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

Stem definition	Drug id	CAS RN
polymers	4324	52757-95-6

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
6.40	g	O

ADMET properties:

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

Approvals:

Date	Agency	Company	Orphan
Oct. 30, 1998	FDA

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
Nephrogenic systemic fibrosis	415.91	17.66	100	8005	4456	63476461
Skin induration	214.84	17.66	55	8050	3168	63477749
Crystal deposit intestine	182.04	17.66	27	8078	65	63480852
Skin hypertrophy	164.53	17.66	45	8060	3346	63477571
Peritonitis bacterial	161.31	17.66	48	8057	4831	63476086
Calciphylaxis	159.49	17.66	43	8062	3029	63477888
Skin tightness	136.35	17.66	41	8064	4275	63476642
Arteriovenous fistula site complication	135.70	17.66	27	8078	486	63480431
Peritonitis	131.15	17.66	57	8048	17097	63463820
Skin fibrosis	94.24	17.66	22	8083	858	63480059

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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
Nephrogenic systemic fibrosis	270.24	16.24	80	8835	3925	34944091
Crystal deposit intestine	200.11	16.24	33	8882	78	34947938
Skin induration	140.85	16.24	42	8873	2109	34945907
Arteriovenous fistula site complication	119.60	16.24	27	8888	440	34947576
Peritonitis	104.28	16.24	60	8855	16305	34931711
Skin hypertrophy	104.17	16.24	35	8880	2594	34945422
Skin fibrosis	93.22	16.24	26	8889	1026	34946990
Skin tightness	89.28	16.24	30	8885	2223	34945793
Peritonitis bacterial	72.43	16.24	34	8881	6076	34941940
Blood parathyroid hormone increased	71.42	16.24	23	8892	1491	34946525

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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
Nephrogenic systemic fibrosis	466.32	16.05	125	14340	6035	79723888
Crystal deposit intestine	369.68	16.05	59	14406	169	79729754
Skin induration	251.14	16.05	72	14393	4453	79725470
Arteriovenous fistula site complication	231.77	16.05	50	14415	939	79728984
Skin hypertrophy	193.41	16.05	60	14405	4868	79725055
Peritonitis bacterial	183.33	16.05	68	14397	9499	79720424
Calciphylaxis	182.71	16.05	54	14411	3716	79726207
Peritonitis	182.63	16.05	93	14372	27943	79701980
Skin tightness	162.42	16.05	54	14411	5468	79724455
Skin fibrosis	129.93	16.05	34	14431	1490	79728433

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	V03AE02	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Drugs for treatment of hyperkalemia and hyperphosphatemia
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 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
007677	NDDF
135118	RXNORM
13916	MMSL
152751-57-0	SECONDARY_CAS_RN
307571	MMSL
3085017	PUBCHEM_CID
329195003	SNOMEDCT_US
395871000	SNOMEDCT_US
4021141	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	17856-0021	TABLET	800 mg	ORAL	NDA	23 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0777	TABLET	800 mg	ORAL	NDA	24 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0020	TABLET, FILM COATED	400 mg	ORAL	NDA	26 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0020	TABLET, FILM COATED	400 mg	ORAL	NDA	26 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0021	TABLET, FILM COATED	800 mg	ORAL	NDA	26 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0021	TABLET, FILM COATED	800 mg	ORAL	NDA	26 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	0955-1048	TABLET, FILM COATED	800 mg	ORAL	NDA AUTHORIZED GENERIC	26 sections
Sevelamer Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1048	TABLET, FILM COATED	800 mg	ORAL	NDA AUTHORIZED GENERIC	26 sections

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