Piflufolastat F 18
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Overview
Piflufolastat F 18 is an radioactive diagnostic agent that is FDA approved for the treatment 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.. Common adverse reactions include headache, dysgeusia, and fatigue..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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.
Radiation 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.
- Use waterproof gloves and effective radiation shielding, including syringe shields, when preparing and handling PYLARIFY.
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.
- 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.
Patient 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.
Image 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).
Image 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.
Radiation 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 in the CT acquisition.
- 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Piflufolastat F 18 in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Piflufolastat F 18 in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Piflufolastat F 18 FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Piflufolastat F 18 in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Piflufolastat F 18 in pediatric patients.
Contraindications
There is limited information regarding Piflufolastat F 18 Contraindications in the drug label.
Warnings
There is limited information regarding Piflufolastat F 18 Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Piflufolastat F 18 Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Piflufolastat F 18 Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Piflufolastat F 18 Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Piflufolastat F 18 in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Piflufolastat F 18 in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Piflufolastat F 18 during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Piflufolastat F 18 in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Piflufolastat F 18 in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Piflufolastat F 18 in geriatric settings.
Gender
There is no FDA guidance on the use of Piflufolastat F 18 with respect to specific gender populations.
Race
There is no FDA guidance on the use of Piflufolastat F 18 with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Piflufolastat F 18 in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Piflufolastat F 18 in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Piflufolastat F 18 in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Piflufolastat F 18 in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Piflufolastat F 18 Administration in the drug label.
Monitoring
There is limited information regarding Piflufolastat F 18 Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Piflufolastat F 18 and IV administrations.
Overdosage
There is limited information regarding Piflufolastat F 18 overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Piflufolastat F 18 Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Piflufolastat F 18 Mechanism of Action in the drug label.
Structure
There is limited information regarding Piflufolastat F 18 Structure in the drug label.
Pharmacodynamics
There is limited information regarding Piflufolastat F 18 Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Piflufolastat F 18 Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Piflufolastat F 18 Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Piflufolastat F 18 Clinical Studies in the drug label.
How Supplied
There is limited information regarding Piflufolastat F 18 How Supplied in the drug label.
Storage
There is limited information regarding Piflufolastat F 18 Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Piflufolastat F 18 Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Piflufolastat F 18 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
PYLARIFY
Look-Alike Drug Names
There is limited information regarding Piflufolastat F 18 Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.