Piflufolastat F 18

What is Piflufolastat F 18 ?

• Piflufolastat F 18 (PYLARIFY) is a radioactive diagnostic agent indicated for positron emission tomography (PET).

What are the uses of this medicine?

This medicine 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.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid coadministration with 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.

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

• PYLARIFY is a radioactive drug.
• Only authorized persons qualified by training and experience should receive, use, and administer PYLARIFY.
• Handle PYLARIFY with appropriate safety measures to minimize radiation exposure during administration .
• Use waterproof gloves and effective radiation shielding, including syringe shields, when preparing and handling PYLARIFY.

Recommended dosage

• The recommended amount of radioactivity to be administered for PET imaging is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi) administered as a single bolus intravenous injection.

Administration

• Use aseptic technique and radiation shielding when preparing and administering PYLARIFY.
• Visually inspect the radiopharmaceutical solution. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution).
• Calculate the necessary volume to administer based on calibration time and required dose. PYLARIFY may be diluted with 0.9% Sodium Chloride Injection, USP.
• Assay the dose in a suitable dose calibrator prior to administration.
• Follow the PYLARIFY injection with an intravenous flush of 0.9% Sodium Chloride Injection USP.
• Dispose of any unused PYLARIFY in compliance with applicable regulations.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: clear, colorless solution in a multiple-dose vial containing 37 MBq/mL to 2,960 MBq/mL (1 mCi/mL to 80 mCi/mL) of piflufolastat F 18 at calibration date and time.

This medicine is available in fallowing brand namesː

• PYLARIFY

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• dysgeusia
• fatigue

What special precautions should I follow?

• Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may not be immediate.
• Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.
• Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.

What to do in case of emergency/overdose?

• In the event of an overdose of PYLARIFY, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding.
• A diuretic might also be considered.
• If possible, an estimate of the radiation effective dose administered to the patient should be made.

Can this medicine be used in pregnancy?

• PYLARIFY is not indicated for use in females.
• There is no information on the risk of adverse developmental outcomes in pregnant women or animals with the use of piflufolastat F 18.

Can this medicine be used in children?

• The safety and effectiveness of PYLARIFY in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: PIFLUFOLASTAT F-18
• Inactive ingredients: ALCOHOL ,ISOTONIC SODIUM CHLORIDE SOLUTION

Who manufactures and distributes this medicine?

Packager: Progenics Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

Storage

• Store PYLARIFY at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F).
• PYLARIFY does not contain a preservative.
• Store PYLARIFY in the original container with radiation shielding.
• The expiration date and time are provided on the container label.
• Use PYLARIFY within 10 hours from the time of end of synthesis.

Handling

• This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

• Dailymed label info on Piflufolastat F 18
• FDA Piflufolastat F 18

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