Piflufolastat f-18
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From MedlinePlus, U.S. National Library of Medicine
Radioactive Diagnostic Agent
Dosing in kidney impairment
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 in the CT acquisition. [See table below.]
| Organ/Tissue | Mean Absorbed dose per Unit Administered Activity (mGy/MBq) | |
|---|---|---|
| Mean | Standard Deviation | |
| Adrenal glands | 0.0131 | 0.0013 |
| Brain | 0.0021 | 0.0003 |
| Breasts | 0.0058 | 0.0007 |
| Gallbladder wall | 0.0141 | 0.0012 |
| Lower large intestine wall | 0.0073 | 0.001 |
| Small intestine | 0.0089 | 0.0009 |
| Stomach wall | 0.0092 | 0.0008 |
| Upper large intestine wall | 0.0091 | 0.0009 |
| Heart wall | 0.0171 | 0.0022 |
| Kidneys | 0.123 | 0.0434 |
| Liver | 0.037 | 0.0058 |
| Lungs | 0.0102 | 0.0016 |
| Muscle | 0.0069 | 0.0008 |
| Pancreas | 0.0124 | 0.0011 |
| Red bone marrow | 0.0071 | 0.0007 |
| Osteogenic cells | 0.0099 | 0.0012 |
| Skin | 0.0052 | 0.0006 |
| Spleen | 0.0271 | 0.0115 |
| Testes | 0.0059 | 0.0008 |
| Thymus gland | 0.007 | 0.0008 |
| Thyroid | 0.0062 | 0.0009 |
| Urinary bladder wall | 0.0072 | 0.001 |
| Effective dose | 0.0116 (mSv/MBq) | 0.0022 (mSv/MBq) |
Preparation and administration
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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 TRUVU.
Visually inspect the radiopharmaceutical solution. Do not use if it contains particulate matter or if it is discolored (PYLARIFY TRUVU is a clear, colorless to pale yellow solution). Calculate the necessary volume to administer based on calibration time and required dose. PYLARIFY TRUVU may be diluted with 0.9% Sodium Chloride Injection.
Assay the dose in a suitable dose calibrator prior to administration. Post Administration Instructions Follow the PYLARIFY TRUVU injection with an intravenous flush of 0.9% Sodium Chloride Injection. Dispose of any unused PYLARIFY TRUVU in compliance with applicable regulations.
Patient Preparation Instruct patients to drink water to ensure adequate hydration prior to administration of PYLARIFY TRUVU and to continue drinking and voiding frequently for the first few hours following administration to reduce radiation exposure [see Warnings and Precautions ] .
Drug interactions
Check piflufolastat f-18 against a medication listLabel text (1 paragraph)
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.
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary PYLARIFY TRUVU 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 TRUVU, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.