How to Use PYLARIFY®

Patient preparation icon
Patient
Preparation1,2

Prior to Arrival

  • There is no fasting requirement prior to the injection of PYLARIFY® (piflufolastat F 18) injection
  • Patients are encouraged to be well hydrated prior to drug dosing and scan1

Upon Arrival2

  • The patient’s weight and height should be measured with the patient in a gown or light clothing
  • A large-bore intravenous (IV) catheter line should be placed in an antecubital vein or equivalent venous access
  • Ensure patency of the line with a saline flush
  • Prior to positioning the patient on the PET scanner, patients should be asked to void to enhance image quality
Dosing and administration icon
RADIATION SAFETY,
DOSING, AND ADMINISTRATION1,3

Radiation Safety

  • PYLARIFY® is a radioactive drug. Only authorized persons qualified by training and experience should receive, use, and administer PYLARIFY®1
  • ALARA (As Low As Reasonably Achievable) safety measures need to be used when handling and preparing the dose for injection3
  • Handle PYLARIFY® with appropriate safety measures to minimize radiation exposure during administration1
    • Diagnostic radiopharmaceuticals, including PYLARIFY®, 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 health care workers from unintentional radiation exposure
  • Use waterproof gloves and effective radiation shielding, including syringe shields, when preparing and handling PYLARIFY®1

Dosing and Administration1

  • 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
  • PYLARIFY® 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® 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® injection with an intravenous flush of 0.9% Sodium Chloride Injection, USP
  • Dispose of any unused PYLARIFY® in compliance with applicable regulations
Image acquisition icon
Image
Acquisition
Guidelines1,2
  • The recommended start time for image acquisition is 60 minutes after PYLARIFY® 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
  • Patients will generally be positioned supine in the PET/CT scanner with arms raised above the head (to minimize beam hardening and Field of View (FOV) truncation artifacts). If patients cannot tolerate this position for the duration of the PET/CT study, a different patient positioning may be chosen1,2
  • A low-dose, non-contrast enhanced CT scan will be acquired for attenuation correction and anatomical localization of findings in the PET scan2
    • Only oral water contrast is acceptable
  • The axial FOV will range from mid-thigh through the vertex of the skull. Additional FOV can be acquired of the lower extremities if there is known or suspected disease2
  • 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)1,2
PET image icon
PET Image
Correction,
Reconstruction,
& Post-Processing2
  • The PET data will be corrected for:
    • Geometrical response
    • Detector efficiency (normalization)
    • System dead time
    • Random coincidences
    • Scatter
    • Attenuation using standard algorithms provided by the scanner manufacturer
  • Iterative reconstruction algorithms shall be used (rather than filtered back-projection)
  • If available, Time of Flight (TOF) should be used
  • Perform reconstructions with and without attenuation correction
  • PET image volume that can be analyzed on one or more of the following: PET scanner console, PET image display workstation, Picture Archiving and Communication System (PACS), etc
  • Post-processed image data have been transformed in some manner, including but not limited to:
    • Smoothing
    • Sharpening
    • Image zoom
    • Rotation/translation
    • Resampling
    • Interpolation
    • Slice averaging, Maximum Intensity Projection (MIP), etc
Storing PYLARIFY® icon
Storing
PYLARIFY®1
  • 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
Image reader training icon
Image Reader
Training
  • Lantheus has partnered with the Society of Nuclear Medicine and Molecular Imaging to deliver training on how to interpret PYLARIFY® images. Visit the online learning site

IMPORTANT SAFETY
INFORMATION

Contraindications

None.

Warnings and Precautions

References

  1. PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company
  2. Data on file. New York, NY: Progenics Pharmaceuticals, Inc.; 2021.
  3. Radiation safety. Centers for Disease Control and Prevention. Updated December 7, 2015. Accessed April 4, 2021. https://www.cdc.gov/nceh/radiation/alara.html