PYLARIFY (piflufolastat f-18)

DistributionFollowing intravenous administration of piflufolastat F 18, blood levels decline in a biphasic fashion. The distribution half-life is 0.17 ± 0.044 hours and the elimination half-life is 3.47 ± 0.49 hours. Piflufolastat F 18 distributes to the kidneys (16.5% of administered activity), liver (9.3%), and lung (2.9%), within 60 minutes of intravenous administration.

EliminationElimination is by urinary excretion. In the first 8 hours post-injection, approximately 50% of administered ra...

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). OSPREY OSPREY enrolled a cohort of 268 men with biopsy-proven prostate cancer who were considered candidates for radical prostatectomy and pelvic lymph node dissection. These patients were all considered to have high risk disease based on criteria such as Gleason score, PSA level, and tumor stage. Each patient received a single PYLARIFY PET/CT from mid-thigh to skull vertex. Three central readers independent...

The most common reported adverse reactions are headache, dysgeusia, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Progenics Pharmaceuticals, Inc. at 1-800-362-2668 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect t...

None. None. ( 4 )

Risk of Image Misinterpretation : PYLARIFY uptake can be seen in a variety of tumor types as well as in non-malignant processes and normal tissues. Image interpretation errors can occur with PYLARIFY imaging. ( 5.1 ) Hypersensitivity Reactions : Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. ( 5.2 ) Radiation Risk : Ensure safe drug handling to protect patients and health care workers from unintentional radiation exposur...

7 DRUG INTERACTIONS Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.