PYLARIFY TRUVU
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PYLARIFY TRUVU (PYLARIFY TRUVU).
PYLARIFY is a PSMA-targeted PET imaging agent composed of a urea-based PSMA ligand (piflufolastat) labeled with fluorine-18. It binds to prostate-specific membrane antigen (PSMA) on prostate cancer cells, allowing PET imaging for detection of PSMA-positive lesions.
| Metabolism | [18F]piflufolastat is not metabolized significantly in humans. No major metabolites detected in plasma. |
| Excretion | Renal excretion: approximately 93% (3% unchanged, 97% as metabolites). Fecal excretion: approximately 5%. Biliary excretion is negligible. |
| Half-life | Terminal elimination half-life: approximately 77 hours (range 68-85 hours) in patients with prostate cancer. This supports a 2-week dosing interval for single-photon emission computed tomography (SPECT) imaging. |
| Protein binding | Approximately 95% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution: approximately 4.1 L (0.05 L/kg for a 70 kg adult). This indicates distribution primarily in plasma and extracellular fluid with limited tissue penetration. |
| Bioavailability | Bioavailability: 100% for intravenous administration. No oral formulation is available. |
| Onset of Action | Intravenous injection: within 5 minutes for SPECT imaging. Peak tumor localization occurs at approximately 1 hour post-injection. |
| Duration of Action | Duration of action: Sufficient for SPECT imaging up to 4 hours post-injection. Imaging is typically performed 3-4 hours after injection. Clinical effect (imaging) lasts for approximately 24 hours. |
1 mg/kg intravenously every 3 months.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min; safety not established for GFR <30 mL/min. |
| Liver impairment | No dose adjustment recommended for Child-Pugh A or B; not studied in Child-Pugh C. |
| Pediatric use | Not approved for use in pediatric patients. |
| Geriatric use | No specific adjustment; use based on renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PYLARIFY TRUVU (PYLARIFY TRUVU).
| Breastfeeding | No data on excretion of piflufolastat F 18 in human milk. Radiopharmaceuticals may be excreted. Advise temporary cessation of breastfeeding (pump and discard) for at least 12 hours after administration to minimize radiation exposure to infant. M/P ratio unknown. |
| Teratogenic Risk | Pylarify Truvu (piflufolastat F 18) is a radiopharmaceutical. In pregnancy, all radiopharmaceuticals carry a potential risk of fetal harm due to radiation exposure. First trimester: highest risk of teratogenesis (malformations) from ionizing radiation. Second and third trimesters: risk of growth restriction, CNS effects, and childhood cancer. Use only if benefit clearly outweighs risk. No data on developmental toxicity in animals. |
■ FDA Black Box Warning
None.
| Serious Effects |
["None known."]
| Precautions | ["Image interpretation errors: risk of false positives from non-malignant PSMA-expressing tissues (e.g., renal tubules, salivary glands) or false negatives in lesions with low PSMA expression.","Radiation exposure: comparable to other PET radiopharmaceuticals; consider cumulative exposure."] |
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| Fetal Monitoring | Monitor maternal vital signs during injection for hypersensitivity. Fetal monitoring not routinely indicated unless maternal reaction occurs. Post-administration, advise adequate hydration to promote excretion. No specific fetal monitoring recommended due to diagnostic use. |
| Fertility Effects | No human fertility studies. Ionizing radiation exposure to gonads may impair fertility. Theoretical risk to germ cells. Not recommended for use in individuals planning pregnancy unless necessary. |