ILLUCCIX Kit for the preparation of gallium Ga 68 gozetotide injection Kit — NDC 74725-100-25 (Billing 74725-0100-25)
This is a package of ILLUCCIX Kit for the preparation of gallium Ga 68 gozetotide injection Kit from Telix Pharmaceuticals (US) Inc., marketed since Dec 2021 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 082959
- GCN: 51777
- GPI-14 (Medi-Span): 94356530306420
- HICL (First Databank): 047747
- AHFS class code: 36:00.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $878.83 | — |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 74725-0100-25 You're viewing this Main listing | 1 KIT in 1 CARTON * 2.5 mL in 1 VIAL, MULTI-DOSE * 6.4 mL in 1 VIAL, MULTI-DOSE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE | 2021-12-17 | — | Active |
| 74725-0100-64 74725-100-64 | 1 KIT in 1 CARTON * 2.5 mL in 1 VIAL, MULTI-DOSE * 6.4 mL in 1 VIAL, MULTI-DOSE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE | 2021-12-17 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 54% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
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What NDC number is used to bill for this package of ILLUCCIX Kit for the preparation of gallium Ga 68 gozetotide injection Kit?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Illuccixthis 74725-0100-25 | Telix | 1 kit | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11027031 ↗ | Method of use | U-3317 | Jul 28, 2035 |
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- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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Manufacturer & labeler
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Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
2 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 )
2.1Radiation 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.
2.2Recommended 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.
2.3Patient 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 )] .
2.4General 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… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 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 ▾
4 CONTRAINDICATIONS None None ( 4 )
⚠️ Warnings and Cautions ▾
5 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 )
5.1Risk 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) ] .
5.2Radiation 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 )] .
5.1Risk 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) ] .
5.2Radiation 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 )] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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.
6.1Clinical 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 ±
40.7MBq (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 ±
23.1MBq (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.
6.2Postmarketing 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 ▾
7 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 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.2Lactation 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.
8.4Pediatric Use The safety and effectiveness of gallium Ga 68 gozetotide in pediatric patients have not been established.
8.5Geriatric 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.
8.1Pregnancy 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.
8.2Lactation 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.
8.4Pediatric Use The safety and effectiveness of gallium Ga 68 gozetotide in pediatric patients have not been established.
8.5Geriatric 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 ▾
10 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Gallium Ga 68 gozetotide binds to PSMA. It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium 68 (Ga 68) is a β+ emitting radionuclide that allows positron emission tomography.
12.2Pharmacodynamics The relationship between gallium Ga 68 gozetotide plasma concentrations and successful imaging was not explored in clinical trials.
12.3Pharmacokinetics Distribution Intravenously injected gallium Ga 68 gozetotide is cleared from the blood and is accumulated preferentially in the liver (15%), kidneys (7%), spleen (2%), and salivary glands (0.5%). Gallium Ga 68 gozetotide uptake is also seen in the adrenals and prostate. There is no uptake in the cerebral cortex or in the heart, and usually lung uptake is low.
Elimination A total of 14% of the injected dose is excreted in urine in the first 2 hours post-injection.
12.1Mechanism of Action Gallium Ga 68 gozetotide binds to PSMA. It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium 68 (Ga 68) is a β+ emitting radionuclide that allows positron emission tomography.
12.2Pharmacodynamics The relationship between gallium Ga 68 gozetotide plasma concentrations and successful imaging was not explored in clinical trials.
12.3Pharmacokinetics Distribution Intravenously injected gallium Ga 68 gozetotide is cleared from the blood and is accumulated preferentially in the liver (15%), kidneys (7%), spleen (2%), and salivary glands (0.5%). Gallium Ga 68 gozetotide uptake is also seen in the adrenals and prostate. There is no uptake in the cerebral cortex or in the heart, and usually lung uptake is low.
Elimination A total of 14% of the injected dose is excreted in urine in the first 2 hours post-injection.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 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.
📋 Description ▾
11 DESCRIPTION
11.1Drug 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
11.2Nuclear 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
11.1Drug 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… [Excerpted — this section continues on DailyMed.]
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Imaging Prior to Initial Definitive Therapy The efficacy of ILLUCCIX for PET of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy has been established based on a study of another formulation of gallium Ga 68 gozetotide. Below is a display of the results of the prospective, open label study PSMA-PreRP (NCT03368547 and NCT02919111, referred to as Study 1). This two-center study enrolled 325 patients with biopsy-proven prostate cancer who were considered candidates for prostatectomy and pelvic lymph node dissection.
All enrolled patients met at least one of the following criteria: serum prostate-specific antigen (PSA) of at least 10 ng/mL, tumor stage cT2b or greater, or Gleason score greater than 6. Each patient received a single gallium Ga 68 gozetotide PET/CT or PET/MR from mid-thigh to skull base. A total of 123 patients (38%) proceeded to standard-of-care prostatectomy and template pelvic lymph node dissection and had sufficient histopathology data for evaluation (evaluable patients).
Three members of a pool of six central readers independently interpreted each PET scan for the presence of abnormal gallium Ga 68 gozetotide uptake in pelvic lymph nodes located in the common iliac, external iliac, internal iliac, and obturator subregions bilaterally as well as in any other pelvic location. The readers were blinded to all clinical information except for the history of prostate cancer prior to definitive treatment. Extrapelvic sites and the prostate gland itself were not analyzed in this study.
For each patient, gallium Ga 68 gozetotide PET results and reference standard histopathology obtained from dissected pelvic lymph nodes were compared by region (left hemipelvis, right hemipelvis, and other). For the 123 evaluable patients, the mean age was 65 years (range 45 to 76 years), and 89% were White. The median serum PSA was 11.8 ng/mL.
The summed Gleason score was 7 for 44%, 8 for 20%, and 9 for 31% of the patients, with the remainder of the patients having Gleason scores of 6 or 10. Table 8 compares majority PET reads to pelvic lymph node histopathology results at the patient-level with region matching, such that at least one true positive region defines a true positive patient. As shown, approximately 24% of subjects studied were found to have pelvic nodal metastases based on histopathology (95% confidence interval: 17%, 32%).
Table 8: Patient-Level Performance of Gallium Ga 68 Gozetotide PET for Detection of Pelvic Lymph Node Metastasis with region matching where at least one true positive region defines a true positive patient in Men with Prostate Cancer with Suspected Metastasis in Study 1 (n=123) Histopathology Predictive value PPV: positive predictive value, NPV: negative predictive value (95% CI) Positive Negative PET scan Positive 14 9 PPV 61% (41%, 81%) Negative 16 84 NPV 84% (79%, 91%) Total 30 93 Diagnostic performance (95% CI) Sensitivity 47% (29%, 65%) Specificity 90% (84%, 96%) Among the pool of six readers, sensitivity ranged from 36% to 60%, specificity from 83% to 96%, positive predictive value from 38% to 80%, and negative predictive value from 80% to 88%.
In an exploratory subgroup analysis based on summed Gleason score, there was a numerical trend toward more true positives in patients with Gleason score of 8 or higher compared to those with Gleason score of 7 or lower. An exploratory analysis was performed to estimate the sensitivity and specificity for pelvic nodal metastasis detection in all scanned patients, including the patients who were lacking histopathology reference standard. An imputation method was used based on patient-specific factors.
This exploratory analysis resulted in an imputed sensitivity of 47%, with a 95% confidence interval ranging from 38% to 55%, and an imputed specificity of 74%, with a 95% confidence interval ranging from 68% to 80% for all patients imaged with gallium Ga 68 gozetot… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies were performed to evaluate the carcinogenicity potential of gallium Ga 68 gozetotide.
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies were performed to evaluate the carcinogenicity potential of gallium Ga 68 gozetotide.
📄 Recent Major Changes ▾
Indications and Usage ( 1 ) 9/2025 Dosage and Administration, 9/2025 General Instructions for Drug Preparation ( 2.4 ) Image Interpretation ( 2.11 ) Dosage and Administration, 1/2026 General Instructions for Drug Preparation ( 2.4 ) Preparation with Cyclotron-Produced Ga 68 via GE FASTlab Liquid Target System ( 2.5 ) Preparation with EZAG GalliaPharm Generator ( 2.6 ) Preparation with Cyclotron-Produced Ga 68 via ARTMS QIS Solid Target System ( 2.7 ) Preparation with IRE ELiT Galli Eo Generator ( 2.8 ) Specifications and Quality Control ( 2.9 ) Warnings and Precautions, Risk for Misinterpretation ( 5.1 ) 9/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - Kit Carton - Configuration A NDC 74725-100-25 Rx-Only illuccix ® (kit for the preparation of gallium Ga 68 gozetotide Injection) 25 mcg/vial gozetotide For Intravenous Use Only Multiple-Dose Kit Kit for the preparation of gallium Ga 68 gozetotide Injection is supplied as multiple dose kit containing: Prescribing Information Diagnostic label Syringe label Vial 1 (Gozetotide vial) contains 25 mcg gozetotide vial Vial 2A (Acetate Buffer Vial) contains acetate buffer Vial 3 (Sterile Vacuumed Reaction Vial) CONFIGURATION: A Configuration A is for use with Ga 68 produced via cyclotron or EZAG GalliaPharm ® PRINCIPAL DISPLAY PANEL - Kit Carton - Configuration A
PRINCIPAL DISPLAY PANEL - Kit Carton - Configuration B NDC 74725-100-64 Rx Only illuccix ® (kit for the preparation of gallium Ga 68 gozetotide Injection) 25 mcg/vial gozetotide For Intravenous Use Only Multiple-Dose Kit Kit for the preparation of gallium Ga 68 gozetotide Injection is supplied as a multiple-dose kit containing: Prescribing Information Diagnostic Label Syringe Label Vial 1 (Gozetotide) Vial 2B (Acetate Buffer) Vial 3 (Sterile Vacuumed Reaction Vial) CONFIGURATION: B Configuration B is for use with the IRE ELiT Galli Eo ® or ARTMS solid target.
PRINCIPAL DISPLAY PANEL - Kit Carton - Configuration B
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