Florbetaben

Mechanism-of-action class: Positron Emitting Activity.

• NEURACEQ is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products NEURACEQ is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products (1)

• None None.contraindicated

The recommended amount of radioactivity is 300 MBq (8.1 mCi) administered as a slow single intravenous bolus (6 sec/mL) in a total volume of up to 10 mL. (2.2) Follow the injection with an intravenous flush of approximately 10 mL of 0.9% sodium chloride injection. (2.2) Obtain 15-minute to 20-minute PET images starting approximately 45 minutes to 130 minutes after drug administration. (2.3) See full prescribing information for image interpretation and radiation dosimetry. (2.4, 2.5) 2.1 Radiation Safety - Drug Handling Handle NEURACEQ with appropriate safety measures to minimize radiation exposure during administration [ see Warnings and Precautions ( 5.2 )]. Use waterproof gloves and effective radiation shielding, including lead-glass syringe shields when handling and administering NEURACEQ. Radiopharmaceuticals, including NEURACEQ, should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. 2.2 Recommended Dosing and Administration Instructions Recommended Dosage The recommended amount of radioactivity of NEURACEQ is 300 MBq (8.1 mCi) in a total volume of up to 10 mL, administered as a single slow intravenous bolus (6 sec/mL). The maximum mass dose is 30 micrograms. Follow the administration with an intravenous flush of approximately 10 mL of 0.9% sodium chloride injection.

Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. (5.1) Radiation Risk: NEURACEQ contributes to a patient’s long-term cumulative radiation exposure. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. (2.1, 2.2, 5.2) 5.1 Risk of Image Misinterpretation and Other Errors Errors may occur in the estimation of brain amyloid beta neuritic plaque density during NEURACEQ image interpretation [ see Clinical Studies ( 14 ) ]. The use of clinical information in the interpretation of NEURACEQ images has not been evaluated and may lead to an inaccurate assessment. Severe brain atrophy as well as motion artifacts that result in image distortion may limit the ability to distinguish gray and white matter on a NEURACEQ scan. Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal [see Dosage and Administration ( 2.4 )] . 5.2 Radiation Risk NEURACEQ 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 drug handling to protect patients and health care providers from unintentional radiation exposure.

Most common adverse reactions (incidence ≥ 1%) were injection site pain, injection site erythema, and injection site irritation (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Lantheus Biosciences Ltd. at 1‑833-491-2524 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of NEURACEQ was evaluated in 872 adult subjects who received NEURACEQ by intravenous injection in clinical trials. Of these subjects, 724 received a single dose, 78 received two doses, and 70 received three doses at yearly intervals as part of annual repeat scanning. Table 2 shows adverse reactions reported in 1% of these 1,090 administrations from the clinical trials. Table 2: Adverse Reactions Reported in 1% of NEURACEQ Administrations in Adults in Clinical Trials Adverse Reaction NEURACEQ N=1,090 Administrations % Injection site pain 3.4 Injection site erythema 1.7 Injection site irritation 1.1

8.1 Pregnancy 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 florbetaben F 18 to evaluate its effect on female reproduction and embryo-fetal development. All radiopharmaceuticals, including NEURACEQ, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation 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 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. 8.2 Lactation Risk Summary There are no data on the presence of florbetaben F 18 in human milk, the effects on the breastfed infant, or the effects on milk production.

In the event of administration of a radiation overdose with NEURACEQ, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition.

• Mar 19, 2014NDANDA204677Lantheus

1. 1Amyloid Related Imaging Abnormality-oedema/effusion635%
2. 2Injection Site Pain424%
3. 3Asthenia318%
4. 4Fatigue318%
5. 5Dizziness212%
6. 6Dyspnoea212%
7. 7Headache212%
8. 8Hyperhidrosis212%
9. 9Nausea212%
10. 10Accidental Underdose15.9%
11. 11Amyloid Related Imaging Abnormality-microhaemorrhages And Haemosiderin Deposits15.9%
12. 12Aphasia15.9%
13. 13Balance Disorder15.9%
14. 14Burning Sensation15.9%
15. 15Cerebrovascular Accident15.9%

The 10 most recently updated of 47 ClinicalTrials.gov registrations naming Florbetaben as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
  Recruiting · Phase 1 · Interventional · 90 enrolled · National Institute of Mental Health (NIMH)
  NCT07169630updated 2026-06-12
• Alzheimer's Disease Neuroimaging Initiative 4
  Enrolling by invitation · Observational · 1,500 enrolled · University of Southern California
  NCT05617014updated 2026-06-05
• Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging
  Not yet recruiting · Interventional · 50 enrolled · University of Zurich
  NCT07624760updated 2026-06-03
• Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
  Completed · Phase 3 · Interventional · 244 enrolled · Lantheus Germany GmbH
  NCT05184088updated 2026-06-02
• Test-retest Study With [18F]FBB in Cardiac Amyloidosis
  Recruiting · Phase 1 · Interventional · 15 enrolled · Lantheus Germany GmbH
  NCT06790394updated 2026-06-02
• Brain Amyloid- Retention During Wakefulness and Following Emergence From Sleep in Healthy People
  Completed · Early phase 1 · Interventional · 22 enrolled · National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  NCT02669225updated 2026-05-22
• Discovery and Validation of Genetic Variants Affecting Microglial Activation in Alzheimer's Disease
  Active not recruiting · Phase 2 · Interventional · 107 enrolled · Columbia University
  NCT04840979updated 2026-05-14
• Florbetaben for Imaging of Vascular Amyloid
  Recruiting · Observational · 30 enrolled · Ottawa Heart Institute Research Corporation
  NCT06091319updated 2026-05-08
• PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
  Recruiting · Phase 1 · Interventional · 184 enrolled · National Institute of Mental Health (NIMH)
  NCT04396873updated 2026-04-24
• Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503
  Recruiting · Early phase 1 · Interventional · 70 enrolled · University of Pennsylvania
  NCT06303921updated 2026-04-24

Frequently asked questions

How does Florbetaben work?

Mechanism-of-action class: Positron Emitting Activity.

What is Florbetaben used for?

According to FDA labeling, Florbetaben carries indications including: NEURACEQ is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products NEURACEQ is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products (1). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Florbetaben?

Florbetaben is classified as Positron Emitting Activity.

What are the contraindications for Florbetaben?

Florbetaben labeling lists contraindications including: None None.. Always consult the full prescribing information and a clinician.