GALLIUM GA-68 PSMA-11- gallium ga-68 gozetotide injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

GALLIUM GA-68 GOZETOTIDE (UNII: ZJ0EKR6M10) (GALLIUM GA-68 GOZETOTIDE - UNII:ZJ0EKR6M10)

Disponível em:

UCSF Radiopharmaceutical Facility

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Gallium Ga 68 Gozeotide Injection 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. None Risk Summary Gallium Ga 68 Gozetotide Injection 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 Gallium Ga 68 Gozetotide Injection, 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 Injection. Risk Summary Gallium Ga 68 Gozetotide Injection is not indicated for use in females. There ar

Resumo do produto:

Gallium Ga 68 Gozetotide Injection (NDC 24275-0525-1) is a clear, colorless solution, supplied in a capped glass vial containing 18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) of gallium Ga 68 gozetotide at end of synthesis, in approximately 11 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. The expiration date and time are provided on the container label. Use Gallium Ga 68 Gozetotide Injection within 4 hours of calibration time. Storage Store Gallium Ga 68 Gozetotide Injection upright in a lead shielded container at 25°C (77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F). Store Gallium Ga 68 Gozetotide Injection within the original container in radiation shielding. Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States, or Licensing States as appropriate.

Status de autorização:

New Drug Application

Características técnicas

GALLIUM GA-68 PSMA-11- GALLIUM GA-68 GOZETOTIDE INJECTION, SOLUTION
UCSF RADIOPHARMACEUTICAL FACILITY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALLIUM GA 68
GOZETOTIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR GALLIUM
GA 68 GOZETOTIDE INJECTION.
GALLIUM GA 68 GOZETOTIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2020( GOZETOTIDE IS ALSO KNOWN AS PSMA-11)
INDICATIONS AND USAGE
Gallium Ga 68 Gozetotide Injection 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. ( 1)
DOSAGE AND ADMINISTRATION
Use appropriate aseptic technique and radiation safety handling
measures to maintain sterility during
all operations involved in the manipulation and administration of
Gallium Ga 68 Gozetotide Injection. (
2.1)
The recommended adult dose 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 to 100 minutes after administration. The patient
should void immediately prior to
initiation of imaging. Scan should begin caudally and proceed
cranially. ( 2.4)
See full prescribing information for additional preparation,
administration, imaging, and radiation
dosimetry information. ( 2)
DOSAGE FORMS AND STRENGTHS
Injection: clear, colorless solution in a multiple-dose vial
containing 18.5 MBq/mL to 185 MBq/mL (0.5
mCi/mL to 5 mCi/mL) Gallium Ga 68 Gozetotide at calibration time ( 3)
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
Risk for misdiagnosis: Gallium Ga 68 gozetotide uptake can be seen in
a variety of tumor types and in
non-malignant processes. Image interpretatio