NEURACEQ- florbetaben f 18 injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

FLORBETABEN F-18 (UNII: TLA7312TOI) (FLORBETABEN F-18 - UNII:TLA7312TOI)

Dostopno od:

Life Molecular Imaging, Ltd

INN (mednarodno ime):

FLORBETABEN F-18

Sestava:

FLORBETABEN F-18 135 mCi in 1 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

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.

Status dovoljenje:

New Drug Application

Lastnosti izdelka

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