2.3 Patient Preparation Instruct patients to drink water prior to administration of POSLUMA to ensure adequate hydration and to continue drinking and voiding frequently for the first few hours following administration to reduce radiation exposure. 2.4 Image Acquisition
• Patients should void immediately prior to imaging. • Position the patient supine with arms above the head.
• Begin image acquisition approximately 60 minutes after POSLUMA injection. • Image acquisition should start from mid-thigh and proceed to the base of the skull. • Scan duration is approximately 20 minutes depending on the number of bed positions and acquisition time per bed position (typically 3 minutes). Adapt imaging technique according to the equipment used and patient characteristics in order to obtain the best image quality possible. 2.5 Image Display and Interpretation POSLUMA binds to PSMA. PET images obtained using POSLUMA indicate the presence of PSMA in tissues [see Clinical Pharmacology ( 12.1)] . Lesions should be considered suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake is expected. Tumors that do not express PSMA will not be visualized. Increased uptake in tumors is not specific for prostate cancer [see Warnings and Precautions (5.1)]. 2.6 Radiation Dosimetry Estimated absorbed radiation doses for adult patients following intravenous injection of POSLUMA are shown in Table 1. The effective radiation dose resulting from the administration of the recommended activity of 296 MBq of POSLUMA is 4.1 mSv. The radiation absorbed doses to the critical organs of adrenal glands, kidneys, and submandibular glands for the recommended activity of 296 MBq are 54.3 mGy, 51 mGy, and 43.8 mGy, respectively. When PET/CT is performed, exposure to radiation will increase by an amount dependent on the settings used in the CT acquisition. Table 1: Estimated Radiation Absorbed Doses in Organs/Tissues in Adults who Received POSLUMA Organ/Tissue Absorbed Dose per Unit Administered Activity (mGy/MBq) Mean Adrenal glands 0.184 Brain 0.002 Breasts 0.004 Gallbladder wall 0.017 Lower large intestine wall 0.007 Upper large intestine wall 0.01 Heart wall 0.02 Kidneys 0.172 Lacrimal glands 0.08 * Liver 0.062 Lungs 0.01
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Reference ID: 5180081
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