florbetaben F 18 (Rx)

Brand and Other Names:Neuraceq
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 50-5000 MBq/mL (1.4-135 mCi/mL) in 30 mL multi-dose vials
  • At time of administration, 300 MBq (8.1 mCi) are contained in up to 10 mL solution for injection

Beta-Amyloid Plaque Estimation

Radioactive, adjunctive diagnostic agent indicated for PET brain imaging to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer disease (AD) and other causes of cognitive decline

A negative scan indicates sparse-to-no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD as a cause of cognitive impairment, whereas a positive scan indicates moderate-to-frequent amyloid neuritic plaques

Moderate-to-frequent amyloid plagues are found in patients with AD but may also be present in those with other types of neurologic conditions, as well as in older people with normal cognition

Dosage

  • 300 megabecquerels (MBq), ie, 8.1 millicuries (mCi) IV bolus administered by slow IV bolus (1 mL/6 seconds) in a total volume of up to 10 mL
  • Follow injection with an IV flush of 10 mL of 0.9% NaCl

Image Display & Interpretation

A 15 to 20-minute PET image should be acquired starting 45-130 minutes after IV injection

The patient should be supine; position head to center the brain, including the cerebellum, in the PET scanner field of view

Reduce head movement with tape, or other flexible head restraints may be used

Display

  • Display images in the transaxial orientation using gray scale or inverse gray scale
  • Sagittal and coronal planes may be used for additional orientation purposes
  • CT or MR images may be helpful for anatomic reference purposes; however, visual assessment should be performed using the axial planes according to the recommended reading methodology

Interpretation

  • Visually compare the activity in cortical gray matter with activity in adjacent white matter Regions displayed in the PET images which ‘anatomically’ correspond to white matter structures (eg, the cerebellar white matter or the splenium) should be identified to help the readers orient themselves
  • View and assess images in a systematic manner, starting with the cerebellum and scrolling up through the lateral temporal and frontal lobes, the posterior cingulate cortex/precuneus, and the parietal lobes
  • For a gray matter cortical region to be assessed as showing "tracer uptake" the majority of slices from the respective region must be affected
  • For each patient, the PET image assessment is categorized as either beta-amyloid-positive or beta-amyloid-negative
  • Beta-amyloid negative: Tracer uptake (ie, signal intensity) in gray matter is lower than in white matter in all 4 brain regions (no beta-amyloid deposition)
  • Beta-amyloid positive: Smaller area(s) of tracer uptake equal to or higher than that present in white matter extending beyond the white matter rim to the outer cortical margin involving the majority of the slices within at least 1 of the 4 brain regions (moderate beta-amyloid deposition), or a large confluent area of tracer uptake equal to or higher than that present in white matter extending beyond the white matter rim to the outer cortical margin and involving the entire region, including the majority of slices within at least 1 of the 4 brain regions (pronounced beta-amyloid deposition)
  • See figures of PET images in the prescribing information for further information

Not indicated

Next:

Adverse Effects

1-10%

Injection site pain (3.9%)

Injection site erythema (1.7%)

Injection site irritation (1.2%)

Previous
Next:

Warnings

Contraindications

None

Cautions

Risk for image misinterpretation

  • Errors may occur in the estimation of brain neuritic plaque density during image interpretation; perform image interpretation independently of the patient’s clinical information
  • Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the scan as well as motion artifacts that distort the image

Radiation risk

  • Similar to other radiopharmaceuticals, flutemetamol F18 contributes to a patient’s overall long-term cumulative radiation exposure; long-term cumulative radiation exposure is associated with an increased risk of cancer
  • Ensure safe handling to protect patients and healthcare workers from unintentional radiation exposure
Previous
Next:

Pregnancy & Lactation

Pregnancy

There are no available data on pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Animal data

  • Animal reproduction studies have not been conducted; all radiopharmaceuticals, have a potential to cause fetal harm depending on stage of fetal development and magnitude of radiopharmaceutical dose; if considering administration to a pregnant woman, inform patient about potential for adverse pregnancy outcomes based on radiation dose from drug and gestational timing of exposure

Lactation

There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; exposure to a breastfed infant can be minimized by temporary discontinuation of breastfeeding

Developmental and health benefits of breastfeeding should be considered along with mother's clinical need for drug and any potential adverse effects on breastfed child from drug from underlying maternal condition

To decrease radiation exposure to breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours after administration of drug

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Previous
Next:

Pharmacology

Mechanism of Action

F18-labeled stilbene derivative that binds to beta-amyloid plaques in the brain which produces a positron signal that is detected by a PET scanner

Distribution

10 minutes after IV bolus injection of 300 MBq, ~6% of the injected radioactivity was distributed to the brain

Plasma concentrations declined by ~75% at 20 minutes postinjection, and by ~90% at 50 minutes

The F18 in circulation during the 45 to 130-minute imaging window was principally associated with polar metabolites of florbetaben

Protein bound: 98.5%

Metabolism

Predominantly catalyzed by CYP2J2 and CYP4F2

Elimination

Half-life: 1 hr

Excretion: Primarily via hepatobiliary route; 30% urine (mostly as polar metabolites)

Previous
Next:

Administration

IV Preparation

Must not be diluted

Inspect the radiopharmaceutical dose solution prior to administration and do not use it if it contains particulate matter or is discolored

Use aseptic technique and radiation shielding to withdraw solution

Assay the dose in a suitable dose calibrator prior to administration

Radiation Safety

Radioactive drug; handle with appropriate safety measures to minimize radiation exposure during administration use waterproof gloves and effective shielding, including lead-glass syringe shields when handling

Radiopharmaceuticals should only be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radioactive materials and by whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals

IV Administration

The injection must be IV in order to avoid irradiation as a result of local extravasation, as well as imaging artifacts

Verify patency of the indwelling catheter by a saline test injection prior to administration

Inject IV bolus (6 sec/mL) into a large vein in the arm, followed by a saline flush of approximately 10 mL

Storage

Store at room temperature 25ºC (77°F); excursions permitted to 2-42°C (36-108°F)

The product does not contain a preservative Store within the original container or equivalent radiation shielding

This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State

Previous
Next:

Images

No images available for this drug.
Previous
Next:

Patient Handout

A Patient Handout is not currently available for this monograph.
Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.