39/20. Copper Cu 64-(DETECTNET)- (Sep 2020)- Neuroendocrine Tumors
Drug Name:39/20. Copper Cu 64-(DETECTNET)- (Sep 2020)- Neuroendocrine Tumors
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
DRUG INTERACTIONS-summary
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.
Indication:
U.S. FDA APPROVED DRUGS DURING 2020
Sr.No- 39
Adverse Reaction:
ADVERSE REACTIONS
Reported adverse reactions include nausea, vomiting, and flushing.
Contra-Indications:
WARNINGS AND PRECAUTIONS
• Radiation Risk: Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure Advise patients to hydrate before a n d a f t e r administration and to void frequently after administration.
• Risk for Image Misinterpretation: Uptake of Detectnet can be seen in a variety of tumor types other than NETs, in other pathologic conditions, and as a normal physiologic variant (e.g., uncinate process of the pancreas).
Dosages/ Overdosage Etc:
Patient Information:
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
Manufactured, Packed and Distributed by: Curium US LLC 2703 Wagner Place Maryland Heights, MO 63043
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. 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 (ß+) emitting radionuclide with an emission yield that allows positron emission tomography (PET) imaging.
2. Pharmacodynamics- The relationship between copper Cu 64 dotatate plasma concentrations and successful imaging was not explored in clinical trials.
3. 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.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
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.
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.
2. Lactation Risk Summary - 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.
3. Pediatric use- The safety and effectiveness of Detectnet have not been established in pediatric patients.
4.Geriatric 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.
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.
