#1 utilized PSMA PET imaging agent in the US
Chosen by doctors for more than 400,000 scans
PYLARIFY is FDA-approved for positron emission tomography (PET) imaging for men with suspected metastasis or suspected recurrence of prostate cancer following initial definitive therapy.
About prostate cancer
Finding your path forward
Prostate cancer is one of the most common cancers occurring in men, so healthcare professionals are very experienced in diagnosing and treating it. While speaking with your doctor about a prostate cancer diagnosis or possible recurrence may feel overwhelming, clear information can lead to clear answers.
How imaging may help along the way
To see where cancer is and where cancer is not, doctors use imaging (such as PET or CT scans, MRI, or bone scans). This allows them to look inside the body to see if cancer is present or whether cancer has progressed. This is called staging. It can help you and your doctor plan what's next with confidence. If cancer comes back after treatment, your doctor may order imaging again.
APPROVED USE
PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent. PYLARIFY is used along with positron emission tomography (PET) imaging for men with prostate cancer:
- with suspected metastasis who are candidates for initial definitive therapy.
- with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level.
PYLARIFY Injection is designed to detect prostate-specific membrane antigen (PSMA) positive lesions when used with PET imaging (scans).
IMPORTANT SAFETY INFORMATION
How well does PYLARIFY work?
- As with all diagnostic imaging tests such as X-rays, bone scans, and computed tomography (CT) scans, it is possible that the physician (a radiologist or nuclear medicine physician) who reviews your PYLARIFY PET/CT scan could interpret your results incorrectly. This means that a negative PYLARIFY PET/CT scan does not rule out that you have prostate cancer, and a positive PYLARIFY PET/CT scan does not confirm that you have prostate cancer.
- PYLARIFY seems to be affected by the amount (level) of PSA in your blood. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify prostate cancer.
Hypersensitivity reactions:
- Patients should be monitored for hypersensitivity reactions, especially those with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.
Radiation exposure:
- PYLARIFY is a radioactive diagnostic agent and adds to your long-term overall amount of radiation exposure, which could lead to an increased risk of cancer. You should stay well hydrated before, during, and after you are given PYLARIFY and urinate frequently to reduce radiation exposure.
What are the possible side effects of PYLARIFY?
- There were no serious reactions reported in patients who received scans in clinical trials with PYLARIFY, but some patients did report side effects associated with the use of PYLARIFY.
- The most commonly reported adverse reactions are headache, fatigue, and unusual taste in the mouth. An allergic reaction to PYLARIFY was reported in one patient with a significant history of allergic reactions.
Tell your doctor if you have any side effect that bothers you or does not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-888-INFO-FDA (1-888-463-6332).
Please read the accompanying full Prescribing Information.
APPROVED USE
PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent. PYLARIFY is used along with positron emission tomography (PET) imaging for men with prostate cancer:
- with suspected metastasis who are candidates for initial definitive therapy.
- with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level.
PYLARIFY Injection is designed to detect prostate-specific membrane antigen (PSMA) positive lesions when used with PET imaging (scans).
PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent. PYLARIFY is used along with positron emission tomography (PET) imaging for men with prostate cancer:
- with suspected metastasis who are candidates for initial definitive therapy.
- with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level.
PYLARIFY Injection is designed to detect prostate-specific membrane antigen (PSMA) positive lesions when used with PET imaging (scans).
IMPORTANT SAFETY INFORMATION
How well does PYLARIFY work?
- As with all diagnostic imaging tests such as X-rays, bone scans, and computed tomography (CT) scans, it is possible that the physician (a radiologist or nuclear medicine physician) who reviews your PYLARIFY PET/CT scan could interpret your results incorrectly. This means that a negative PYLARIFY PET/CT scan does not rule out that you have prostate cancer, and a positive PYLARIFY PET/CT scan does not confirm that you have prostate cancer.
- PYLARIFY seems to be affected by the amount (level) of PSA in your blood. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify prostate cancer.
Hypersensitivity reactions:
- Patients should be monitored for hypersensitivity reactions, especially those with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.
Radiation exposure:
- PYLARIFY is a radioactive diagnostic agent and adds to your long-term overall amount of radiation exposure, which could lead to an increased risk of cancer. You should stay well hydrated before, during, and after you are given PYLARIFY and urinate frequently to reduce radiation exposure.
What are the possible side effects of PYLARIFY?
- There were no serious reactions reported in patients who received scans in clinical trials with PYLARIFY, but some patients did report side effects associated with the use of PYLARIFY.
- The most commonly reported adverse reactions are headache, fatigue, and unusual taste in the mouth. An allergic reaction to PYLARIFY was reported in one patient with a significant history of allergic reactions.
Tell your doctor if you have any side effect that bothers you or does not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-888-INFO-FDA (1-888-463-6332).
Please read the accompanying full Prescribing Information.
How well does PYLARIFY work?
- As with all diagnostic imaging tests such as X-rays, bone scans, and computed tomography (CT) scans, it is possible that the physician (a radiologist or nuclear medicine physician) who reviews your PYLARIFY PET/CT scan could interpret your results incorrectly. This means that a negative PYLARIFY PET/CT scan does not rule out that you have prostate cancer, and a positive PYLARIFY PET/CT scan does not confirm that you have prostate cancer.
- PYLARIFY seems to be affected by the amount (level) of PSA in your blood. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify prostate cancer.
Hypersensitivity reactions:
- Patients should be monitored for hypersensitivity reactions, especially those with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.
Radiation exposure:
- PYLARIFY is a radioactive diagnostic agent and adds to your long-term overall amount of radiation exposure, which could lead to an increased risk of cancer. You should stay well hydrated before, during, and after you are given PYLARIFY and urinate frequently to reduce radiation exposure.
What are the possible side effects of PYLARIFY?
- There were no serious reactions reported in patients who received scans in clinical trials with PYLARIFY, but some patients did report side effects associated with the use of PYLARIFY.
- The most commonly reported adverse reactions are headache, fatigue, and unusual taste in the mouth. An allergic reaction to PYLARIFY was reported in one patient with a significant history of allergic reactions.
Tell your doctor if you have any side effect that bothers you or does not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-888-INFO-FDA (1-888-463-6332).
Please read the accompanying full Prescribing Information.