GA-68-DOTATOC- edotreotide gallium ga-68 injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

EDOTREOTIDE GALLIUM GA-68 (UNII: Y68179SY2L) (EDOTREOTIDE GALLIUM GA-68 - UNII:Y68179SY2L)

Tilgængelig fra:

UIHC – P E T Imaging Center

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Ga 68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. None Risk Summary There are no available data on the use of Ga 68 DOTATOC Injection in pregnant women to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Ga 68 DOTATOC. However, all radiopharmaceuticals, including Ga 68 DOTATOC Injection have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Ga 68 DOTATOC Injection administration to a pregnant woman, inform the patient of the potential for adverse pregnancy outcomes based on the radiation dose from Ga 68 DOTATOC Injection and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregn

Produkt oversigt:

Ga 68 DOTATOC Injection is supplied in a multiple-dose, capped 30 mL glass vial containing 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of Ga 68 DOTATOC at calibration time in approximately 14 mL of solution (NDC 24417-681-30). Store Ga 68 DOTATOC Injection upright in a lead shielded container at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). 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. Store and dispose of Ga 68 DOTATOC Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State.

Autorisation status:

New Drug Application

Produktets egenskaber

GA-68-DOTATOC- EDOTREOTIDE GALLIUM GA-68 INJECTION, SOLUTION
UIHC – P E T IMAGING CENTER
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GA
68 DOTATOC
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GA 68 DOTATOC
INJECTION.
GA 68 DOTATOC INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2019
RECENT MAJOR CHANGES
Warnings and Precautions (5.2)
12/2021
INDICATIONS AND USAGE
Ga 68 DOTATOC Injection is a radioactive diagnostic agent indicated
for use with positron emission
tomography (PET) for localization of somatostatin receptor positive
neuroendocrine tumors (NETs) in adult
and pediatric patients. (1)
DOSAGE AND ADMINISTRATION
Recommended dose for adults is 148 MBq (4 mCi) as a bolus intravenous
injection (2.2)
Recommended dose for pediatric patients is 1.59 MBq/kg (0.043 mCi/kg)
with a range of 11.1 MBq (0.3
mCi) to 111 MBq (3 mCi), as a bolus intravenous injection (2.2)
Initiate imaging 55 to 90 minutes after drug administration (2.4)
See full prescribing information for additional preparation,
administration, imaging and radiation
dosimetry information (2)
DOSAGE FORMS AND STRENGTHS
Injection: 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of Ga 68
DOTATOC Injection in a
multiple-dose glass vial (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Radiation Risk: Ensure safe handling and preparation procedures to
protect patients and health care
workers from unintentional radiation exposure Advise patients to
hydrate before and after
administration and to void frequently after administration (2.1, 2.3,
5.1)
Hypersensitivity Reactions: Most reported reactions were rash and
pruritus and reversible either
spontaneously or with routine symptomatic management. (5.2)
Risk for Image Misinterpretation: Uptake of Ga 68 DOTATOC injection
can be seen in a variety of tumor
types that contain somatostatin receptors, and in other pathologic
conditions, and as a normal
physiologic variant (e.g. uncinate process of the pancre