Stem definition | Drug id | CAS RN |
---|---|---|
peptides and glycopeptides | 1546 | 108736-35-2 |
Dose | Unit | Route |
---|---|---|
3 | mg | P |
Property | Value | Reference |
---|---|---|
Vd (Volume of distribution) | 0.20 L/kg | Lombardo F, Berellini G, Obach RS |
CL (Clearance) | 5.70 mL/min/kg | Lombardo F, Berellini G, Obach RS |
t_half (Half-life) | 1.03 hours | Lombardo F, Berellini G, Obach RS |
Date | Agency | Company | Orphan |
---|---|---|---|
Aug. 30, 2007 | FDA | IPSEN PHARMA |
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 |
---|---|---|---|---|---|---|
Inappropriate schedule of product administration | 309.59 | 20.43 | 165 | 7000 | 64848 | 46614049 |
Insulin-like growth factor increased | 164.25 | 20.43 | 35 | 7130 | 738 | 46678159 |
Injection site mass | 161.27 | 20.43 | 67 | 7098 | 14973 | 46663924 |
Diarrhoea | 128.74 | 20.43 | 271 | 6894 | 559331 | 46119566 |
Injection site pain | 101.11 | 20.43 | 102 | 7063 | 107050 | 46571847 |
Cholelithiasis | 84.94 | 20.43 | 60 | 7105 | 38621 | 46640276 |
Blood growth hormone increased | 83.81 | 20.43 | 18 | 7147 | 394 | 46678503 |
Flatulence | 75.74 | 20.43 | 50 | 7115 | 28828 | 46650069 |
Abdominal distension | 74.99 | 20.43 | 73 | 7092 | 73278 | 46605619 |
Abdominal pain | 71.48 | 20.43 | 127 | 7038 | 229904 | 46448993 |
Neoplasm progression | 59.97 | 20.43 | 42 | 7123 | 26641 | 46652256 |
Off label use | 45.03 | 20.43 | 144 | 7021 | 379697 | 46299200 |
Injection site nodule | 42.90 | 20.43 | 17 | 7148 | 3354 | 46675543 |
Carcinoid crisis | 40.16 | 20.43 | 9 | 7156 | 241 | 46678656 |
Disease progression | 37.12 | 20.43 | 57 | 7108 | 91243 | 46587654 |
Intestinal obstruction | 36.52 | 20.43 | 31 | 7134 | 26044 | 46652853 |
Incorrect route of product administration | 34.97 | 20.43 | 25 | 7140 | 16358 | 46662539 |
Blood glucose decreased | 33.97 | 20.43 | 26 | 7139 | 18866 | 46660031 |
Pancreatic neuroendocrine tumour | 33.05 | 20.43 | 8 | 7157 | 302 | 46678595 |
Abdominal pain upper | 32.53 | 20.43 | 70 | 7095 | 145235 | 46533662 |
Needle issue | 31.12 | 20.43 | 16 | 7149 | 5788 | 46673109 |
Steatorrhoea | 31.03 | 20.43 | 8 | 7157 | 392 | 46678505 |
Terminal state | 30.91 | 20.43 | 12 | 7153 | 2242 | 46676655 |
Blood glucose increased | 30.74 | 20.43 | 46 | 7119 | 71967 | 46606930 |
Insulinoma | 29.37 | 20.43 | 6 | 7159 | 102 | 46678795 |
Carcinoid syndrome | 28.59 | 20.43 | 6 | 7159 | 117 | 46678780 |
Injection site haemorrhage | 27.73 | 20.43 | 24 | 7141 | 20685 | 46658212 |
Product dose omission issue | 26.71 | 20.43 | 71 | 7094 | 168449 | 46510448 |
Nausea | 26.59 | 20.43 | 188 | 6977 | 687266 | 45991631 |
Hypoglycaemia | 26.52 | 20.43 | 37 | 7128 | 54312 | 46624585 |
Gastroenteropancreatic neuroendocrine tumour disease | 26.41 | 20.43 | 5 | 7160 | 56 | 46678841 |
Blood chromogranin A increased | 26.35 | 20.43 | 6 | 7159 | 173 | 46678724 |
Weight decreased | 25.85 | 20.43 | 81 | 7084 | 210768 | 46468129 |
Postoperative adhesion | 24.93 | 20.43 | 6 | 7159 | 221 | 46678676 |
Faeces pale | 24.22 | 20.43 | 9 | 7156 | 1493 | 46677404 |
Neuroendocrine tumour | 23.47 | 20.43 | 7 | 7158 | 588 | 46678309 |
Vomiting | 23.11 | 20.43 | 133 | 7032 | 452661 | 46226236 |
Thyroid neoplasm | 22.27 | 20.43 | 11 | 7154 | 3658 | 46675239 |
Injection site hypoaesthesia | 22.13 | 20.43 | 6 | 7159 | 357 | 46678540 |
Malignant neoplasm progression | 21.56 | 20.43 | 37 | 7128 | 64889 | 46614008 |
Constipation | 21.43 | 20.43 | 67 | 7098 | 174030 | 46504867 |
Metastases to liver | 20.93 | 20.43 | 20 | 7145 | 19565 | 46659332 |
Muscle neoplasm | 20.88 | 20.43 | 4 | 7161 | 48 | 46678849 |
Gallbladder neoplasm | 20.65 | 20.43 | 4 | 7161 | 51 | 46678846 |
Lymphatic system neoplasm | 20.51 | 20.43 | 4 | 7161 | 53 | 46678844 |
Pituitary tumour | 20.51 | 20.43 | 7 | 7158 | 908 | 46677989 |
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 |
---|---|---|---|---|---|---|
Inappropriate schedule of product administration | 225.61 | 22.16 | 116 | 4803 | 39612 | 29907947 |
Diarrhoea | 150.39 | 22.16 | 225 | 4694 | 333878 | 29613681 |
Injection site pain | 139.40 | 22.16 | 77 | 4842 | 30233 | 29917326 |
Insulin-like growth factor increased | 125.29 | 22.16 | 30 | 4889 | 1011 | 29946548 |
Neoplasm progression | 108.96 | 22.16 | 55 | 4864 | 17968 | 29929591 |
Injection site mass | 105.19 | 22.16 | 37 | 4882 | 4916 | 29942643 |
Abdominal pain | 79.21 | 22.16 | 104 | 4815 | 135550 | 29812009 |
Off label use | 75.34 | 22.16 | 141 | 4778 | 249149 | 29698410 |
Injection site haemorrhage | 72.14 | 22.16 | 32 | 4887 | 7823 | 29939736 |
Flatulence | 67.03 | 22.16 | 40 | 4879 | 18089 | 29929470 |
Cholelithiasis | 65.51 | 22.16 | 41 | 4878 | 20184 | 29927375 |
Pituitary tumour removal | 54.01 | 22.16 | 7 | 4912 | 0 | 29947559 |
Carcinoid heart disease | 50.84 | 22.16 | 7 | 4912 | 4 | 29947555 |
Disease progression | 49.23 | 22.16 | 63 | 4856 | 79811 | 29867748 |
Incorrect route of product administration | 41.89 | 22.16 | 25 | 4894 | 11290 | 29936269 |
Injection site nodule | 35.23 | 22.16 | 12 | 4907 | 1446 | 29946113 |
Injection site abscess | 30.27 | 22.16 | 9 | 4910 | 699 | 29946860 |
Abdominal pain upper | 28.95 | 22.16 | 43 | 4876 | 62508 | 29885051 |
Nausea | 26.19 | 22.16 | 107 | 4812 | 296850 | 29650709 |
Steatorrhoea | 26.00 | 22.16 | 8 | 4911 | 698 | 29946861 |
Keratitis | 25.90 | 22.16 | 9 | 4910 | 1151 | 29946408 |
Hepatic neoplasm | 25.21 | 22.16 | 10 | 4909 | 1849 | 29945710 |
Abdominal distension | 24.94 | 22.16 | 34 | 4885 | 45675 | 29901884 |
Pituitary tumour benign | 24.64 | 22.16 | 8 | 4911 | 831 | 29946728 |
Source | Code | Description |
---|---|---|
ATC | H01CB03 | SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES HYPOTHALAMIC HORMONES Somatostatin and analogues |
FDA MoA | N0000000194 | Somatostatin Receptor Agonists |
MeSH PA | D000970 | Antineoplastic Agents |
FDA EPC | N0000175904 | Somatostatin Analog |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Acromegaly | indication | 74107003 | DOID:2449 |
Hypersomatotropic gigantism | indication | 86073008 | |
Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
Disorder of gallbladder | contraindication | 39621005 | DOID:0060262 |
Hypothyroidism | contraindication | 40930008 | DOID:1459 |
Bradycardia | contraindication | 48867003 | |
Hyperglycemia | contraindication | 80394007 | DOID:4195 |
Impaired renal function disorder | contraindication | 197663003 | |
Disease of liver | contraindication | 235856003 | DOID:409 |
Hypoglycemic disorder | contraindication | 237630007 | |
Calculus in biliary tract | contraindication | 266474003 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 9.65 | acidic |
pKa2 | 12.16 | acidic |
pKa3 | 12.71 | acidic |
pKa4 | 13.18 | acidic |
pKa5 | 13.43 | acidic |
pKa6 | 13.67 | acidic |
pKa7 | 10.31 | Basic |
pKa8 | 6.97 | Basic |
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | SOMATULINE DEPOT | IPSEN PHARMA | N022074 | Aug. 30, 2007 | RX | SOLUTION | SUBCUTANEOUS | Dec. 16, 2021 | TREATMENT OF PATIENTS WITH UNRESECTABLE,WELL- OR MODERATELY-DIFFERENTIATED LOCALLY ADVANCED OR METASTATIC GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS TO IMPROVE PROGRESSION-FREE SURVIVAL |
EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) | SOMATULINE DEPOT | IPSEN PHARMA | N022074 | Aug. 30, 2007 | RX | SOLUTION | SUBCUTANEOUS | Dec. 16, 2021 | TREATMENT OF PATIENTS WITH UNRESECTABLE,WELL- OR MODERATELY-DIFFERENTIATED LOCALLY ADVANCED OR METASTATIC GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS TO IMPROVE PROGRESSION-FREE SURVIVAL |
EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | SOMATULINE DEPOT | IPSEN PHARMA | N022074 | Aug. 30, 2007 | RX | SOLUTION | SUBCUTANEOUS | Dec. 16, 2021 | TREATMENT OF PATIENTS WITH UNRESECTABLE,WELL- OR MODERATELY-DIFFERENTIATED LOCALLY ADVANCED OR METASTATIC GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS TO IMPROVE PROGRESSION-FREE SURVIVAL |
EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | SOMATULINE DEPOT | IPSEN PHARMA | N022074 | Aug. 30, 2007 | RX | SOLUTION | SUBCUTANEOUS | Sept. 15, 2024 | TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANULLLOG RESCUE THERAPY |
EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) | SOMATULINE DEPOT | IPSEN PHARMA | N022074 | Aug. 30, 2007 | RX | SOLUTION | SUBCUTANEOUS | Sept. 15, 2024 | TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANULLLOG RESCUE THERAPY |
EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | SOMATULINE DEPOT | IPSEN PHARMA | N022074 | Aug. 30, 2007 | RX | SOLUTION | SUBCUTANEOUS | Sept. 15, 2024 | TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANULLLOG RESCUE THERAPY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Somatostatin receptor type 5 | GPCR | AGONIST | Ki | 9.30 | IUPHAR | CHEMBL | |||
Somatostatin receptor type 2 | GPCR | AGONIST | Ki | 9.60 | IUPHAR | CHEMBL | |||
Somatostatin receptor type 3 | GPCR | AGONIST | Ki | 8 | IUPHAR | ||||
Somatostatin receptor type 4 | GPCR | Ki | 7.18 | PDSP | |||||
Somatostatin receptor type 1 | GPCR | Ki | 6.30 | PDSP | |||||
Somatostatin receptor type 2 | Unclassified | AGONIST | Ki | 8.80 | IUPHAR | ||||
Somatostatin receptor type 3 | GPCR | AGONIST | IC50 | 8.20 | IUPHAR | ||||
Somatostatin receptor type 3 | Unclassified | AGONIST | Ki | 6.90 | IUPHAR | ||||
Somatostatin receptor type 5 | GPCR | AGONIST | Ki | 7.60 | IUPHAR | ||||
Somatostatin receptor type 2 | GPCR | AGONIST | Ki | 9.10 | IUPHAR |
ID | Source |
---|---|
4026631 | VUID |
N0000179366 | NUI |
D04666 | KEGG_DRUG |
127984-74-1 | SECONDARY_CAS_RN |
4026631 | VANDF |
C0051846 | UMLSCUI |
CHEBI:135901 | CHEBI |
CHEMBL1201185 | ChEMBL_ID |
CHEMBL1201184 | ChEMBL_ID |
DB06791 | DRUGBANK_ID |
C060347 | MESH_SUPPLEMENTAL_RECORD_UI |
2031 | IUPHAR_LIGAND_ID |
6649 | INN_ID |
0G3DE8943Y | UNII |
6918010 | PUBCHEM_CID |
236167 | RXNORM |
18121 | MMSL |
d04961 | MMSL |
005272 | NDDF |
005273 | NDDF |
327379003 | SNOMEDCT_US |
395765000 | SNOMEDCT_US |
429611006 | SNOMEDCT_US |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
SOMATULINE DEPOT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-1060 | INJECTION | 60 mg | SUBCUTANEOUS | NDA | 29 sections |
SOMATULINE DEPOT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-1090 | INJECTION | 90 mg | SUBCUTANEOUS | NDA | 29 sections |
SOMATULINE DEPOT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-1120 | INJECTION | 120 mg | SUBCUTANEOUS | NDA | 29 sections |