PYLARIFY TRUVU

PYLARIFY TRUVU is an FDA-registered drug product whose active ingredient is PIFLUFOLASTAT F-18. It is labelled by Aphelion LLC taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 85347-001, application NDA220089, label effective 20260701. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PIFLUFOLASTAT F-18 are most often described in connection with: pylarify truvu, positron emission, tomography pet, prostate-specific membrane, antigen psma, positive lesions, prostate cancer, suspected metastasis. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE PYLARIFY TRUVU 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 PYLARIFY TRUVU is a radioactive diagnostic drug 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 ( 1 )

2 DOSAGE AND ADMINISTRATION Recommended amount of radioactivity is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection. ( 2.2 ) Initiate imaging approximately 60 minutes after PYLARIFY TRUVU administration. The patient should void immediately prior to initiation of imaging. Image acquisition should start from mid-thigh and proceed to the skull vertex. ( 2.3 , 2.4 ) See full prescribing information for additional preparation, handling, administration, imaging, and radiation dosimetry information. ( 2 ) 2.1 Radiation Safety – Drug Handling Handle PYLARIFY TRUVU with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.3) ] . Use waterproof gloves and effective radiation shielding, including syringe shields, when preparing and handling PYLARIFY TRUVU. Radiopharmaceuticals, including PYLARIFY TRUVU, should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. 2.2 Recommended Dosage and Administration Instructions Recommended Dose 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. Preparation 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). Calculate the necessary volume to administer based on calibration time and required dose. PYLARIFY TRUVU may be diluted with 0.9% Sodium Chloride Injection. Assay the dose in a suitable dose calibrator prior to administration. Post Administration Instructions Follow the PYLARIFY TRUVU injection with an intravenous flush of 0.9% Sodium Chloride Injection. Dispose of any unused PYLARIFY TRUVU in compliance with applicable regulations. 2.3 Patient Preparation Instruct patients to drink water to ensure adequate hydration prior to administration of PYLARIFY TRUVU and to continue drinking and voiding frequently for the first few hours following administration to reduce radiation exposure [see Warnings and Precautions (5.3) ] . 2.4 Image Acquisition The recommended start time for image acquisition is 60 minutes after PYLARIFY TRUVU administration. Starting image acquisition more than 90 minutes after injection may adversely impact imaging performance. Patients should void immediately prior to image acquisition. 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). 2.5 Image Display and Interpretation Piflufolastat F 18 binds to prostate-specific membrane antigen (PSMA). 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 [ see Warnings and Precautions (5.1) ]. 2.6 Radiation Dosimetry Radiation absorbed dose estimates are shown in Table 1 for organs and tissues of adult male patients from intravenous administration of PYLARIFY TRUVU. The radiation effective dose resulting from administration of 370 MBq (10 mCi) of PYLARIFY TRUVU to an adult weighing 70 kg is estimated to be 4.3 mSv. The radiation doses for this administered dose to the critical organs, which are the kidneys, liver, and spleen, are 45.5 mGy, 13.7 mGy, and 10 mGy respectively. When PET/CT is performed, exposure to radiation will increase by an amount dependent on the settings used in the CT acquisition. Table 1. Estimated Radiation Absorbed Doses in Organs/Tissues in Adults Receiving PYLARIFY TRUVU Organ/Tissue Mean Absorbed dose per Unit Administered Activity (mGy/MBq) Mean Standard Deviation Adrenal glands 0.0131 0.0013 Brain 0.0021 0.0003 Breasts 0.0058 0.0007 Gallbladder wall 0.0141 0.0012 Lower large intestine wall 0.0073 0.001 Small intestine 0.0089 0.0009 Stomach wall 0.0092 0.0008 Upper large intestine wall 0.0091 0.0009 Heart wall 0.0171 0.0022 Kidneys 0.123 0.0434 Liver 0.037 0.0058 Lungs 0.0102 0.0016 Muscle 0.0069 0.0008 Pancreas 0.0124 0.0011 Red bone marrow 0.0071 0.0007 Osteogenic cells 0.0099 0.0012 Skin 0.0052 0.0006 Spleen 0.0271 0.0115 Testes 0.0059 0.0008 Thymus gland 0.007 0.0008 Thyroid 0.0062 0.0009 Urinary bladder wall 0.0072 0.001 Effective dose 0.0116 (mSv/MBq) 0.0022 (mSv/MBq)

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence > 0.5%) are headache, dysgeusia, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aphelion LLC at 1-800-362-2668 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PYLARIFY TRUVU has been established based on data from clinical studies of another formulation of piflufolastat F 18 in patients with prostate cancer [see Clinical Studies (14) ] . The results of these two studies are presented below. The safety population included 593 patients, each receiving one dose of piflufolastat F 18. The average injected activity was 340 ± 26 MBq (9.2 ± 0.7 mCi). The adverse reactions reported in >0.5% of patients within the studies are shown in Table 2. In addition, a hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reaction. Table 2. Adverse Reactions with a Frequency >0.5% in Patients Who Received Piflufolastat F 18 (n = 593) Adverse Reaction n (%) Headache 13 (2%) Dysgeusia 10 (2%) Fatigue 7 (1%)

What is PYLARIFY TRUVU used for?
1 INDICATIONS AND USAGE PYLARIFY TRUVU 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 PYLARIFY TRUVU is a radioactive diagnostic drug …

Who makes PYLARIFY TRUVU?
Aphelion LLC is the labeler of record for PYLARIFY TRUVU.

What form does PYLARIFY TRUVU come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is PYLARIFY TRUVU prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has PYLARIFY TRUVU been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.