Copper cu 64 dotatate injection
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alara Ece Dagsali, M.D.
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Overview
Copper cu 64 dotatate injection is a somatostatin receptor-positive neuroendocrine tumors (NETs) that is FDA approved for the diagnosis of Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.. Common adverse reactions include The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity reactions.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
Dosage Radiation Safety – Drug Handling 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.
Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
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.
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 ( 5.1)] .
Pregnancy Status
Assessment of pregnancy status is recommended in females of reproductive potential before administering Detectnet.
Image Acquisition For Detectnet PET imaging, a whole-body acquisition from the skull vertex to mid-thigh is recommended. Image acquisition can begin between 45 to 90 minutes after the intravenous administration of Detectnet. Adapt Detectnet uptake time and scan duration according to the equipment used and the patient and tumor characteristics, to obtain the optimal image quality.
Image Interpretation Copper Cu 64 dotatate binds to somatostatin receptors. Based upon the intensity of the signals, PET images obtained using copper Cu 64 dotatate injection indicate the presence and density of somatostatin receptors in tissues. Uptake can also be seen in a variety of non-NET tumors that contain somatostatin receptors or as a normal physiologic variant. NET tumors that do not bear somatostatin receptors will not be visualized.
Radiation Dosimetry Estimated radiation absorbed doses per injected activity for organs and tissues of adult patients following an intravenous administration of copper Cu 64 dotatate injection
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Copper cu 64 dotatate injection in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Copper cu 64 dotatate injection in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Copper cu 64 dotatate injection FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Copper cu 64 dotatate injection in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Copper cu 64 dotatate injection in pediatric patients.
Contraindications
None
Warnings
Radiation Risk Diagnostic radiopharmaceuticals, including Detectnet, contribute to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. 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 Hypersensitivity reactions following administration of somatostatin receptor imaging agents predominantly consisted of cutaneous reactions such as rash and pruritus. Reactions reversed either spontaneously or with routine symptomatic management. Less frequently hypersensitivity reactions included angioedema or cases with features of anaphylaxis.
Risk for Image Misinterpretation The uptake of copper Cu 64 dotatate reflects the level of somatostatin receptor density in NETs, however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors. Increased uptake might also be seen in other non-cancerous pathologic conditions that express somatostatin receptors including thyroid disease or in subacute inflammation, or might occur as a normal physiologic variant (e.g. uncinate process of the pancreas).
A negative scan after the administration of Detectnet in patients who do not have a history of NET disease does not rule out disease.
Adverse Reactions
Clinical Trials 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.
In safety and efficacy trials, 71 subjects received a single dose of Detectnet. Of these 71 subjects, 21 were healthy volunteers and the remainder were patients with known or suspected NET.
The following adverse reactions occurred at a rate of < 2%:
- Gastrointestinal Disorders:nausea, vomiting
- Vascular Disorders:flushing
In published clinical experience, 126 patients with known history of NET received a single dose of copper Cu 64 dotatate injection. Four patients were reported to have experienced nausea immediately after injection.
Postmarketing 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.
Immune System Disorders:Hypersensitivity reactions, predominantly rash, pruritus, less frequently angioedema or features of anaphylaxis
Drug Interactions
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
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Copper cu 64 dotatate injection in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Copper cu 64 dotatate injection in women who are pregnant.
Labor and Delivery
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.
Nursing Mothers
There are no data on the presence of copper Cu 64 dotatate in human milk, the effect on the breastfed infant, or the effect on milk production. Lactation studies have not been conducted in animals.
Advise a lactating woman to interrupt breastfeeding for 12 hours after Detectnet administration in order to minimize radiation exposure to a breastfed infant.
Pediatric Use
The safety and effectiveness of Detectnet have not been established in pediatric patients.
Geriatic Use
Clinical studies of Detectnet did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Gender
There is no FDA guidance on the use of Copper cu 64 dotatate injection with respect to specific gender populations.
Race
There is no FDA guidance on the use of Copper cu 64 dotatate injection with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Copper cu 64 dotatate injection in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Copper cu 64 dotatate injection in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Copper cu 64 dotatate injection in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Copper cu 64 dotatate injection in patients who are immunocompromised.
Administration and Monitoring
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.
Monitoring
There is limited information regarding Copper cu 64 dotatate injection Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Copper cu 64 dotatate injection and IV administrations.
Overdosage
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.
Pharmacology
There is limited information regarding Copper cu 64 dotatate injection Pharmacology in the drug label.
Mechanism of Action
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.
Structure
There is limited information regarding Copper cu 64 dotatate injection Structure in the drug label.
Pharmacodynamics
The relationship between copper Cu 64 dotatate plasma concentrations and successful imaging was not explored in clinical trials.
Pharmacokinetics
Distribution
After 1 to 3 hours of a single dose administration of copper Cu 64 dotatate injection, the maximum radioactivity is observed in adrenal glands, kidney, pituitary glands, spleen, and liver.
Elimination
Metabolism
The metabolism of copper Cu 64 dotatate is unknown.
Excretion
Following a single intravenous dose (4.15 ± 0.13 mCi) of Detectnet (n = 6), between 16% to 40% radioactivity of the injected dose was recovered in urine over a 6-hour collection time.
Specific Populations
The effect of hepatic impairment or renal impairment on copper Cu 64 dotatate pharmacokinetics has not been studied.
Nonclinical Toxicology
Carcinogenicity and mutagenicity studies have not been conducted with copper Cu 64 dotatate injection; however, radiation is a carcinogen and mutagen.
No animal studies were conducted to determine the effects of copper Cu 64 dotatate on fertility or embryology.
Clinical Studies
The efficacy of Detectnet was established in two single-center, open-label studies. Study 1 prospectively evaluated a total of 63 subjects, including 42 patients with known or suspected NET based on histology, conventional imaging, or clinical evaluations and 21 healthy volunteers. Of the 42 patients, 37 (88%) had a history of NETs at the time of Detectnet imaging. Among the total study population of 63 subjects, 28 (44%) were men and 35 (56%) were women with most subjects being white (86%). The mean age of the subjects was 54 years (range 25 to 82 years).
Detectnet images from each subject were interpreted as either positive or negative for NET by three independent readers who were blinded to clinical information and other imaging results. PET imaging results were compared to a composite reference standard consisting of a single oncologist’s blinded assessment of subject diagnosis based on available histopathology results, reports of conventional imaging (MRI, contrast CT, bone scintigraphy, F 18 fludeoxyglucose PET/CT, F 18 sodium fluoride PET/CT, In 111 pentetreotide SPECT/CT, Ga 68 dotatate PET/CT) performed within 8 weeks prior to Detectnet imaging, and clinical and laboratory data including chromogranin A and serotonin levels. The proportion of subjects positive for disease per composite reference who were identified as positive by Detectnet imaging was used to quantify positive percent agreement. The proportion of subjects without disease per composite reference who were identified as negative by Detectnet imaging was used to quantify negative percent agreement. Table 5 shows the performance of Detectnet in the detection of NET for Study 1.
How Supplied
Detectnet (NDC 69945-064-01) is supplied as a sterile, clear, colorless to yellow solution in a 10 mL single-dose vial containing 148 MBq (4 mCi) (37 MBq (1 mCi) per mL) of copper Cu 64 dotatate at calibration date and time.
The sealed vial is contained in a shielded (lead) container for radiation protection. The product is shipped in a Type A package.
Discard unused portion from the single-patient use vial.
Storage
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.
This radiopharmaceutical is for distribution and use by persons under license by the U.S. Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State. Store and dispose of Detectnet in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.
Images
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Patient Counseling Information
Radiation Risk
Advise patients to drink water to ensure adequate hydration prior to their PET study and recommend they drink and urinate as often as possible during the first hours following the administration of Detectnet, in order to reduce radiation exposure.
Pregnancy
Advise a pregnant woman of the potential risks of fetal exposure to radiation doses with Detectnet .
Lactation
Advise a lactating woman to interrupt breastfeeding for 12 hours after Detectnet administration in order to minimize radiation exposure to a breastfed infant.
Precautions with Alcohol
Alcohol-Copper cu 64 dotatate injection interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
DETECTNET
Look-Alike Drug Names
There is limited information regarding Copper cu 64 dotatate injection Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.