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

Stem definition	Drug id	CAS RN
antisense oligonucleotides	5319	1492984-65-2

Description:

Molecule	Description
Synonyms: inotersen inotersen sodium tegsedi ISIS 420915	Inotersen is an antisense oligonucleotide that causes degradation of mutant and wild-type TTR mRNA through binding to the TTR mRNA, which results in a reduction of serum TTR protein and TTR protein deposits in tissues. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

inotersen
inotersen sodium
tegsedi
ISIS 420915

Inotersen is an antisense oligonucleotide that causes degradation of mutant and wild-type TTR mRNA through binding to the TTR mRNA, which results in a reduction of serum TTR protein and TTR protein deposits in tissues.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
41	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
July 6, 2018	EMA	Akcea Therapeutics Ireland Limited
Oct. 5, 2018	FDA	AKCEA THERAPS

FDA Adverse Event Reporting System (Female)

Show entries

Search:

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
Urine protein/creatinine ratio increased	365.48	40.47	53	1844	617	63486508
Protein urine present	288.74	40.47	60	1837	6060	63481065
Urinary casts	259.67	40.47	40	1857	715	63486410
Bacterial test positive	250.10	40.47	52	1845	5255	63481870
Urine leukocyte esterase positive	245.84	40.47	48	1849	3531	63483594
Urine abnormality	230.08	40.47	51	1846	6968	63480157
Urinary occult blood positive	208.16	40.47	25	1872	50	63487075
Urinary sediment present	197.70	40.47	37	1860	2166	63484959
White blood cells urine positive	194.14	40.47	42	1855	5116	63482009
Nitrite urine present	168.86	40.47	29	1868	1037	63486088

Showing 1 to 10 of 23 entries

Previous1 2 3Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

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
Urine protein/creatinine ratio increased	466.01	40.93	70	1953	512	34954396
Protein urine present	390.67	40.93	84	1939	5144	34949764
Urine abnormality	341.35	40.93	64	1959	1935	34952973
Urinary casts	338.21	40.93	51	1972	382	34954526
Bacterial test positive	301.68	40.93	62	1961	3031	34951877
Urine protein/creatinine ratio abnormal	266.90	40.93	33	1990	32	34954876
Glomerular filtration rate decreased	254.05	40.93	71	1952	12890	34942018
Urinary occult blood positive	225.11	40.93	29	1994	50	34954858
Urine ketone body present	222.91	40.93	41	1982	1107	34953801
Urine leukocyte esterase positive	187.40	40.93	31	1992	440	34954468

Showing 1 to 10 of 24 entries

Previous1 2 3Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

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
Urine protein/creatinine ratio increased	793.19	41.84	121	4034	1113	79739120
Protein urine present	661.32	41.84	143	4012	9969	79730264
Urinary casts	571.39	41.84	91	4064	1128	79739105
Bacterial test positive	535.78	41.84	114	4041	7335	79732898
Urine abnormality	530.22	41.84	115	4040	8104	79732129
Glomerular filtration rate decreased	418.72	41.84	116	4039	22586	79717647
Urinary occult blood positive	404.32	41.84	54	4101	161	79740072
Urine leukocyte esterase positive	389.26	41.84	79	4076	4012	79736221
Creatinine urine abnormal	341.23	41.84	40	4115	16	79740217
Urine protein/creatinine ratio abnormal	324.81	41.84	43	4112	117	79740116

Showing 1 to 10 of 35 entries

Previous1 2 3 4Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	N07XX15	NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs
FDA CS	M0025055	Oligonucleotides, Antisense
FDA EPC	N0000191626	Antisense Oligonucleotide
FDA EPC	N0000193849	Transthyretin-directed RNA Interaction
FDA PE	N0000008852	Decreased RNA Integrity
FDA PE	N0000009531	Increased Protein Breakdown
MeSH PA	D015335	Molecular Probes
MeSH PA	D020319	Oligodeoxyribonucleotides, Antisense
MeSH PA	D016376	Oligonucleotides, Antisense

Showing 1 to 9 of 9 entries

Previous1Next

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

Show entries

Search:

Disease	Relation	SNOMED_ID	DOID
Polyneuropathy in amyloidosis	indication	193187004
Glomerulonephritis	contraindication	36171008	DOID:2921
Thrombocytopenic disorder	contraindication	302215000	DOID:1588

Showing 1 to 3 of 3 entries

Previous1Next

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)	TEGSEDI	AKCEA THERAPS	N211172	Oct. 5, 2018	RX	SOLUTION	SUBCUTANEOUS	9399774	April 29, 2031	TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN AMYLOIDOSIS

Showing 1 to 1 of 1 entries

Previous1Next

Orange Book exclusivity data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)	TEGSEDI	AKCEA THERAPS	N211172	Oct. 5, 2018	RX	SOLUTION	SUBCUTANEOUS	Oct. 5, 2023	NEW CHEMICAL ENTITY
EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)	TEGSEDI	AKCEA THERAPS	N211172	Oct. 5, 2018	RX	SOLUTION	SUBCUTANEOUS	Oct. 5, 2025	INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

Showing 1 to 2 of 2 entries

Previous1Next

Bioactivity Summary:

Show entries

Search:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
transthyretin (TTR) mRNA	RNA	P02766	TTHY_HUMAN	ANTISENSE INHIBITOR				UNKNOWN	DRUG LABEL

Showing 1 to 1 of 1 entries

Previous1Next

External reference:

Show entries

Search:

ID	Source
017681	NDDF
017682	NDDF
0IEO0F56LV	UNII
10294	INN_ID
121493436	PUBCHEM_CID
1432726-13-0	SECONDARY_CAS_RN
2099289	RXNORM
294316	MMSL
35311	MMSL
4037952	VANDF

Showing 1 to 10 of 20 entries

Previous1 2Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Tegsedi	HUMAN PRESCRIPTION DRUG LABEL	1	72126-007	INJECTION, SOLUTION	284 mg	SUBCUTANEOUS	NDA	27 sections
Tegsedi	HUMAN PRESCRIPTION DRUG LABEL	1	72126-007	INJECTION, SOLUTION	284 mg	SUBCUTANEOUS	NDA	27 sections
Tegsedi	HUMAN PRESCRIPTION DRUG LABEL	1	72126-007	INJECTION, SOLUTION	284 mg	SUBCUTANEOUS	NDA	27 sections

Showing 1 to 3 of 3 entries

Previous1Next