PYLARIFY PIFLUFOLASTAT F-18 80 mCi/mL Injection, 50 mL
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII VR5Y7PDT5W
A saltwater solution with the same concentration as blood. It's used as a vehicle or diluent in injectable medicines to help distribute the active drug and maintain proper fluid balance in the body.
2 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $3,774.62 | $3,774.62 / 1 vial |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pylarify 80 mCi/mLthis 71258-0022-01 | Progenics | 50 ml | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 8778305 ↗ | Drug substance | U-3130 | Sep 21, 2030 |
| US 9861713 ↗ | Drug substance | U-3130 | Jul 31, 2029 |
| US 10947197 ↗ | Drug substance | U-3130 | Jun 9, 2037 |
| US 11851407 ↗ | Drug substance | U-3130 | Jun 9, 2037 |
| US 12070513 ↗ | Drug substance | U-3130 | Jul 31, 2029 |
| US 8487129 ↗ | Drug substance | — | Nov 7, 2027 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | May 26, 2026 |
Is there a generic version of PYLARIFY 37-2,960 MBQ/ML VIAL?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
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🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71258-0022-01 You're viewing this | 50 mL in 1 VIAL, MULTI-DOSE (71258-022-01) | 2021-05-26 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE PYLARIFY 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 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.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 )
2.1Radiation 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.
2.2Recommended 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 radiopharmaceutical solution.
Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). Calculate the necessary volume to administer based on calibration time and required dose. PYLARIFY may be diluted with 0.9% Sodium Chloride Injection, USP.
Assay the dose in a suitable dose calibrator prior to administration. Post Administration Instructions 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.
2.3Patient Preparation Instruct patients to drink water to ensure adequate hydration prior to administration of PYLARIFY and to continue drinking and voiding frequently for the first few hours following administration to reduce radiation exposure [see Warnings and Precautions (5.3) ] .
2.4Image Acquisition 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. 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).
2.5Image Display and Interpretation PYLARIFY binds to prostate-specific membrane antigen (PSMA). Based on the intensity of the signals, PET images obtained using PYLARIFY indicate the presence of PSMA in tissues. Lesions should be considered suspicious 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) ].
2.6Radiation Dosimetry Radiation absorbed dose estimates are shown in Table 1 for organs and tissues of adult male patients from intravenous administration of PYLARIFY. The radiation effective dose resulting from administration of 370 MBq (10 mCi) of PYLARIFY 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 i…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless solution in a multiple-dose vial containing 37 MBq/mL to 2,960 MBq/mL (1 mCi/mL to 80 mCi/mL) of piflufolastat F 18 at calibration date and time. Injection: clear, colorless solution in a multiple-dose vial containing 37 MBq/mL to 2,960 MBq/mL (1 mCi/mL to 80 mCi/mL) of piflufolastat F 18 at calibration date and time. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk of Image Misinterpretation : PYLARIFY uptake can be seen in a variety of tumor types as well as in non-malignant processes and normal tissues. Image interpretation errors can occur with PYLARIFY imaging. ( 5.1 ) Hypersensitivity Reactions : Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods.
( 5.2 ) Radiation Risk : Ensure safe drug handling to protect patients and health care workers from unintentional radiation exposure. ( 5.3 )
5.1Risk 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 [ see Clinical Studies (14) ].
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 [ see Clinical Studies (14) ]. 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.
5.2Hypersensitivity Reactions Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may not be immediate. Always have trained staff and resuscitation equipment available.
5.3Radiation Risks Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation [see Dosage and Administration (2.6) ] . 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 [see Dosage and Administration (2.3) ] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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.
6.1Clinical 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%)
🔄 Drug Interactions ▾
7 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary PYLARIFY 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, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
8.2Lactation Risk Summary PYLARIFY is not indicated for use in females. There is no information on the presence of piflufolastat F 18 in human milk, the effect on the breastfed infant, or the effect on milk production.
8.4Pediatric Use The safety and effectiveness of PYLARIFY in pediatric patients have not been established.
8.5Geriatric Use Of the 593 patients in completed clinical studies of PYLARIFY, 355 (60%) were ≥65 years old, while 76 (12.8%) were ≥75 years old. The efficacy and safety of PYLARIFY appear similar in adult and geriatric patients with prostate cancer, although the number of patients in the trials was not large enough to allow definitive comparison.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary PYLARIFY 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, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of PYLARIFY in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 593 patients in completed clinical studies of PYLARIFY, 355 (60%) were ≥65 years old, while 76 (12.8%) were ≥75 years old. The efficacy and safety of PYLARIFY appear similar in adult and geriatric patients with prostate cancer, although the number of patients in the trials was not large enough to allow definitive comparison.
🆘 Overdosage ▾
10 OVERDOSAGE In the event of an overdose of PYLARIFY, 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Piflufolastat F 18 binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Fluorine-18 (F 18) is a β+ emitting radionuclide that enables positron emission tomography.
12.2Pharmacodynamics The relationship between piflufolastat F 18 plasma concentrations and image interpretation has not been studied.
12.3Pharmacokinetics Distribution Following intravenous administration of piflufolastat F 18, blood levels decline in a biphasic fashion. The distribution half-life is 0.17 ± 0.044 hours and the elimination half-life is 3.47 ± 0.49 hours. Piflufolastat F 18 distributes to the kidneys (16.5% of administered activity), liver (9.3%), and lung (2.9%), within 60 minutes of intravenous administration.
Elimination Elimination is by urinary excretion. In the first 8 hours post-injection, approximately 50% of administered radioactivity is excreted in the urine.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Piflufolastat F 18 binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Fluorine-18 (F 18) is a β+ emitting radionuclide that enables positron emission tomography.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied PYLARIFY injection is supplied in a 50 mL multiple-dose glass vial (NDC# 71258-022-01) containing a clear, colorless solution at a strength of 37 MBq/mL to 2,960 MBq/mL (1 mCi/mL to 80 mCi/mL) piflufolastat F 18 at calibration time and date.
16.2Storage and Handling Storage 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. Handling This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
📦 Storage and Handling ▾
16.2Storage and Handling Storage 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. Handling This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
📋 Description ▾
11 DESCRIPTION
11.1Chemical Characteristics PYLARIFY contains fluorine 18 (F 18), radiolabeled prostate-specific membrane antigen inhibitor imaging agent. Chemically piflufolastat F 18 is 2-(3-{1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}ureido)-pentanedioic acid. The molecular weight is 441.4 and the structural formula is: The chiral purity of the unlabeled piflufolastat F 18 precursor is greater than 99% (S,S).
PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0.01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78.9 mg ethanol in 0.9% sodium chloride injection USP. The pH of the solution is 4.5 to 7.0.
PYLARIFY has a radiochemical purity of at least 95% up to 10 hours following end of synthesis, and specific activity of at least 1000 mCi/µmol at the time of administration. Chemical Structure
11.2Physical Characteristics PYLARIFY is radiolabeled with fluorine 18 (F 18), a cyclotron produced radionuclide that decays by positron emission to stable oxygen 18 with a half-life of 109.8 minutes. The principal photons useful for diagnostic imaging are the coincident pair of 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 3). Table 3.
Principal Radiation Produced from Decay of Fluorine 18 Radiation Energy (keV) Abundance (%) Positron 249.8
96.9Gamma 511 193.5
11.3External Radiation The point source air-kerma coefficient for F 18 is 3.75 × 10 -17 Gy m 2 /(Bq s). The first half-value thickness of lead (Pb) for F 18 gamma rays is approximately 6 mm. The relative reduction of radiation emitted by F 18 that results from various thicknesses of lead shielding is shown in Table 4.
The use of 8 cm Pb decreases the radiation transmission (i.e. exposure) by a factor of about 10,000. Table 4. Radiation Attenuation of 511 keV Gamma Rays by Lead Shielding Shield Thickness cm of Lead (Pb) Coefficient of Attenuation 0.6 0.5 2 0.1 4 0.01 6 0.001 8 0.0001
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Adequate Hydration Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their PET study and urge them to drink and urinate as often as possible during the first hours following the administration of PYLARIFY, in order to reduce radiation exposure [ see Dosage and Administration (2.3) and Warnings and Precautions (5.3) ].