NETSPOT- 68ga-dotatate kit

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

DOTATATE (UNII: MRL3739G66) (DOTATATE GALLIUM GA-68 - UNII:9L17Y0H71P)

Dostupné z:

Advanced Accelerator Applications USA, Inc

INN (Medzinárodný Name):

DOTATATE

Zloženie:

DOTATATE 40 ug

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

NETSPOT, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. None. Risk Summary There are no studies with gallium Ga 68 dotatate in pregnant women to inform any drug-associated risks; however, radioactive emissions, including those from gallium Ga 68 dotatate, can cause fetal harm. Animal reproduction studies have not been conducted with gallium Ga 68 dotatate. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Risk Summary There is no information on the presence of gallium Ga 68 dotatate in human milk, the effect on the breastfed child, or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for gallium Ga 68 dotatate injection and a

Prehľad produktov:

NETSPOT is supplied as a multiple-dose kit (NDC# 69488-001-40) for preparing multiple doses of gallium-68 radiolabeled dotatate injection. The kit contains: The radionuclide is not part of the kit. Before radiolabeling with gallium-68, the contents of this kit are not radioactive. Expiry date is indicated on the original outer packaging, and on the vials. This medicinal product must not be used beyond the date indicated on the packaging. For prolonged storage, store NETSPOT in its original packaging at room temperature below 25°C (77°F) (do not freeze). After radiolabeling [see Dosage and Administration (2.3)] with activities of up to 1,110 MBq (30 mCi), keep gallium Ga 68 dotatate injection upright with an appropriate shielding to protect from radiation, at a temperature below 25°C (77°F) (do not freeze), and use within 4 hours. The storage of the radiolabeled product must comply with regulatory requirements for radioactive materials.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

NETSPOT- 68GA-DOTATATE
ADVANCED ACCELERATOR APPLICATIONS USA, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NETSPOT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NETSPOT.
NETSPOT (KIT FOR THE PREPARATION OF GALLIUM GA 68 DOTATATE INJECTION),
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2016
RECENT MAJOR CHANGES
Dosage and Administration (2.3)
10/2023
INDICATIONS AND USAGE
NETSPOT, after radiolabeling with gallium-68, 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
After radiolabeling, handle gallium Ga 68 dotatate injection with
appropriate safety measures to
minimize radiation exposure. (2.1)
Instruct patients to drink a sufficient amount of water before
administration, during the first hours
following administration and to void frequently. (2.1)
Recommended dose is 2 MBq/kg (0.054 mCi/kg) of body weight up to 200
MBq (5.4 mCi) administered
as intravenous bolus injection. (2.2)
See the Full Prescribing Information for detailed instructions on how
to prepare gallium Ga 68 dotatate
injection (e.g., radiolabeling). (2.3)
DOSAGE FORMS AND STRENGTHS
NETSPOT is supplied as a multiple-dose kit containing:
VIAL 1 (reaction vial with lyophilized powder) containing 40 mcg of
dotatate. (3)
VIAL 2 (buffer vial) containing 1 mL of reaction buffer solution. (3)
After radiolabeling with gallium-68 and pH adjustment with Reaction
Buffer, Vial 1 contains a sterile
solution of gallium Ga 68 dotatate at a strength up to 218 MBq/mL
(5.89 mCi/mL). (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Radiation Risk: Gallium Ga 68 dotatate contributes to a patient’s
overall long-term cumulative radiation
exposure. Ensure safe handling and preparation procedures to protect
patients and health care workers
from unintentional radiation exposure. Restrict close con