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| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzymes | 5199 | 37228-64-1 |
| Molecule | Description |
|---|---|
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Synonyms:
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Taliglucerase alfa, a long term enzyme replacement therapy, is a recombinant analog of human lysosomal glucocerebrosidase that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide, reducing the amount of accumulated glucocerebroside. Taliglucerase alfa uptake into cellular lysosomes is mediated by binding of Taliglucerase alfa mannose oligosaccharide chains to specific mannose receptors on the cell surface leading to internalization and subsequent transport to the lysosomes.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 1, 2012 | FDA | PFIZER |
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| 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 | 47.62 | 34.15 | 23 | 486 | 95879 | 42524947 |
| Chitotriosidase increased | 36.07 | 34.15 | 4 | 505 | 11 | 42620815 |
| Drug monitoring procedure not performed | 35.79 | 34.15 | 6 | 503 | 472 | 42620354 |
| 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 | 71.08 | 34.06 | 38 | 1222 | 203599 | 110384440 |
| Drug monitoring procedure not performed | 54.98 | 34.06 | 10 | 1250 | 1320 | 110586719 |
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| Source | Code | Description |
|---|---|---|
| ATC | A16AB11 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Enzymes |
| FDA CS | M0009360 | Glucosylceramidase |
| FDA EPC | N0000175820 | Hydrolytic Lysosomal Glucocerebroside-specific Enzyme |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic non-neuropathic Gaucher's disease | indication | 62201009 |
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| ID | Source |
|---|---|
| 0R4NLX88O4 | UNII |
| 4031611 | VANDF |
| C3273401 | UMLSCUI |
| CHEBI:750322 | CHEBI |
| CHEMBL1964120 | ChEMBL_ID |
| DB08876 | DRUGBANK_ID |
| D09675 | KEGG_DRUG |
| 9082 | INN_ID |
| C582473 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7444 | IUPHAR_LIGAND_ID |
| 708713007 | SNOMEDCT_US |
| 715566003 | SNOMEDCT_US |
| 28522 | MMSL |
| d07867 | MMSL |
| 014341 | NDDF |
| 1005808-93-4 | SECONDARY_CAS_RN |
| 1291609 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ELELYSO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0106 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 U | INTRAVENOUS | BLA | 25 sections |