Active Ingredient: Piflufolastat ¹⁸F
Piflufolastat (18F) is for diagnostic use only.
Piflufolastat (18F) is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, between 3 megabecquerel piflufolastat ¹⁸F per kilogram of body weight and 5 megabecquerel piflufolastat ¹⁸F per kilogram of body weight, one dose.
Piflufolastat is for use in designated nuclear medicine facilities only and should only be handled by authorised personnel.
The mean recommended activity of (18F) piflufolastat is 4 MBq/kg of body weight and can vary from 3 to 5 MBq/kg of body weight depending on the PET equipment and acquisition mode used. The minimum activity should not fall below 190 MBq and the maximum activity should not exceed 360 MBq.
The patient should be well hydrated before the start of the examination and urged to void before the examination in order to reduce bladder activity and as often as possible during the first hours after the examination in order to reduce radiation exposure.
A diuretic expected to act within the uptake time period may be administered to improve interpretation of piflufolastat (18F) PET/CT as it results in less activity depositions in ureters and the bladder.
Close contact with infants and pregnant women should be restricted during the initial 12 hours following the injection.
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