How to use PYLARIFY

Patient Preparation^1,2

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

Radiation Safety, Dosing, and Administration^1,3

Radiation safety

PYLARIFY is a radioactive drug. Only authorized persons qualified by training and experience should receive, use, and administer PYLARIFY¹
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 PYLARIFY¹

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 Guidelines^1,2

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 chosen^1,2
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 Correction, Reconstruction, and 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 PYLARIFY¹

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

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

CT=computed tomography; PET=positron emission tomography.

INDICATION

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent 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

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation

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. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY 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 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 of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions

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

Radiation Risks

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. 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 with PYLARIFY. 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 in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-26681-80‌0-36‌2-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

REFERENCES

PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
Data on file. New York, NY: Progenics Pharmaceuticals, Inc.; 2024.
Radiation and Your Health. Centers for Disease Control and Prevention. Updated Feburary 26, 2024. Accessed August 18, 2024. https://www.cdc.gov/radiation-health/safety/alara.html

How to use PYLARIFY

Image Reader Training

INDICATION

Hypersensitivity Reactions

Radiation Risks

INDICATION

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