Pylclari 1 500 MBq/mL solution for injection – patient leaflet, side effects, dosage

1. What Pylclari is and what it is used for

This medicine is a radiopharmaceutical product 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 a PET scan which is used to detect specific types of cancer cells with a protein called prostate-specific membrane antigen (PSMA). A PET scan with this medicine is used in patients with prostate cancer to help your doctor find the locations of the cancer to determine your next treatment or identify if and where the cancer may have come back if you have had previous treatment.

You should discuss the results of the test with the doctor that requested the scan. The use of Pylclari does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

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

Pylclari must not be used

If you are allergic to Pylclari or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Take special care 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 the start of the examination in order to urinate as often as possible during the first hours after the scan.

Children and adolescents

This medicine 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 hormonotherapy to treat your prostate cancer, since they may interfere with the interpretation of the images.

Pregnancy and breast-feeding

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 to use machines.

Pylclari contains alcohol (ethanol)

This medicine contains up to 900 mg 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 not have any noticeable effect.

Pylclari contains sodium

This medicine contains up to 35 mg of sodium (main component of cooking/Table salt) in each dose. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.

3. How Pylclari is given

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Pylclari will only be used in specially controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this medicine and will keep you informed of their actions.

Recommended dose

The nuclear medicine doctor supervising the procedure will decide on the quantity of this medicine to be used in your case. It will be the smallest quantity necessary to get the desired information. The recommended amount is 4 MBq/kg of body weight; it is about 280 megabecquerel for an adult of 70kg (MBq, the unit used to express radioactivity).

Administration of Pylclari and conduct of the procedure

• This medicine will be given as a single injection into a vein in your arm.
• One injection is sufficient to conduct the test that your doctor needs.

Duration of the procedure

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

The scan will usually start between 90 and 120 minutes after Pylclari injection is given.

After administration of Pylclari you should:

• avoid any close contact with young children and pregnant women for the 12 hours following the injection
• drink plenty of water in order to urinate (pass water) frequently, to eliminate the product from your body.

The nuclear medicine doctor will inform you if you need to take any other special precautions after receiving this medicine. Contact your nuclear medicine doctor if you have any questions.

If you have been given more Pylclari than you should

An overdose is unlikely because you will only receive a single dose of Pylclari precisely controlled by the nuclear medicine doctor supervising the procedure.

However, in case of an overdose, you will receive the appropriate treatment. The nuclear medicine doctor in charge of the procedure may provide ways to increase the passing of urine in order to facilitate the removal of the medicine from your body.

Should you have any further question on the use of Pylclari, please ask your nuclear medicine doctor who supervises 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 (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 that it needs to work normally),
• confusion about time and place,
• tiredness,
• dizziness,
• increased sensitivity or heightened pain response to stimuli such as light touch or sound,
• migraine,
• vertigo (a spinning sensation),
• muscular weakness,
• visual field defect,
• dry skin,
• rash,
• arthralgia (joint pain),
• pain in extremity,
• dysuria (urination trouble),
• chest discomfort,
• rash at the site of administration,
• feeling abnormal,
• pain at the site of administration.

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

• fainting
• nausea (feeling sick)
• vomiting

This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.

Reporting of side effects

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How Pylclari is stored

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.

The following information is intended for the specialist only.

Pylclari must not be used after the expiry date which is stated on the shield label after ‘EXP’.

6. Contents of the pack and other information

What Pylclari contains

• 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, sodium chloride 9 mg/ml (0.9%) solution for injection and sodium ascorbate.

Please see section 2 “Pylclari contains sodium and ethanol”.

What Pylclari looks like 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 date and time of calibration.

Marketing Authorisation Holder

Curium Pharma UK Ltd

Suite 211b Central

Second Floor, Building 1000

Lakeside North Harbour

Portsmouth

PO6 3EN

United Kingdom

Manufacturers

CURIUM PET FRANCE

10 AVENUE CHARLES PEGUY

95200 SARCELLES – FRANCE

This leaflet was last revised in: September 2026