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)

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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
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

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FDA Adverse Event Reporting System (Male)

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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
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

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FDA Adverse Event Reporting System (Geriatric)

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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
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

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

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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

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🐶 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:

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ID	Source
007676	NDDF
012471	NDDF
11593706	PUBCHEM_CID
131538	MMSL
214824	RXNORM
215523	MMSL
25062	MMSL
3085017	PUBCHEM_CID
329195003	SNOMEDCT_US
395871000	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Renvela	HUMAN PRESCRIPTION DRUG LABEL	1	17856-0130	TABLET, FILM COATED	800 mg	ORAL	NDA	26 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	0115-1365	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

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