Florbetapir f-18
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From MedlinePlus, U.S. National Library of Medicine
Radioactive Diagnostic Agent
Dosing in kidney impairment
| ORGAN/TISSUE | MEAN ABSORBED DOSE PER UNIT ADMINISTERED ACTIVITY (microGy/MBq) |
| Adrenal | 14 |
| Brain | 10 |
| Breasts | 6 |
| Gallbladder Wall | 143 |
| Heart Wall | 13 |
| Kidneys | 14 |
| Liver | 64 |
| Lower Large Intestine Wall | 28 |
| Lungs | 9 |
| Muscle | 9 |
| Osteogenic Cells | 28 |
| Ovaries | 18 |
| Pancreas | 14 |
| Red Marrow | 14 |
| Skin | 6 |
| Small Intestine | 66 |
| Spleen | 9 |
| Stomach Wall | 12 |
| Testes | 7 |
| Thymus | 7 |
| Thyroid | 7 |
| Upper Large Intestine Wall | 74 |
| Urinary Bladder Wall | 27 |
| Uterus | 16 |
| Total Body | 12 |
| Effective Dose (microSv/MBq) | 19 |
Preparation and administration
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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] . 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.
Contraindications
None. None ( 4 )
Pregnancy and lactation
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.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.