Piflufolastat F-18

What Piflufolastat F-18 is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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) …

— FDA label: Pylarify Truvu, Aphelion LLC, effective July 1, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, intravenous), Pylarify Truvu, Aphelion LLC; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 2 FDA labels for this medicine have a boxed warning.

Piflufolastat F-18 side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

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.

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(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%)

— FDA label: Pylarify Truvu, Aphelion LLC, effective July 1, 2026. Read the full label on DailyMed →

Piflufolastat F-18 drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of piflufolastat F 18 in prostate cancer. The effect of these therapies on performance of PYLARIFY TRUVU PET has not been established.

— FDA label: Pylarify Truvu, Aphelion LLC, effective July 1, 2026. Read the full label on DailyMed →

Piflufolastat F-18 dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

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.

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(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.

— FDA label: Pylarify Truvu, Aphelion LLC, effective July 1, 2026. This is part of the section. Read the full label on DailyMed →

Piflufolastat F-18 in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary PYLARIFY TRUVU 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. All radiopharmaceuticals, including PYLARIFY TRUVU, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

— FDA label: Pylarify Truvu, Aphelion LLC, effective July 1, 2026. Read the full label on DailyMed →

Piflufolastat F-18 overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

In the event of an overdose of PYLARIFY TRUVU, 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.

— FDA label: Pylarify Truvu, Aphelion LLC, effective July 1, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Progenics Pharmaceuticals, Inc.1 product
• Aphelion LLC1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• PylarifyBrand page: products, maker and price
• Pylarify TruvuBrand page: products, maker and price
• Prostate cancerCondition named on the label: hospitals that treat it
• Progenics Pharmaceuticals, Inc.Maker or distributor
• Aphelion LLCMaker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Pylarify Truvu, Aphelion LLC, effective July 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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