Neuraceq

Neuraceq

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FDA Labeling Changes

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Uses

Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-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 Neuraceq scan indicates sparse to no amyloid 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 Neuraceq 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. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations of Use

    • A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder.

    • Safety and effectiveness of Neuraceq have not been established for:

       • Predicting development of dementia or other neurologic conditions;

       • Monitoring responses to therapies.

History

There is currently no drug history available for this drug.

Other Information

Neuraceq contains florbetaben F18, a molecular imaging agent that binds to β-amyloid plaques in the brain, and is intended for use with PET imaging. Chemically, florbetaben F18 is described as 4-[(E)-2-(4-{2-[2-(2-[18F] fluoroethoxy) ethoxy] ethoxy}phenyl)vinyl]-N-methylaniline. The molecular weight is 358.45 and the structural formula is:

structure

Neuraceq is a sterile, non-pyrogenic radioactive diagnostic agent for intravenous injection. The clear solution is supplied ready to use. Each mL contains up to 3 micrograms and 50-5000 MBq (1.4 – 135 mCi) florbetaben F18 EOS, 4.4 mg ascorbic acid, 118 mg ethanol, 200 mg macrogol 400, 28.8 mg sodium ascorbate. The pH of the solution is between 4.5 and 7.

11.1 Physical Characteristics

Neuraceq is radiolabeled with [18F] fluorine (F18) that decays by positron (ß+) emission to O 18 and has a half-life of 109.8 minutes. The principal photons useful for diagnostic imaging are the coincident pair of 511 keV gamma photons resulting from the interaction of the emitted positron with an electron (Table 3).

Table 3: Principal Radiation Produced from Decay of Fluorine 18
Radiation Energy Level (keV) Abundance (%)
Positron 249.8 96.7
Gamma 511 193.4
11.2 External Radiation

The point source air-kerma coefficienta for F18 is 3.74E -17 Gy m2/ (Bq s); this coefficient was formerly defined as the specific gamma-ray constant of 5.7 R/hr/mCi at 1 cm. The first half-value thickness of lead for F18-fluorine gamma rays is approximately 6 mmb. The relative reduction of radiation emitted by F18-fluorine that results from various thicknesses of lead shielding is shown in Table 4. The use of ~8 cm of lead (Pb) will decrease the radiation transmission (i.e. exposure) by a factor of about 10,000.

Table 4: Radiation Attenuation of 511 keV Gamma Rays by Lead Shielding
Shield Thickness
cm of Lead (Pb)
Coefficient of Attenuation
0.6 0.5
2 0.1
4 0.01
6 0.001
8 0.0001

aEckerman KF and A Endo. MIRD: Radionuclide Data and Decay Schemes, 2nd Edition, 2008.
bDerived from data in NCRP Report No. 49. 1998, Appendix C

11.1 Physical Characteristics

Neuraceq is radiolabeled with [18F] fluorine (F18) that decays by positron (ß+) emission to O 18 and has a half-life of 109.8 minutes. The principal photons useful for diagnostic imaging are the coincident pair of 511 keV gamma photons resulting from the interaction of the emitted positron with an electron (Table 3).

Table 3: Principal Radiation Produced from Decay of Fluorine 18
Radiation Energy Level (keV) Abundance (%)
Positron 249.8 96.7
Gamma 511 193.4
11.2 External Radiation

The point source air-kerma coefficienta for F18 is 3.74E -17 Gy m2/ (Bq s); this coefficient was formerly defined as the specific gamma-ray constant of 5.7 R/hr/mCi at 1 cm. The first half-value thickness of lead for F18-fluorine gamma rays is approximately 6 mmb. The relative reduction of radiation emitted by F18-fluorine that results from various thicknesses of lead shielding is shown in Table 4. The use of ~8 cm of lead (Pb) will decrease the radiation transmission (i.e. exposure) by a factor of about 10,000.

Table 4: Radiation Attenuation of 511 keV Gamma Rays by Lead Shielding
Shield Thickness
cm of Lead (Pb)
Coefficient of Attenuation
0.6 0.5
2 0.1
4 0.01
6 0.001
8 0.0001

aEckerman KF and A Endo. MIRD: Radionuclide Data and Decay Schemes, 2nd Edition, 2008.
bDerived from data in NCRP Report No. 49. 1998, Appendix C

Neuraceq Manufacturers


  • Piramal Imaging, Sa
    Neuraceq (Florbetaben F 18) Injection, Solution [Piramal Imaging, Sa]

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