LOCAMETZ- kit for the preparation of gallium ga 68 gozetotide injection, powder, lyophilized, for solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Advanced Accelerator Applications USA, Inc

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

LOCAMETZ, after radiolabeling with gallium-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 LOCAMETZ is not indicated for use in females. There are no available data with gallium Ga 68 gozetotide 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 LOCAMETZ, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide. Risk Summar

Produkto santrauka:

How Supplied LOCAMETZ is supplied as a kit for the preparation of gallium Ga 68 gozetotide injection in a carton of 1 vial (NDC# 69488-017-61). Each multiple-dose vial contains 25 micrograms of gozetotide as white lyophilized powder packaged in a 10 mL type I Plus glass vial closed with a rubber stopper and sealed with a flip-off cap. Storage and Handling Before radiolabeling, store at 2°C to 25°C (36°F to 77°F). Do not freeze. After radiolabeling, store upright with an appropriate lead shielding to protect from radiation, below 30°C (86°F). Do not freeze. After radiolabeling, use within 6 hours. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Autorizacija statusas:

New Drug Application

Prekės savybės

LOCAMETZ- KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE
INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
ADVANCED ACCELERATOR APPLICATIONS USA, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOCAMETZ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LOCAMETZ.
LOCAMETZ (KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE
INJECTION), FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 2020
RECENT MAJOR CHANGES
Dosage and Administration, Drug Preparation (2.4)
6/2023
INDICATIONS AND USAGE
LOCAMETZ, after radiolabeling with gallium-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 radiation safety measures and aseptic precautions
while handling and administering
gallium Ga 68 gozetotide injection. (2.1)
The recommended amount of radioactivity is 111 MBq to 259 MBq (3 mCi
to 7 mCi). Administered as
slow intravenous injection. (2.2)
Advise patients to be well hydrated prior to the administration and to
void immediately prior to and
frequently after image acquisition. (2.3)
A diuretic expected to act within the uptake time period may be
administered at the time of radiotracer
injection. (2.6)
Acquire PET whole body images 50 minutes to 100 minutes after
administration. (2.7)
See the full prescribing information for detailed instructions on
preparation, administration, imaging,
and radiation dosimetry. (2)
DOSAGE FORMS AND STRENGTHS
Kit for the preparation of gallium Ga 68 gozetotide injection supplied
in a multiple-dose vial containing
25 mcg of gozetotide as a white lyophil