国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
GOZETOTIDE (UNII: 9AG41L3AOQ) (GOZETOTIDE - UNII:9AG41L3AOQ)
Telix Pharmaceuticals (US) Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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 with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated. None 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. Ri
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: 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: 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 ambient 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. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
New Drug Application
ILLUCCIX- KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION TELIX PHARMACEUTICALS (US) INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ILLUCCIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ILLUCCIX. ILLUCCIX® (KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION), FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2020 RECENT MAJOR CHANGES Indications and usage ( 1) 3/2023 Dosage and Administration, Image Interpretation ( 2.7) 3/2023 Warnings and Precautions, Risk for Misinterpretation ( 5.1) 3/2023 INDICATIONS AND USAGE 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 with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated ( 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. ( 2.6) See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information. ( 2) DOSAGE FORMS AND STRENGTHS ILLUCCIX is supplied as a kit containing: (3) Vial 1 (Gozetotide Vial) contains 25 mcg gozetotide and 10 mc 完全なドキュメントを読む