Florbetapir F 18
FDA Drug Information • Also known as: Amyvid
- Brand Names
- Amyvid
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 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 ....
What Is Florbetapir F 18 Used For?
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
2 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...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS 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.
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Pregnancy and Breastfeeding
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.
Overdosage
10 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.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 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.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.