Florbetapir

Florbetapir F 18 binds to amyloid beta plaques and the F 18 isotope produces a positron signal that is detected by a PET scanner. In in vitro binding studies using postmortem human brain homogenates containing amyloid beta plaques, the dissociation constant (Kd) for florbetapir was 3.7 ± 0.3 nM.

• AMYVID 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 AMYVID 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 )ICD-10: G30.9

• None.contraindicated

The recommended amount of radioactivity is 370 MBq (10 mCi) administered as a single intravenous bolus 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 10-minute PET images starting approximately 30 minutes to 50 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 AMYVID with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions ( 5.2 )] . Use waterproof gloves and effective radiation shielding, including syringe shields when handling and administering AMYVID. Radiopharmaceuticals, including AMYVID, 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 Dosage and Administration Instructions Recommended Dosage The recommended amount of radioactivity of AMYVID is 370 MBq (10 mCi) in a total volume of up to 10 mL, administered as a single intravenous bolus. The maximum mass dose is 50 mcg. Follow the injection 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: AMYVID 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 AMYVID image interpretation [see Clinical Studies ( 14 )]. The use of clinical information in the interpretation of AMYVID images has not been evaluated and may lead to an inaccurate assessment. Extensive brain atrophy as well as motion artifacts that distort the image may limit the ability to distinguish gray and white matter on an AMYVID 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 AMYVID 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 ≥ 0.4%) were headache, musculoskeletal pain, increased blood pressure, nausea, fatigue, injection site reaction, anxiety, back pain, claustrophobia, dizziness, feeling cold, insomnia, and neck pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 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 AMYVID was evaluated in 555 adult subjects who received AMYVID by intravenous injection in clinical trials. Table 2 shows adverse reactions reported in ≥ 0.4% of subjects from the clinical trials. Table 2: Adverse Reactions Reported in ≥ 0.4% of Adult Subjects Who Received AMYVID in Clinical Trials a Includes the terms blood pressure increased and hypertension. b Includes the terms injection site hemorrhage, injection site irritation, and injection site pain. c Includes the terms feeling cold and chills. Adverse Reaction AMYVID N=555 % Headache 1.8 Musculoskeletal pain 0.7 Blood pressure increased a 0.7 Nausea 0.7 Fatigue 0.5 Injection site reaction b 0.5 Anxiety 0.4 Back pain 0.4 Claustrophobia 0.4 Dizziness 0.4 Feeling cold c 0.4 Insomnia 0.4 Neck pain 0.4 Adverse reactions that occurred in <0.4% of subjects included infusion site rash, dysgeusia, pruritus, urticaria, and flushing.

Lactation: Temporarily discontinue breastfeeding. A lactating woman should pump and discard breast milk for 24 hours after AMYVID administration. ( 8.2 ) 8.1 Pregnancy Risk Summary There are no available data on AMYVID 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 florbetapir F 18 to evaluate its effect on female reproduction and embryo-fetal development. All radiopharmaceuticals, including AMYVID, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose. If considering AMYVID 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.

Metabolism

Following intravenous administration of 370 MBq (10 mCi) of AMYVID in healthy subjects, florbetapir F 18 was distributed throughout the body with less than 5% of the injected F 18 radioactivity present in the blood by 20 minutes following administration, and less than 2% present by 45 minutes after administration. The F 18 in circulation during the 30-minute to 90-minute imaging window was principally in the form of polar florbetapir metabolites.

In the event of administration of a radiation overdose with AMYVID, hydration and frequent urination should be encouraged to minimize radiation exposure to the patient.

• Apr 6, 2012NDANDA202008Avid Radiopharms Inc

1. 1Amyloid Related Imaging Abnormality-oedema/effusion2825%
2. 2Amyloid Related Imaging Abnormality-microhaemorrhages And Haemosiderin Deposits2724%
3. 3Headache1413%
4. 4Superficial Siderosis Of Central Nervous System98.0%
5. 5Injection Site Pain76.3%
6. 6Chest Pain43.6%
7. 7Fatigue43.6%
8. 8Nausea43.6%
9. 9Burning Sensation32.7%
10. 10Confusional State32.7%
11. 11Drug Ineffective32.7%
12. 12Erythema32.7%
13. 13Fall32.7%
14. 14False Negative Investigation Result32.7%
15. 15Flushing32.7%

The 10 most recently updated of 100 ClinicalTrials.gov registrations naming Florbetapir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Cerebral Amyloid Imaging Using Florbetapir (AV-45)
  Completed · Phase 3 · Interventional · 92 enrolled · Centre Hospitalier Universitaire, Amiens
  NCT02813434updated 2026-06-11
• Alzheimer's Disease Neuroimaging Initiative 4
  Enrolling by invitation · Observational · 1,500 enrolled · University of Southern California
  NCT05617014updated 2026-06-05
• Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)
  Completed · Interventional · 92 enrolled · University Hospital, Tours
  NCT01962753updated 2026-05-19
• Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau
  Not yet recruiting · Phase 1 · Interventional · 6 enrolled · Columbia University
  NCT06600880updated 2026-05-13
• Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults
  Completed · Interventional · 344 enrolled · University Hospital, Toulouse
  NCT03129269updated 2026-05-04
• Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol
  Recruiting · Phase 2 · Interventional · 200 enrolled · Akiva Mintz
  NCT07012993updated 2026-04-13
• Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage
  Completed · Interventional · 70 enrolled · University Hospital, Toulouse
  NCT01619709updated 2026-04-06
• Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis
  Completed · Phase 1 · Phase 2 · Interventional · 8 enrolled · Mayo Clinic
  NCT03019029updated 2026-03-16
• Biomarker Exploration in Aging, Cognition and Neurodegeneration
  Recruiting · Phase 3 · Interventional · 300 enrolled · University of California, Irvine
  NCT03860857updated 2026-01-23
• Study to Understand Novel Biomarkers in Researching Dementia
  Recruiting · Observational · 1,800 enrolled · Washington University School of Medicine
  NCT06547099updated 2026-01-16

Frequently asked questions

How does Florbetapir work?

Florbetapir F 18 binds to amyloid beta plaques and the F 18 isotope produces a positron signal that is detected by a PET scanner. In in vitro binding studies using postmortem human brain homogenates containing amyloid beta plaques, the dissociation constant (Kd) for florbetapir was 3.7 ± 0.3 nM.

What is Florbetapir used for?

According to FDA labeling, Florbetapir carries indications including: AMYVID 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 AMYVID 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 are the contraindications for Florbetapir?

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