Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
FLORBETABEN F-18 (UNII: TLA7312TOI) (FLORBETABEN F-18 - UNII:TLA7312TOI)
Life Molecular Imaging, Ltd
FLORBETABEN F-18
FLORBETABEN F-18 135 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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: o Predicting development of dementia or other neurologic conditions; o Monitoring responses to therapies. None Risk Summary There are no available data on Neuraceq use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Neuraceq. All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding [see Clinical Considerations ]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition. Clinical Considerations To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours after administration of Neuraceq. Neuraceq is not indicated for use in pediatric patients. Of the 872 subjects in clinical studies of Neuraceq, 603 (69%) were 65 years or over, while 304 (35%) were 75 years or over. No overall differences in safety were observed between these subjects and younger subjects.
Neuraceq is supplied in a 50 mL glass vial containing up to 50 mL of a clear solution at a strength of 50 MBq/mL to 5,000 MBq/mL (1.4 mCi/mL to 135 mCi/mL) florbetaben F18 at end of synthesis. Each vial contains multiple doses and is enclosed in a shielded container to minimize external radiation exposure. Store Neuraceq at room temperature 25°C (77°F); excursions permitted to 2°C to 42°C (36°F to 108°F). The product does not contain a preservative. Store Neuraceq within the original container or equivalent radiation shielding. Neuraceq must not be diluted. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
New Drug Application
NEURACEQ- FLORBETABEN F 18 INJECTION, SOLUTION LIFE MOLECULAR IMAGING, LTD ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NEURACEQ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEURACEQ. NEURACEQ (FLORBETABEN F 18 INJECTION), FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2014 INDICATIONS AND USAGE Neuraceq® is a radioactive diagnostic agent 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 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. (1) Limitations of Use (1) • A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. (1) • Safety and effectiveness of Neuraceq have not been established for: (1) • Predicting development of dementia or other neurologic conditions (1) • Monitoring responses to therapies (1) DOSAGE AND ADMINISTRATION Use appropriate radiation handling measures (2.1). • The recommended dose is 300 MBq (8.1 mCi) as a slow single intravenous bolus (6 sec/mL) in a total volume of up to 10 mL. (2.2) • Obtain 15 minute to 20 minute PET images starting from 45 minutes to 130 minutes after intravenous administration (2.3) • Image interpretation: refer to full prescribing information (2.4) • The Lesen Sie das vollständige Dokument