Brand Name
Ga-68-DOTATOC
Generic Name
Edotreotide
View Brand Information FDA approval date: September 01, 2019
Form: Injection
What is Ga-68-DOTATOC (Edotreotide)?
Ga 68 DOTATOC Injection is indicated for use with positron emission tomography for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients. Ga 68 DOTATOC Injection is a radioactive diagnostic agent indicated for use with positron emission tomography for localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients.
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Brand Information
Ga-68-DOTATOC (EDOTREOTIDE GALLIUM GA-68)
1INDICATIONS AND USAGE
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.
2DOSAGE FORMS AND STRENGTHS
Injection: Gallium Ga 68 DOTATOC Injection is a clear, colorless solution in a 30 mL multiple-dose vial containing 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of Ga 68 DOTATOC Injection at calibration date and time.
3CONTRAINDICATIONS
None
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity reactions
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Ga-68 DOTATOC injection was evaluated in 334 patients in clinical trials of patients receiving a single dose of Ga-68 DOTATOC injection for imaging known or suspected NET.
The following adverse reactions occurred at a rate of < 2%:
The following adverse reactions occurred at a rate of a < 1%
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of other somatostatin receptor imaging agents. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug.
5DRUG INTERACTIONS
Non-radioactive somatostatin analogs bind to the same somatostatin receptors as Ga 68 DOTATOC Injection. Image patients with Ga 68 DOTATOC Injection just prior to dosing with long-acting analogs of somatostatin. Short-acting analogs of somatostatin can be used up to 24 hours before imaging with Ga 68 DOTATOC Injection
6OVERDOSAGE
In the event of a radiation overdose, reduce the absorbed dose to the patient by increasing the elimination of the radionuclide from the body by reinforced hydration, frequent bladder voiding, and diuretics, if needed. If possible, perform an estimate of the radioactive dose given to the patient.
7CLINICAL STUDIES
The safety and efficacy of Ga-68 DOTATOC Injection were established in two single-center, open-label studies (Study A and Study B) in which 282 patients with known or suspected SSTR-positive NETs received a single dose of Ga-68 DOTATOC. A total of 238 of the 282 patients (84%) had a history of neoplasm at the time of Ga-68 DOTATOC imaging. Among the 282 patients, 59% were female and 95% white; the mean age was 54 years (range from 4 to 82 years).
The Ga-68 DOTATOC images were rated by two independent readers blinded to clinical information as either positive or negative for NET within each patient. The imaging results were compared to a composite reference consisting of histopathology and imaging (MR, CT, or In-111 pentetreotide imaging) acquired within 1 year of the Ga-68 DOTATOC imaging, as well as chromogranin A and pancreastatin levels. The proportion of patients positive for NET per composite reference who were identified as positive by the Ga-68 DOTATOC image was used to quantify positive percent agreement. The proportion of patients without NET per composite reference who were identified as negative by the Ga-68 DOTATOC image was used to quantify negative percent agreement.
8HOW SUPPLIED/STORAGE AND HANDLING
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).
9PRINCIPAL DISPLAY PANEL - 14 mL Vial Label
DOTATOC Ga 68 INJECTION
BATCH#
Rx ONLY
Sterile, non-pyrogenic
Multiple-dose Vial
NDC# 24417-681-30
Manufactured by:
TOTAL ACTIVITY: mCi
Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F–86°F);
Do not use if cloudy or if contains particulate matter.
