LOCAMETZ Kit for radiopharmaceutical preparation Ref.[50606] Active ingredients: Gallium ⁶⁸Ga gozetotide

This medicinal product should only be administered by trained healthcare professionals with technical expertise in using and handling nuclear medicine imaging agents and only in a designated nuclear medicine facility.

Posology

The recommended dose of gallium (⁶⁸Ga) gozetotide is 1.8-2.2 MBq/kg of body weight, with a minimum dose of 111 MBq up to a maximum dose of 259 MBq.

Special populations

Elderly

No dose adjustment is required in patients aged 65 years and above.

Renal impairment

There are no data with gallium (⁶⁸Ga) gozetotide in patients with moderate to severe/end-stage renal impairment. No dose adjustment is considered necessary in patients with renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is required in patients with hepatic impairment (see section 5.2).

Paediatric population

There is no relevant use of Locametz in the paediatric population for the identification of PSMA-positive lesions in prostate cancer.

Method of administration

This medicinal product is for intravenous and multidose use. It should be reconstituted and radiolabelled before administration to the patient.

After reconstitution and radiolabelling, gallium (⁶⁸Ga) gozetotide solution should be administered by slow intravenous injection. Local extravasation resulting in inadvertent radiation exposure to the patient and imaging artefacts should be avoided. The injection should be followed by an intravenous flush of sterile sodium chloride 9 mg/ml (0.9%) solution for injection to ensure full delivery of the dose.

The total radioactivity in the syringe should be verified with a dose calibrator immediately before and after administration to the patient. The dose calibrator must be calibrated and comply with international standards. Instructions regarding the dilution of the gallium (⁶⁸Ga) gozetotide solution should be followed (see section 12).

For patient preparation, see section 4.4.

For instructions on reconstitution and radiolabelling of the medicinal product before administration, see section 12.

Image acquisition

Gallium (⁶⁸Ga) gozetotide PET image acquisition should be performed by scanning the whole body starting at mid-thigh and proceeding to skull base. PET images should be acquired 50 to 100 minutes after the intravenous administration of gallium (⁶⁸Ga) gozetotide solution.

Image acquisition start time and duration should be adapted to the equipment used, the patient and the tumour characteristics, in order to obtain the best image quality possible.

Use of computer tomography (CT) or magnetic resonance imaging (MRI) for attenuation correction is recommended.

Dosimetry

Gallium-68 is produced by means of a germanium-68/gallium-68 (⁶⁸Ge/⁶⁸Ga) generator and decays with a half-life of 68 min to stable zinc-68. Gallium-68 decays as follows:

• 89% through positron emission with a mean energy of 836 keV, followed by photonic annihilation radiations of 511 keV (178%).
• 10% through orbital electron capture (X-ray or Auger emissions), and
• 3% through 13 gamma transitions from 5 excited levels.

The effective radiation dose of gallium (⁶⁸Ga) gozetotide is 0.022 mSv/MBq, resulting in an approximate effective radiation dose of 5.70 mSv for an administered maximum activity of 259 MBq.

Median radiation absorbed doses for organs and tissues of adult patients (N=6) following intravenous injection of gallium (⁶⁸Ga) gozetotide including observed ranges were calculated by Sandgren et al, 2019, using ICRP/ICRU voxel phantom with the software IDAC-Dose 2.1. Median radiation absorbed doses of gallium (⁶⁸Ga) gozetotide are shown in Table 4.

Table 4. Estimated median radiation absorbed doses of gallium (⁶⁸Ga) gozetotide:

^* as reported by Sandgren et al, 2019; all other organ estimates were estimated based on the time-integrated activity coefficients of the source organs published in the paper
^** reported in Sandgren as a single value labelled "Colon"
¹ doses were calculated using the software IDAC-Dose 2.1.
² derived according to ICRP Publication 103

In the event of administration of a radiation overdose with gallium (⁶⁸Ga) gozetotide, the radiation absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by hydration and frequent bladder voiding. It might be helpful to estimate the effective radiation dose that was applied.

Unopened vial: 1 year.

After reconstitution and radiolabelling, chemical and physical in-use stability have been demonstrated for 6 hours at 30°C (see section 6.4). Store upright.

From a microbiological point of view, unless the method of opening, reconstitution, radiolabelling, or dilution precludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of the user.

Before reconstitution, store below 25°C.

For storage conditions after reconstitution and radiolabelling of the medicinal product, see section 6.3.

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

Locametz is supplied as a multidose kit for the radiopharmaceutical preparation of gallium (⁶⁸Ga) gozetotide solution for injection (see sections 2 and 3). Locametz contains one 10 mL type I Plus glass vial closed with a rubber stopper and sealed with a flip-off cap.

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.

The content of the vial is intended only for use in the preparation of gallium (⁶⁸Ga) gozetotide solution for injection and is not to be administered directly to the patient without first undergoing the preparative procedure (see sections 4.2 and 12).

Precautions to be taken before handling or administration of the medicinal product

Before reconstitution, the content of Locametz is not radioactive. After reconstitution and radiolabelling, effective radiation shielding of the gallium (⁶⁸Ga) gozetotide solution for injection must be maintained (see section 3).

After reconstitution and radiolabelling, Locametz contains a sterile solution for injection of gallium (⁶⁸Ga) gozetotide at an activity of up to 1 369 MBq. The gallium (⁶⁸Ga) gozetotide solution for injection also contains hydrochloric acid derived from the gallium-68 chloride solution.

Gallium (⁶⁸Ga) gozetotide solution for injection is a sterile, clear, colourless solution for intravenous administration, without undissolved matter and with pH between 3.2 to 6.5.

Appropriate aseptic precautions should be taken when withdrawing and administering gallium (⁶⁸Ga) gozetotide solution for injection.

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

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

For instructions on reconstitution and radiolabelling of the medicinal product before administration, see section 12.

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