Ga-68-DOTATOC

What is Ga-68-DOTATOC?

Ga-68-DOTATOC Injection is a radioactive diagnostic agent indicated for use with positron emission tomography (PET).

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What are the uses of this medicine?

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.

How does this medicine work?

• Ga 68 DOTATOC binds to somatostatin receptors, with highest affinity (Ki = 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.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 DOTATOC Injection and may affect imaging.
• 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.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage

• Recommended dose for adults is 148 MBq (4 mCi) as a bolus intravenous injection.
• 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.
• Initiate imaging 55 to 90 minutes after drug administration.

Administration

• 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.
• Use Ga 68 DOTATOC Injection within 3 hours of calibration time.
• Use aseptic technique and radiation shielding when withdrawing and administering Ga 68 DOTATOC Injection.
• Inspect Ga 68 DOTATOC Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored.
• Calculate the necessary volume to administer based on measured activity, volume, calibration time, and date.
• Measure the patient dose immediately prior to administration in a dose calibrator.
• After injection of Ga 68 DOTATOC Injection, administer an intravenous flush of sodium chloride injection, 0.9% to ensure full delivery of the dose.
• Dispose of any unused drug in a safe manner in compliance with applicable regulations.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 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

This medicine is available in fallowing brand namesː

• Ga 68 DOTATOC

What side effects can this medication cause?

The most common side effects of this medicine include:

• Nausea
• pruritis
• flushing

What special precautions should I follow?

• 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.
• 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).

What to do in case of emergency/overdose?

Management for overdosage

• 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.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• The safety and efficacy of Ga 68 DOTATOC Injection have been established in pediatric patients with neuroendocrine tumors.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• EDOTREOTIDE GALLIUM GA-68

Inactive ingredients:

• ALCOHOL
• sodium chloride

Who manufactures and distributes this medicine?

• Packager: UIHC – P E T Imaging Center

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Ga-68-DOTATOC
• FDA Ga-68-DOTATOC

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