“They gave me PYLARIFY. I went and had lunch, came back, and then they did the scan. The scan took about 20 minutes.”
ERIC
Veteran, family man, and actual PYLARIFY patient
Individual results may vary.
How to prepare for a scan with PYLARIFY
Drink fluids before and after your scan
Staying properly hydrated and going to the bathroom are important, before and after your scan
With PYLARIFY, fasting might not be required
Although fasting before a scan with PYLARIFY is not required, your doctor might ask you to
What do you need to know before the scan?
- Your weight and height will be measured and recorded
- An intravenous (IV) catheter line will be placed in a vein, most likely in your arm
- You'll receive an injection of PYLARIFY 1 hour before your scan
- It'll take approximately 1 hour for PYLARIFY to circulate through your bloodstream and into any cancer cells that may be present
- You may be asked to use the restroom after your injection of PYLARIFY and before starting your scan
What should you expect during the scan?
- After you've received your injection of PYLARIFY, you'll lie on your back on the scanner bed with your arms raised above your head; a trained scan technician or nurse will be there to help
- The scanner bed will move slowly into the scanner, and the scan will begin. The scan will be painless
- The scan will typically start at your mid-thigh and go all the way up to your head
- The scan could last up to 40 minutes, and you may be asked to change body positions
Is there anything you need to know after the PYLARIFY scan?
- The results will be sent to your doctor
- Be sure to continue to hydrate and go to the bathroom for the first few hours
- Schedule a follow-up appointment with your doctor so that you can see and review the results and discuss a treatment plan
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.