Version May 2024
Note: Measure dose by a suitable radioactivity calibration system immediately prior to administration. Dose may vary depending on patient's body weight and image acquisition parameters.
Brain imaging: IV: 8.1 mCi (300 MBq); maximum: 30 mcg mass dose
There is no dosage adjustment provided in the manufacturer's labeling.
There is no dosage adjustment provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%: Local: Pain at injection site (3%), erythema at injection site (2%), irritation at injection site (1%)
There are no contraindications listed within the manufacturer's labeling.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to florbetaben F18, or any component of the formulation.
Concerns related to adverse effects:
• Malignancy: Patients are exposed to some radiation during treatment; large cumulative amounts of radiation exposure may increase the risk of cancer.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Experienced staff: Images should only be interpreted by specially trained personnel.
• Limitations: A positive scan does not establish a diagnosis of Alzheimer disease or other cognitive disorders. Safety and effectiveness have not been established for predicting the development of a neurological condition (eg, dementia) or monitoring responses to therapy. Image interpretation provides an estimate of the brain beta-amyloid plaque density; it does not determine clinical diagnosis.
• Risk for misinterpretation and errors: Images should be interpreted independently of the patient's clinical information. The use of clinical information in the interpretation of images has not been evaluated and may lead to errors. Errors may also occur due to severe brain atrophy and image distortion. Scan results are indicative of the brain neuritic amyloid plaque content only at the time of imaging. A negative scan result does not preclude the development of brain amyloid in the future.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
NeuraCeq: 1.4-135 MCI/ML (1 ea) [contains alcohol, usp, polyethylene glycol (macrogol)]
No
Solution (NeuraCeq Intravenous)
1.4-135 mci/mL (per each): $3,360.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
NeuraCeq: 1.4-135 MCI/ML (30 mL) [contains alcohol, usp]
Administer as a single slow intravenous bolus (6 seconds/mL) in a total volume of 10 mL or less; do not dilute. Following injection, flush with NS to ensure full delivery of dose. Initiate 15 to 20 minute PET image 45 to 130 minutes after injection. Patient should remain supine with brain centered in the PET scanner field of view.
Radiopharmaceutical; use appropriate precautions for handling and disposal. Waterproof gloves should be worn and effective shielding should be used during handling and administration.
Brain imaging: 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 disease and other causes of cognitive decline.
Pregnancy status should be evaluated prior to use in women of reproductive potential (Parker 2010).
All radiopharmaceuticals have the potential to cause fetal harm. Florbetaben F18 can be detected by radiation dosimetry in the uterus and ovary following injection.
It is not known if florbetaben 18 is present in breast milk.
According to the manufacturer, the decision to breastfeed following imaging should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. The manufacturer recommends patients pump and discard breast milk for 24 hours after administration to minimize potential infant exposure via breast milk. F18 can be detected by radiation dosimetry in breast tissue. Elective diagnostic procedures should be delayed until breastfeeding has stopped (Parker 2010).
Following IV administration, florbetaben F18 crosses the blood brain barrier and binds to β-amyloid plaques in the brain. The F18 isotope produces a positron signal that is detected by a PET scanner.
Distribution: ~6% of the total dose distributed to the brain 10 minutes postadministration
Protein binding: 98.5%
Metabolism: Predominantly catalyzed by CYP2J2 and CYP4F2
Half-life elimination: ~1 hour
Time to peak, plasma: Plasma concentrations declined ~75% and ~90% at 20 and 50 minutes, respectively
Excretion: Urine: ~30% (12 hours postadministration)
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
