Pylarify

Pylarify (piflufolastat F-18) is used for PET imaging of prostate cancer that is prostate-specific membrane antigen (PSMA) positive. Pylarify is not a treatment for prostate cancer; it is a diagnostic imaging tool. It is valuable for the early detection of metastatic or recurrent prostate cancer.

After Pylarify is given, it attaches to PSMA, a protein found in high amounts on most prostate cancer cells. Pylarify carries a small amount of radioactive material called fluorine-18. A PET scanner can then detect this signal, allowing doctors to see areas where prostate cancer may be present very clearly.

Pylarify is for prostate cancer that is PSMA positive in men with:

• suspected metastasis (cancer that has spread to other parts of the body) who are candidates for initial definitive therapy.
• suspected recurrence (cancer that has come back) based on an elevated serum prostate-specific antigen (PSA) level.

This medicine is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

On March 6, 2026, FDA approval was received for Pylarify TruVu, an improved formulation of Pylarify. Pylarify TruVu offers the same diagnostic performance as the original Pylarify but enables larger manufacturing batches, improving patient access. A phased commercial launch is expected in late 2026.

• Pylarify TruVu has the same indications and side effects as Pylarify.

Once Pylarify is administered as an injection:

• Pylarify targets PSMA (prostate-specific membrane antigen), a protein expressed on most prostate cancer cells.
• Pylarify is labeled with fluorine-18 (F-18), a radioactive tracer.
• After injection, it binds to PSMA-positive cells.
• A PET scanner detects the radiation signal, highlighting areas of possible cancer with high sensitivity.

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

The safety and effectiveness of this medicine in pediatric patients have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of piflufolastat F 18 injection in the elderly.

Pregnancy

Pylarify is not indicated for use in females. There is no information on the risk of adverse developmental outcomes in pregnant women or animals with the use of piflufolastat F 18. All radiopharmaceuticals, including Pylarify, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

Breastfeeding

Pylarify is not indicated for use in females. There is no information on the presence of piflufolastat F 18 in human milk, the effect on the breastfed infant, or the effect on milk production.

The most common Pylarify side effects are headache, altered taste, and fatigue. Pain, redness, or irritation at the injection site may also occur.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Difficulty with breathing or swallowing
• fast heartbeat
• skin itching, rash, or redness
• swelling of the face, throat, or tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have a PET scan.

• Pylarify is injected intravenously into a vein.
• Short waiting period (typically ~60 minutes).
• PET scan takes about 20–30 minutes.
• Usually done as an outpatient procedure.

Tips:

• Drink enough water to be hydrated before the PET scan.
• You will need to urinate right away before the start of imaging and as often as possible for the first few hours after the PET scan.

It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have difficulty breathing or swallowing, a fast heartbeat, skin itching, rash, or redness, or swelling of the face, throat, or tongue after you receive the injection.

While receiving this medicine, you will be exposed to radiation and increase risk of cancer. If you have any questions about this, talk to your doctor.

Although certain medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

• Store at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F).
• This medicine does not contain a preservative.
• Store in the original container with radiation shielding.
• The expiration date and time are provided on the container label.
• Use Pylarify within 10 hours from the time of end of synthesis. Handling.
• This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Manufactured for: Progenics Pharmaceuticals, Inc. 331 Treble Cove Road Billerica, MA 01862