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

Stem definition	Drug id	CAS RN
	4901	160337-95-1

Description:

Molecule	Description
Synonyms: soliqua insulin glargine insulin glargine (genetical recombination) insulin glargine (rDNA origin) insulin glargine recombinant lantus lantus solostar toujeo	A recombinant LONG ACTING INSULIN and HYPOGLYCEMIC AGENT that is used to manage BLOOD GLUCOSE in patients with DIABETES MELLITUS. Molecular weight: 6062.96 Formula: C267H404N72O78S6 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: 2437.98 ALOGS: ROTB: None

Molecule

Description

Synonyms:

soliqua
insulin glargine
insulin glargine (genetical recombination)
insulin glargine (rDNA origin)
insulin glargine recombinant
lantus
lantus solostar
toujeo

A recombinant LONG ACTING INSULIN and HYPOGLYCEMIC AGENT that is used to manage BLOOD GLUCOSE in patients with DIABETES MELLITUS.

Molecular weight: 6062.96
Formula: C267H404N72O78S6
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA: 2437.98
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
40	U	P
40	U	P

ADMET properties:

None

Approvals:

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Date	Agency	Company
April 20, 2000	FDA	SANOFI AVENTIS US
June 9, 2000	EMA	sanofi-aventis Deutschland GmbH
March 25, 2020	PMDA	Sanofi K.K.

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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
Blood glucose increased	4459.92	9.49	2756	163385	81000	63241881
Hypoglycaemia	3502.00	9.49	2096	164045	57969	63264912
Diabetic ketoacidosis	1978.55	9.49	999	165142	19506	63303375
Diabetes mellitus inadequate control	1314.51	9.49	687	165454	14439	63308442
Hyperglycaemia	1196.40	9.49	942	165199	40925	63281956
Blood glucose decreased	1161.91	9.49	709	165432	20243	63302638
Glycosylated haemoglobin increased	870.66	9.49	489	165652	11909	63310972
Blood glucose abnormal	727.40	9.49	373	165768	7519	63315362
Device operational issue	715.35	9.49	163	165978	123	63322758
Ketoacidosis	535.44	9.49	251	165890	4127	63318754

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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
Hypoglycaemia	3231.49	10.18	2381	158917	52259	34743374
Blood glucose increased	2690.27	10.18	2322	158976	64396	34731237
Diabetic ketoacidosis	1052.60	10.18	781	160517	17251	34778382
Blood glucose decreased	1008.98	10.18	675	160623	12562	34783071
Diabetes mellitus inadequate control	986.61	10.18	670	160628	12794	34782839
Hyperglycaemia	812.91	10.18	956	160342	38524	34757109
Glycosylated haemoglobin increased	555.40	10.18	443	160855	10917	34784716
Blood glucose abnormal	473.92	10.18	312	160986	5640	34789993
Device operational issue	472.37	10.18	118	161180	55	34795578
Blood glucose fluctuation	430.63	10.18	255	161043	3789	34791844

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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
Hypoglycaemia	6008.04	9.27	3914	263362	97680	79379432
Blood glucose increased	4950.45	9.27	3645	263631	111330	79365782
Diabetic ketoacidosis	2358.23	9.27	1453	265823	32669	79444443
Diabetes mellitus inadequate control	1853.57	9.27	1102	266174	23162	79453950
Hyperglycaemia	1701.36	9.27	1599	265677	68736	79408376
Blood glucose decreased	1498.86	9.27	991	266285	25243	79451869
Device operational issue	1042.59	9.27	246	267030	146	79476966
Glycosylated haemoglobin increased	1029.06	9.27	698	266578	18562	79458550
Blood glucose abnormal	835.81	9.27	491	266785	10075	79467037
Acute kidney injury	679.79	9.27	3484	263792	515920	78961192

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A10AE04	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES INSULINS AND ANALOGUES Insulins and analogues for injection, long-acting
ATC	A10AE54	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES INSULINS AND ANALOGUES Insulins and analogues for injection, long-acting
CHEBI has role	CHEBI:35526	antidiabetic
FDA Chemical/Ingredient	N0000004931	Insulin
FDA CS	M0011417	Insulin
FDA EPC	N0000175453	Insulin Analog
FDA EPC	N0000175944	Insulin
MeSH PA	D007004	Hypoglycemic 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	DOID
Diabetes mellitus type 2	indication	44054006	DOID:9352
Diabetes mellitus type 1	indication	46635009	DOID:9744

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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:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Insulin receptor	Kinase	P06213	INSR_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
000869	NDDF
000870	NDDF
006518	NDDF
009131	NDDF
009132	NDDF
118984375	PUBCHEM_CID
118984454	PUBCHEM_CID
126210001	SNOMEDCT_US
126212009	SNOMEDCT_US
1604540	RXNORM

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BASAGLAR KwikPen	HUMAN PRESCRIPTION DRUG LABEL	1	0002-7715	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	33 sections
BASAGLAR KwikPen	HUMAN PRESCRIPTION DRUG LABEL	1	0002-7715	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	33 sections
BASAGLAR Tempo Pen	HUMAN PRESCRIPTION DRUG LABEL	1	0002-8214	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	33 sections
BASAGLAR Tempo Pen	HUMAN PRESCRIPTION DRUG LABEL	1	0002-8214	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	33 sections
Insulin Glargine	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1729	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	33 sections
Insulin Glargine	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1729	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	33 sections
Insulin Glargine Solostar	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1728	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	33 sections
Insulin Glargine Solostar	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1728	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	33 sections
Insulin glargine U-300	HUMAN PRESCRIPTION DRUG LABEL	1	0955-3900	INJECTION, SOLUTION	300 [iU]	SUBCUTANEOUS	BLA	33 sections
Insulin glargine U-300 Max	HUMAN PRESCRIPTION DRUG LABEL	1	0955-2900	INJECTION, SOLUTION	300 [iU]	SUBCUTANEOUS	BLA	33 sections

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