sevelamer carbonate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
polymers	4331	845273-93-0

Description:

Molecule	Description
Synonyms: sevelamer carbonate renvela	Molecular weight: Formula: CHO3(C3H8N)a(C9H18N2O)c(C3H7N)b CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

sevelamer carbonate
renvela

Molecular weight:
Formula: CHO3(C3H8N)a(C9H18N2O)c(C3H7N)b
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 9, 2009	EMA	GENZYME EUROPE BV
Oct. 19, 2007	FDA	GENZYME

FDA Adverse Event Reporting System (Female)

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
Crystal deposit intestine	138.00	19.54	20	5108	72	63483822
Constipation	135.37	19.54	125	5003	224818	63259076
Peritonitis bacterial	118.06	19.54	34	5094	4845	63479049
Hyperphosphataemia	98.37	19.54	25	5103	2223	63481671
Death	79.25	19.54	122	5006	374259	63109635
Hypervolaemia	73.91	19.54	39	5089	28374	63455520
Peritonitis	69.95	19.54	32	5096	17122	63466772
Dialysis	60.67	19.54	25	5103	10402	63473492
End stage renal disease	60.12	19.54	22	5106	6671	63477223
Blood parathyroid hormone increased	51.11	19.54	16	5112	3022	63480872
Hospitalisation	42.85	19.54	43	5085	85038	63398856
Renal failure	42.69	19.54	50	5078	117602	63366292
Diarrhoea	37.08	19.54	134	4994	715232	62768662
Chronic kidney disease	34.70	19.54	29	5099	45369	63438525
Hypotension	33.21	19.54	70	5058	272534	63211360
Nausea	32.24	19.54	145	4983	854326	62629568
Blood potassium increased	31.02	19.54	19	5109	18290	63465604
Treatment noncompliance	30.95	19.54	25	5103	37300	63446594
Blood phosphorus abnormal	30.32	19.54	6	5122	169	63483725
Arteriovenous fistula thrombosis	28.77	19.54	6	5122	221	63483673
Blood parathyroid hormone abnormal	28.64	19.54	6	5122	226	63483668
Blood phosphorus increased	26.99	19.54	10	5118	3135	63480759
Pruritus	25.16	19.54	75	5053	361378	63122516
Peritoneal dialysis	24.67	19.54	6	5122	445	63483449
Status epilepticus	23.76	19.54	15	5113	15218	63468676
Gastrointestinal injury	23.25	19.54	6	5122	566	63483328
Precocious puberty	23.04	19.54	5	5123	223	63483671
Vomiting	22.54	19.54	97	5031	559520	62924374
Renal transplant	22.10	19.54	7	5121	1373	63482521
Drug ineffective	21.63	19.54	32	5096	1044733	62439161
Diffuse alopecia	20.45	19.54	6	5122	910	63482984
Nephrogenic systemic fibrosis	20.15	19.54	9	5119	4547	63479347
Hypocalcaemia	19.68	19.54	18	5110	31695	63452199
Plasma cell myeloma	19.64	19.54	19	5109	35886	63448008

FDA Adverse Event Reporting System (Male)

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
Hyperphosphataemia	121.95	19.80	39	5019	4398	34947475
Crystal deposit intestine	108.44	19.80	18	5040	93	34951780
Constipation	77.45	19.80	97	4961	136885	34814988
Peritonitis bacterial	66.27	19.80	27	5031	6083	34945790
Hospitalisation	57.90	19.80	55	5003	56847	34895026
End stage renal disease	56.63	19.80	27	5031	8834	34943039
Ventricular hyperkinesia	53.54	19.80	11	5047	205	34951668
Right atrial enlargement	51.38	19.80	11	5047	252	34951621
Death	51.06	19.80	149	4909	397900	34553973
Hypochromasia	49.20	19.80	11	5047	310	34951563
Mitral valve thickening	46.96	19.80	11	5047	383	34951490
Serum ferritin increased	46.33	19.80	21	5037	6125	34945748
Hypervolaemia	45.90	19.80	31	5027	19678	34932195
Mean platelet volume increased	43.71	19.80	11	5047	519	34951354
Left ventricular enlargement	40.65	19.80	11	5047	691	34951182
Left atrial enlargement	37.88	19.80	11	5047	894	34950979
Peritonitis	36.34	19.80	25	5033	16340	34935533
Blood phosphorus increased	35.99	19.80	19	5039	7702	34944171
Rectal ulcer	32.47	19.80	10	5048	994	34950879
Haemoglobin decreased	30.44	19.80	59	4999	120713	34831160
Product commingling	30.25	19.80	5	5053	25	34951848
Spontaneous haemorrhage	28.18	19.80	7	5051	313	34951560
Electrocardiogram T wave inversion	28.15	19.80	11	5047	2220	34949653
Cardiac arrest	28.00	19.80	50	5008	96109	34855764
Hypertensive heart disease	27.33	19.80	11	5047	2397	34949476
Blood chloride increased	25.43	19.80	11	5047	2870	34949003
High density lipoprotein decreased	23.81	19.80	11	5047	3349	34948524
Blood phosphorus abnormal	22.78	19.80	5	5053	129	34951744
Gastrointestinal mucosal disorder	22.21	19.80	6	5052	374	34951499
Blood iron decreased	21.76	19.80	12	5046	5301	34946572
Transferrin saturation decreased	20.84	19.80	6	5052	473	34951400
Blood pressure systolic decreased	20.75	19.80	11	5047	4492	34947381
Renal failure	20.68	19.80	53	5005	130504	34821369
Aortic valve incompetence	20.58	19.80	12	5046	5892	34945981

FDA Adverse Event Reporting System (Geriatric)

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
Crystal deposit intestine	232.92	18.11	37	8773	191	79735387
Peritonitis bacterial	179.56	18.11	59	8751	9508	79726070
Hyperphosphataemia	172.54	18.11	52	8758	6324	79729254
Hypervolaemia	105.21	18.11	63	8747	42627	79692951
Death	96.02	18.11	200	8610	566314	79169264
End stage renal disease	70.70	18.11	32	8778	12188	79723390
Hospitalisation	70.21	18.11	68	8742	94168	79641410
Peritonitis	68.08	18.11	41	8769	27995	79707583
Large intestinal ulcer	60.53	18.11	22	8788	4775	79730803
Constipation	58.72	18.11	109	8701	282941	79452637
Ventricular hyperkinesia	52.93	18.11	11	8799	288	79735290
Dialysis	52.74	18.11	30	8780	18432	79717146
Right atrial enlargement	49.88	18.11	11	8799	384	79735194
Mitral valve thickening	49.02	18.11	11	8799	416	79735162
Serum ferritin increased	48.29	18.11	23	8787	9824	79725754
Blood parathyroid hormone increased	47.98	18.11	17	8793	3428	79732150
Blood phosphorus increased	47.21	18.11	23	8787	10324	79725254
Blood parathyroid hormone abnormal	44.91	18.11	10	8800	365	79735213
Haemoglobin decreased	44.11	18.11	84	8726	222035	79513543
Hypochromasia	43.68	18.11	11	8799	685	79734893
Left ventricular enlargement	42.92	18.11	11	8799	735	79734843
Colitis	40.35	18.11	45	8765	73262	79662316
Rectal ulcer	39.55	18.11	13	8797	2091	79733487
Mean platelet volume increased	38.49	18.11	11	8799	1109	79734469
Left atrial enlargement	37.72	18.11	11	8799	1192	79734386
Arteriovenous fistula site haemorrhage	34.54	18.11	8	8802	349	79735229
Hypocalcaemia	31.59	18.11	33	8777	49891	79685687
Blood phosphorus abnormal	30.62	18.11	7	8803	288	79735290
Cardiac arrest	30.40	18.11	62	8748	172034	79563544
Gastrointestinal mucosal disorder	29.88	18.11	9	8801	1090	79734488
Drug ineffective	29.84	18.11	46	8764	1080867	78654711
Plasma cell myeloma	28.12	18.11	32	8778	53227	79682351
Hypertensive heart disease	27.49	18.11	12	8798	4194	79731384
Chronic kidney disease	27.17	18.11	35	8775	66119	79669459
Renal failure	26.06	18.11	64	8746	200904	79534674
Renal transplant	25.99	18.11	10	8800	2537	79733041
Calciphylaxis	25.43	18.11	11	8799	3759	79731819
Product commingling	24.76	18.11	5	8805	113	79735465
Transferrin saturation increased	23.95	18.11	5	8805	134	79735444
Spontaneous haemorrhage	23.55	18.11	7	8803	810	79734768
High density lipoprotein decreased	23.21	18.11	11	8799	4644	79730934
Aplasia pure red cell	23.13	18.11	13	8797	7797	79727781
Gastrointestinal haemorrhage	22.37	18.11	50	8760	147669	79587909
Gastrointestinal injury	22.27	18.11	7	8803	976	79734602
Blood chloride increased	22.14	18.11	11	8799	5145	79730433
Ileal perforation	21.99	18.11	7	8803	1018	79734560
Electrocardiogram T wave inversion	21.72	18.11	11	8799	5361	79730217
Arteriovenous fistula occlusion	21.60	18.11	6	8804	546	79735032
Blood potassium increased	21.54	18.11	21	8789	29254	79706324
Mucosal ulceration	21.45	18.11	8	8802	1865	79733713
Haemodialysis	21.34	18.11	17	8793	18151	79717427
Aortic valve incompetence	20.74	18.11	13	8797	9517	79726061
Nausea	20.21	18.11	177	8633	957019	78778559
Anti-erythropoietin antibody positive	20.05	18.11	6	8804	711	79734867
Blood calcium abnormal	19.90	18.11	7	8803	1382	79734196
Precocious puberty	19.57	18.11	5	8805	330	79735248
Colitis ischaemic	19.40	18.11	15	8795	15344	79720234
Arteriovenous fistula operation	19.09	18.11	5	8805	364	79735214
Unresponsive to stimuli	19.07	18.11	27	8783	55761	79679817
Peritoneal dialysis	19.00	18.11	6	8804	850	79734728
Blood pressure systolic decreased	18.95	18.11	13	8797	11063	79724515
Left ventricular hypertrophy	18.83	18.11	13	8797	11178	79724400
Diffuse alopecia	18.24	18.11	6	8804	967	79734611
Anaemia	18.21	18.11	97	8713	444918	79290660
Arteriovenous fistula site complication	18.15	18.11	6	8804	983	79734595

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
FDA MoA	N0000020074	Phosphate Chelating Activity
MeSH PA	D002614	Chelating Agents
MeSH PA	D064449	Sequestering Agents
FDA EPC	N0000175597	Phosphate Binder

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

Disease	Relation	SNOMED_ID
Renal dialysis	indication	265764009
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:

ID	Source
4027337	VUID
N0000176141	NUI
D06642	KEGG_DRUG
4024131	VANDF
4027337	VANDF
C1721288	UMLSCUI
CHEMBL1201799	ChEMBL_ID
CHEMBL1201798	ChEMBL_ID
D000069603	MESH_DESCRIPTOR_UI
9YCX42I8IU	UNII
11593706	PUBCHEM_CID
214824	RXNORM
131538	MMSL
215523	MMSL
25062	MMSL
d04363	MMSL
007676	NDDF
012471	NDDF
329195003	SNOMEDCT_US
395871000	SNOMEDCT_US
428826003	SNOMEDCT_US
C0718050	UMLSCUI
DB00658	DRUGBANK_ID
7620	INN_ID
3085017	PUBCHEM_CID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
sevelamer carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1365	POWDER, FOR SUSPENSION	800 mg	ORAL	ANDA	22 sections
sevelamer carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1365	POWDER, FOR SUSPENSION	800 mg	ORAL	ANDA	22 sections
sevelamer carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1366	POWDER, FOR SUSPENSION	2400 mg	ORAL	ANDA	22 sections
sevelamer carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1366	POWDER, FOR SUSPENSION	2400 mg	ORAL	ANDA	22 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8239	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5219	TABLET, FILM COATED	800 mg	ORAL	ANDA	27 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6707	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1050	TABLET, FILM COATED	800 mg	ORAL	NDA AUTHORIZED GENERIC	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1050	TABLET, FILM COATED	800 mg	ORAL	NDA AUTHORIZED GENERIC	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1050	TABLET, FILM COATED	800 mg	ORAL	NDA AUTHORIZED GENERIC	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1052	POWDER, FOR SUSPENSION	0.80 g	ORAL	NDA AUTHORIZED GENERIC	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1052	POWDER, FOR SUSPENSION	0.80 g	ORAL	NDA AUTHORIZED GENERIC	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1052	POWDER, FOR SUSPENSION	0.80 g	ORAL	NDA AUTHORIZED GENERIC	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1054	POWDER, FOR SUSPENSION	2.40 g	ORAL	NDA AUTHORIZED GENERIC	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1054	POWDER, FOR SUSPENSION	2.40 g	ORAL	NDA AUTHORIZED GENERIC	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1054	POWDER, FOR SUSPENSION	2.40 g	ORAL	NDA AUTHORIZED GENERIC	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1057	TABLET, FILM COATED	800 mg	ORAL	NDA authorized generic	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	10135-660	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
Sevelamer carbonate	Human Prescription Drug Label	1	16571-739	TABLET, FILM COATED	800 mg	ORAL	ANDA	27 sections
Sevelamer carbonate	Human Prescription Drug Label	1	16571-739	TABLET, FILM COATED	800 mg	ORAL	ANDA	27 sections
Sevelamer Carbonate	Human Prescription Drug Label	1	16714-814	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
Sevelamer Carbonate	Human Prescription Drug Label	1	16714-814	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	17856-0058	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
Renvela	HUMAN PRESCRIPTION DRUG LABEL	1	17856-0130	TABLET, FILM COATED	800 mg	ORAL	NDA	26 sections
Sevelamer Carbonate	Human Prescription Drug Label	1	17856-0921	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
Sevelamer Carbonate	Human Prescription Drug Label	1	17856-0921	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	24979-186	TABLET, FILM COATED	800 mg	ORAL	ANDA	27 sections
Sevelamer Carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	24979-186	TABLET, FILM COATED	800 mg	ORAL	ANDA	27 sections
Sevelamer Carbonate	Human Prescription Drug Label	1	33342-215	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
SEVELAMER CARBONATE	HUMAN PRESCRIPTION DRUG LABEL	1	42571-378	TABLET	800 mg	ORAL	ANDA	25 sections