Copper oxodotreotide cu-64
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From MedlinePlus, U.S. National Library of Medicine
Radioactive Diagnostic Agent
Dosing in kidney impairment
For an administered activity of 148 MBq (4 mCi) the typical radiation dose to the critical organs, which are the liver, the kidneys/adrenals, and the spleen, are about 24 mGy, 21 mGy and 17 mGy, respectively. Because the spleen has one of the highest physiological uptakes, higher uptake and radiation dose to other organs or pathologic tissues may occur in patients with splenectomy.
| Target Organ | Mean Mean of 5 patients.absorbed dose (mGy/MBq) |
| Adrenals | 0.137 |
| Brain | 0.013 |
| Breasts | 0.013 |
| Gallbladder wall | 0.040 |
| Lower large intestine wall | 0.043 |
| Small intestine | 0.066 |
| Stomach wall | 0.019 |
| Upper large intestine wall | 0.022 |
| Heart wall | 0.019 |
| Kidneys | 0.139 |
| Liver | 0.161 |
| Lungs | 0.017 |
| Muscle | 0.019 |
| Ovaries | 0.019 |
| Pancreas | 0.093 |
| Red marrow | 0.027 |
| Osteogenic cells | 0.034 |
| Skin | 0.012 |
| Spleen | 0.115 |
| Testes | 0.014 |
| Thymus | 0.015 |
| Thyroid | 0.014 |
| Urinary bladder wall | 0.037 |
| Uterus | 0.019 |
| Total body | 0.025 |
| Effective dose (mSv/MBq) | 0.032 |
Preparation and administration
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Recommended Dosage and Administration Instructions Recommended Dosage 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. 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.
Patient Preparation Somatostatin Analogs Image patients just prior to dosing with somatostatin analogs. For patients on long-acting somatostatin analogs, a wash-out period of 28 days is recommended prior to imaging. For patients on short-acting somatostatin analogs, a washout period of 2 days is recommended prior to imaging [see Drug Interactions] .
Patient Hydration Instruct patients to drink water to ensure adequate hydration prior to administration of Detectnet and to continue to drink and void frequently during the first hours following administration to reduce radiation exposure [see Warnings and Precautions] . Pregnancy Status Assessment of pregnancy status is recommended in females of reproductive potential before administering Detectnet.
Drug interactions
Check copper oxodotreotide cu-64 against a medication listLabel text (2 paragraphs)
Somatostatin Analogs: Somatostatin analogs competitively bind to the same somatostatin receptors as copper Cu 64 dotatate and may affect imaging. Image patients just prior to dosing with somatostatin analogs. For patients on long-acting somatostatin analogs, a wash-out period of 28 days is recommended prior to imaging. For patients on short-acting somatostatin analogs, a washout period of 2 days is recommended prior to imaging. ( 2.3 , 7.1 )
7.1 Somatostatin Analogs Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2). Image patients just prior to dosing with somatostatin analogs. For patients on long-acting somatostatin analogs, a wash-out period of 28 days is recommended prior to imaging. For patients on short-acting somatostatin analogs, a washout period of 2 days is recommended prior to imaging [see Dosage and Administration ( 2.3 )].
Contraindications
None. None ( 4 ).
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for copper oxodotreotide cu-64. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary 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. 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. No animal reproduction studies have been conducted with copper Cu 64 dotatate injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.