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| Stem definition | Drug id | CAS RN |
|---|---|---|
| peptides and glycopeptides | 5092 | 83712-60-1 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Single-stranded polydeoxyribonucleotide extracted from mammalian organs and used in the treatment of HEPATIC VENO-OCCLUSIVE DISEASE in patients with kidney or lung abnormalities following HEMATOPOIETIC STEM CELL TRANSPLANTATION. The compound is a sodium salt.
|
| Dose | Unit | Route |
|---|---|---|
| 1.75 | g | P |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 18, 2019 | PMDA | Nippon Shinyaku Co., Ltd. | |
| Oct. 18, 2013 | EMA | Gentium S.r.l. | |
| March 30, 2016 | FDA | GENTIUM SRL |
| 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 |
|---|---|---|---|---|---|---|
| Off label use | 236.28 | 79.30 | 149 | 922 | 1102103 | 89525273 |
| Multiple organ dysfunction syndrome | 162.43 | 79.30 | 51 | 1020 | 68285 | 90559091 |
| Death | 130.12 | 79.30 | 75 | 996 | 456476 | 90170900 |
| Graft versus host disease | 87.02 | 79.30 | 20 | 1051 | 8124 | 90619252 |
| 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 |
|---|---|---|---|---|---|---|
| Off label use | 286.39 | 80.64 | 223 | 1577 | 638112 | 41981423 |
| Multiple organ dysfunction syndrome | 200.52 | 80.64 | 92 | 1708 | 96943 | 42522592 |
| Cystitis haemorrhagic | 117.02 | 80.64 | 32 | 1768 | 7297 | 42612238 |
| Venoocclusive disease | 95.79 | 80.64 | 24 | 1776 | 3891 | 42615644 |
| Death | 93.33 | 80.64 | 106 | 1694 | 471079 | 42148456 |
| Gastrointestinal haemorrhage | 84.52 | 80.64 | 52 | 1748 | 97674 | 42521861 |
| 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 |
|---|---|---|---|---|---|---|
| Venoocclusive disease | 1409.37 | 87.58 | 230 | 3103 | 6120 | 110579846 |
| Off label use | 953.22 | 87.58 | 566 | 2767 | 1499619 | 109086347 |
| Multiple organ dysfunction syndrome | 325.75 | 87.58 | 134 | 3199 | 151576 | 110434390 |
| Death | 222.39 | 87.58 | 176 | 3157 | 698693 | 109887273 |
| Venoocclusive liver disease | 166.78 | 87.58 | 46 | 3287 | 15161 | 110570805 |
| Graft versus host disease | 135.35 | 87.58 | 41 | 3292 | 18765 | 110567201 |
| Acute graft versus host disease | 123.12 | 87.58 | 35 | 3298 | 12846 | 110573120 |
| Gastrointestinal haemorrhage | 117.87 | 87.58 | 69 | 3264 | 165449 | 110420517 |
| Hypotension | 116.75 | 87.58 | 108 | 3225 | 523741 | 110062225 |
| Acute myeloid leukaemia | 106.97 | 87.58 | 41 | 3292 | 38069 | 110547897 |
| Cystitis haemorrhagic | 102.53 | 87.58 | 30 | 3303 | 12179 | 110573787 |
None
| Source | Code | Description |
|---|---|---|
| ATC | B01AX01 | BLOOD AND BLOOD FORMING ORGANS ANTITHROMBOTIC AGENTS ANTITHROMBOTIC AGENTS Other antithrombotic agents |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D005343 | Fibrinolytic Agents |
| MeSH PA | D006401 | Hematologic Agents |
| MeSH PA | D010975 | Platelet Aggregation Inhibitors |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50249 | anticoagulant |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Veno-occlusive disease of the liver | indication | 65617004 |
None
None
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 200MG/2.5ML (80MG/ML) | DEFITELIO | JAZZ PHARMS INC | N208114 | March 30, 2016 | RX | SOLUTION | INTRAVENOUS | 11236328 | June 22, 2032 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH HEPATIC VENO-OCCLUSIVE DISEASE (VOD), ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME (SOS), WITH RENAL OR PULMONARY DYSFUNCTION FOLLOWING HEMATOPOIETIC STEM-CELL TRANSPLANTATION (HSCT) |
None
None
| ID | Source |
|---|---|
| D07423 | KEGG_DRUG |
| 4035614 | VANDF |
| 4035615 | VANDF |
| C0057257 | UMLSCUI |
| CHEBI:753370 | CHEBI |
| CHEMBL2108396 | ChEMBL_ID |
| DB04932 | DRUGBANK_ID |
| CHEMBL3707226 | ChEMBL_ID |
| C036901 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9087 | IUPHAR_LIGAND_ID |
| 1311089 | RXNORM |
| 221104 | MMSL |
| 31588 | MMSL |
| d06744 | MMSL |
| 010017 | NDDF |
| 016771 | NDDF |
| 441573002 | SNOMEDCT_US |
| 442263003 | SNOMEDCT_US |
| 717036000 | SNOMEDCT_US |
| 4876 | INN_ID |
| L7CHH2B2J0 | UNII |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| DEFITELIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-800 | INJECTION, SOLUTION | 80 mg | INTRAVENOUS | NDA | 25 sections |