ILLUCCIX Configuration

What it is

ILLUCCIX is a kit for the preparation of Ga-68 Glu-urea-Lys(ahx)-hbed-CC radiopharmaceutical for intravenous use. The kit is supplied in two different configurations, each containing 3 vials. After reconstitution, the prepared Ga-68 Glu-urea-Lys(ahx)-hbed-CC injection is a sterile, pyrogen-free, clear, colourless, buffered solution with a pH between 4.0–5.0. Ga-68 Glu-urea-Lys(ahx)-hbed-CC binds to the prostate-specific membrane antigen (PSMA) on cells that express PSMA including malignant prostate cancer cells, which overexpress PSMA. Ga-68 is a β+ emitting radionuclide with an emission yield that allows positron emission tomography (PET) imaging.

Approved indications

ILLUCCIX, after radiolabelling with Ga-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging combined with computerised tomography (CT) in patients with prostate cancer: — who are at risk of metastasis and who are suitable for initial definitive therapy. — who have suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. — for the selection of patients with metastatic prostate cancer in whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

Dosing overview

The recommended amount of activity to be administered intravenously is 185 MBq (5 mCi) with a range of 166.5 to 203.5 MBq (4.5 to 5.5 mCi) and a maximum dose of 25 microgram of Glu-urea-Lys(ahx)-hbed-CC. After reconstitution with Ga-68 eluate from an appropriate source, Ga-68 Glu-urea-Lys(ahx)-hbed-CC is administered by intravenous injection (bolus).

Key safety warnings

Due to the acidic pH of Gallium (68Ga) Glu-urea-Lys(ahx)-hbed-CC injection, local vein irritation can occur. Accidental extravasation may also cause local irritation. In case of local vein irritation, injection must be adapted accordingly by the health care professional. In case of extravasation, the injection must be stopped, the site of injection must be changed and the affected area should be irrigated with sodium chloride solution. Image interpretation errors can occur with Ga-68 Glu-urea-Lys(ahx)-hbed-CC PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. It is recommended that appropriately trained and experienced personnel perform and interpret Ga-68 Glu-urea-Lys(ahx)-hbed-CC PET. Ga-68 Glu-urea-Lys(ahx)-hbed-CC uptake is not specific for prostate cancer. An important pitfall is uptake in coeliac ganglia of the autonomic nervous system which may be misinterpreted as retroperitoneal lymph node metastases. Ga-68 Glu-urea-Lys(ahx)-hbed-CC uptake may occur with other types of cancer and with benign conditions such as prostatitis, benign prostatic hyperplasia, Paget's disease, fibrous dysplasia, and osteophytosis. False-positive cases have been also described in association with an inflammatory response after cryotherapy and radiation artefacts in patients previously treated with radiotherapy. Like other radiopharmaceuticals, Ga-68 Glu-urea-Lys(ahx)-hbed-CC contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Safe handling should be ensured to minimize radiation exposure to the patient and health care workers.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 2.

Regulatory history

ILLUCCIX Configuration A and Configuration B were first listed on the Australian Register of Therapeutic Goods on 10 November 2021. The approval date was 1 November 2021.