Florbetaben F-18 (NeuraCeq) is an intravenously administered radiopharmaceutical agent that is used to detect Beta-amyloid plaques in patients with Alzheimer's disease.

Florbetaben F-18 Uses:

• Brain imaging:

  • It is indicated 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 and other causes of cognitive decline.

Florbetaben F-18 (NeuraCeq) Dose in Adults

Note: Measure the dose by a suitable radioactivity calibration system immediately before administration. The dose may vary depending on the patient's body weight and image acquisition parameters.

Florbetaben F-18 (NeuraCeq) Dose in Brain imaging:

• IV: 8.1 mCi (300 MBq);
• maximum: 30 mcg mass dose

Use in Children:

Not indicated.

Pregnancy Risk Factor C

• It has not yet been tested in animal reproduction studies. 
• It should be avoided during pregnancy, as radiopharmaceutical products can cause harm to the fetus.
• Women with reproductive potential should avoid pregnancy.
• After injection, Florbetaben F18 may be detected using radiation dosimetry.

Florbetaben F-18 use during breastfeeding:

• It is unknown whether breastmilk contains florbetaben 18.
• Manufacturers recommend that you avoid it while breastfeeding, or discontinue breastfeeding temporarily for 24 hours after administration.
• Breastmilk can be pumped, then discarded until breastmilk is resumed. You can give formula milk to your infant or breastmilk that you have previously stored.
• Radiation dosimetry can detect F18 in breast tissue.

Dose in Kidney Disease

There is no dosage adjustment provided in the manufacturer's labeling.

Dose in Liver disease:

There is no dosage adjustment provided in the manufacturer's labeling.

Side Effects of Florbetaben F-18 (NeuraCeq):

• Local:

  • Pain at injection site
  • Erythema at injection site
  • Irritation at injection site

Contraindications to Florbetaben F-18 (NeuraCeq):

The manufacturer's labeling does not contain any contraindications.

Canadian labeling: Additional contraindications not in US labeling

• Allergy reactions to florbetabenF18 or any component of this formulation

Warnings and precautions

• Malignancy

  • Patients who are exposed to high doses of radiation cumulatively run the risk of developing malignancies.

Monitoring Parameters:

Monitor for allergic reactions.

How to administer Florbetaben F-18 (NeuraCeq)?

• It is administered as a slow single intravenous injection @ 6 seconds/ml in a total volume of 10 ml or less.
• Avoid diluting it. After the drug is administered, flush the intravenous line with NS to ensure full delivery of the dose.
• After 45 - 130 minutes of the injection, initiate PET imaging. Maintain the patient in a supine position with the brain-centered in the PET scanner field of view.
• Since it is a radiopharmaceutical, appropriate handling and precautions should be taken while disposing of. 
• Waterproof gloves should be worn and effective shielding should be used during handling and administration.

Mechanism of action of Florbetaben F-18 (NeuraCeq):

• The drug is intravenously administered and crosses the blood brain barrier to attach to the brain's b-amyloid plaques. 
• A PET scanner detects the positive signals produced by F18 isotope.

Distribution:

• about 6% of the total dose is distributed to the brain 10 minutes after administration

Protein binding:

• 98.5%

Metabolism:

• Predominantly catalyzed by CYP2J2 and CYP4F2

Half-life elimination:

• about 1 hour

Time to peak, plasma:

• Plasma concentrations declined about 75% and about 90% at 20 and 50 minutes, respectively

Excretion:

• Urine: ~30% (12 hours after administration)

International Brand Names of Florbetaben F-18:

• NeuraCeq

Florbetaben F-18 Brand Names in Pakistan:

No Brands Available in Pakistan.