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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.

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) that 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).

For more information, please see Full Prescribing information for PYLARIFY.

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APPROVED USE

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