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copper dotatate Cu-64 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5411 | 1426155-87-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Copper Cu-64 dotatate is a radioactive diagnostic drug. It 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 (beta+) emitting radionuclide with an emission yield that allows positron emission tomography (PET) imaging.
|
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 3, 2020 | FDA | RADIOMEDIX |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 289.55 | 35.62 | 107 | 2232 | 106763 | 90519345 |
| Metastases to liver | 81.86 | 35.62 | 30 | 2309 | 28777 | 90597331 |
| Carcinoid crisis | 76.27 | 35.62 | 12 | 2327 | 286 | 90625822 |
| Abdominal pain | 66.16 | 35.62 | 65 | 2274 | 395656 | 90230452 |
| Thrombocytopenia | 56.25 | 35.62 | 45 | 2294 | 208680 | 90417428 |
| Platelet count decreased | 56.04 | 35.62 | 38 | 2301 | 136931 | 90489177 |
| Carcinoid syndrome | 49.95 | 35.62 | 8 | 2331 | 214 | 90625894 |
| Flushing | 49.71 | 35.62 | 30 | 2309 | 88461 | 90537647 |
| Nausea | 48.48 | 35.62 | 95 | 2244 | 1110221 | 89515887 |
| Lymphocyte count decreased | 42.90 | 35.62 | 20 | 2319 | 35030 | 90591078 |
| Ill-defined disorder | 41.73 | 35.62 | 36 | 2303 | 184855 | 90441253 |
| Ascites | 39.87 | 35.62 | 21 | 2318 | 47719 | 90578389 |
| Myelodysplastic syndrome | 38.83 | 35.62 | 16 | 2323 | 20887 | 90605221 |
| Neuroendocrine tumour | 38.76 | 35.62 | 8 | 2331 | 893 | 90625215 |
| General physical health deterioration | 36.05 | 35.62 | 45 | 2294 | 355070 | 90271038 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 269.15 | 28.92 | 131 | 2483 | 108269 | 42510452 |
| Metastases to liver | 158.88 | 28.92 | 53 | 2561 | 16273 | 42602448 |
| Ill-defined disorder | 116.33 | 28.92 | 42 | 2572 | 16254 | 42602467 |
| Platelet count decreased | 60.43 | 28.92 | 57 | 2557 | 138524 | 42480197 |
| Metastases to bone | 55.59 | 28.92 | 24 | 2590 | 14785 | 42603936 |
| Disease progression | 51.29 | 28.92 | 53 | 2561 | 143603 | 42475118 |
| Pancreatic neuroendocrine tumour | 46.19 | 28.92 | 9 | 2605 | 311 | 42618410 |
| Blood chromogranin A increased | 45.97 | 28.92 | 9 | 2605 | 319 | 42618402 |
| General physical health deterioration | 38.82 | 28.92 | 47 | 2567 | 151199 | 42467522 |
| Lymphocyte count decreased | 36.04 | 28.92 | 22 | 2592 | 27787 | 42590934 |
| Carcinoid syndrome | 34.29 | 28.92 | 6 | 2608 | 113 | 42618608 |
| Hepatic lesion | 29.85 | 28.92 | 11 | 2603 | 4483 | 42614238 |
| Carcinoid crisis | 29.25 | 28.92 | 6 | 2608 | 270 | 42618451 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 391.96 | 28.85 | 164 | 3542 | 174403 | 110411190 |
| Metastases to liver | 185.00 | 28.85 | 62 | 3644 | 35324 | 110550269 |
| Platelet count decreased | 94.78 | 28.85 | 71 | 3635 | 230372 | 110355221 |
| Carcinoid crisis | 92.17 | 28.85 | 16 | 3690 | 539 | 110585054 |
| Abdominal pain | 73.58 | 28.85 | 88 | 3618 | 512901 | 110072692 |
| Carcinoid syndrome | 73.17 | 28.85 | 12 | 3694 | 285 | 110585308 |
| Metastases to bone | 65.05 | 28.85 | 28 | 3678 | 31344 | 110554249 |
| Lymphocyte count decreased | 60.10 | 28.85 | 32 | 3674 | 57211 | 110528382 |
| Hepatic lesion | 56.97 | 28.85 | 18 | 3688 | 8475 | 110577118 |
| Thrombocytopenia | 48.50 | 28.85 | 59 | 3647 | 348826 | 110236767 |
| Flushing | 40.14 | 28.85 | 31 | 3675 | 104705 | 110480888 |
| Carcinoid heart disease | 39.79 | 28.85 | 6 | 3700 | 81 | 110585512 |
| Nausea | 39.52 | 28.85 | 110 | 3596 | 1235580 | 109350013 |
| Blood chromogranin A increased | 38.32 | 28.85 | 8 | 3698 | 725 | 110584868 |
| Neuroendocrine tumour | 37.25 | 28.85 | 9 | 3697 | 1578 | 110584015 |
| Decreased appetite | 37.06 | 28.85 | 61 | 3645 | 475785 | 110109808 |
| Myelodysplastic syndrome | 31.22 | 28.85 | 18 | 3688 | 37466 | 110548127 |
| Ill-defined disorder | 31.16 | 28.85 | 32 | 3674 | 156821 | 110428772 |
| Ascites | 30.28 | 28.85 | 25 | 3681 | 92783 | 110492810 |
| Disease progression | 30.23 | 28.85 | 39 | 3667 | 243995 | 110341598 |
| Lymphopenia | 30.06 | 28.85 | 18 | 3688 | 40152 | 110545441 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
None
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Positron emission tomography | indication | 82918005 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 4mL (1mCi/ML) | DETECTNET | CURIUM | N213227 | Sept. 3, 2020 | RX | SOLUTION | INTRAVENOUS | 10159759 | Aug. 23, 2032 | USE OF CU-64 DOTATATE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS |
| 4mL (1mCi/ML) | DETECTNET | CURIUM | N213227 | Sept. 3, 2020 | RX | SOLUTION | INTRAVENOUS | 11160888 | Aug. 23, 2032 | USE OF CU-64 DOTATATE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS |
| 4mL (1mCi/ML) | DETECTNET | CURIUM | N213227 | Sept. 3, 2020 | RX | SOLUTION | INTRAVENOUS | 10383961 | July 2, 2033 | USE OF CU-64 DOTATATE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 4mL (1mCi/ML) | DETECTNET | CURIUM | N213227 | Sept. 3, 2020 | RX | SOLUTION | INTRAVENOUS | Sept. 3, 2027 | FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Somatostatin receptor type 2 | GPCR | BINDING AGENT | Kd | 7.69 | SCIENTIFIC LITERATURE | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| D11882 | KEGG_DRUG |
| CHEMBL4297339 | ChEMBL_ID |
| C000718307 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB15873 | DRUGBANK_ID |
| 926371003 | SNOMEDCT_US |
| 926394002 | SNOMEDCT_US |
| C3502191 | UMLSCUI |
| CHEBI:756834 | CHEBI |
| 340817 | MMSL |
| 39013 | MMSL |
| d09680 | MMSL |
| 124220636 | PUBCHEM_CID |
| 018491 | NDDF |
| 10470 | INN_ID |
| 13898 | INN_ID |
| 2396442 | RXNORM |
| 8STE3V0I8V | UNII |
| 99R86Y6V0M | UNII |
| 9L17Y0H71P | UNII |
| AE221IM3BB | UNII |
| C9FNV56812 | UNII |
| MRL3739G66 | UNII |
| N3858377KC | UNII |
| SP9ZNW6WAK | UNII |
| 9L17Y0H71P | INXIGHT DRUGS |
| AE221IM3BB | INXIGHT DRUGS |
Pharmaceutical products:
None