Stem definition | Drug id | CAS RN |
---|---|---|
5204 | 722492-56-0 |
Molecule | Description |
---|---|
Synonyms:
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Ferumoxytol consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.
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Date | Agency | Company | Orphan |
---|---|---|---|
June 15, 2012 | EMA | Takeda Pharma A/S | |
June 30, 2009 | FDA | AMAG PHARMS INC |
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 |
---|---|---|---|---|---|---|
Flushing | 242.79 | 53.59 | 95 | 2314 | 74992 | 63411621 |
Dyspnoea | 202.87 | 53.59 | 179 | 2230 | 661134 | 62825479 |
Anaphylactic reaction | 169.86 | 53.59 | 71 | 2338 | 66029 | 63420584 |
Unresponsive to stimuli | 161.18 | 53.59 | 57 | 2352 | 33759 | 63452854 |
Infusion related reaction | 127.12 | 53.59 | 91 | 2318 | 245430 | 63241183 |
Chest discomfort | 104.77 | 53.59 | 60 | 2349 | 109909 | 63376704 |
Back pain | 86.86 | 53.59 | 75 | 2334 | 264070 | 63222543 |
Hypersensitivity | 72.58 | 53.59 | 71 | 2338 | 292614 | 63193999 |
Hypotension | 69.20 | 53.59 | 67 | 2342 | 272537 | 63214076 |
Pulse absent | 67.43 | 53.59 | 19 | 2390 | 5355 | 63481258 |
Hyperhidrosis | 57.87 | 53.59 | 41 | 2368 | 107795 | 63378818 |
Chest pain | 56.45 | 53.59 | 54 | 2355 | 215905 | 63270708 |
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 |
---|---|---|---|---|---|---|
Unresponsive to stimuli | 145.82 | 52.62 | 50 | 1263 | 27519 | 34928099 |
Anaphylactic reaction | 115.92 | 52.62 | 44 | 1269 | 32257 | 34923361 |
Flushing | 97.96 | 52.62 | 39 | 1274 | 32381 | 34923237 |
Hypotension | 88.85 | 52.62 | 70 | 1243 | 221579 | 34734039 |
Dyspnoea | 79.84 | 52.62 | 83 | 1230 | 376699 | 34578919 |
Infusion related reaction | 61.99 | 52.62 | 33 | 1280 | 53024 | 34902594 |
Back pain | 58.50 | 52.62 | 43 | 1270 | 121746 | 34833872 |
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 |
---|---|---|---|---|---|---|
Flushing | 312.05 | 48.26 | 125 | 3467 | 88143 | 79652653 |
Unresponsive to stimuli | 261.14 | 48.26 | 97 | 3495 | 55691 | 79685105 |
Anaphylactic reaction | 236.14 | 48.26 | 101 | 3491 | 83642 | 79657154 |
Dyspnoea | 235.47 | 48.26 | 236 | 3356 | 856789 | 78884007 |
Infusion related reaction | 178.49 | 48.26 | 117 | 3475 | 230120 | 79510676 |
Hypotension | 139.81 | 48.26 | 132 | 3460 | 440185 | 79300611 |
Back pain | 134.14 | 48.26 | 110 | 3482 | 304070 | 79436726 |
Chest discomfort | 128.78 | 48.26 | 79 | 3513 | 137965 | 79602831 |
Pulse absent | 104.69 | 48.26 | 32 | 3560 | 10071 | 79730725 |
Hyperhidrosis | 98.01 | 48.26 | 69 | 3523 | 151423 | 79589373 |
Chest pain | 82.35 | 48.26 | 81 | 3511 | 282223 | 79458573 |
Hypersensitivity | 77.87 | 48.26 | 76 | 3516 | 262163 | 79478633 |
Oxygen saturation decreased | 65.86 | 48.26 | 51 | 3541 | 128996 | 79611800 |
Dizziness | 55.73 | 48.26 | 91 | 3501 | 526350 | 79214446 |
Nausea | 55.42 | 48.26 | 128 | 3464 | 957068 | 78783728 |
None
Source | Code | Description |
---|---|---|
FDA CS | M0011718 | Iron |
FDA EPC | N0000177913 | Parenteral Iron Replacement |
MeSH PA | D006397 | Hematinics |
MeSH PA | D006401 | Hematologic Agents |
MeSH PA | D057947 | Parenteral Nutrition Solutions |
MeSH PA | D019999 | Pharmaceutical Solutions |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Iron deficiency anemia | indication | 87522002 |
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ID | Source |
---|---|
4028919 | VANDF |
C0060274 | UMLSCUI |
CHEBI:46726 | CHEBI |
CHEMBL1201867 | ChEMBL_ID |
DB06215 | DRUGBANK_ID |
D04177 | KEGG_DRUG |
D052203 | MESH_DESCRIPTOR_UI |
166183 | MMSL |
348766 | MMSL |
d07459 | MMSL |
013180 | NDDF |
442951001 | SNOMEDCT_US |
442952008 | SNOMEDCT_US |
49868115 | PUBCHEM_CID |
473387 | RXNORM |
CLH5FT6412 | UNII |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Ferumoxytol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3154 | INJECTION | 510 mg | INTRAVENOUS | ANDA | 27 sections |
Ferumoxytol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3154 | INJECTION | 510 mg | INTRAVENOUS | ANDA | 27 sections |
Ferumoxytol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3154 | INJECTION | 510 mg | INTRAVENOUS | ANDA | 27 sections |
Feraheme | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59338-775 | INJECTION | 510 mg | INTRAVENOUS | NDA | 28 sections |
Feraheme | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59338-775 | INJECTION | 510 mg | INTRAVENOUS | NDA | 28 sections |
Feraheme | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59338-775 | INJECTION | 510 mg | INTRAVENOUS | NDA | 28 sections |