Description
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Highlights of Prescribing Information
These highlights do not include all the information needed to use PYLARIFY® safely and effectively. See full prescribing information for PYLARIFY.
PYLARIFY® (piflufolastat F 18) injection, for intravenous use
Initial U.S. Approval: 2021 Buy Pylarify For Sale Online In USA
Indications and Usage for Pylarify
PYLARIFY is a radioactive diagnostic agent 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. (1)
Pylarify Dosage and Administration
- Recommended dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection. (2.2)
- Initiate imaging approximately 60 minutes after PYLARIFY administration. The patient should void immediately prior to initiation of imaging. Image acquisition should start from mid-thigh and proceed to the skull vertex. (2.3, 2.4) Pylarify For Sale
- See full prescribing information for additional preparation, handling, administration, imaging, and radiation dosimetry information. (2)
Dosage Forms and Strengths
Injection: clear, colorless solution in a multiple-dose vial containing 37 MBq/mL to 2,960 MBq/mL (1 mCi/mL to 80 mCi/mL) of piflufolastat F 18 at calibration date and time. (3)
Full Prescribing Information
1. Indications and Usage for Pylarify
PYLARIFY 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. Buy Pylarify For Sale Online In USA
2. Pylarify Dosage and Administration
2.1 Radiation Safety – Drug Handling
PYLARIFY is a radioactive drug. Only authorized persons qualified by training and experience should receive, use, and administer PYLARIFY. Handle PYLARIFY with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.3)]. Use waterproof gloves and effective radiation shielding, including syringe shields, when preparing and handling PYLARIFY.
2.2 Recommended Dosage and Administration Instructions
Recommended Dose
The recommended amount of radioactivity to be administered for PET imaging is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi) administered as a single bolus intravenous injection.
Preparation and Administration
- Use aseptic technique and radiation shielding when preparing and administering PYLARIFY.
- Visually inspect the radiopharmaceutical solution. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution).
- Calculate the necessary volume to administer based on calibration time and required dose. PYLARIFY may be diluted with 0.9% Sodium Chloride Injection, USP.
- Assay the dose in a suitable dose calibrator prior to administration. Buy Pylarify For Sale Online In USA
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