telix pharmaceuticals (us) inc. - Medication Listings

11.1 Chemical Characteristics ILLUCCIX, a radioactive diagnostic agent, is supplied as a sterile, multiple-dose kit for the preparation of Gallium Ga 68 Gozetotide Injection for intravenous use. Gozetotide is also known as PSMA-11. Gallium Ga 68 gozetotide is a radioconjugate composed of a human prostate specific membrane antigen (PSMA)-targeting ligand peptide conjugated via the acyclic radiometal chelator, N,N'-bis [2-hydroxy-5-(carboxyethyl)benzyl] ethylenediamine-N,N'-diacetic acid (HBED-CC) to the radioisotope Ga 68. The amino acid sequence of the gozetotide peptide is Glu-NH-CO-NH-Lys(Ahx), (Ahx = 6-aminohexanoic acid). Gallium Ga 68 gozetotide has a molecular weight of 1011.9 g/mol and its chemical structure is shown in Figure 4 . Figure 4: Chemical Structure of Gallium Ga 68 Gozetotide Figure 4 11.2 Physical Characteristics ILLUCCIX is supplied as a 3-vial kit which contains the non-radioactive ingredients needed to produce Gallium Ga 68 Gozetotide Injection. There are two configurations available to allow preparation of Gallium Ga 68 Gozetotide Injection using Ga 68 from different generator or cyclotron sources [ see How Supplied/Storage and Handling ( 16 ) ]. The prepared Gallium Ga 68 Gozetotide Injection for intravenous use is a sterile, pyrogen free, clear, colorless, buffered solution with a pH between 4.0 to 5.0. 11.3 External Radiation Table 4 , Table 5 , and Table 6 display the principal radiation emission data, radiation attenuation by lead shielding, and physical decay of Ga 68. Table 4: Principal Radiation Emission Data (>1%) Radiation/ Emission % Disintegration Mean Energy (MeV) beta+ 88% 0.8360 beta+ 1.1% 0.3526 gamma 178% 0.5110 gamma 3.0% 1.0770 X-ray 2.8% 0.0086 X-ray 1.4% 0.0086 Table 5: Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 6 0.5 12 0.25 17 0.1 34 0.01 51 0.001 Table 6: Physical Decay Chart for Ga 68 Minutes Fraction Remaining 0 1 15 0.858 30 0.736 60 0.541 90 0.398 120 0.293 180 0.158 360 0.025 11.1 Chemical Characteristics ILLUCCIX, a radioactive diagnostic agent, is supplied as a sterile, multiple-dose kit for the preparation of Gallium Ga 68 Gozetotide Injection for intravenous use. Gozetotide is also known as PSMA-11. Gallium Ga 68 gozetotide is a radioconjugate composed of a human prostate specific membrane antigen (PSMA)-targeting ligand peptide conjugated via the acyclic radiometal chelator, N,N'-bis [2-hydroxy-5-(carboxyethyl)benzyl] ethylenediamine-N,N'-diacetic acid (HBED-CC) to the radioisotope Ga 68. The amino acid sequence of the gozetotide peptide is Glu-NH-CO-NH-Lys(Ahx), (Ahx = 6-aminohexanoic acid). Gallium Ga 68 gozetotide has a molecular weight of 1011.9 g/mol and its chemical structure is shown in Figure 4 . Figure 4: Chemical Structure of Gallium Ga 68 Gozetotide Figure 4 11.2 Physical Characteristics ILLUCCIX is supplied as a 3-vial kit which contains the non-radioactive ingredients needed to produce Gallium Ga 68 Gozetotide Injection. There are two configurations available to allow preparation of Gallium Ga 68 Gozetotide Injection using Ga 68 from different generator or cyclotron sources [ see How Supplied/Storage and Handling ( 16 ) ]. The prepared Gallium Ga 68 Gozetotide Injection for intravenous use is a sterile, pyrogen free, clear, colorless, buffered solution with a pH between 4.0 to 5.0. 11.3 External Radiation Table 4 , Table 5 , and Table 6 display the principal radiation emission data, radiation attenuation by lead shielding, and physical decay of Ga 68. Table 4: Principal Radiation Emission Data (>1%) Radiation/ Emission % Disintegration Mean Energy (MeV) beta+ 88% 0.8360 beta+ 1.1% 0.3526 gamma 178% 0.5110 gamma 3.0% 1.0770 X-ray 2.8% 0.0086 X-ray 1.4% 0.0086 Table 5: Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 6 0.5 12 0.25 17 0.1 34 0.01 51 0.001 Table 6: Physical Decay Chart for Ga 68 Minutes Fraction Remaining 0 1 15 0.858 30 0.736 60 0.541 90 0.398 120 0.293 180 0.158 360 0.025