Imaging agents:

Recent Updates:

Monograph added.

Indications for PYLARIFY:

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.

Adult Dosage:

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).

Children Dosage:

Not established.

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 Classification:

Radioactive diagnostic agent.

PYLARIFY Interactions:

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

Adverse Reactions:

Headache, dysgeusia, fatigue.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (50mL)—1