ILLUCCIX- kit for the preparation of gallium ga 68 gozetotide injection kit

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

GOZETOTIDE (UNII: 9AG41L3AOQ) (GOZETOTIDE - UNII:9AG41L3AOQ)

可用日期:

Telix Pharmaceuticals (US) Inc.

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

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.

授权状态:

New Drug Application

产品特点

ILLUCCIX- KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE
INJECTION
TELIX PHARMACEUTICALS (US) INC.
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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