PYLARIFY 80 mCi/mL
PIFLUFOLASTAT F-18 · INJECTION · Progenics Pharmaceuticals, Inc.
Pylarify is a radioactive diagnostic injection used to help detect prostate cancer during medical imaging scans. It works by targeting specific markers on prostate cancer cells, allowing doctors to better visualize where cancer may be present in the body.
Key Facts
- Brand Name
- PYLARIFY
- Generic Name
- PIFLUFOLASTAT F-18
- NDC Code (Product)
71258-022- Manufacturer
- Progenics Pharmaceuticals, Inc.
- Strength
- 80 mCi/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA214793
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 05/26/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. PYLARIFY is a radioactive diagnostic agent 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dose 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 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 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 [see Warnings and Precautions (5.3) ] . Use waterproof gloves and effective radiation shielding, including syringe shields, when preparing and handling PYLARIFY. 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 acceptable range of 296 MBq …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG 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 PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.
Adverse Reactions
6 ADVERSE REACTIONS The most common reported adverse reactions are headache, dysgeusia, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Progenics Pharmaceuticals, Inc. 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 was evaluated in 593 patients, each receiving one dose of PYLARIFY. 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 PYLARIFY (n = 593) Adverse Reaction n (%) Headache 13 (2%) Dysgeusia 10 (2%) Fatigue 7 (1%)
Frequently Asked Questions
What is PYLARIFY used for?
Pylarify is a radioactive diagnostic injection used to help detect prostate cancer during medical imaging scans. It works by targeting specific markers on prostate cancer cells, allowing doctors to better visualize where cancer may be present in the body.
Is PYLARIFY a controlled substance?
PYLARIFY is not classified as a controlled substance by the DEA.
What is the generic name for PYLARIFY?
The generic name for PYLARIFY is PIFLUFOLASTAT F-18. There are no other listed brand versions of PIFLUFOLASTAT F-18.
What is the NDC code for PYLARIFY 80 mCi/mL?
The NDC (National Drug Code) for PYLARIFY 80 mCi/mL is 71258-022, listed by Progenics Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)