Illuccix

Kit for the preparation of gallium Ga 68 gozetotide injection · Kit · Intravenous

Prescription (Rx)

Uses

1 INDICATIONS AND USAGE ILLUCCIX, after radiolabeling with Ga 68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ILLUCCIX, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ( 1 )

Dosage and administration

Use appropriate aseptic technique and radiation safety handling measures in the manipulation and administration of Gallium Ga 68 Gozetotide Injection. ( 2.1 ) The recommended amount of radioactivity for adults is 111 MBq to 259 MBq (3 mCi to 7 mCi) as a bolus intravenous injection. ( 2.2 ) A diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection. ( 2.2 ) Initiate imaging 50 minutes to 100 minutes after administration. The patient should void immediately prior to initiation of imaging. The scan should begin caudally and proceed cranially. ( 2.10 ) See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information. ( 2 ) 2.1 Radiation Safety - Drug Handling After reconstitution and radiolabeling of ILLUCCIX, the vial contains Gallium Ga 68 Gozetotide Injection. Handle Gallium Ga 68 Gozetotide Injection with appropriate safety measures to minimize radiation exposure [ see Warnings and Precautions ( 5.2 ) ]. Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Gallium Ga 68 Gozetotide Injection. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. 2.2 Recommended Dosage and Administration Instructions Recommended Dosage In adults, the recommended amount of radioactivity to be administered for PET is 111 MBq to 259 MBq (3 mCi to 7 mCi) administered as an intravenous bolus injection. Administration Use aseptic technique and radiation shielding when withdrawing and administering Gallium Ga 68 Gozetotide Injection. Calculate the necessary volume to administer based on calibration time and required dose. Inspect Gallium Ga 68 Gozetotide Injection visually for particulate matter and discoloration before administration. Only use solutions that are clear, colorless to slightly yellow, and without visible particles. Gallium Ga 68 Gozetotide Injection may be diluted with sterile 0.9% Sodium Chloride Injection, USP. Assay the final dose in a dose calibrator immediately before administration to the patient. After injection of Gallium Ga 68 Gozetotide Injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection to ensure full delivery of the dose. Dispose of any unused drug in a safe manner in compliance with applicable regulations. Unless contraindicated, a diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection to potentially decrease artifact from radiotracer accumulation in the urinary bladder and ureters. 2.3 Patient Preparation Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Gallium Ga 68 Gozetotide Injection and to continue to drink and void frequently following administration to reduce radiation exposure, particularly during the first hour after administration [see Warnings and Precautions ( 5.2 )] . 2.4 General Instructions for Drug Preparation Ga 68 Sources and ILLUCCIX Carton Configurations ILLUCCIX is supplied as a kit in two different configurations, A or B, for preparation of Gallium Ga 68 Gozetotide Injection with eluate from different Ga 68 sources. See Table 1 for ILLUCCIX carton configurations to be used with different Ga 68 sources. Table 1. Ga 68 Sources and ILLUCCIX Carton Configuration Ga 68 Source ILLUCCIX Carton Configuration to be Used Cyclotron-produced via GE FASTlab Liquid Target System A Eckert & Ziegler (EZAG) GalliaPharm Germanium 68/Gallium 68 (Ge 68/Ga 68) generator A Cyclotron-produced via Alternative Radioisotope Technologies for Medical Science (ARTMS) QUANTM Irradiation System (QIS) B IRE ELiT Galli Eo Ge 68/Ga 68 generator B The Ge 68/Ga 68 generators and cyclotron are not supplied with ILLUCCIX. Follow the instructions for use provided by the Ge 68/Ga 68 generator or cyclotron manufacturer. Components of ILLUCCIX consist of Vial 1 (Gozetotide), Vial 2A or Vial 2B (Acetate Buffer), and Vial 3 (Sterile Vacuumed Reaction Vial) [see How Supplied/Storage and Handling (16) ] . General Instructions Before use, remove the ILLUCCIX kit containing all three components from the refrigerator and allow the kit to reach room temperature for 1 hour. Follow aseptic techniques in all drug preparation and handling. Use suitable shielding to reduce radiation exposure. Wear waterproof gloves. Place a "radioactive" label on Vial 3 (Sterile Vacuumed Reaction Vial) with product name, lot number and date. Remove the vial cap from Vial 1 (Gozetotide), Vial 2A or Vial 2B (Acetate Buffer) and Vial 3 (Sterile Vacuumed Reaction Vial). Swab the top of each vial with alcohol to disinfect the surface and allow the top of each vial to dry. Use the shortest possible needle for the transfer of the Gallium Ga 68 Chloride solution to minimize any potential metallic contamination. The needle should be clean and dilute acid resistant. Use only plastic syringes for preparation and administration. Do not use syringes with rubber plungers. Prior to use of any vial, confirm the correct vial by a visual check of the vial label. Follow the specific preparation procedure dependent on Ga 68 source [see Dosage and Administration (2.5 , 2.6 , 2.7 , 2.8) ] . 2.5 Preparation with Cyclotron-Produced Ga 68 via GE FASTlab Liquid Target System Collection of Gallium Ga 68 Chloride Solution After purification by the FASTlab Liquid Target System, the Gallium Ga 68 Chloride solution is passed through a sterile filter and into the cassette product vial automatically by the FASTlab Liquid Target System.

Dosage forms and strengths

Kit for the preparation of Gallium Ga 68 Gozetotide Injection contains: Vial 1 (Gozetotide): 25 mcg of gozetotide as a white to off-white lyophilized powder in a multiple-dose vial Vial 2A (2.5 mL) or Vial 2B (6.4 mL) (Acetate Buffer): 150 mg anhydrous sodium acetate as a sterile clear colorless solution Vial 2A in Configuration A for use with cyclotron-produced Ga 68 via GE FASTlab Liquid Target System or EZAG Gallia Pharm generator Vial 2B in Configuration B for use with ARTMS QIS or IRE ELiT Galli Eo generator Vial 3 (Sterile Vacuumed Reaction Vial): a sterile, evacuated vial that serves as the collection vial for Ga 68 chloride and radiolabeling reaction After radiolabeling with Ga 68, Vial 3 contains up to 1,850 MBq (50 mCi) of Gallium Ga 68 Gozetotide Injection in 7.5 mL at calibration date and time as a clear, colorless to slightly yellow solution in a multiple-dose vial. Kit for the preparation of Gallium Ga 68 Gozetotide Injection contains: Vial 1 (Gozetotide): 25 mcg gozetotide as a lyophilized powder in a multiple-dose vial Vial 2A (2.5 mL) or Vial 2B (6.4 mL) (Acetate Buffer): 150 mg of anhydrous sodium acetate as a sterile solution Vial 2A in Configuration A for use with cyclotron-produced Ga 68 via GE FASTlab Liquid Target System or EZAG generator Vial 2B in Configuration B for use with ARTMS QIS or IRE generator Vial 3 (Sterile Vacuumed Reaction Vial) for the collection of gallium Ga 68 chloride and radiolabeling reaction After radiolabeling with Ga 68, Vial 3 contains up to 1,850 MBq (50 mCi) of Gallium Ga 68 Gozetotide Injection in 7.5 mL in a multiple-dose vial at calibration date and time. ( 3 )

Contraindications

None None ( 4 )

Warnings and precautions

Risk for Misinterpretation: Gallium Ga 68 gozetotide uptake can be seen in a variety of tumor types and in non-malignant processes. Interpretation of ILLUCCIX PET imaging with histopathology and/or other diagnostic procedures is recommended. ( 5.1 ) Radiation Risks: Ensure safe handling to protect patients and health care providers from unintentional radiation exposure. ( 2.1 , 5.2 ) 5.1 Risk for Misinterpretation Image interpretation errors can occur with ILLUCCIX 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. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. The performance of ILLUCCIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of ILLUCCIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score [ see Clinical Studies (14.1 , 14.2) ] . 5.2 Radiation Risks Gallium Ga 68 gozetotide contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care providers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration ( 2.1 , 2.3 )] . 5.1 Risk for Misinterpretation Image interpretation errors can occur with ILLUCCIX 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. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. The performance of ILLUCCIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of ILLUCCIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score [ see Clinical Studies (14.1 , 14.2) ] . 5.2 Radiation Risks Gallium Ga 68 gozetotide contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care providers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration ( 2.1 , 2.3 )] .

Side effects

The most commonly reported adverse reactions (incidence ≥ 0.5%) include fatigue, nausea, constipation, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Telix Pharmaceuticals (US) Inc. at 1-844-455-8638 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ILLUCCIX has been established based on three prospective studies of gallium Ga 68 gozetotide in patients with prostate cancer (i.e., Studies 1, 2, and 3). Adverse reactions from these studies are reported below. In Studies 1 and 2 using another formulation of gallium Ga 68 gozetotide injection, 960 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount (mean ± SD) of radioactivity 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi) [ see Clinical Studies ( 14.1 , 14.2 ) ]. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%. In a randomized, multicenter, open-label clinical study (NCT03511664, referred to as Study 3) in which gallium Ga 68 gozetotide was used to identify PSMA-positive patients on PET imaging to determine eligibility for PSMA-directed therapy, 1,003 patients with progressive metastatic castration-resistant prostate cancer (mCRPC) received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Patients were males with median age of 70 years (range, 40 to 94 years), were White (87%), Black or African American (7%), or Asian (2.4%), and had median baseline PSA levels of 74 ng/mL (range, 0 to 8,995 ng/mL). Adverse reactions occurring at ≥ 0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in Study 3 are presented in Table 4. Table 4 : Adverse Reactions (≥ 0.5%) in Patients with Metastatic Prostate Cancer Who Received Gallium Ga 68 Gozetotide Injection in Study 3 Adverse Reaction Gallium Ga 68 Gozetotide Injection N = 1,003 n (%) General disorders Fatigue 12 (1.2) Gastrointestinal disorders Nausea 8 (0.8) Constipation 5 (0.5) Vomiting 5 (0.5) Adverse reactions occurring at a rate of < 0.5% in the study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ILLUCCIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General Disorders and Administration Site Conditions : injection site pain.

Drug interactions

Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

Use in specific populations

8.1 Pregnancy Risk Summary ILLUCCIX is not indicated for use in females. There are no available data with gallium Ga 68 gozetotide injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including ILLUCCIX, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide. 8.2 Lactation Risk Summary ILLUCCIX is not indicated for use in females. There are no data on the presence of gallium Ga 68 gozetotide in human milk, the effect on the breastfed infant, or the effect on milk production. 8.4 Pediatric Use The safety and effectiveness of gallium Ga 68 gozetotide in pediatric patients have not been established. 8.5 Geriatric Use The efficacy of gallium Ga 68 gozetotide PET in geriatric patients with prostate cancer is based on data from three prospective studies. Of the total number of patients in Studies 1 and 2 [see Clinical Studies (14.1 , 14.2) ] , 691 of 960 (72%) patients were 65 years of age and older while 195 (20%) were 75 years of age and older. Of the total number of patients in Study 3 [ see Adverse Reactions (6.1) ], 752 of 1,003 (75%) patients were 65 years of age and older while 284 (28%) were 75 years of age and older. The efficacy and safety profiles of gallium Ga 68 gozetotide appear similar in younger adult and geriatric patients with prostate cancer and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. 8.1 Pregnancy Risk Summary ILLUCCIX is not indicated for use in females. There are no available data with gallium Ga 68 gozetotide injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including ILLUCCIX, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide. 8.2 Lactation Risk Summary ILLUCCIX is not indicated for use in females. There are no data on the presence of gallium Ga 68 gozetotide in human milk, the effect on the breastfed infant, or the effect on milk production. 8.4 Pediatric Use The safety and effectiveness of gallium Ga 68 gozetotide in pediatric patients have not been established. 8.5 Geriatric Use The efficacy of gallium Ga 68 gozetotide PET in geriatric patients with prostate cancer is based on data from three prospective studies. Of the total number of patients in Studies 1 and 2 [see Clinical Studies (14.1 , 14.2) ] , 691 of 960 (72%) patients were 65 years of age and older while 195 (20%) were 75 years of age and older. Of the total number of patients in Study 3 [ see Adverse Reactions (6.1) ], 752 of 1,003 (75%) patients were 65 years of age and older while 284 (28%) were 75 years of age and older. The efficacy and safety profiles of gallium Ga 68 gozetotide appear similar in younger adult and geriatric patients with prostate cancer and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients.

Overdosage

In the event of an overdose of gallium Ga 68 gozetotide, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding. A diuretic might also be considered. If possible, an estimate of the radiation effective dose given to the patient should be made.

Description

11.1 Drug Characteristics ILLUCCIX (kit for the preparation of gallium Ga 68 gozetotide injection), after radiolabeling with Ga 68, is a radioactive diagnostic agent 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 6. Figure 6: Chemical Structure of Gallium Ga 68 Gozetotide Kit Characteristics ILLUCCIX is supplied as a kit which contains the non-radioactive ingredients needed to produce Gallium Ga 68 Gozetotide Injection. There are two configurations, A or B, available to allow preparation of Gallium Ga 68 Gozetotide Injection using Ga 68 from different generator or cyclotron sources. Each configuration consists of gozetotide (Vial 1), acetate buffer (Vial 2A or Vial 2B), and a sterile vacuumed reaction vial (Vial 3). Vial 1 (Gozetotide): Each vial contains 25 mcg gozetotide and 10 mcg D-mannose. Vial 2A (Acetate Buffer): Each vial contains 150 mg anhydrous sodium acetate in 2.5 mL of 0.292 M hydrochloric acid. Vial 2B (Acetate Buffer): Each vial contains 150 mg anhydrous sodium acetate in 6.4 mL of 0.175 M hydrochloric acid. Vial 3 (Sterile Vacuumed Reaction Vial): a sterile, evacuated vial that serves as the collection vial for Ga 68 chloride and radiolabeling reaction. The prepared Gallium Ga 68 Gozetotide Injection is a sterile, pyrogen free, clear, colorless to slightly yellow, buffered solution containing up to 1,850 MBq (50 mCi) of gallium Ga 68 gozetotide in 7.5 mL with a pH between 4.0 to 5.0. Figure 6 11.2 Nuclear Physical Characteristics Gallium-68 (Ga 68) decays with a half-life of 68 minutes to stable zinc-68. Table 5, Table 6, and Table 7 display the principal radiation emission data, radiation attenuation by lead shielding, and physical decay of Ga 68. Table 5: Principal Radiation Emission Data (>1%) for Ga 68 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 6: 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 7: 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 Drug Characteristics ILLUCCIX (kit for the preparation of gallium Ga 68 gozetotide injection), after radiolabeling with Ga 68, is a radioactive diagnostic agent 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 6. Figure 6: Chemical Structure of Gallium Ga 68 Gozetotide Kit Characteristics ILLUCCIX is supplied as a kit which contains the non-radioactive ingredients needed to produce Gallium Ga 68 Gozetotide Injection. There are two configurations, A or B, available to allow preparation of Gallium Ga 68 Gozetotide Injection using Ga 68 from different generator or cyclotron sources. Each configuration consists of gozetotide (Vial 1), acetate buffer (Vial 2A or Vial 2B), and a sterile vacuumed reaction vial (Vial 3). Vial 1 (Gozetotide): Each vial contains 25 mcg gozetotide and 10 mcg D-mannose. Vial 2A (Acetate Buffer): Each vial contains 150 mg anhydrous sodium acetate in 2.5 mL of 0.292 M hydrochloric acid. Vial 2B (Acetate Buffer): Each vial contains 150 mg anhydrous sodium acetate in 6.4 mL of 0.175 M hydrochloric acid. Vial 3 (Sterile Vacuumed Reaction Vial): a sterile, evacuated vial that serves as the collection vial for Ga 68 chloride and radiolabeling reaction. The prepared Gallium Ga 68 Gozetotide Injection is a sterile, pyrogen free, clear, colorless to slightly yellow, buffered solution containing up to 1,850 MBq (50 mCi) of gallium Ga 68 gozetotide in 7.5 mL with a pH between 4.0 to 5.0. Figure 6 11.2 Nuclear Physical Characteristics Gallium-68 (Ga 68) decays with a half-life of 68 minutes to stable zinc-68. Table 5, Table 6, and Table 7 display the principal radiation emission data, radiation attenuation by lead shielding, and physical decay of Ga 68. Table 5: Principal Radiation Emission Data (>1%) for Ga 68 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 6: 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 7: 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

How supplied

How Supplied ILLUCCIX (kit for the preparation of gallium Ga 68 gozetotide injection) is available in two different configurations. ILLUCCIX Configuration "A" (NDC 74725-100-25), intended for use with Ga 68 produced from a cyclotron and purified via GE FASTlab Liquid Target System or Eckert & Ziegler GalliaPharm Ge 68/Ga 68 generator, contains: Vial 1 (Gozetotide): 25 mcg gozetotide as a sterile white to off-white lyophilized powder in a multiple-dose vial with a blue flip-off cap (NDC 74725-101-25) Vial 2A (Acetate Buffer): 150 mg/2.5 mL of anhydrous sodium acetate as a sterile clear colorless solution in a vial with a red flip off cap (NDC 74725-102-25) Vial 3 (Sterile Vacuumed Reaction Vial): an evacuated sterile vial with white flip off cap used to collect Ga 68 chloride from generator or cyclotron and radiolabeling reaction; a multiple-dose vial after radiolabeling ILLUCCIX Configuration "B" (NDC 74725-100-64), intended for use with Ga 68 produced from ARTMS QIS or an IRE Galli Eo Ge 68/Ga 68 generator, contains: Vial 1 (Gozetotide): 25 mcg gozetotide as a sterile white to off-white lyophilized powder in a multiple-dose vial with a blue flip-off cap (NDC 74725-101-25) Vial 2B (Acetate Buffer): 150 mg/6.4 mL of anhydrous sodium acetate as a sterile clear colorless solution in a vial with a green flip off cap (NDC 74725-103-64) Vial 3 (Sterile Vacuumed Reaction Vial): an evacuated sterile vial with white flip off cap used to collect Ga 68 chloride from generator or cyclotron and radiolabeling reaction; a multiple-dose vial after radiolabeling The radionuclide is not part of the kit. Before radiolabeling with Ga 68, the contents of this kit are not radioactive. Storage and Handling Store ILLUCCIX refrigerated upright in the original packaging at 2° to 8°C (36° to 46°F). Do not freeze. After radiolabeling, keep Gallium Ga 68 Gozetotide Injection upright with appropriate shielding to protect from radiation at room temperature (25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)). Use Gallium Ga 68 Gozetotide Injection within 4 hours of preparation. Dispose of the product in accordance with all federal, state, and local laws and institutional requirements. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Label text from the FDA structured product label by Telix Pharmaceuticals (US) Inc. (revised Jun 15, 2026). Long sections are shortened; the complete label is on DailyMed.

Illuccix NDC products (1)

NDC	Strength & form	Labeler	Type
74725-100	Kit	Telix Pharmaceuticals (US) Inc.	NDA

Frequently asked questions

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Illuccix is listed by 1 labeler in the FDA NDC directory, including Telix Pharmaceuticals (US) Inc..