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

Stem definitionDrug idCAS RN
peptides and glycopeptides 1546 108736-35-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • lanreotide
  • angiopeptin
  • ipstyl
  • lanreotide autogel
  • somatulin-autogel
  • somatuline
  • lanreotide acetate
synthetic octapeptide analog of somatostatin; inhibits accelerated transplant atherosclerosis in rabbit heart arteries
  • Molecular weight: 1096.33
  • Formula: C54H69N11O10S2
  • CLOGP: 3.42
  • LIPINSKI: 3
  • HAC: 21
  • HDO: 13
  • TPSA: 355.08
  • ALOGS: -5.34
  • ROTB: 17

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
3 mg P

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.70 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.03 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 30, 2007 FDA IPSEN PHARMA
Dec. 12, 2020 PMDA TEIJIN PHARMA LIMITED

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
Inappropriate schedule of product administration 303.28 19.56 173 8224 71658 50525069
Injection site mass 193.60 19.56 79 8318 15601 50581126
Insulin-like growth factor increased 193.37 19.56 41 8356 777 50595950
Diarrhoea 156.85 19.56 317 8080 588159 50008568
Injection site pain 120.16 19.56 118 8279 110906 50485821
Cholelithiasis 102.68 19.56 69 8328 37904 50558823
Abdominal pain 89.89 19.56 149 8248 236079 50360648
Blood growth hormone increased 86.89 19.56 19 8378 418 50596309
Flatulence 83.17 19.56 55 8342 29403 50567324
Abdominal distension 79.73 19.56 78 8319 72825 50523902
Neoplasm progression 74.09 19.56 51 8346 29106 50567621
Off label use 55.10 19.56 188 8209 474238 50122489
Disease progression 52.81 19.56 72 8325 95794 50500933
Injection site nodule 52.25 19.56 20 8377 3328 50593399
Carcinoid tumour pulmonary 44.68 19.56 11 8386 412 50596315
Carcinoid crisis 40.17 19.56 9 8388 222 50596505
Intestinal obstruction 40.12 19.56 34 8363 26349 50570378
Blood glucose increased 39.91 19.56 54 8343 71270 50525457
Abdominal pain upper 38.59 19.56 83 8314 159226 50437501
Product dose omission issue 38.09 19.56 90 8307 183748 50412979
Terminal state 38.00 19.56 14 8383 2096 50594631
Weight decreased 36.16 19.56 99 8298 221146 50375581
Hypoglycaemia 35.33 19.56 44 8353 53537 50543190
Blood glucose decreased 35.19 19.56 27 8370 18184 50578543
Nausea 34.61 19.56 217 8180 705181 49891546
Needle issue 34.59 19.56 19 8378 7256 50589471
Insulinoma 30.77 19.56 6 8391 73 50596654
Asthenia 30.59 19.56 119 8278 318923 50277804
Incorrect route of product administration 30.34 19.56 25 8372 18641 50578086
Steatorrhoea 30.33 19.56 8 8389 396 50596331
Product administered at inappropriate site 29.07 19.56 12 8385 2431 50594296
Carcinoid syndrome 28.68 19.56 6 8391 106 50596621
Menopausal symptoms 27.62 19.56 11 8386 2032 50594695
Bronchiolitis 25.99 19.56 11 8386 2370 50594357
Pituitary tumour removal 24.59 19.56 4 8393 15 50596712
Drug hypersensitivity 24.10 19.56 6 8391 251004 50345723
Vomiting 23.90 19.56 144 8253 460614 50136113
Blood chromogranin A increased 23.82 19.56 6 8391 247 50596480
Flushing 23.67 19.56 41 8356 66974 50529753
Faeces pale 23.60 19.56 9 8388 1482 50595245
Injection site haemorrhage 23.59 19.56 23 8374 21323 50575404
Constipation 23.55 19.56 76 8321 185632 50411095
Postoperative adhesion 23.37 19.56 6 8391 267 50596460
Injection site pruritus 23.20 19.56 31 8366 40380 50556347
Malaise 22.86 19.56 113 8284 335419 50261308
Gastroenteropancreatic neuroendocrine tumour disease 22.63 19.56 4 8393 27 50596700
Toxicity to various agents 22.61 19.56 4 8393 212495 50384232
Thyroid neoplasm 21.92 19.56 11 8386 3496 50593231
Malignant neoplasm progression 21.90 19.56 40 8357 68084 50528643
Muscle neoplasm 21.61 19.56 4 8393 36 50596691
Neoplasm 21.55 19.56 13 8384 5915 50590812
Injection site hypoaesthesia 21.37 19.56 6 8391 376 50596351
Gallbladder neoplasm 21.32 19.56 4 8393 39 50596688
Lymphatic system neoplasm 21.23 19.56 4 8393 40 50596687
Biliary dilatation 21.17 19.56 9 8388 1960 50594767
Metastases to liver 20.99 19.56 21 8376 20083 50576644
Spleen disorder 20.69 19.56 7 8390 817 50595910
Decreased appetite 20.07 19.56 76 8321 200847 50395880
Body height increased 19.93 19.56 4 8393 57 50596670

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
Inappropriate schedule of product administration 194.51 21.79 113 5245 44359 29524810
Diarrhoea 153.56 21.79 239 5119 332459 29236710
Injection site pain 137.89 21.79 81 5277 32365 29536804
Insulin-like growth factor increased 135.59 21.79 33 5325 1078 29568091
Neoplasm progression 116.40 21.79 60 5298 18552 29550617
Injection site mass 105.46 21.79 39 5319 5416 29563753
Abdominal pain 84.90 21.79 113 5245 135244 29433925
Flatulence 74.58 21.79 44 5314 17665 29551504
Injection site haemorrhage 70.20 21.79 33 5325 8353 29560816
Disease progression 68.32 21.79 79 5279 81837 29487332
Off label use 67.88 21.79 160 5198 300640 29268529
Cholelithiasis 67.32 21.79 42 5316 18630 29550539
Carcinoid heart disease 60.93 21.79 9 5349 12 29569157
Incorrect route of product administration 48.53 21.79 28 5330 10773 29558396
Pituitary tumour removal 38.08 21.79 5 5353 0 29569169
Injection site nodule 33.98 21.79 12 5346 1458 29567711
Terminal state 33.13 21.79 15 5343 3479 29565690
Injection site abscess 29.38 21.79 9 5349 700 29568469
Abdominal pain upper 29.35 21.79 45 5313 60948 29508221
Pancreatic neuroendocrine tumour metastatic 29.21 21.79 6 5352 88 29569081
Pituitary tumour benign 28.47 21.79 9 5349 777 29568392
Hepatic neoplasm 27.83 21.79 11 5347 1825 29567344
Metastases to liver 26.80 21.79 20 5338 11836 29557333
Insulin-like growth factor abnormal 26.80 21.79 4 5354 6 29569163
Abdominal distension 26.62 21.79 37 5321 45874 29523295
Steatorrhoea 25.36 21.79 8 5350 686 29568483
Keratitis 24.65 21.79 9 5349 1203 29567966
Hepatic pain 24.55 21.79 9 5349 1216 29567953
Product dose omission issue 24.55 21.79 54 5304 96329 29472840
Growth hormone deficiency 23.86 21.79 6 5352 224 29568945
Carcinoid crisis 23.69 21.79 6 5352 231 29568938
Asthenia 22.84 21.79 88 5270 215162 29354007
Nausea 22.07 21.79 107 5251 289148 29280021

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
Inappropriate schedule of product administration 308.14 18.42 197 11418 92089 64395028
Insulin-like growth factor increased 232.51 18.42 55 11560 1597 64485520
Diarrhoea 230.34 18.42 440 11175 722264 63764853
Injection site mass 173.45 18.42 77 11538 17193 64469924
Injection site pain 172.56 18.42 150 11465 111258 64375859
Abdominal pain 157.19 18.42 234 11381 312141 64174976
Flatulence 143.82 18.42 86 11529 35580 64451537
Neoplasm progression 137.81 18.42 88 11527 40876 64446241
Cholelithiasis 129.37 18.42 88 11527 45418 64441699
Abdominal distension 91.35 18.42 99 11516 95895 64391222
Off label use 81.46 18.42 274 11341 632532 63854585
Disease progression 78.03 18.42 111 11504 141569 64345548
Injection site nodule 65.88 18.42 24 11591 3206 64483911
Blood growth hormone increased 58.58 18.42 15 11600 607 64486510
Terminal state 58.44 18.42 24 11591 4420 64482697
Injection site haemorrhage 57.46 18.42 42 11573 24236 64462881
Weight decreased 54.98 18.42 143 11472 285596 64201521
Pituitary tumour removal 51.25 18.42 8 11607 19 64487098
Intestinal obstruction 50.37 18.42 46 11569 36240 64450877
Nausea 50.00 18.42 275 11340 785525 63701592
Abdominal pain upper 49.52 18.42 102 11513 174928 64312189
Asthenia 49.34 18.42 179 11436 427865 64059252
Incorrect route of product administration 47.79 18.42 37 11578 23261 64463856
Product dose omission issue 47.65 18.42 107 11508 194640 64292477
Blood glucose increased 46.97 18.42 72 11543 98001 64389116
Carcinoid tumour pulmonary 46.40 18.42 11 11604 322 64486795
Carcinoid heart disease 45.71 18.42 8 11607 46 64487071
Metastases to liver 42.65 18.42 35 11580 23906 64463211
Injection site abscess 42.52 18.42 14 11601 1384 64485733
Steatorrhoea 41.43 18.42 12 11603 774 64486343
Malignant neoplasm progression 40.78 18.42 73 11542 112798 64374319
Blood chromogranin A increased 39.79 18.42 10 11605 375 64486742
Hepatic neoplasm 38.37 18.42 16 11599 3061 64484056
Carcinoid crisis 38.15 18.42 10 11605 444 64486673
Vomiting 37.73 18.42 197 11418 550920 63936197
Blood glucose decreased 37.45 18.42 32 11583 23091 64464026
Insulin-like growth factor abnormal 36.29 18.42 6 11609 23 64487094
Insulinoma 34.83 18.42 7 11608 92 64487025
Hypoglycaemia 33.57 18.42 59 11556 89833 64397284
Drug interaction 33.02 18.42 12 11603 362071 64125046
Constipation 31.68 18.42 102 11513 229235 64257882
Flushing 31.17 18.42 53 11562 78595 64408522
Menopausal symptoms 29.43 18.42 11 11604 1579 64485538
Drug hypersensitivity 29.41 18.42 4 11611 237811 64249306
Pituitary tumour 29.37 18.42 10 11605 1096 64486021
Needle issue 28.89 18.42 19 11596 9253 64477864
Pituitary tumour benign 28.85 18.42 12 11603 2281 64484836
Metastases to bone 28.54 18.42 26 11589 20409 64466708
Faeces pale 27.53 18.42 12 11603 2559 64484558
Thyroid neoplasm 27.15 18.42 12 11603 2645 64484472
Carcinoid syndrome 26.06 18.42 6 11609 154 64486963
Growth hormone deficiency 26.02 18.42 7 11608 344 64486773
Biliary obstruction 25.76 18.42 13 11602 3851 64483266
Tumour necrosis 25.12 18.42 10 11605 1699 64485418
Injection site hypoaesthesia 24.89 18.42 7 11608 406 64486711
Gallbladder neoplasm 24.45 18.42 5 11610 72 64487045
Acromegaly 24.02 18.42 5 11610 79 64487038
Hepatic pain 23.97 18.42 12 11603 3496 64483621
Pneumonia 23.05 18.42 41 11574 559535 63927582
Hepatic embolisation 22.71 18.42 4 11611 24 64487093
Injection site induration 22.37 18.42 16 11599 8916 64478201
Gastroenteropancreatic neuroendocrine tumour disease 21.94 18.42 4 11611 30 64487087
Keratitis 21.90 18.42 11 11604 3226 64483891
Postoperative adhesion 21.79 18.42 6 11609 322 64486795
Hepatobiliary disease 21.71 18.42 7 11608 647 64486470
Hormone level abnormal 21.65 18.42 9 11606 1708 64485409
Rash 21.32 18.42 31 11584 458518 64028599
Biliary colic 21.26 18.42 11 11604 3433 64483684
Headache 21.05 18.42 165 11450 529302 63957815
Neoplasm 20.92 18.42 14 11601 7017 64480100
Decreased appetite 20.87 18.42 103 11512 281186 64205931
Bronchiolitis 20.68 18.42 11 11604 3630 64483487
Lymphatic system neoplasm 20.56 18.42 4 11611 44 64487073
Bile duct stone 20.03 18.42 12 11603 4966 64482151
Cholecystitis 19.96 18.42 21 11594 19615 64467502
Muscle neoplasm 19.94 18.42 4 11611 52 64487065
Injection site pruritus 19.84 18.42 29 11586 37797 64449320
Fatigue 19.50 18.42 213 11402 748517 63738600
Malaise 19.49 18.42 130 11485 396117 64091000
Product administered at inappropriate site 19.39 18.42 10 11605 3100 64484017
Biliary dilatation 19.25 18.42 9 11606 2259 64484858

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC H01CB03 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
HYPOTHALAMIC HORMONES
Somatostatin and analogues
FDA MoA N0000000194 Somatostatin Receptor Agonists
MeSH PA D000970 Antineoplastic Agents
FDA EPC N0000175904 Somatostatin Analog

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

DiseaseRelationSNOMED_IDDOID
Acromegaly indication 74107003 DOID:2449
Hypersomatotropic gigantism indication 86073008
Thyroid-stimulating hormone secreting pituitary tumour indication 127024001 DOID:1785
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Bradycardia contraindication 48867003
Hyperglycemia contraindication 80394007 DOID:4195
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Hypoglycemic disorder contraindication 237630007
Calculus in biliary tract contraindication 266474003




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.65 acidic
pKa2 12.16 acidic
pKa3 12.71 acidic
pKa4 13.18 acidic
pKa5 13.43 acidic
pKa6 13.67 acidic
pKa7 10.31 Basic
pKa8 6.97 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOMATULINE DEPOT IPSEN PHARMA N022074 Aug. 30, 2007 RX SOLUTION SUBCUTANEOUS Sept. 15, 2024 TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY
EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOMATULINE DEPOT IPSEN PHARMA N022074 Aug. 30, 2007 RX SOLUTION SUBCUTANEOUS Sept. 15, 2024 TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY
EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOMATULINE DEPOT IPSEN PHARMA N022074 Aug. 30, 2007 RX SOLUTION SUBCUTANEOUS Sept. 15, 2024 TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Somatostatin receptor type 2 GPCR AGONIST Ki 9.60 IUPHAR CHEMBL
Somatostatin receptor type 5 GPCR AGONIST Ki 9.30 IUPHAR CHEMBL
Somatostatin receptor type 1 GPCR Ki 6.30 PDSP
Somatostatin receptor type 4 GPCR Ki 7.18 PDSP
Somatostatin receptor type 3 GPCR AGONIST Ki 8 IUPHAR
Somatostatin receptor type 2 GPCR AGONIST Ki 9.10 IUPHAR
Somatostatin receptor type 3 GPCR AGONIST IC50 8.20 IUPHAR
Somatostatin receptor type 5 GPCR AGONIST Ki 7.60 IUPHAR
Somatostatin receptor type 2 GPCR AGONIST Ki 8.80 IUPHAR
Somatostatin receptor type 3 GPCR AGONIST Ki 6.90 IUPHAR

External reference:

IDSource
4026631 VUID
N0000179366 NUI
D04666 KEGG_DRUG
127984-74-1 SECONDARY_CAS_RN
4026631 VANDF
C0209211 UMLSCUI
CHEBI:135901 CHEBI
CHEMBL1201185 ChEMBL_ID
CHEMBL1201184 ChEMBL_ID
DB06791 DRUGBANK_ID
C060347 MESH_SUPPLEMENTAL_RECORD_UI
2031 IUPHAR_LIGAND_ID
6649 INN_ID
0G3DE8943Y UNII
6918011 PUBCHEM_CID
236167 RXNORM
18121 MMSL
354365 MMSL
d04961 MMSL
005272 NDDF
005273 NDDF
327379003 SNOMEDCT_US
395765000 SNOMEDCT_US
429611006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1060 INJECTION 60 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1060 INJECTION 60 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1090 INJECTION 90 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1090 INJECTION 90 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1120 INJECTION 120 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1120 INJECTION 120 mg SUBCUTANEOUS NDA 29 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 69097-870 INJECTION 120 mg SUBCUTANEOUS NDA 26 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 69097-880 INJECTION 60 mg SUBCUTANEOUS NDA 26 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 69097-890 INJECTION 90 mg SUBCUTANEOUS NDA 26 sections