Piflufolastat f-18

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. 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.

Piflufolastat F 18 binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Fluorine-18 (F 18) is a β+ emitting radionuclide that enables positron emission tomography.

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. 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. See full prescribing information for additional preparation, handling, administration, imaging, and radiation dosimetry information.

None. None.

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. Hypersensitivity Reactions: Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Radiation Risk: Ensure safe drug handling to protect patients and health care workers from unintentional radiation exposure.

The most common reported adverse reactions are headache, dysgeusia, and fatigue.

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.

Storage Store PYLARIFY at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Store PYLARIFY in the original container with radiation shielding.