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Pylarify Generic Name & Formulations
Legal Class
Rx
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
Manufacturer
Generic Availability
NO
Pylarify Indications
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
Adult
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
Not established.
Pylarify Contraindications
Not Applicable
Pylarify Boxed Warnings
Not Applicable
Pylarify Warnings/Precautions
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
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
