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How to Use PYLARIFY TruVu

Radiation safety

  • PYLARIFY TruVu is a radioactive drug. Only authorized persons qualified by training and experience should receive, use, and administer PYLARIFY TruVu
  • Handle PYLARIFY TruVu with appropriate safety measures to minimize radiation exposure during administration
  • Diagnostic radiopharmaceuticals, including PYLARIFY TruVu, expose patients to radiation
  • Radiation exposure is associated with a dose-dependent increased risk of cancer
  • Ensure safe handling and preparation procedures to protect patients and healthcare workers from unintentional radiation exposure

Dosing and administration

  • Use aseptic technique and radiation shielding when preparing and administering PYLARIFY TruVu
  • Visually inspect the radiopharmaceutical solution. Do not use if it contains particulate matter or if it is discolored. PYLARIFY TruVu is a clear, colorless to pale yellow solution
  • PYLARIFY TruVu may be diluted with 0.9% Sodium Chloride Injection, USP
  • Assay the dose in a suitable dose calibrator prior to administration
  • Inject a bolus of 9 mCi (333 MBq) of PYLARIFY TruVu with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi) administered as a single bolus intravenous injection
  • Follow the PYLARIFY TruVu injection with an intravenous flush of 0.9% Sodium Chloride Injection, USP
  • Dispose of any unused PYLARIFY TruVu in compliance with applicable regulations

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY TruVu. The effect of these therapies on the performance of PYLARIFY TruVu has not been established.

  • There is no fasting requirement prior to the injection of PYLARIFY TruVu injection
  • Patients are encouraged to be well hydrated prior to drug dosing and scan
  • Instruct patients to continue drinking and voiding frequently for the first few hours following administration to reduce radiation exposure

  • The recommended start time for image acquisition is 60 minutes after PYLARIFY TruVu injection
  • Starting image acquisition more than 90 minutes after injection may adversely impact imaging performance
  • Patient should void after drug administration and immediately prior to imaging
  • Position the patient supine with arms above the head. Image acquisition should start from mid-thigh and proceed to the skull vertex. Scan duration is 12 minutes to 40 minutes depending on the number of bed positions (typically 6 to 8) and acquisition time per bed position (typically 2 minutes to 5 minutes)
  • The scan should start at the mid-thigh and proceed to the skull vertex. The number of bed positions and the acquisition time per bed position will be specific to the patient and scanner. Scan duration is 12 minutes to 40 minutes depending on the number of bed positions (typically 6 to 8) and acquisition time per bed position (typically 2 minutes to 5 minutes)

  • Based on the intensity of the signals, PET images obtained using PYLARIFY TruVu indicate the presence of PSMA in tissues
  • Lesions should be considered positive if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake is expected. Tumors that do not express PSMA will not be visualized. Increased uptake in tumors is not specific for prostate cancer

  • Store PYLARIFY TruVu upright in the original container with radiation shielding at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]
  • PYLARIFY TruVu does not contain a preservative
  • The expiration date and time are provided on the container label
  • Use PYLARIFY TruVu within 10 hours from the time of end of synthesis
  • Dispose of any unused product in compliance with applicable regulations

PET=positron emission tomography.

To report suspected adverse reactions for PYLARIFY TRUVU, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for PYLARIFY TRUVU.

INDICATION

PYLARIFY TRUVU (piflufolastat F 18) Injection 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.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY TRUVU 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. The performance of PYLARIFY TRUVU for imaging biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY TRUVU for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY TRUVU uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.

Hypersensitivity Reactions

Monitor patients for hypersensitivity reactions, particularly those with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks

PYLARIFY TRUVU exposes patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. 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.

Adverse Reactions

The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug Interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY TRUVU in prostate cancer. The effect of these therapies on performance of PYLARIFY TRUVU PET has not been established.

To report suspected adverse reactions for PYLARIFY TRUVU, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for PYLARIFY TRUVU.

REFERENCE

1. PYLARIFY TruVu™ [package insert]. North Billerica, MA: Aphelion LLC, a Lantheus company.