Pylclari 1.000 MBq/ml solution for injection

Package leaflet: Information for the patient

Introduction

Package leaflet: Package leaflet: information for the patient

Pylclari 1 000 MBq/ml solution for injection

Pylclari 1 500 MBq/ml solution for injection

piflufolastat (18F)

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician, who will supervise the procedure.
• If you experience any side effects, consult your nuclear medicine physician, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Pylclari is and what it is used for
2. What you need to know before you are administered Pylclari
3. How Pylclari is administered
4. Possible side effects
5. How to store Pylclari
6. Contents of the pack and other information

1. What Pylclari is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

Pylclari contains the active substance piflufolastat (18F), which includes radioactive fluorine (18F). It is administered so that doctors can perform a special type of scan called positron emission tomography (PET) to detect specific types of cancer cells that have a protein called prostate-specific membrane antigen (PSMA). This medicine is used in patients:

• with prostate cancer who are at high risk of the disease spreading to other parts of the body and who are suitable for treatment that may cure the cancer
• who have received prior treatment for prostate cancer and in whom recurrence of the cancer is suspected based on results from other tests (e.g., prostate-specific antigen, PSA).

The PET scan with Pylclari can help your doctor locate where the disease is present.

You should discuss the test results with the doctor who ordered the scan.

The use of Pylclari involves exposure to small amounts of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you need to know before you are given Pylclari

Do not administer Pylclari

If you are allergic to piflufolastat (18F) or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Exercise special caution with Pylclari

• if you have kidney problems
• if you are on a low-sodium diet (see section 2, "Pylclari contains sodium").

Before administration of Pylclari you should

Drink plenty of water before starting the examination in order to urinate as frequently as possible during the first hours after the examination.

Children and adolescents

This medicine is not intended for use in children and adolescents.

Other medicines and Pylclari

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, such as hormone therapy for the treatment of your prostate cancer, as they may interfere with the physician's interpretation of the images.

Pregnancy and breastfeeding

This medicine is not intended for use in women.

Driving and using machines

It is considered unlikely that this medicine will affect your ability to drive or operate machinery.

Pylclari contains alcohol (ethanol)

This medicine contains up to 900 mg of alcohol per administration, equivalent to less than 23 ml of beer or 11 ml of wine. The small amount of alcohol in this medicine will have no significant effect.

Pylclari contains sodium

This medicine contains up to 35 mg of sodium (the main component of table salt) per dose. This corresponds to 2% of the maximum recommended daily sodium intake for an adult.

3. How Pylclari is administered

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Pylclari must only be used in specially controlled areas. Only trained and experienced personnel in the safe use of this product may handle and administer it. These individuals will take the necessary special precautions to safely use this medicine and will keep you informed about their actions.

Dosage

The nuclear medicine specialist supervising the procedure will determine the amount of this medicine to be used in your case. It will be the smallest quantity necessary to obtain the required information. The recommended average dose is 4 MBq/kg of body weight; this corresponds to approximately 280 megabecquerels for a 70 kg adult (MBq, a unit used to express radioactivity).

Administration of Pylclari and performance of the procedure

• This medicine will be administered as a single intravenous injection into a vein in your arm.
• A single injection is sufficient to perform the test required by your doctor.

Duration of the procedure

The nuclear medicine physician will inform you about the usual duration of the procedure.

The scan will typically begin between 90 and 120 minutes after the injection of Pylclari.

After receiving Pylclari, you must:

• avoid close contact with young children and pregnant women for 12 hours after the injection
• drink plenty of fluids to urinate frequently, helping eliminate the medicine from your body.

The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any doubts.

If you have received more Pylclari than you should have

Since this product is administered by a physician under strictly controlled conditions, it is unlikely that you will receive an overdose.

However, in the event of an overdose, appropriate treatment will be provided. The nuclear medicine physician in charge of the procedure may recommend measures to increase diuresis to help eliminate the medicine from your body.

If you have any further questions about the use of Pylclari, please ask your supervising nuclear medicine physician.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Frequent (may affect up to 1 in 10 people):

• dysgeusia (altered taste in the mouth),
• headache.

Uncommon (may affect up to 1 in 100 people):

• hypersensitivity (allergic reactions),
• dehydration (when the body loses too much water and other fluids needed to function normally),
• confusion regarding time and space,
• fatigue,
• dizziness,
• increased sensitivity or heightened response to pain from stimuli such as light touch or sound,
• migraine,
• vertigo (sensation of dizziness),
• muscle weakness,
• visual field defect,
• dry skin,
• rash,
• joint pain,
• pain in extremities,
• dysuria (difficulty urinating),
• chest discomfort,
• rash at the administration site,
• abnormal sensation,
• pain at the administration site.

Frequency not known (cannot be estimated from the available data):

• Fainting
• nausea (feeling unwell)
• vomiting

This radiopharmaceutical product emits low amounts of ionizing radiation associated with a minimal risk of cancer and hereditary abnormalities.

Reporting of adverse effects

If you experience any type of adverse effect, consult the nuclear medicine specialist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pylclari

You will not be required to store this medicine. This medicine is stored under the specialist's responsibility in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.

The following information is intended for specialists only.

Do not use Pylclari after the expiry date stated on the label following "EXP".

6. Package contents and other information

Composition of Pylclari

• The active substance is piflufolastat (18F). Each ml of solution contains 1,000 MBq or 1,500 MBq of Pylclari at the time and date of calibration.
• The other components are ethanol, 9 mg/ml of sodium chloride injectable solution (0.9%) and sodium ascorbate. Please see section 2, "Pylclari contains sodium and ethanol".

Appearance of Pylclari and contents of the pack

Pylclari is a clear, colourless solution presented in a glass vial.

Each multidose vial contains 0.5 to 10 ml of solution, corresponding to 500 to 15,000 MBq at the time and date of calibration.

Marketing Authorization Holder

CURIUM PET FRANCE

3 rue Marie Curie, Biopole Clermont-Limagne

63 360 Saint-Beauzire - France

Manufacturers

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

This leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.>

This information is intended for healthcare professionals only:

The full summary of product characteristics for Pylclari is included as a separate document in the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Refer to the summary of product characteristics.