Generic Name
Piflufolastat F-18
Brand Names
Pylarify, Pylarify Truvu
FDA approval date: May 26, 2021
Classification: Radioactive Diagnostic Agent
Form: Injection
What is Pylarify (Piflufolastat F-18)?
PYLARIFY is indicated for positron emission tomography of prostate-specific membrane antigen 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 level. PYLARIFY is a radioactive diagnostic agent indicated for positron emission tomography of prostate-specific membrane antigen 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 level.
Approved To Treat
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Brand Information
PYLARIFY (PIFLUFOLASTAT F-18)
1INDICATIONS AND USAGE
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.
2DOSAGE 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.
3CONTRAINDICATIONS
None.
4OVERDOSAGE
In the event of an overdose of PYLARIFY, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding. A diuretic might also be considered. If possible, an estimate of the radiation effective dose administered to the patient should be made.
5CLINICAL STUDIES
The safety and efficacy of PYLARIFY were evaluated in two prospective, open-label, multi-center clinical studies in men with prostate cancer: OSPREY (NCT02981368) and CONDOR (NCT03739684).
6PRINCIPAL DISPLAY PANEL - 80 mCi/mL Vial Label
Sterile
PYLARIFY
Non-pyrogenic
37 MBq/mL to 2,960 MBq/mL (1 mCi/mL to 80 mCi/mL)
Batch #: _________
EOS Date:_________EOS Time: _________
Activity @ EOS:_________mCi
Concentration:_________mCi/mL
Volume:_________mL
Exp. Date:_________Exp. Time: _________
