Version May 2024
Diagnostic imaging: IV: Usual dose: 333 MBq (9 mCi); range: 296 to 370 MBq (8 to 10 mCi) as a single dose.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Gastrointestinal: Dysgeusia (2%)
Nervous system: Fatigue (1%), headache (2%)
<1%: Hypersensitivity: Hypersensitivity reaction
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions have occurred, especially in patients with a history of allergic reactions to drugs or food; reactions may be delayed. Appropriate equipment and emergency medications should be available during use.
• Radiation accumulation: Piflufolastat F18 administration contributes to the patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and health care personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Appropriate use: Piflufolastat F18 binds to prostate-specific membrane antigen (PSMA); positron emission tomography (PET) images indicate the presence of PSMA in tissues. Tumors may be suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake was expected; tumors not containing PSMA are not visualized.
• Risk for misinterpretation: Uptake of piflufolastat F18 is not specific to prostate cancer and may occur with other types of cancer and nonmalignant processes (eg, fibrous dysplasia, osteophytosis, Paget disease). A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm prostate cancer. The performance of piflufolastat F18 for recurrent prostate cancer may be affected by serum prostate-specific antigen levels and site of disease. The performance of piflufolastat F18 for metastatic pelvic lymph nodes may be affected by Gleason score. Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, is recommended.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Intravenous:
Pylarify: 9 mCi (1 ea) [contains alcohol, usp]
No
Solution Prefilled Syringe (Pylarify Intravenous)
9MCI (per each): $6,267.22
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Administer as an IV bolus; may dilute with NS. Immediately prior to administration, measure and verify the radioactivity in the syringe with a dose calibrator to ensure radioactivity administered. After administration, flush with NS to ensure full delivery of the dose.
Patients should void immediately prior to start of imaging. Imaging should begin at the mid-thigh and proceed to the skull vertex. Begin positron emission tomography (PET) scanning 60 minutes after administration of piflufolastat F18; beginning scan >90 minutes after administration may affect imagining results.
Patients should drink a sufficient amount of water to ensure adequate hydration prior to administration and in the first hours following administration and void frequently (particularly in the first few hours) following administration to reduce radiation exposure.
Radiopharmaceutical; use appropriate precautions for handling and disposal. When handling and administering, follow appropriate safety measures to minimize radiation exposure during administration; use waterproof gloves and effective shielding, including syringe shields.
Diagnostic imaging: Use with positron emission tomography (PET) of prostate-specific membrane antigen positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen level.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and health care personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Androgen Deprivation Therapy Agents: May diminish the diagnostic effect of Piflufolastat F18. Management: Androgen deprivation therapy (ADT) may result in changes in the uptake of piflufolastat F18 in prostate cancer. The impact of ADT on the performance of piflufolastat F18 is unknown, but use of alternative agents should be considered. Risk D: Consider therapy modification
Antiandrogens: May diminish the diagnostic effect of Piflufolastat F18. Management: Therapies targeting the androgen pathway may result in changes in the uptake of piflufolastat F18 in prostate cancer. The impact of these therapies on the performance of piflufolastat F18 is unknown; consider use of alternative agents. Risk D: Consider therapy modification
Piflufolastat F18 is not indicated for use in patients who could become pregnant; animal reproduction studies were not conducted. All radiopharmaceuticals have the potential to cause fetal harm.
It is not known if piflufolastat F18 is present in breast milk.
Piflufolastat F18 is a radioactive diagnostic agent that binds to cells that express prostate-specific membrane antigen, including malignant prostate cancer cells. Fluorine-18 (F 18) is a beta+ emitting radionuclide with an emission yield that allows positron emission tomography (PET) imaging. Tumors that do not express prostate-specific membrane antigen will not be visualized by imaging.
Distribution: To the kidneys (16.5%), liver (9.3%), lung (2.9%), and prostate; distribution half-life: 0.17 ± 0.044 hours.
Half-life elimination: 3.47 ± 0.49 hours.
Excretion: Urine (~50%).
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