PYLCLARI 1 500 MBQ/ml solution for injection medication leaflet

V09IX16 piflufolastat (18F) • Various | Tumour detection | Other diagnostic radiopharmaceuticals for tumour detection

Piflufolastat (18F) is a radiopharmaceutical diagnostic medicine used for PET scans in men with prostate cancer. It binds to prostate-specific membrane antigen, or PSMA, which is present on many prostate cancer cells. The images can help doctors look for metastases before definitive treatment or investigate suspected recurrence when PSA levels rise.

It is given as an intravenous injection before the PET scan. After the injection, you will wait for a short time according to the imaging centre’s protocol, and then the scan is performed. Drink fluids before and after the examination if allowed, and urinate often afterwards to help reduce radiation exposure to the bladder.

Side effects are usually uncommon and mild, but may include headache, tiredness, an unpleasant taste, nausea or injection-site reactions. Like any medicine given into a vein, it can rarely cause allergic reactions. Tell the staff immediately if you develop itching, rash, trouble breathing, dizziness, swelling, or any sudden unusual symptom.

The test involves a small dose of radiation, justified by the diagnostic benefit, but results must be interpreted by trained specialists. Some areas may take up the tracer without being cancer, and some tumours may not be visible. Tell your doctor about allergies, kidney problems, recent treatments, and any difficulty lying still during the scan.

General data about PYLCLARI 1 500 MBQ/ml

Substance: piflufolastat (18F)

Date of last drug list: 01-03-2026

Commercial code: W71689001

Concentration: 1 500 MBq / ml

Pharmaceutical form: solution for injection

Quantity: 1

Product type: original

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: CURIUM PET FRANCE - FRANTA

Holder: CURIUM PET FRANCE - FRANTA

Number: 1746/2023/02

Shelf life: 10 h de la data and ora calibrarii;data and ora de expirare sunt indicate pe etichete

Concentrations available for piflufolastat (18F)

1 000 MBq/ml, 1 500 MBq/ml