AMYVID PROCEDURE TIME

Total procedure time 40 to 60 minutes from tracer injection to scan completion1

Injection followed by 30- to 50-minute uptake1

10-minute PET scan1

Up to 60 minutes of stable image contrast following 30-minute uptake1

  • Provides flexibility for scheduling and technical delays
  • Offers an opportunity for a repeat scan, if necessary

Amyvid dosing and administration1

The recommended dose for Amyvid is 370 MBq (10 mCi), maximum 50 μg mass dose, administered as a single intravenous bolus in a total volume of 10 mL or less. Follow the injection with an intravenous flush of 0.9% sterile sodium chloride.1

  • Inspect the radiopharmaceutical dose solution prior to administration and do not use if it contains particulate matter or is discolored
  • Use aseptic technique and radiation shielding to withdraw Amyvid solution
  • Assay the dose in a suitable dose calibrator prior to administration
  • Inject Amyvid through a short intravenous catheter (approximately 1.5 inches or less) to minimize the potential for adsorption of the drug to the catheter. Portions of the Amyvid dose may adhere to longer catheters

SELECT IMPORTANT SAFETY INFORMATION
Radiation Safety - Drug Handling

  • Amyvid is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration. Use waterproof gloves and effective shielding, including syringe shields when handling Amyvid. Radiopharmaceuticals, including Amyvid, should only be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals.

AMYLOID PET TRACERS: UPTAKE AND SCAN TIMES1-3

TRACER
UPTAKE
SCAN TIME
TOTAL ESTIMATED TIME
Amyvid® (florbetapir F 18 injection) UPTAKE: 30-50 minutes SCAN TIME: 10 minutes TOTAL ESTIMATED TIME: 40-60 minutes
Neuraceq® (florbetaben F 18 injection) UPTAKE: 45-130 minutes SCAN TIME: 15-20 minutes TOTAL ESTIMATED TIME: 60-150 minutes
Vizamyl™ (flutemetamol F 18 injection) UPTAKE: 60-120 minutes SCAN TIME: 10-20 minutes TOTAL ESTIMATED TIME: 70-140 minutes
  • This is a comparison of the uptake and scan times of currently FDA-approved amyloid PET tracers and is NOT a comparison of efficacy and safety
  • Neuraceq is a trademark of Life Molecular Imaging
  • Vizamyl is a trademark of General Electric Company or one of its subsidiaries

SELECT IMPORTANT SAFETY INFORMATION:
WARNINGS AND PRECAUTIONS

Risk for Image Misinterpretation and Other Errors

  • Errors may occur in the Amyvid estimation of brain neuritic plaque density during image interpretation
  • Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the Amyvid scan as well as motion artifacts that distort the image
  • Amyvid scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future

References

  1. Amyvid [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
  2. Neuraceq [Prescribing Information]. Matran, Switzerland: Life Molecular Imaging, S.A.
  3. Vizamyl [Prescribing Information]. Arlington Heights, IL: GE Healthcare.

INDICATION

Amyvid is a radioactive diagnostic agent for Positron Emission Tomography (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.

A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.

Amyvid for intravenous use is supplied in multidose vials containing 500-1900 MBq/mL Florbetapir F 18.

Limitations of Use:

  • A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder
  • Safety and effectiveness of Amyvid have not been established for:
    • Predicting development of dementia or other neurologic condition
    • Monitoring responses to therapies

WARNINGS AND PRECAUTIONS

Risk for Image Misinterpretation and Other Errors

  • Errors may occur in the Amyvid estimation of brain neuritic plaque density during image interpretation
  • Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the Amyvid scan as well as motion artifacts that distort the image
  • Amyvid scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future

Radiation Risk

  • Amyvid, similar to other radiopharmaceuticals, 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

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions reported in clinical trials were headache (1.8%), musculoskeletal pain (0.7%), blood pressure increased (0.7%), nausea (0.7%), fatigue (0.5%), and injection site reaction (0.5%)

Please see full Prescribing Information for Amyvid.

AM HCP ISI 10JAN2014