Amyvid

Florbetapir F 18 · Injection, Solution · Intravenous

Prescription (Rx) Radioactive Diagnostic Agent

Uses

1 INDICATIONS AND USAGE 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 )

Dosage and administration

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. Patient Preparation Instruct patients to hydrate before and after AMYVID administration and to void following AMYVID administration before imaging and frequently thereafter [see Warnings and Precautions ( 5.2 )] . Administration Use aseptic technique and radiation shielding when withdrawing and administering AMYVID. Visually inspect AMYVID for particulate matter and discoloration prior to administration. Do not use AMYVID if it contains particulate matter or if it is discolored. Do not dilute AMYVID. Assay the dose in a dose calibrator prior to administration. Inject AMYVID through a short intravenous catheter (approximately 1.5 inches or less) to minimize the potential for adsorption of the drug to the catheter. Portions of the AMYVID dose may adhere to longer catheters. Dispose of unused product in a safe manner in compliance with applicable regulations. 2.3 Image Acquisition Instructions Position the patient supine with the head positioned to center the brain, including the cerebellum, in the PET scanner field of view. Tape or other flexible head restraints may be employed to reduce head movement. Acquire 10-minute PET images starting 30 minutes to 50 minutes after AMYVID administration. Image reconstruction should include attenuation correction with resulting transaxial pixel sizes between 2 mm and 3 mm. 2.4 Image Display and Interpretation Image Display Display images in the transaxial orientation with access as needed to the sagittal and coronal planes. In reviewing the images, include all transaxial slices of the brain using a black-white scale set to the maximum intensity of all the brain pixels. Initially locate the brain slice with the highest levels of image contrast (highest signal intensity) and adjust the contrast appropriately. Start image interpretation by displaying slices sequentially from the bottom of the brain to the top. Periodically refer to the sagittal and coronal plane image display as needed to better define the signal intensity and to ensure that the entire brain is displayed. Visual Assessment AMYVID images should be interpreted only by readers who successfully complete the training program provided by the manufacturer. Perform image interpretation independently of the patient's clinical features, relying on the recognition of unique image features. Interpret AMYVID images based upon the distribution of signal intensity within the cerebral cortex by comparing the signal intensity in the cortical gray matter and the adjacent white matter. The signal intensity in the cerebellum does not contribute to the scan interpretation. For example, a positive scan may show retained cerebellar gray-white contrast even when the cortical gray-white contrast is lost. Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or image blur. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal [see Warnings and Precautions ( 5.1 )] . Negative AMYVID Scan Negative scans show more signal in white matter than in adjacent cortical gray matter, creating clear gray-white contrast. A negative scan indicates sparse to no amyloid beta neuritic plaques. In patients being evaluated for AD and other causes of cognitive decline who have not been treated with amyloid beta-directed therapy, a negative scan is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition and reduces the likelihood that a patient's cognitive impairment is due to AD. A negative scan result does not preclude the accumulation of amyloid beta in the brain in the future. Positive AMYVID Scan Positive scans show cortical areas with reduction or loss of the normally distinct gray-white contrast. These scans will have one or more areas with increased cortical gray matter signal which results in reduced (or absent) gray-white contrast. Specifically, a positive scan will have either: a) Two or more brain areas (each larger than a single cortical gyrus) in which there is reduced or absent gray-white contrast. This is the most common appearance of a positive scan. or b) One or more areas in which cortical gray matter signal is intense and clearly exceeds the signal in adjacent white matter. A positive scan establishes the presence of moderate to frequent amyloid beta neuritic plaques.

Dosage forms and strengths

Injection: 500 MBq/mL to 1,900 MBq/mL (13.5 mCi/mL to 51 mCi/mL) of florbetapir F 18 in up to 100 mL volume at end of synthesis (EOS) as a clear, colorless solution in a multiple-dose vial. Injection: 500 MBq/mL to 1,900 MBq/mL (13.5 mCi/mL to 51 mCi/mL) of florbetapir F 18 in up to 100 mL volume at end of synthesis in a multiple-dose vial ( 3 )

Contraindications

None. None ( 4 )

Warnings and precautions

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. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration ( 2.1 , 2.2 )] .

Side effects

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.

Use in specific populations

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. 8.2 Lactation Risk Summary There are no data on the presence of florbetapir F 18 in human milk, the effects on the breastfed infant, or effects on milk production. Lactation studies have not been conducted in animals. Exposure of AMYVID to a breastfed infant can be minimized by temporary discontinuation of breastfeeding ( see Clinical Considerations ). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for AMYVID and any potential adverse effects on the breastfed child from AMYVID or from the underlying maternal condition. Clinical Considerations To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours (>10 half-lives of radioactive decay for the F 18 isotope) following administration of AMYVID. 8.4 Pediatric Use The safety and effectiveness of AMYVID have not been established in pediatric patients. 8.5 Geriatric Use Of the 496 patients in clinical studies of AMYVID, 307 patients were 65 years of age and older, while 203 patients were 75 years of age and older. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.

Pregnancy

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.

Pediatric use

8.4 Pediatric Use The safety and effectiveness of AMYVID have not been established in pediatric patients.

Geriatric use

8.5 Geriatric Use Of the 496 patients in clinical studies of AMYVID, 307 patients were 65 years of age and older, while 203 patients were 75 years of age and older. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.

Overdosage

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.

Description

11.1 Drug Characteristics AMYVID (florbetapir F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, florbetapir F 18 is (E)-4-(2-(6-(2-(2-(2[ 18 F] fluoroethoxy)ethoxy)ethoxy)pyridine-3-yl)vinyl)-N-methylbenzamine. The molecular weight is 359 and the structural formula is: AMYVID is a sterile, non-pyrogenic clear, colorless solution. Each mL contains 0.1 mcg to 19 mcg of florbetapir and 500 MBq to 1,900 MBq (13.5 mCi to 51 mCi) of florbetapir F 18 at EOS and the following inactive ingredients: 4.5 mg sodium ascorbate and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection. The pH of the solution is between 5.5 and 8.0. Structural Formula 11.2 Nuclear Physical Characteristics Fluorine-18 (F 18) decays by positron (β + ) emission to oxygen-18 and has a physical half-life of 109.8 minutes. The principal photons useful for diagnostic imaging are the coincident pair of 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron ( Table 3 ). Table 3: Principal Radiation Produced from Decay of Fluorine-18 Radiation Energy Level (keV) Abundance (%) Positron 249.8 96.9 Gamma 511 193.5 The point source air-kerma coefficient for F 18 is 3.74E -17 Gy m 2 /(Bq s); this coefficient was formerly defined as the specific gamma-ray constant of 5.7 R/hr/mCi at 1 cm. The first half-value thickness of lead (Pb) for F 18 gamma rays is approximately 6 mm. The relative reduction of radiation emitted by F 18 that results from various thicknesses of lead shielding is shown in Table 4 . The use of ~8 cm of Pb will decrease the radiation transmission (i.e., exposure) by a factor of about 10,000. Table 4: Radiation Attenuation of 511 keV Gamma Rays by Lead Shielding Shield Thickness cm of Lead (Pb) Coefficient of Attenuation 0.6 0.5 2 0.1 4 0.01 6 0.001 8 0.0001 For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 5 . Table 5: Physical Decay Chart for Fluorine-18 Minutes Fraction Remaining 0 1.00 15 0.909 30 0.826 60 0.683 110 0.500 220 0.250 440 0.060

Mechanism of action

12.1 Mechanism of Action 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. The binding of florbetapir F 18 to amyloid beta aggregates was demonstrated in postmortem human brain sections using autoradiographic methods, thioflavin S and traditional silver staining correlation studies as well as immunohistochemistry (monoclonal antibody to amyloid beta) correlation studies. Florbetapir binding to tau protein and a battery of neuroreceptors was not detected in in vitro studies.

How supplied

How Supplied AMYVID (florbetapir F 18 injection) is a clear, colorless solution supplied in a shielded multiple-dose vial available as: Concentration @ EOS Volume Vial Size NDC 500 MBq/mL to 1,900 MBq/mL (13.5 mCi/mL to 51 mCi/mL) 10 mL to 50 mL 50 mL 0002-1200-50 500 MBq/mL to 1,900 MBq/mL (13.5 mCi/mL to 51 mCi/mL) 10 mL to 100 mL 100 mL 0002-1200-48 Storage and Handling Store AMYVID in the original container with radiation shielding at 25ºC (77°F); excursions permitted to 15ºC to 30ºC (59°F to 86°F) [see USP Controlled Room Temperature]. AMYVID does not contain a preservative. Do not use after the expiration date and time provided on the container label. AMYVID multiple-dose vial expires 10 hours after EOS. Dispose of unused product in accordance with all federal, state, and local laws and institutional requirements. This preparation is for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Patient information

Radiation Risk Advise patients of the radiation risk of AMYVID. Instruct patients to drink water to ensure adequate hydration prior to administration of AMYVID and to continue drinking and voiding frequently following administration to reduce radiation exposure [see Warnings and Precautions ( 5.2 )] . Pregnancy Inform pregnant women of the potential risks of fetal exposure to radiation doses with AMYVID [see Use in Specific Populations ( 8.1 )] . Lactation Advise a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for 24 hours (>10 half-lives of radioactive decay for the F 18 isotope) after AMYVID administration to minimize radiation exposure to the breastfed infant [see Use in Specific Populations ( 8.2 )] . Marketed by Lilly USA, LLC Indianapolis, IN 46285 USA Copyright © 2012, 2025, Eli Lilly and Company. All rights reserved. AMV-0005-USPI-20250709

Label text from the FDA structured product label by Eli Lilly and Company (revised Dec 11, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Florbetapir F-18 in 1 product

Amyvid NDC products (1)

NDC	Strength & form	Labeler	Type
0002-1200	Florbetapir F-18 51 mCi/mL Injection, Solution	Eli Lilly and Company	NDA

Frequently asked questions

What is Amyvid used for?

What are the side effects of Amyvid?

Who makes Amyvid?

Amyvid is listed by 1 labeler in the FDA NDC directory, including Eli Lilly and Company.