarily interrupt breastfeeding for 24 hr (>10 half-lives of radioactive decay for the F 18 isotope) after exposure

If breastfeeding is interrupted, the patient should pump and discard her breast milk and use alternate infant nutrition sources (eg, stored breast milk or infant formula) for 24 hr after administration

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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

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

Less serious side effects may include:

• headache;

• joint or muscle pain;

• 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.

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.

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.