• Imaging agents

Pylarify Generic Name & Formulations

General Description

Piflufolastat F 18 [37–2960MBq/mL (1–80mCi/mL)]; per vial; soln for IV inj.

Pharmacological Class

Radioactive diagnostic agent.

How Supplied

Multiple-dose vial (50mL)—1

Generic Availability


Pylarify Indications


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 or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Pylarify Dosage and Administration


See full labeling. Give 333MBq (9mCi) with an acceptable range of 296–370MBq (8–10MCi) as a single bolus IV inj, followed by an IV flush of NaCl 0.9% inj. Start image acquisition 60mins after inj (>90mins after inj may impact imaging performance). The radiation effective dose from 370MBq (10mCi) dose is 4.3mSv (to an adult weighing 70kg).


Not established.

Pylarify Contraindications

Not Applicable

Pylarify Boxed Warnings

Not Applicable

Pylarify Warnings/Precautions


Risk of radiation exposure. Should only be used by trained and experienced physicians in the safe use and handling of radionuclides to minimize radiation exposure. Ensure adequate hydration. Have resuscitation equipment readily available. Monitor for hypersensitivity reactions esp. in those with a history of allergy to other drugs and foods. Risk for image misinterpretation and other errors.

Pylarify Pharmacokinetics

See Literature

Pylarify Interactions


Concomitant androgen deprivation therapy and others targeting the androgen pathway may result in changes in Pylarify uptake in prostate cancer.

Pylarify Adverse Reactions

Adverse Reactions

Headache, dysgeusia, fatigue.

Pylarify Clinical Trials

See Literature

Pylarify Note

Not Applicable

Pylarify Patient Counseling

See Literature