Pylclari

Package leaflet: Information for the patient

Pylclari 1,000 MBq/mL injection solution, 1,500 MBq/mL injection solution

piflufolastat (F)
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the doctor who will supervise the procedure.
• If you experience any side effect, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet

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

1. What Pylclari is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
Pylclari contains the active substance piflufolastat (F), which contains radioactive fluorine (F). It is administered so that physicians can perform a specific type of scan called positron emission tomography (PET), which enables the detection of specific types of tumour cells expressing a protein known as prostate-specific membrane antigen (PSMA). This medicinal product is used in patients:

• with high-risk prostate cancer likely to spread to other parts of the body and who may receive targeted treatment to cure the tumour
• who have received prior treatment for prostate cancer and in whom recurrence is suspected based on results from other tests (e.g., prostate-specific antigen, PSA).

The PET scan with Pylclari can help the physician locate the disease.
You should discuss the clinical test results with the physician who ordered the scan.
Using Pylclari involves exposure to small amounts of radioactivity. Your physician 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 receiving Pylclari

Pylclari must not be used
If you are allergic to piflufolastat (F) or to any of the other ingredients of this
medicinal product (listed in section 6).
Warnings and precautions
Exercise particular caution with Pylclari

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

Before administration of Pylclari
You must drink plenty of water before the start of the examination, so as to urinate as frequently as possible during the first hours after the examination.
Children and adolescents
This medicinal product is not intended for use in children and adolescents.
Other medicines and Pylclari
Inform the nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, such as hormonal therapy for the treatment of prostate cancer, as they may interfere with the interpretation of diagnostic images.
Pregnancy and breastfeeding
This medicinal product is not intended for use in women.
Driving and using machines
It is considered unlikely that this medicinal product will affect the ability to drive or use machinery.
Pylclari contains alcohol (ethanol)
This medicinal product contains up to 900 mg of alcohol per administration, equivalent to less than the alcohol content of 23 mL of beer or 11 mL of wine. The small amount of alcohol in this medicinal product will not produce significant effects.
Pylclari contains sodium
This medicinal product contains up to 35 mg of sodium (a main component of table salt) in each dose. This corresponds to 2% of the maximum recommended daily dietary intake for an adult.

3. How to use Pylclari

The use, handling, and disposal of radiopharmaceuticals are governed by strict legal regulations. Pylclari will be used only in specifically monitored areas. This product will be handled and administered exclusively by trained and qualified personnel to ensure safe use. These operators must pay particular attention to the safe handling of this medicinal product and will inform you about the actions they are about to perform.

Recommended dose
The nuclear medicine physician supervising the procedure will determine the amount of medicinal product to be used. This will be the minimum 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, the unit used to express radioactivity).

Administration of Pylclari and procedure performance
The medicinal product is administered via a single injection into a vein in the arm.

• Only one injection is required to perform the examination requested by the physician.

Duration of the procedure
The nuclear medicine physician will inform you about the usual duration of the procedure.
Scanning usually begins between 90 and 120 minutes after the injection of Pylclari.

After receiving Pylclari you must:

• avoid any close contact with young children and pregnant women during the 12 hours following the injection
• drink plenty of water to urinate frequently, thereby eliminating the medicinal product from your body.

The nuclear medicine physician will inform you of any other specific precautions you may need to take after receiving this medicinal product. If you have any doubts, please consult your nuclear medicine physician.

If you have been given more Pylclari than you should have
The likelihood of overdose is unlikely, as you will receive only one precisely controlled dose of Pylclari, administered under the supervision of the nuclear medicine physician.
However, in the event of an overdose, you will receive appropriate treatment. To help facilitate elimination of the medicinal product from your body, the nuclear medicine physician in charge of the procedure may advise you to increase your urinary flow.

For any further questions regarding the use of Pylclari, please consult the nuclear medicine physician supervising the procedure.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.
Common (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 for normal functions)

• confusion regarding time and place

• fatigue

• dizziness

• increased sensitivity or response to pain in response to light touch or sounds

• migraine

• vertigo (sensation of loss of balance)

• muscle weakness

• visual field defect

• dry skin

• rash

• arthralgia (joint pain)

• limb pain

• dysuria (problems urinating)

• chest discomfort

• skin rash at the administration site

• abnormal sensation or pain at the administration site.

• Not known (frequency cannot be estimated from the available data):

• fainting

• nausea

• vomiting

This radiopharmaceutical will emit low levels of ionizing radiation, associated with a very low risk of cancer and hereditary abnormalities.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your nuclear medicine physician. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How Pylclari is stored

Do not store this medicinal product. This medicinal product is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended exclusively for the specialist.
Pylclari must not be used after the expiry date stated on the label of the shielding, next to “Exp.”

6. Package contents and other information

What Pylclari contains

• The active substance is piflufolastat (F). Each mL of solution contains 1,000 MBq or 1,500 MBq of Pylclari at the date and time of calibration.
• The other components are ethanol, sodium chloride 9 mg/mL (0.9%) for injectable solutions and sodium ascorbate. See section 2 “Pylclari contains sodium and ethanol”.

Appearance of Pylclari and contents of the pack
Pylclari is a clear, colourless solution contained in a glass vial.
Each multidose vial contains 0.5 to 10 mL of solution, corresponding to 500–15,000 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
CURIUM PET FRANCE CURIUM FINLAND OY
10 AVENUE CHARLES PEGUY SAUKONPAADENRANTA 2
95200 SARCELLES - FRANCE HELSINKI, 00180 - FINLAND
CURIUM PHARMA SPAIN, S.A.

C/ MANUEL BARTOLOMÉ COSSIO, 10
E-28040 MADRID - SPAIN
CURIUM PHARMA SPAIN, S.A.

THOMAS ALVA EDISON, 7
41092 SEVILLE - SPAIN
SYN INNOVATION LABORATORIES

SOUSAKI SITE AG. THEODOROI
CORINTHIA PREFECTURE 20003 - GREECE
CURIUM AUSTRIA GMBH CURIUM PET FRANCE
SEILERSTÄTTE 4 3 RUE MARIE CURIE, BIOPOLE CLERMONT-
LINZ, 4020 - AUSTRIA LIMAGNE
63 360 SAINT-BEAUZIRE - FRANCE
CURIUM PET FRANCE

CHU DE BRABOIS
4 RUE DU MORVAN
54500 VANDŒUVRE-LES-NANCY CEDEX -
FRANCE
CYCLOTRON VU CURIUM PET FRANCE
VAN DER BOECHORSTSTRAAT 6A 1-3 RUE GERMAINE RICHIER
AMSTERDAM, 1081 BT - NETHERLANDS 37100 TOURS – FRANCE
INSTITUTE OF CLINICAL PHYSIOLOGY OF CURIUM ITALY S.R.L.
CNR TOR VERGATA, VIALE OXFORD, 81, ROME
VIA GIUSEPPE MORUZZI, 1, PISA 00133 – ITALY
56124 – ITALY
CURIUM PET FRANCE

AVENUE DE LA BATAILLE FLANDRES
DUNKERQUE
35000 RENNES – FRANCE
CURIUM PET FRANCE CURIUM ITALY S.R.L.
ONCOPOLE DE TOULOUSE PIAZZALE SANTA MARIA DELLA
3 PLACE PIERRE POTIER MISERICORDIA 15
31100 TOULOUSE – FRANCE 33100 UDINE – ITALY
ÚJV ŘEŽ A.S.

REZ
HLAVNI 130
HUSINEC, 250 68 – CZECH REPUBLIC
MONROL BULGARIA EOOD ÚJV ŘEŽ A.S.
LYULIN DISTRICT ZLUTY KOPEC 7A
ULITSA BANSKO SHOSE 128 STARE BRNO
SOFIA 1331 – BULGARIA BRNO, 602 00 - CZECH REPUBLIC
MONROL EUROPE S.R.L
STRADA GRADINARILOR NR 1
PANTELIMON 077145 – ROMANIA
SYNEKTIK PHARMA SP. Z O.O.
UL. PREZYDENTA STEFANA
ARTWINSKIEGO 3
KIELCE, 25-734 – POLAND
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 is available in all languages of the European Union/European Economic Area (EU/EEA) on the website of the European Medicines Agency.

The following information is intended for healthcare professionals only:

The complete SmPC (Summary of Product Characteristics) of Pylclari is provided as a
separate document in the product packaging, with the aim of providing healthcare professionals
with additional scientific and technical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.