sucroferric oxyhydroxide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
5121 8047-67-4

Description:

MoleculeDescription

Synonyms:

  • ferric oxyhydroxide
  • sucroferric oxyhydroxide
  • velphoro
  • ferric oxide saccharated
  • saccharated iron oxide
an oral phosphate binder for treatment of hyperphosphatemia
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.11 g O
1.50 g O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Nov. 27, 2013 FDA VIFOR FRESENIUS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Death 474.27 51.39 176 802 456375 90171094
Diarrhoea 115.55 51.39 88 890 939102 89688367
Shunt occlusion 75.31 51.39 12 966 763 90626706
Product taste abnormal 73.88 51.39 14 964 2446 90625023
Serum ferritin increased 58.55 51.39 14 964 7367 90620102
Hospitalisation 57.98 51.39 28 950 128072 90499397
Shunt stenosis 56.82 51.39 9 969 550 90626919

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Death 628.58 31.38 325 1485 470860 42148665
Haemoglobin increased 127.70 31.38 32 1778 5174 42614351
Faeces discoloured 125.76 31.38 41 1769 16973 42602552
Diarrhoea 123.82 31.38 122 1688 460727 42158798
Shunt stenosis 121.22 31.38 22 1788 755 42618770
Product taste abnormal 75.60 31.38 16 1794 1223 42618302
Transferrin saturation increased 72.69 31.38 11 1799 118 42619407
Serum ferritin increased 72.45 31.38 22 1788 7197 42612328
Shunt occlusion 55.49 31.38 12 1798 1015 42618510
Hospitalisation 43.19 31.38 31 1779 74299 42545226
Haematocrit increased 39.90 31.38 11 1799 2556 42616969
Tooth discolouration 39.87 31.38 8 1802 469 42619056
Constipation 34.04 31.38 38 1772 162253 42457272

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Shunt stenosis 192.92 34.23 31 1752 1385 110586131
Haemoglobin increased 146.00 34.23 33 1750 9114 110578402
Shunt occlusion 131.53 34.23 23 1760 1714 110585802
Diarrhoea 118.89 34.23 116 1667 1139389 109448127
Serum ferritin increased 117.09 34.23 29 1754 11818 110575698
Transferrin saturation increased 93.22 34.23 13 1770 216 110587300
Product taste abnormal 67.71 34.23 14 1769 2538 110584978
Hyperparathyroidism secondary 64.11 34.23 14 1769 3290 110584226
Faeces discoloured 63.67 34.23 23 1760 33925 110553591
Haematocrit increased 53.31 34.23 13 1770 4946 110582570
Death 44.01 34.23 55 1728 698814 109888702
Peritonitis bacterial 43.61 34.23 13 1770 10520 110576996
Peripheral arterial occlusive disease 36.46 34.23 11 1772 9269 110578247
Hospitalisation 34.74 34.23 24 1759 142469 110445047

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B03AB02 BLOOD AND BLOOD FORMING ORGANS
ANTIANEMIC PREPARATIONS
IRON PREPARATIONS
Iron trivalent, oral preparations
ATC V03AE05 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Drugs for treatment of hyperkalemia and hyperphosphatemia
FDA MoA N0000020074 Phosphate Chelating Activity
FDA EPC N0000175597 Phosphate Binder

Related Drugs by ATC class:

B03AB Iron trivalent, oral preparations 4 drugs
chondroitin sulfate-iron complexferric hydroxideferric maltolsodium feredetate
V03AE Drugs for treatment of hyperkalemia and hyperphosphatemia 10 drugs
calcium acetatecalcium acetate and magnesium carbonatecalcium polystyrene sulfonatecolestilanferric citratelanthanum carbonatepatiromer calciumsevelamersodium polystyrene sulfonatesodium zirconium cyclosilicate

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hyperphosphatemia indication 20165001 DOID:0050459




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 500MG IRON VELPHORO VIFOR FRESENIUS N205109 Nov. 27, 2013 RX TABLET, CHEWABLE ORAL 9561251 Jan. 23, 2030 CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 500MG IRON VELPHORO VIFOR FRESENIUS N205109 Nov. 27, 2013 RX TABLET, CHEWABLE ORAL July 1, 2027 NEW PATIENT POPULATION
EQ 500MG IRON VELPHORO VIFOR FRESENIUS N205109 Nov. 27, 2013 RX TABLET, CHEWABLE ORAL Jan. 1, 2028 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

None

External reference:

IDSource
20344-49-4 SECONDARY_CAS_RN
D04616 KEGG_DRUG
4021278 VANDF
4033084 VANDF
C3696416 UMLSCUI
CHEBI:758535 CHEBI
CHEMBL4802224 ChEMBL_ID
91663255 PUBCHEM_CID
DB09146 DRUGBANK_ID
CHEMBL1200823 ChEMBL_ID
C000599459 MESH_SUPPLEMENTAL_RECORD_UI
C092844 MESH_SUPPLEMENTAL_RECORD_UI
DB14695 DRUGBANK_ID
1484283 RXNORM
15814 MMSL
221324 MMSL
30331 MMSL
30334 MMSL
397006 MMSL
d04725 MMSL
d08266 MMSL
007471 NDDF
008975 NDDF
015366 NDDF
1285045009 SNOMEDCT_US
129497004 SNOMEDCT_US
387206004 SNOMEDCT_US
421953007 SNOMEDCT_US
737661000168109 SNOMEDCT_US
87PZU03K0K UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Velphoro HUMAN PRESCRIPTION DRUG LABEL 1 49230-645 TABLET, CHEWABLE 500 mg ORAL NDA 29 sections