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

Stem definitionDrug idCAS RN
5057 207748-29-6

Description:

MoleculeDescription

Synonyms:

  • insulin glulisine
  • insulin glulisine (genetical recombination)
  • HMR 1964
  • apidra
  • glulisine apidra
  • insulin glulisine recombinant
  • insulin glulisine [rDNA origin]
  • insulin glulisine (rDNA origin)
Insulin glulisine [rDNA origin] is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid.
  • Molecular weight: 5822.64
  • Formula: C258H384N64O78S6
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 2293.28
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
40 U P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 27, 2004 EMA
April 16, 2004 FDA SANOFI AVENTIS US

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hypoglycaemia 421.37 20.62 158 3834 53423 50547709
Diabetic ketoacidosis 217.19 20.62 73 3919 17799 50583333
Blood glucose increased 130.73 20.62 77 3915 71247 50529885
Hyperglycaemia 101.78 20.62 52 3940 36353 50564779
Diabetes mellitus inadequate control 92.89 20.62 36 3956 13109 50588023
Wrong product administered 81.60 20.62 26 3966 5334 50595798
Sopor 60.21 20.62 30 3962 19849 50581283
Glycosylated haemoglobin increased 50.82 20.62 22 3970 10584 50590548
Acute kidney injury 44.82 20.62 71 3921 227987 50373145
Hyperkalaemia 42.29 20.62 33 3959 48056 50553076
Product quality issue 40.48 20.62 27 3965 30831 50570301
Blood glucose abnormal 39.19 20.62 16 3976 6656 50594476
Hypoglycaemic coma 38.33 20.62 12 3980 2321 50598811
Ketoacidosis 32.30 20.62 12 3980 3883 50597249
Blood glucose decreased 28.98 20.62 18 3974 18193 50582939
Blood glucose fluctuation 28.01 20.62 11 3981 4135 50596997
Dehydration 27.88 20.62 46 3946 152403 50448729
Anti-insulin antibody positive 27.69 20.62 5 3987 87 50601045
Haemorrhagic erosive gastritis 27.61 20.62 6 3986 276 50600856
Daydreaming 26.80 20.62 6 3986 317 50600815
Exposure during pregnancy 25.54 20.62 39 3953 120976 50480156
Syncope 24.33 20.62 35 3957 102967 50498165
Simple partial seizures 23.66 20.62 6 3986 541 50600591
Thyroid cyst 23.38 20.62 6 3986 567 50600565
Lactic acidosis 23.24 20.62 20 3972 33335 50567797
Monoclonal gammopathy 22.98 20.62 6 3986 607 50600525
Hypoglycaemic unconsciousness 22.01 20.62 6 3986 716 50600416
Diabetic retinal oedema 21.38 20.62 5 3987 321 50600811

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hypoglycaemia 274.20 19.77 143 4933 48203 29521248
Blood glucose increased 121.83 19.77 92 4984 58892 29510559
Wrong product administered 110.70 19.77 38 5038 4493 29564958
Blood glucose abnormal 106.42 19.77 38 5038 5045 29564406
Diabetes mellitus inadequate control 101.76 19.77 47 5029 12087 29557364
Hyperglycaemia 94.96 19.77 64 5012 34223 29535228
Blood glucose fluctuation 87.21 19.77 30 5046 3567 29565884
Intestinal haemorrhage 68.16 19.77 24 5052 3055 29566396
Hypoglycaemic coma 56.18 19.77 19 5057 2144 29567307
Anti-insulin antibody positive 52.74 19.77 11 5065 185 29569266
Diabetic ketoacidosis 46.83 19.77 31 5045 16042 29553409
Haematoma 40.84 19.77 33 5043 23179 29546272
Blood glucose decreased 39.39 19.77 25 5051 12044 29557407
Urinary incontinence 39.08 19.77 28 5048 16453 29552998
Morganella infection 38.27 19.77 10 5066 461 29568990
Ketoacidosis 36.54 19.77 16 5060 3623 29565828
Bronchial haemorrhage 34.59 19.77 10 5066 673 29568778
Glycosylated haemoglobin increased 34.49 19.77 21 5055 9405 29560046
Acute kidney injury 33.88 19.77 111 4965 265156 29304295
Waist circumference increased 33.64 19.77 10 5066 742 29568709
Anti-insulin antibody increased 30.73 19.77 6 5070 71 29569380
Mucosal haemorrhage 30.42 19.77 11 5065 1510 29567941
Cognitive disorder 30.34 19.77 28 5048 23471 29545980
Diabetic bullosis 30.11 19.77 5 5071 21 29569430
Contraindicated product administered 28.03 19.77 24 5052 18242 29551209
Hyperhidrosis 26.50 19.77 43 5033 64497 29504954
Renal failure 26.47 19.77 61 5015 118538 29450913
Balance disorder 23.53 19.77 30 5046 36140 29533311
Device operational issue 21.54 19.77 5 5071 140 29569311
Spinal pain 20.83 19.77 12 5064 4852 29564599
Sopor 20.19 19.77 16 5060 10918 29558533
Diabetic foot 19.86 19.77 9 5067 2207 29567244
General physical health deterioration 19.81 19.77 50 5026 102807 29466644

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hypoglycaemia 583.15 18.39 264 7845 89628 64400995
Blood glucose increased 194.16 18.39 132 7977 97941 64392682
Diabetic ketoacidosis 181.26 18.39 84 8025 29761 64460862
Diabetes mellitus inadequate control 171.21 18.39 73 8036 21248 64469375
Hyperglycaemia 139.77 18.39 90 8019 60878 64429745
Wrong product administered 136.46 18.39 47 8062 7673 64482950
Acute kidney injury 90.81 18.39 184 7925 449056 64041567
Blood glucose abnormal 86.64 18.39 35 8074 8878 64481745
Blood glucose fluctuation 77.84 18.39 29 8080 5926 64484697
Hypoglycaemic coma 75.44 18.39 26 8083 4248 64486375
Anti-insulin antibody positive 69.50 18.39 14 8095 273 64490350
Glycosylated haemoglobin increased 67.02 18.39 35 8074 15984 64474639
Sopor 63.52 18.39 42 8067 29619 64461004
Ketoacidosis 50.14 18.39 22 8087 6841 64483782
Intestinal haemorrhage 44.62 18.39 19 8090 5495 64485128
General physical health deterioration 43.80 18.39 86 8023 204339 64286284
Blood glucose decreased 42.97 18.39 30 8079 23093 64467530
Product quality issue 34.13 18.39 29 8080 29770 64460853
Hyperkalaemia 34.05 18.39 52 8057 101077 64389546
Morganella infection 33.84 18.39 10 8099 996 64489627
Bronchial haemorrhage 31.92 18.39 10 8099 1212 64489411
Diabetic bullosis 31.87 18.39 5 8104 20 64490603
Waist circumference increased 30.79 18.39 10 8099 1361 64489262
Anti-insulin antibody increased 29.88 18.39 6 8103 115 64490508
Toxicity to various agents 29.74 18.39 5 8104 363508 64127115
Hyperhidrosis 29.73 18.39 55 8054 124865 64365758
Mucosal haemorrhage 29.41 18.39 11 8098 2270 64488353
Dehydration 28.32 18.39 75 8034 216688 64273935
Haematoma 25.08 18.39 30 8079 46220 64444403
Hypoglycaemic unconsciousness 24.46 18.39 8 8101 1113 64489510
Lactic acidosis 24.17 18.39 34 8075 61376 64429247
Product administration error 23.96 18.39 23 8086 27620 64463003
Renal failure 23.86 18.39 63 8046 181625 64308998
Thyroid cyst 22.85 18.39 6 8103 387 64490236
Haemorrhagic erosive gastritis 21.68 18.39 6 8103 472 64490151
Syncope 20.02 18.39 54 8055 157581 64333042
Diabetic foot 19.92 18.39 9 8100 2996 64487627
Simple partial seizures 19.67 18.39 6 8103 665 64489958
Monoclonal gammopathy 19.04 18.39 6 8103 741 64489882
Loss of consciousness 19.02 18.39 51 8058 148314 64342309
Hypoglycaemic seizure 18.88 18.39 6 8103 762 64489861
Diabetic retinal oedema 18.75 18.39 5 8104 342 64490281
Accidental overdose 18.57 18.39 22 8087 33535 64457088
Daydreaming 18.56 18.39 6 8103 804 64489819

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A10AB06 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
INSULINS AND ANALOGUES
Insulins and analogues for injection, fast-acting
FDA CS M0011417 Insulin
FDA Chemical/Ingredient N0000004931 Insulin
FDA EPC N0000175453 Insulin Analog
MeSH PA D007004 Hypoglycemic Agents
CHEBI has role CHEBI:35526 antidiabetic
FDA EPC N0000175944 Insulin

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus indication 73211009 DOID:9351




🐶 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Insulin receptor Kinase AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
7XIY785AZD UNII
D04540 KEGG_DRUG
4021469 VUID
N0000179777 NUI
4017559 VANDF
4017569 VANDF
4019786 VANDF
4021469 VANDF
C1313386 UMLSCUI
CHEBI:5931 CHEBI
CHEMBL1201613 ChEMBL_ID
16136701 PUBCHEM_CID
DB01309 DRUGBANK_ID
8044 INN_ID
C479079 MESH_SUPPLEMENTAL_RECORD_UI
118984375 PUBCHEM_CID
DB00030 DRUGBANK_ID
253182 RXNORM
18596 MMSL
4885 MMSL
4886 MMSL
53478 MMSL
d00262 MMSL
d04369 MMSL
d05278 MMSL
126210001 SNOMEDCT_US
411530000 SNOMEDCT_US
411532008 SNOMEDCT_US
417423002 SNOMEDCT_US
420609005 SNOMEDCT_US
96367001 SNOMEDCT_US
C0795635 UMLSCUI
5186 INN_ID
000869 NDDF
000870 NDDF
006518 NDDF
010953 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Apidra HUMAN PRESCRIPTION DRUG LABEL 1 0088-2500 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 31 sections
Apidra SoloStar HUMAN PRESCRIPTION DRUG LABEL 1 0088-2502 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 31 sections