Copper (64Cu) oxodotreotide

What Is Copper (64Cu) oxodotreotide?

• Copper (64Cu) oxodotreotide (Detectnet) is a radioactive diagnostic agent indicated for use with positron emission tomography (PET).

Copper (64Cu) oxodotreotide

What are the uses of this medicine?

• Detectnet is a drug for detection of the specific type of tumors called somatostatin receptor positive neuroendocrine tumors (NETs) in adults.
• NETs are rare tumors that develop in certain hormone-producing cells of the body’s neuroendocrine system.

How does this medicine work?

• Copper Cu 64 dotatate binds to somatostatin receptors with highest affinity for subtype 2 receptors (SSTR2).
• It binds to cells that express somatostatin receptors including malignant neuroendocrine cells, which overexpress SSTR2 receptors.
• Copper Cu 64 is a positron (β+) emitting radionuclide with an emission yield that allows positron emission tomography (PET) imaging.

Who Should Not Use this medicine ?

• This medicine have no usage limitations

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• Handle Detectnet with appropriate safety measures to minimize radiation exposure.
• Use waterproof gloves, effective radiation shielding and appropriate safety measures when preparing and handling Detectnet.
• In adults, the recommended amount of radioactivity to be administered for PET imaging is 148 MBq (4 mCi) administered as an intravenous injection over a period of approximately 1 minute.
• Begin acquiring images 45 to 90 minutes after drug administration.

Administration

• Use Detectnet within 2 hours after calibration time.
• Use aseptic technique and radiation shielding when withdrawing and administering Detectnet.
• Inspect Detectnet 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.
• Use a dose calibrator to measure the patient dose immediately prior to administration of Detectnet.
• After injection of Detectnet, administer an intravenous flush of 0.9% sodium chloride injection, USP.
• 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: 148 MBq (4 mCi) (37 MBq (1 mCi) per 1 mL) of copper Cu 64 dotatate in a single-dose vial.

This medicine is available in fallowing brand namesː

• Detectnet

What side effects can this medication cause?

Common possible side effects of this medicine include:

• nausea
• vomiting
• 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.
• A negative scan after the administration of Detectnet in patients who do not have a history of NET disease does not rule out disease.

What to do in case of emergency/overdose?

• In the event of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by reinforced hydration and frequent bladder voiding.
• A diuretic might also be considered.
• If possible, estimation of the radioactive dose given to the patient should be performed.

Can this medicine be used in pregnancy?

• There are no data on Detectnet use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• All radiopharmaceuticals, including Detectnet have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
• Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of Detectnet.

Can this medicine be used in children?

• The safety and effectiveness of Detectnet have not been established in pediatric patients.

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

• Store Detectnet in an upright position within the lead shielding to protect handlers from exposure to radiation.
• Store Detectnet at controlled room temperature 20°C to 25°C (68°F to 77°F). Do not use and discard Detectnet 2 hours after the calibration date and time.

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• Dailymed label info on Copper (64Cu) oxodotreotide
• FDA Copper (64Cu) oxodotreotide