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| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzymes | 4989 | 884604-91-5 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
produced by gene activation technology in a human fibroblast cell line and has the same amino acid sequence as the naturally occurring human enzyme glucocerebrosidase
|
| Dose | Unit | Route |
|---|---|---|
| 300 | U | P |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 26, 2010 | FDA | SHIRE HUMAN GENETIC | |
| Aug. 26, 2010 | EMA |
| 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 | 109.90 | 31.78 | 51 | 1348 | 149882 | 90477166 |
| Poor venous access | 60.16 | 31.78 | 19 | 1380 | 19508 | 90607540 |
| Product dose omission issue | 56.80 | 31.78 | 42 | 1357 | 291645 | 90335403 |
| No adverse event | 49.23 | 31.78 | 23 | 1376 | 67959 | 90559089 |
| Abortion spontaneous | 47.72 | 31.78 | 21 | 1378 | 54035 | 90573013 |
| Exposure during pregnancy | 45.61 | 31.78 | 34 | 1365 | 238376 | 90388672 |
| Pregnancy | 44.94 | 31.78 | 21 | 1378 | 62026 | 90565022 |
| Cholangiocarcinoma | 39.93 | 31.78 | 8 | 1391 | 1295 | 90625753 |
| COVID-19 | 36.61 | 31.78 | 26 | 1373 | 168817 | 90458231 |
| 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 | 101.21 | 35.75 | 54 | 1410 | 95848 | 42524023 |
| Bone pain | 68.49 | 35.75 | 27 | 1437 | 23765 | 42596106 |
| Weight fluctuation | 67.44 | 35.75 | 19 | 1445 | 5932 | 42613939 |
| Poor venous access | 59.40 | 35.75 | 18 | 1446 | 7234 | 42612637 |
| COVID-19 | 45.38 | 35.75 | 35 | 1429 | 115913 | 42503958 |
| Infusion related reaction | 44.40 | 35.75 | 27 | 1437 | 60779 | 42559092 |
| Product dose omission issue | 40.53 | 35.75 | 37 | 1427 | 154328 | 42465543 |
| Weight increased | 36.66 | 35.75 | 30 | 1434 | 107953 | 42511918 |
| 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 | 172.11 | 30.44 | 87 | 2491 | 203550 | 110383171 |
| Poor venous access | 93.54 | 30.44 | 31 | 2547 | 24491 | 110562230 |
| Product dose omission issue | 90.12 | 30.44 | 68 | 2510 | 321714 | 110265007 |
| Bone pain | 89.38 | 30.44 | 39 | 2539 | 65094 | 110521627 |
| Weight fluctuation | 80.49 | 30.44 | 27 | 2551 | 22118 | 110564603 |
| COVID-19 | 66.76 | 30.44 | 51 | 2527 | 245009 | 110341712 |
| Blood pressure increased | 40.09 | 30.44 | 39 | 2539 | 258334 | 110328387 |
| Blood pressure abnormal | 39.31 | 30.44 | 16 | 2562 | 22408 | 110564313 |
| Product availability issue | 34.21 | 30.44 | 11 | 2567 | 7879 | 110578842 |
| Irregular sleep phase | 30.83 | 30.44 | 5 | 2573 | 161 | 110586560 |
| Weight increased | 30.66 | 30.44 | 43 | 2535 | 419601 | 110167120 |
None
| Source | Code | Description |
|---|---|---|
| ATC | A16AB10 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Enzymes |
| FDA EPC | N0000175820 | Hydrolytic Lysosomal Glucocerebroside-specific Enzyme |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic non-neuropathic Gaucher's disease | indication | 62201009 |
None
None
None
None
None
None
| ID | Source |
|---|---|
| 23HYE36B0I | UNII |
| D09029 | KEGG_DRUG |
| 4029768 | VUID |
| N0000180860 | NUI |
| 4029768 | VANDF |
| C2919267 | UMLSCUI |
| CHEBI:747652 | CHEBI |
| CHEMBL1201865 | ChEMBL_ID |
| DB06720 | DRUGBANK_ID |
| 8925 | INN_ID |
| 7464 | IUPHAR_LIGAND_ID |
| 901805 | RXNORM |
| 171696 | MMSL |
| 27053 | MMSL |
| d07588 | MMSL |
| 013387 | NDDF |
| 444773003 | SNOMEDCT_US |
| 445499001 | SNOMEDCT_US |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| VPRIV | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54092-701 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 2.50 mg | INTRAVENOUS | BLA | 25 sections |