copper dotatate Cu-64 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
5411 1426155-87-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • copper dotatate Cu-64
  • copper dotatate Cu64
  • copper dotatate
  • detectnet
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.
  • Molecular weight: 1497.55
  • Formula: C65H88CuN14O19S2
  • CLOGP: -9.02
  • LIPINSKI: 3
  • HAC: 33
  • HDO: 15
  • TPSA: 462.50
  • ALOGS: -4.18
  • ROTB: 26

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Sept. 3, 2020 FDA RADIOMEDIX

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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|

DiseaseRelationSNOMED_IDDOID
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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Somatostatin receptor type 2 GPCR BINDING AGENT Kd 7.69 SCIENTIFIC LITERATURE DRUG LABEL

External reference:

IDSource
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