Piflufolastat F-18: uses, dosing, side effects & brands
Piflufolastat F-18 is a medicine sold in the U.S. under 2 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Injectable
- Sold as
- 2 products — Pylarify and Pylarify Truvu
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How piflufolastat f-18 is dosed
From the FDA label for Pylarify (application NDA214793). Other piflufolastat f-18 products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dose 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 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 PYLARIFY is a radioactive drug. Only authorized persons qualified by training and experience should receive, use, and administer PYLARIFY. Handle PYLARIFY 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. 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. Visually inspect the…
Piflufolastat F-18 side effects
The most common reported adverse reactions are headache, dysgeusia, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Progenics Pharmaceuticals, Inc. 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 was evaluated in 593 patients, each receiving one dose of PYLARIFY. 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 PYLARIFY (n = 593) Adverse Reaction n (%) Headache 13 (2%) Dysgeusia 10 (2%) Fatigue 7 (1%)
Who shouldn’t take piflufolastat f-18
None. None. ( 4 )
Piflufolastat F-18 drug interactions
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 PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.
Every piflufolastat f-18 product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → |
Related calculators
Frequently asked questions
What is piflufolastat f-18?
Pylarify (Piflufolastat F-18) is a medication supplied as an injection.
Can you take piflufolastat f-18 with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run piflufolastat f-18 against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is piflufolastat f-18 sold under?
We track 2 piflufolastat f-18-containing products in the U.S.: Pylarify and Pylarify Truvu. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does piflufolastat f-18 come in?
Across the brands we track, piflufolastat f-18 is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic piflufolastat f-18?
We do not currently list a generic-labelled piflufolastat f-18 product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Piflufolastat F-18: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/piflufolastat-f-18
- MLA
- “Piflufolastat F-18: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/piflufolastat-f-18.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for piflufolastat f-18 on DailyMed (NIH) ↗.