pylarify truvu
Pylarify Truvu (Piflufolastat F-18) is a medication supplied as an injection.
Piflufolastat F-18 · by Aphelion
Key facts
- Active ingredient
- Piflufolastat F-18
- Form
- Injectable
- Strength
- Piflufolastat F-18 1mCi/mL-120mCi/mL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Aphelion
- FDA application
- NDA220089
What is Pylarify Truvu?
From the FDA label:11.1 Drug Characteristics PYLARIFY TRUVU (piflufolastat F 18) injection is a radioactive diagnostic drug for intravenous use. The chemical name of 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: PYLARIFY TRUVU is a sterile, clear, colorless to pale yellow solution. Each mL contains 37 MBq to 4,440 MBq (1 mCi to 120 mCi) piflufolastat F 18 at end of synthesis, ≤8 μg of piflufolastat, 5 mg to 15 mg of ascorbic acid, and ≤7.89% (w/v) of ethanol in 0.9% sodium chloride injection. The pH of the solution is 5.0 to 7.0. The specific activity is at least 1,000 mCi/µmol at the time of administration. Chemical Structure 11.2 Nuclear Physical Characteristics PYLARIFY TRUVU 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 96.9 Gamma 511 193.5 The point source air-kerma coefficient for F 18 is 3.75 × 10 -17 Gy m 2 /(Bq s). The first half-value thickness…
How to use
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…
Side effects
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)…
Warnings
Important safety information
Risk of Image Misinterpretation : PYLARIFY TRUVU 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 TRUVU 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 ) 5.1 Risk of Image Misinterpretation Imaging interpretation errors can occur with PYLARIFY TRUVU 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 TRUVU 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 TRUVU 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) ]. Piflufolastat F 18 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. 5.2 Hypersensitivity 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. 5.3 Radiation Risks PYLARIFY TRUVU exposes 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) ] .
Who should not take Pylarify Truvu
None. None. ( 4 )
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 piflufolastat F 18 in prostate cancer. The effect of these therapies on performance of PYLARIFY TRUVU PET has not been established.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- Is there a coupon or discount for Pylarify Truvu?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Pylarify Truvu. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Pylarify Truvu?
- Pylarify Truvu is marketed by Aphelion. You can see Aphelion's full profile, rating, and other products on pharmaranks.
- Is Pylarify Truvu a brand-name or generic drug?
- Pylarify Truvu is a brand-name product with the active ingredient Piflufolastat F-18.
- Is Pylarify Truvu available over the counter?
- No. Pylarify Truvu is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Pylarify Truvu come in?
- Pylarify Truvu is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Pylarify Truvu FDA-registered?
- Pylarify Truvu is on record with the U.S. FDA under application number NDA220089. You can verify this on its official FDA label.
- Is Pylarify Truvu safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Pylarify Truvu. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Pylarify Truvu?
- Pylarify Truvu's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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