Kit For The Preparation Of Gallium Ga 68 Gozetotide Injection
FDA Drug Information • Also known as: Illuccix
- Brand Names
- Illuccix
- Route
- INTRAVENOUS
- Dosage Form
- KIT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 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...
What Is Kit For The Preparation Of Gallium Ga 68 Gozetotide Injection Used For?
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. ( 2.6 ) 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 or at most 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, USP 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 Prior to PET Imaging Instruct patients to drink a sufficient amount of water to...
Side Effects (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. 6.1 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 3. Table 3 : 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
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.
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
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.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ILLUCCIX is supplied as a kit for preparing Gallium Ga 68 Gozetotide Injection. There are two different kit configurations, each containing 3 vials. ILLUCCIX Configuration "A" (NDC 74725-100-25) is intended for use with Ga 68 produced from a cyclotron and purified via GE FASTlab or Eckert & Ziegler GalliaPharm Ge 68/Ga 68 generator and includes: Vial 1 (Gozetotide Vial): contains 25 mcg gozetotide and 10 mcg D-mannose as a lyophilized powder in a sterile 10 mL vial with a blue flip-off cap (NDC 74725-101-25). Vial 2 (Acetate Buffer Vial, Configuration A): contains 150 mg anhydrous sodium acetate in 0.292 M HCl solution (2.5 mL volume) in a sterile 10 mL 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 generators or cyclotron and radiolabeling reaction; a multiple-dose vial after radiolabeling. ILLUCCIX Configuration "B" (NDC 74725-100-64) is intended for use with Ga 68 produced from an IRE Galli Eo Ge 68/Ga 68 generator and includes: Vial 1 (Gozetotide Vial): contains 25 mcg gozetotide and 10 mcg D-mannose as a lyophilized powder in a sterile 10 mL vial with a blue flip-off cap (NDC 74725-101-25). Vial 2 (Acetate Buffer Vial, Configuration B): contains 150 mg anhydrous sodium acetate in 0.175 M HCl solution (6.4 mL volume) in a sterile 10 mL 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 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...
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.