FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer • with suspected metastasis who are candidates for initial definitive therapy. • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. 2 DOSAGE AND ADMINISTRATION 2.1 Radiation Safety - Drug Handling Handle POSLUMA with safety measures to minimize radiation exposure [ see Warnings and Precautions (5.2)] . Use waterproof gloves, effective radiation shielding, including syringe shields, and other appropriate safety measures when handling and administering POSLUMA. Radiopharmaceuticals should be used by or under the control of physicians 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 Dose and Administration Instructions Recommended Dose The recommended amount of radioactivity to be administered in adults is 296 MBq (8 mCi) as an intravenous bolus injection. Preparation and Administration Instructions • Inspect POSLUMA visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored. • Use aseptic technique and radiation shielding when withdrawing and administering POSLUMA. • Calculate the necessary volume to administer based on calibration time and required dose. • The recommended maximum volume of undiluted POSLUMA is 5 mL. • POSLUMA may be diluted with 0.9% Sodium Chloride Injection, USP. • Assay the dose in a dose calibrator before administration. Post Administration Instructions • After the POSLUMA injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection, USP to ensure full delivery of the dose. • Dispose of any unused drug in a safe manner in compliance with applicable regulations.
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Reference ID: 5180081
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