PYLCLARI Solution for injection Ref.[51072] Active ingredients: Piflufolastat ¹⁸F

This medicinal product is for use in designated nuclear medicine facilities only and should only be handled by authorised personnel.

Posology

The mean recommended activity of (¹⁸F) piflufolastat is 4 MBq/kg of body weight and can vary from 3 to 5 MBq/kg of body weight depending on the PET equipment and acquisition mode used. The minimum activity should not fall below 190 MBq and the maximum activity should not exceed 360 MBq.

Renal impairment / Hepatic impairment

Piflufolastat (¹⁸F) has only been studied in patients with mild renal impairment. Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in patients with severe impaired renal function.

Piflufolastat (¹⁸F) has not been studied in patients with hepatic impairment.

Paediatric population

There is no relevant use of piflufolastat (¹⁸F) in the paediatric population.

Method of administration

It is administered by a single intravenous injection.

Pylclari is presented in multidose vial. The minimal volume is 0.5 mL of solution per vial. The volume of solution to be administered can range from 0.2 mL to 10 mL.

Precautions to be taken before handling or administering the medicinal product

For instruction before administration, see section 6.6.

For instructions on dilution of the medicinal product before administration, see section 12.

Image acquisition

It is recommended to position the patient supine with arms above the head. A non contrast-enhanced low-dose CT scan is performed from the vertex of the skull through mid-thigh for attenuation correction and anatomic correlation. The PET acquisition is performed from mid-thigh through the vertex of the skull, starting 90 to 120 minutes after tracer injection. It must include lower extremities if there is known or suspected disease. Image acquisition duration is 12 to 40 minutes depending on the type of PET cameras, number of bed positions (typically 6 to 8) and acquisition time per bed position (typically 2 minutes to 5 minutes). If the acquisition leads to indeterminate findings, and provided a sufficient activity remains for adequate counting statistics, late acquisitions can also be performed, thus reducing background activity.

For patient preparation, see section 4.4.

Dosimetry

Data listed below are from sponsored clinical studies.

Assumptions:

Fluorine (¹⁸F) decays to stable oxygen (¹⁸O) with a half-life of 110 minutes by emitting a positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV. Piflufolastat (18F) exhibits bi-exponential behaviour in blood, with a distribution half-life of 0.17 ± 0.044 hours and an elimination half-life of 3.47 ± 0.49 hours. It distributes to the kidneys (16.5% of administered activity), liver (9.3%), and lung (2.9%), within minutes of intravenous administration.

Methodology:

The time-integrated activity in source tissue was obtained from longitudinal imaging data. Contours or volumes of interest (VOIs) were typically drawn around different activity-containing organs that were identified on each image at each time-point. The S-value was obtained by Monte Carlo simulation. The absorbed doses calculation was performed on OLINDA/EXM software (2005). The resulting effective dose was calculated according to ICRP 60.

The effective dose resulting from the administration of a maximal recommended activity of 360 MBq for an adult weighing 70 kg is about 4.2 mSv.

For an administered activity of 360 MBq, the typical radiation doses to the critical organs (kidneys, liver and spleen) are 44.3 mGy, 13.3 mGy and 9.8 mGy respectively.

The maximum amount of piflufolastat (¹⁸F) injection that can be safely administered to humans has not been determined.

In the event of administration of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis and frequent bladder voiding. It might be helpful to estimate the effective dose that was applied.

11 hours from the end of manufacturing.

Date and time of expiry are indicated on the labels.

After the first withdrawal, this medicinal product does not require any special storage conditions.

After dilution, store for up to 4 hours without exceeding the expiry time.

Store in the original lead shielding.

This medicinal product does not require any special storage conditions.

For storage conditions after first withdrawal of the medicinal product, see section 6.3.

Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.

15 mL colourless Type I glass vial, closed with a chlorobutyl stopper and an aluminium seal.

Pack size: one multidose vial contains 0.5 mL to 10 mL of solution, corresponding to:

• 500 to 10 000 MBq at calibration time of Pylclari 1 000 MBq/mL
• 750 to 15 000 MBq at calibration time of Pylclari 1 500 MBq/mL

General warning

Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.

Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.

Precautions to be taken before handling or administering the medicinal product

This product is administered via an intravenous flexible catheter. The administration must be strictly intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts. The bolus administration will be followed by a flush of 5-10 mL sodium chloride 9 mg/mL (0.9%) solution for injection, to ensure full delivery of the dose.

For instructions on dilution of the medicinal product before administration, see section 12.

If at any time in the preparation of this medicinal product the integrity of the vial is compromised it should not be used.

Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.