PYLCLARI 1.000 MBq/mL INJECTABLE SOLUTION

Introduction

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 for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine doctor, who will be supervising the procedure.
• If you get any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Pylclari and what is it used for

This medicinal product is a radiopharmaceutical for diagnostic use only.

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

• with prostate cancer who have a 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 previous treatment for prostate cancer and in whom the cancer is suspected to have come back based on the results of other tests (e.g., prostate-specific antigen, PSA).

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

You should discuss the results of the test with the doctor who requested the scan.

The use of Pylclari involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will get from the procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.

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

You should not be given Pylclari

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

Warnings and precautions

Be careful with Pylclari

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

Before Pylclari is given to you, you should

Drink plenty of water before starting the examination to urinate as often as possible during the first few hours after the examination.

Children and adolescents

This medicinal product is not intended for use in children and adolescents.

Other medicines and Pylclari

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, such as hormone therapy to treat your prostate cancer, as they may interfere with the interpretation of the images by the doctor.

Pregnancy and breast-feeding

This medicinal product is not intended for use in women.

Driving and using machines

It is considered unlikely that this medicinal product will affect your ability to drive and use machines.

Pylclari contains alcohol (ethanol)

This medicinal product contains up to 900 mg of alcohol per administration, which is equivalent to less than 23 ml of beer or 11 ml of wine. The small amount of alcohol in this medicinal product will not have any noticeable effect.

Pylclari contains sodium

This medicinal product contains up to 35 mg of sodium (main component of cooking/table salt) per dose. This is equivalent to 2% of the maximum recommended daily intake of sodium for an adult.

3. How Pylclari is given

There are strict laws on the use, handling, and disposal of radiopharmaceuticals. Pylclari should only be used in special controlled areas. Only personnel with training and experience in the safe use of this product will be able to handle and administer it. These people will take the necessary precautions to use this medicinal product safely and will keep you informed of their actions.

Dosage

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

Administration of Pylclari and performance of the procedure

• This medicinal product will be given as a single injection into a vein in your arm.
• A single injection is sufficient to perform the test that your doctor needs to do.

Duration of the procedure

Your nuclear medicine doctor will inform you of the usual duration of the procedure.

The scan will usually start between 90 and 120 minutes after the injection of Pylclari.

After Pylclari is given to you, you should:

• avoid close contact with small children and pregnant women for 12 hours after the injection
• drink plenty of water to urinate frequently to eliminate the medicinal product from your body.

Your nuclear medicine doctor will inform you if you need to take special precautions after this medicinal product is given to you. If you have any doubts, ask your nuclear medicine doctor.

If you have been given more Pylclari than you should

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

However, in case of overdose, you will receive the appropriate treatment. The nuclear medicine doctor in charge of the procedure may offer you methods to increase diuresis to help you eliminate the medicinal product from your body.

If you have any further questions on the use of Pylclari, ask your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• dysgeusia (alteration of 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 it needs to function normally),
• confusion about time and space,
• fatigue,
• dizziness,
• increased sensitivity or increased response to pain from stimuli such as light touch or sound,
• migraine,
• vertigo (feeling of dizziness),
• muscle weakness,
• visual field defect,
• dry skin,
• rash,
• joint pain,
• limb pain,
• dysuria (problems urinating),
• chest discomfort,
• rash at the injection site,
• abnormal sensation,
• pain at the injection site.

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

• Fainting
• nausea (discomfort)
• vomiting

This radiopharmaceutical product emits low levels of ionizing radiation associated with a minor risk of cancer and genetic abnormalities.

Reporting of side effects

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V.

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

5. Storage of Pylclari

You will not need to store this medicinal product. This medicinal product is stored under the responsibility of the specialist in suitable premises. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for the specialist.

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

6. Contents of the pack 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 date and time of calibration.
• The other ingredients are ethanol, 9 mg/ml of sodium chloride (0.9%) injection solution, and sodium ascorbate. Please see section 2 "Pylclari contains sodium and ethanol".

Appearance of Pylclari and contents of the pack

Pylclari is a clear and colorless 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 date and time of calibration.

Marketing authorisation holder

CURIUM PET FRANCE

3 rue Marie Curie, Biopole Clermont-Limagne

63 360 Saint-Beauzire - France

Manufacturers

Date of last revision of this leaflet:

Other sources of information

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

On the European Medicines Agency website, you can find this leaflet in all languages of the European Union/European Economic Area.

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This information is intended only for healthcare professionals:

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

Refer to the summary of product characteristics.