Amyvid

— THERAPEUTIC CATEGORIES —
  • Imaging agents

Amyvid Generic Name & Formulations

General Description

Florbetapir F 18 (500–1900MBq/mL [13.5–51mCi/mL] at End of Synthesis [EOS]); soln for IV inj.

Pharmacological Class

Radioactive diagnostic agent.

How Supplied

Multi-dose vials (10mL, 30mL, 50mL)—1

Manufacturer

Generic Availability

NO

Amyvid Indications

Indications

For PET imaging of the brain to estimate β-amyloid neuritic plaque density in adults with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. As an adjunct to other diagnostic evaluations.

Limitations of Use

A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder. Safety and efficacy not established for predicting development of dementia or other neurologic conditions; or for monitoring responses to therapies.

Amyvid Dosage and Administration

Adult

See full labeling. Give 370MBq (10mCi), max 50μg mass dose, as a single IV bolus dose in a total volume of ≤10mL, then follow with a sterile NaCl 0.9% IV flush. Starting 30–50mins after IV inj, acquire a 10-min PET image. The radiation absorbed dose from 370MBq (10mCi) dose is 7mSv.

Children

Not established.

Amyvid Contraindications

Not Applicable

Amyvid Boxed Warnings

Not Applicable

Amyvid Warnings/Precautions

Warnings/Precautions

Risk of radiation exposure. Should only be used by trained and experienced physicians in the safe use and handling of radioactive materials to minimize radiation exposure. Risk of image misinterpretation and other errors. Perform image interpretation independently of patient's clinical information. Pregnancy (Cat.C.); assess status in females of reproductive potential prior to initiation. Nursing mothers: not recommended, or temporarily interrupt for 24hrs after Amyvid exposure.

Amyvid Pharmacokinetics

See Literature

Amyvid Interactions

Amyvid Adverse Reactions

Adverse Reactions

Headache, musculoskeletal pain, increased BP, nausea, fatigue, inj site reactions.

Amyvid Clinical Trials

See Literature

Amyvid Note

Not Applicable

Amyvid Patient Counseling

See Literature