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

Stem definitionDrug idCAS RN
polymers 4324 52757-95-6

Description:

MoleculeDescription

Synonyms:

  • sevelamer
  • sevelamer hydrochloride
  • renagel
  • sevelamer HCl
A polymeric amine that binds phosphate and is used to treat HYPERPHOSPHATEMIA in patients with kidney disease.
  • Molecular weight:
  • Formula: (H2N)a()b(C15H31ClN3O)n(ClH)n(ClH)n(ClH)n
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
6.40 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Oct. 30, 1998 FDA

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
Crystal deposit intestine 219.00 25.83 28 3187 89 90625143
Calciphylaxis 198.65 25.83 41 3174 3335 90621897
Arteriovenous fistula site complication 99.47 25.83 17 3198 492 90624740
Peritonitis 61.65 25.83 24 3191 19681 90605551
Gastrointestinal injury 48.40 25.83 10 3205 814 90624418
Peritonitis bacterial 46.90 25.83 14 3201 5157 90620075
Pemphigoid 43.06 25.83 15 3200 9011 90616221
Dialysis 39.73 25.83 15 3200 11314 90613918
Death 39.12 25.83 63 3152 456488 90168744
Therapeutic drug monitoring analysis incorrectly performed 37.55 25.83 7 3208 334 90624898
Histology abnormal 35.94 25.83 6 3209 150 90625082
Hypocalcaemia 35.94 25.83 21 3194 42347 90582885
Microstomia 35.60 25.83 5 3210 37 90625195
Upper gastrointestinal haemorrhage 35.50 25.83 17 3198 22959 90602273
Shunt stenosis 34.09 25.83 7 3208 552 90624680
Brown tumour 33.90 25.83 5 3210 54 90625178
Oncocytoma 30.55 25.83 4 3211 16 90625216
Dermatitis bullous 30.27 25.83 12 3203 10304 90614928
Renal impairment 30.20 25.83 27 3188 105394 90519838
Hypervolaemia 29.81 25.83 17 3198 32740 90592492
Renal failure 28.84 25.83 29 3186 130978 90494254
Colitis ischaemic 28.19 25.83 12 3203 12334 90612898
Therapeutic drug monitoring analysis not performed 28.06 25.83 7 3208 1322 90623910
Shunt occlusion 26.35 25.83 6 3209 769 90624463
Sepsis 26.09 25.83 32 3183 179782 90445450

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
Crystal deposit intestine 296.98 18.41 42 4528 81 42616684
Arteriovenous fistula site complication 129.50 18.41 25 4545 460 42616305
Calciphylaxis 76.50 18.41 19 4551 1154 42615611
Peritonitis bacterial 53.38 18.41 22 4548 6893 42609872
Large intestinal ulcer 45.88 18.41 15 4555 2448 42614317
Product appearance confusion 44.45 18.41 7 4563 35 42616730
Shunt occlusion 44.42 18.41 12 4558 1015 42615750
Gastrointestinal injury 43.29 18.41 12 4558 1117 42615648
Hypervolaemia 42.43 18.41 28 4542 23097 42593668
Blood parathyroid hormone increased 41.07 18.41 13 4557 1914 42614851
Hospitalisation 41.02 18.41 45 4525 74285 42542480
Shunt stenosis 37.97 18.41 10 4560 767 42615998
Peritonitis 37.71 18.41 24 4546 18609 42598156
Ischaemic enteritis 37.04 18.41 6 4564 37 42616728
Hypogonadism 34.22 18.41 12 4558 2422 42614343
Tendon calcification 33.47 18.41 6 4564 72 42616693
Procalcitonin abnormal 28.80 18.41 7 4563 388 42616377
Hungry bone syndrome 27.89 18.41 6 4564 192 42616573
Colitis ischaemic 27.31 18.41 14 4556 7212 42609553
Dialysis 25.66 18.41 16 4554 11970 42604795
Pseudopolyp 25.15 18.41 6 4564 307 42616458
Large intestine perforation 23.68 18.41 14 4556 9522 42607243
Tumour lysis syndrome 22.85 18.41 19 4551 22212 42594553
Hyperkalaemia 22.72 18.41 35 4535 80423 42536342
Encephalomalacia 21.96 18.41 7 4563 1054 42615711
Rectal ulcer 21.24 18.41 7 4563 1171 42615594
International normalised ratio increased 21.24 18.41 26 4544 48142 42568623
Colitis 20.31 18.41 25 4545 46547 42570218
Gastrointestinal haemorrhage 20.24 18.41 37 4533 97689 42519076
Mucosal necrosis 19.86 18.41 4 4566 92 42616673
PO2 decreased 18.97 18.41 7 4563 1634 42615131
Melaena 18.86 18.41 22 4548 38724 42578041
Peritoneal cloudy effluent 18.84 18.41 5 4565 395 42616370

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
Crystal deposit intestine 498.25 19.61 69 7457 205 110581568
Arteriovenous fistula site complication 233.21 19.61 43 7483 987 110580786
Calciphylaxis 229.68 19.61 54 7472 4133 110577640
Gastrointestinal injury 91.13 19.61 22 7504 1881 110579892
Large intestinal ulcer 79.31 19.61 25 7501 5736 110576037
Peritonitis 77.99 19.61 40 7486 32567 110549206
Peritonitis bacterial 71.74 19.61 27 7499 10506 110571267
Shunt stenosis 71.05 19.61 17 7509 1399 110580374
Hospitalisation 62.91 19.61 62 7464 142431 110439342
Shunt occlusion 62.66 19.61 16 7510 1721 110580052
Dialysis 58.59 19.61 28 7498 19591 110562182
Hypervolaemia 55.14 19.61 37 7489 49423 110532350
Colitis ischaemic 55.05 19.61 26 7500 17724 110564049
Gastrointestinal haemorrhage 53.47 19.61 61 7465 165457 110416316
Blood parathyroid hormone increased 52.57 19.61 17 7509 4231 110577542
Colitis 44.17 19.61 44 7482 102279 110479494
Peritoneal cloudy effluent 43.52 19.61 10 7516 690 110581083
Histology abnormal 43.17 19.61 9 7517 394 110581379
Hypogonadism 41.93 19.61 12 7514 1982 110579791
Product appearance confusion 40.35 19.61 7 7519 112 110581661
Myoclonus 39.96 19.61 26 7500 32972 110548801
Hypocalcaemia 39.66 19.61 34 7492 65332 110516441
Hungry bone syndrome 38.82 19.61 8 7518 331 110581442
Death 37.12 19.61 118 7408 698751 109883022
End stage renal disease 36.46 19.61 21 7505 21452 110560321
Haematochezia 36.32 19.61 42 7484 115482 110466291
Peritoneal dialysis complication 34.84 19.61 11 7515 2535 110579238
Melaena 34.25 19.61 32 7494 68725 110513048
Brown tumour 33.27 19.61 6 7520 121 110581652
Microstomia 32.22 19.61 5 7521 38 110581735
Ischaemic enteritis 31.96 19.61 6 7520 152 110581621
Procalcitonin abnormal 31.72 19.61 7 7519 402 110581371
International normalised ratio increased 31.48 19.61 34 7492 86738 110495035
Tendon calcification 30.55 19.61 6 7520 194 110581579
Hyperphosphataemia 30.45 19.61 17 7509 16364 110565409
Calcinosis 29.62 19.61 10 7516 2842 110578931
Hyperkalaemia 29.39 19.61 41 7485 135755 110446018
Parathyroidectomy 28.26 19.61 6 7520 287 110581486
Therapeutic drug monitoring analysis incorrectly performed 27.86 19.61 7 7519 705 110581068
Oncocytoma 27.05 19.61 4 7522 21 110581752
Sepsis 27.00 19.61 65 7461 327281 110254492
Haemoglobin decreased 25.66 19.61 54 7472 248673 110333100
Pemphigoid 25.02 19.61 16 7510 19691 110562082
Tumour lysis syndrome 25.00 19.61 19 7507 30782 110550991
Hypotension 24.67 19.61 85 7441 523764 110058009
Nephrogenic systemic fibrosis 23.26 19.61 10 7516 5473 110576300
Encephalomalacia 22.69 19.61 7 7519 1495 110580278
Anaemia 22.55 19.61 85 7441 547001 110034772
Large intestine perforation 22.36 19.61 14 7512 16615 110565158
Nephrogenic anaemia 21.59 19.61 9 7517 4568 110577205
Blood creatinine increased 21.59 19.61 42 7484 182847 110398926
Therapeutic drug monitoring analysis not performed 20.96 19.61 7 7519 1924 110579849
Joint swelling 20.27 19.61 3 7523 442842 110138931
Intermittent claudication 19.92 19.61 8 7518 3693 110578080

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V03AE02 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Drugs for treatment of hyperkalemia and hyperphosphatemia
FDA MoA N0000020074 Phosphate Chelating Activity
MeSH PA D002614 Chelating Agents
MeSH PA D064449 Sequestering Agents
FDA EPC N0000175597 Phosphate Binder
CHEBI has role CHEBI:231911 renoprotective agent
CHEBI has role CHEBI:50864 insulin-sensitizing drug

Related Drugs by ATC class:

V03AE Drugs for treatment of hyperkalemia and hyperphosphatemia 10 drugs
calcium acetatecalcium acetate and magnesium carbonatecalcium polystyrene sulfonatecolestilanferric citratelanthanum carbonatepatiromer calciumsodium polystyrene sulfonatesodium zirconium cyclosilicatesucroferric oxyhydroxide

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

DiseaseRelationSNOMED_IDDOID
Renal Osteodystrophy with Hyperphosphatemia indication
Hypophosphatemia contraindication 4996001
Vitamin D deficiency contraindication 34713006
Dysphagia contraindication 40739000
Gastrointestinal obstruction contraindication 126765001
Acute constipation contraindication 197119006
Gastroparesis contraindication 235675006
Operation on gastrointestinal tract contraindication 386621005
Gastrointestinal hypomotility contraindication 421807004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4024131 VUID
N0000022136 NUI
D01983 KEGG_DRUG
152751-57-0 SECONDARY_CAS_RN
4021141 VANDF
4024131 VANDF
4030256 VANDF
C0718050 UMLSCUI
CHEBI:759084 CHEBI
CHEMBL5314349 ChEMBL_ID
CHEMBL1201492 ChEMBL_ID
D000069603 MESH_DESCRIPTOR_UI
DB00658 DRUGBANK_ID
7620 INN_ID
941N5DUU5C UNII
135118 RXNORM
13916 MMSL
307571 MMSL
7783 MMSL
d04363 MMSL
007676 NDDF
007677 NDDF
329195003 SNOMEDCT_US
395871000 SNOMEDCT_US
412304002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
sevelamer hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7209 TABLET, FILM COATED 800 mg PARENTERAL ANDA 25 sections
Renagel HUMAN PRESCRIPTION DRUG LABEL 1 17856-0021 TABLET 800 mg ORAL NDA 23 sections
Sevelamer Hydrochloride Human Prescription Drug Label 1 33342-241 TABLET, FILM COATED 400 mg ORAL ANDA 26 sections
Sevelamer Hydrochloride Human Prescription Drug Label 1 33342-242 TABLET, FILM COATED 800 mg ORAL ANDA 26 sections
Renagel HUMAN PRESCRIPTION DRUG LABEL 1 53808-0777 TABLET 800 mg ORAL NDA 24 sections
sevelamer hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 55154-2647 TABLET, FILM COATED 800 mg PARENTERAL ANDA 25 sections
SEVELAMER HYDROCHLORIDE Human Prescription Drug Label 1 59651-087 TABLET, FILM COATED 400 mg ORAL ANDA 25 sections
SEVELAMER HYDROCHLORIDE Human Prescription Drug Label 1 59651-088 TABLET, FILM COATED 800 mg ORAL ANDA 25 sections
Sevelamer Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 60687-449 TABLET, FILM COATED 800 mg ORAL ANDA 25 sections
Renagel HUMAN PRESCRIPTION DRUG LABEL 1 67544-656 TABLET 800 mg ORAL NDA 24 sections
RENAGEL HUMAN PRESCRIPTION DRUG LABEL 1 68151-4295 TABLET 400 mg ORAL NDA 27 sections
sevelamer hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 68462-446 TABLET, FILM COATED 400 mg ORAL ANDA 25 sections
sevelamer hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 68462-447 TABLET, FILM COATED 800 mg PARENTERAL ANDA 25 sections
Sevelamer Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 70710-2058 TABLET, FILM COATED 800 mg ORAL ANDA 23 sections
Sevelamer hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 70748-173 TABLET 800 mg ORAL ANDA 23 sections
Sevelamer Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 72162-2500 TABLET, FILM COATED 400 mg ORAL ANDA 26 sections
Sevelamer Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 72162-2501 TABLET, FILM COATED 800 mg ORAL ANDA 26 sections
sevelamer hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 72603-148 TABLET, FILM COATED 800 mg ORAL ANDA 24 sections