Edotreotide gallium ga-68 is a prescription medicine indicated with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. MedsAcross supplies Edotreotide gallium ga-68 for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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. 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.
Source: US FDA prescribing information
Ga 68 DOTATOC binds to somatostatin receptors, with highest affinity (K i = 2.5± 0.5 nanomolar) for subtype 2 receptors (sstr2). Ga 68 DOTATOC binds to cells that express somatostatin receptors including malignant neuroendocrine cells, which overexpress sstr2 receptors. Gallium 68 is a β+ emitting radionuclide with associated 511 keV annihilation photons that allow positron emission tomography (PET) imaging.
Source: US FDA prescribing information
Recommended dose for adults is 148 MBq (4 mCi) as a bolus intravenous injection. Recommended dose for pediatric patients is MBq/kg (0.043 mCi/kg) with a range of MBq (0.3 mCi) to 111 MBq (3 mCi), as a bolus intravenous injection. Initiate imaging 55 to 90 minutes after drug administration. See full prescribing information for additional preparation, administration, imaging and radiation dosimetry information Radiation Safety – Drug Handling Handle Ga 68 DOTATOC Injection with appropriate safety measures to minimize radiation exposure. Use waterproof gloves, effective radiation shielding and appropriate safety measures when preparing and handling Ga 68 DOTATOC Injection.
Source: US FDA prescribing information
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Source: US FDA prescribing information
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. Hypersensitivity Reactions: Most reported reactions were rash and pruritus and reversible either spontaneously or with routine symptomatic management. 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 pancreas)
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions Reported adverse reactions include: Nausea, pruritis, and flushing.
Source: US FDA prescribing information
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. Somatostatin Analogs: Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 DOTATOC Injection and may affect imaging –Discontinue short-acting somatostatin analogs 24 hours before imaging with Ga 68 DOTATOC and image just prior to dosing with long-acting somatostatin analogs
Source: US FDA prescribing information
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). 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.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Edotreotide gallium ga-68, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ga-68-DOTATOC 4 mCi/mL injectionIntravenous | UIHC P E T Imaging Center | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | Not recorded | — |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Edotreotide gallium ga-68 and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Edotreotide gallium ga-68, including Ga-68-DOTATOC.
No listed presentation of Edotreotide gallium ga-68 is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Edotreotide gallium ga-68 is classified under ATC code V09IX09 (Edotreotide gallium ga-68).
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