leuprorelin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
pituitary hormone-release stimulating peptides 1559 53714-56-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • leuprorelin
  • leuprolide acetate
  • eligard
  • leupline
  • leuprolide
  • leuprorelin acetate
A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • Molecular weight: 1209.42
  • Formula: C59H84N16O12
  • CLOGP: -3.18
  • LIPINSKI: 3
  • HAC: 28
  • HDO: 16
  • TPSA: 429.04
  • ALOGS: -4.55
  • ROTB: 32

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
60 mcg implant
1 mg P
0.13 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 250 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.01 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.38 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.54 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.90 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 9, 1985 FDA

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
Hot flush 699.95 18.97 294 11719 43875 50549236
Intercepted product preparation error 605.73 18.97 101 11912 290 50592821
Syringe issue 498.55 18.97 113 11900 2031 50591080
Pelvic pain 394.51 18.97 134 11879 11079 50582032
Ovarian hyperstimulation syndrome 334.84 18.97 89 11924 3155 50589956
Occupational exposure to product 334.04 18.97 79 11934 1721 50591390
Vaginal haemorrhage 267.70 18.97 126 11887 24425 50568686
Device leakage 257.79 18.97 83 11930 5795 50587316
Heavy menstrual bleeding 207.94 18.97 92 11921 15445 50577666
Injury associated with device 169.98 18.97 52 11961 3065 50590046
Off label use 166.51 18.97 354 11659 474072 50119039
Abscess sterile 165.86 18.97 25 11988 26 50593085
Hysterectomy 139.68 18.97 57 11956 7833 50585278
Injection site abscess 138.39 18.97 35 11978 1014 50592097
Mood swings 118.06 18.97 63 11950 15891 50577220
Intermenstrual bleeding 96.47 18.97 42 11971 6772 50586339
Uterine leiomyoma 87.46 18.97 41 11972 7850 50585261
Wrong technique in product usage process 83.13 18.97 83 11930 55427 50537684
Menstrual disorder 78.81 18.97 32 11981 4338 50588773
Oestradiol increased 76.82 18.97 14 11999 76 50593035
Injection site abscess sterile 76.03 18.97 11 12002 6 50593105
Ovarian cyst 75.66 18.97 45 11968 13951 50579160
Uterine haemorrhage 72.02 18.97 28 11985 3387 50589724
Haemorrhage 65.84 18.97 72 11941 53369 50539742
Epiphysiolysis 63.17 18.97 10 12003 18 50593093
Dysmenorrhoea 62.31 18.97 25 11988 3285 50589826
Injection site pain 59.93 18.97 100 11913 110924 50482187
Surgery 58.28 18.97 52 11961 30153 50562958
Depression 55.85 18.97 122 11891 165301 50427810
Night sweats 55.47 18.97 53 11960 33521 50559590
Amenorrhoea 53.08 18.97 30 11983 8454 50584657
Anger 52.46 18.97 33 11980 11300 50581811
Abdominal pain 52.06 18.97 148 11865 236080 50357031
Suicidal ideation 47.40 18.97 62 11951 55323 50537788
Migraine 46.33 18.97 72 11941 75208 50517903
Endometrial stromal sarcoma 44.08 18.97 7 12006 13 50593098
Vulvovaginal dryness 42.62 18.97 17 11996 2200 50590911
Product dispensing error 41.42 18.97 26 11987 8865 50584246
Fall 39.67 18.97 15 11998 334917 50258194
Focal nodular hyperplasia 39.01 18.97 11 12002 486 50592625
Blood luteinising hormone increased 37.90 18.97 8 12005 101 50593010
Adnexa uteri pain 37.00 18.97 10 12003 377 50592734
Endometriosis 35.60 18.97 18 11995 4057 50589054
Maternal exposure before pregnancy 35.57 18.97 20 11993 5577 50587534
Ovarian cyst ruptured 34.94 18.97 12 12001 1021 50592090
Joint swelling 34.45 18.97 8 12005 245278 50347833
Product leakage 33.85 18.97 10 12003 522 50592589
Blood follicle stimulating hormone abnormal 33.27 18.97 5 12008 5 50593106
Depressed mood 32.12 18.97 40 11973 33983 50559128
Aplastic anaemia 32.10 18.97 21 11992 7682 50585429
Rheumatoid arthritis 31.84 18.97 5 12008 202545 50390566
Pneumonia 31.76 18.97 26 11987 378375 50214736
Toxicity to various agents 31.75 18.97 6 12007 212493 50380618
Adnexal torsion 31.52 18.97 8 12005 235 50592876
Insomnia 30.47 18.97 101 11912 174764 50418347
Dyspareunia 29.44 18.97 13 12000 2166 50590945
Headache 28.82 18.97 212 11801 506323 50086788
Neoplasm progression 28.68 18.97 35 11978 29122 50563989
Menstruation irregular 28.66 18.97 18 11995 6144 50586967
Dental fistula 28.33 18.97 9 12004 600 50592511
Laparoscopy 28.12 18.97 5 12008 23 50593088
Breast enlargement 27.72 18.97 11 12002 1404 50591707
Prosopagnosia 26.73 18.97 5 12008 32 50593079
Vision blurred 26.48 18.97 58 11955 78589 50514522
Blood luteinising hormone decreased 26.47 18.97 5 12008 34 50593077
Adhesion 25.88 18.97 10 12003 1189 50591922
Myomectomy 25.72 18.97 4 12009 6 50593105
Uterine adhesions 25.23 18.97 5 12008 45 50593066
Genital haemorrhage 25.17 18.97 17 11996 6557 50586554
Metastases to liver 24.58 18.97 27 11986 20077 50573034
Calcium deficiency 24.41 18.97 9 12004 941 50592170
Breast cancer metastatic 24.38 18.97 20 11993 10344 50582767
Abdominal discomfort 23.31 18.97 13 12000 231628 50361483
Amnesia 22.67 18.97 38 11975 42222 50550889
Injection site mass 22.63 18.97 23 11990 15657 50577454
Idiopathic intracranial hypertension 22.36 18.97 11 12002 2338 50590773
Blood oestrogen increased 22.14 18.97 5 12008 88 50593023
Bone pain 22.12 18.97 40 11973 47189 50545922
Product physical consistency issue 22.06 18.97 7 12006 465 50592646
Oophorectomy 21.99 18.97 7 12006 470 50592641
Wrong product administered 20.85 18.97 14 11999 5346 50587765
Diarrhoea 20.84 18.97 71 11942 588405 50004706
Expired product administered 20.80 18.97 14 11999 5368 50587743
Urinary tract infection 20.56 18.97 14 11999 224006 50369105
Hypotension 19.95 18.97 16 11997 235453 50357658
Blood follicle stimulating hormone increased 19.57 18.97 5 12008 151 50592960
Ovarian disorder 19.53 18.97 7 12006 675 50592436
Libido decreased 19.32 18.97 10 12003 2366 50590745
Completed suicide 19.11 18.97 4 12009 131885 50461226

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
Intercepted product preparation error 11014.22 14.00 2055 44428 262 29527782
Syringe issue 10017.57 14.00 2056 44427 1722 29526322
Device leakage 6552.26 14.00 1497 44986 2998 29525046
Wrong technique in product usage process 3486.87 14.00 1440 45043 29988 29498056
Prostatic specific antigen increased 2143.09 14.00 788 45695 11776 29516268
Hot flush 2020.94 14.00 790 45693 14080 29513964
Product physical consistency issue 1395.35 14.00 274 46209 122 29527922
Intercepted medication error 842.64 14.00 186 46297 286 29527758
Prostate cancer metastatic 731.00 14.00 280 46203 4686 29523358
Death 719.55 14.00 1622 44861 340462 29187582
Blood testosterone increased 592.72 14.00 162 46321 826 29527218
Blood testosterone abnormal 557.20 14.00 123 46360 189 29527855
Needle issue 435.39 14.00 190 46293 4493 29523551
Intercepted product administration error 430.44 14.00 83 46400 26 29528018
Metastases to bone 424.57 14.00 237 46246 9661 29518383
Product leakage 412.16 14.00 102 46381 321 29527723
Prostate cancer 344.41 14.00 300 46183 25227 29502817
Osteonecrosis of jaw 338.29 14.00 248 46235 16262 29511782
Prostatic specific antigen abnormal 269.54 14.00 73 46410 357 29527687
Product preparation error 263.57 14.00 99 46384 1563 29526481
Malignant neoplasm progression 262.16 14.00 439 46044 73420 29454624
Hormone-refractory prostate cancer 259.41 14.00 77 46406 552 29527492
Product administration error 219.21 14.00 181 46302 14129 29513915
Injection site pain 197.26 14.00 249 46234 32197 29495847
Terminal state 195.78 14.00 100 46383 3394 29524650
Toxicity to various agents 179.57 14.00 29 46454 173632 29354412
Marasmus 158.96 14.00 50 46433 445 29527599
Prostate cancer recurrent 157.90 14.00 58 46425 857 29527187
Fatigue 154.76 14.00 936 45547 315885 29212159
Incorrect route of product administration 137.68 14.00 123 46360 10678 29517366
Injection site mass 132.60 14.00 91 46392 5364 29522680
Injection site induration 122.31 14.00 66 46417 2510 29525534
Intercepted product storage error 113.71 14.00 30 46453 130 29527914
Metastases to lymph nodes 97.61 14.00 67 46416 3950 29524094
Completed suicide 95.60 14.00 14 46469 90232 29437812
Circumstance or information capable of leading to medication error 89.41 14.00 45 46438 1479 29526565
Injection site granuloma 88.40 14.00 17 46466 5 29528039
Acute kidney injury 84.66 14.00 182 46301 265085 29262959
Hydronephrosis 83.79 14.00 85 46398 8645 29519399
Injection site abscess 83.34 14.00 34 46449 675 29527369
Underdose 79.99 14.00 96 46387 11773 29516271
Palliative care 78.67 14.00 29 46454 433 29527611
Injection site haemorrhage 73.91 14.00 78 46405 8308 29519736
Expired product administered 70.94 14.00 48 46435 2763 29525281
Pelvic mass 70.52 14.00 22 46461 190 29527854
Extra dose administered 69.33 14.00 49 46434 3028 29525016
Injection site necrosis 69.03 14.00 25 46458 354 29527690
Drug interaction 66.64 14.00 131 46352 197254 29330790
Overdose 65.27 14.00 22 46461 79797 29448247
Device connection issue 64.95 14.00 23 46460 304 29527740
Victim of child abuse 64.86 14.00 30 46453 815 29527229
Product reconstitution quality issue 62.61 14.00 17 46466 84 29527960
Bone pain 61.75 14.00 107 46376 18345 29509699
Hypotension 61.37 14.00 134 46349 194220 29333824
Pyrexia 60.59 14.00 240 46243 287382 29240662
Diarrhoea 60.19 14.00 294 46189 332404 29195640
Interstitial lung disease 59.68 14.00 213 46270 57505 29470539
Injection site ulcer 55.09 14.00 19 46464 231 29527813
Injection site nodule 54.43 14.00 32 46451 1438 29526606
Fall 53.82 14.00 468 46015 176710 29351334
Drug hypersensitivity 52.30 14.00 21 46462 68385 29459659
Cough 51.09 14.00 75 46408 126652 29401392
Neutropenia 49.25 14.00 82 46401 131629 29396415
Urinary tract toxicity 48.17 14.00 10 46473 9 29528035
Cystitis radiation 47.92 14.00 13 46470 64 29527980
Metastasis 45.58 14.00 40 46443 3389 29524655
Injection site erythema 45.49 14.00 80 46403 13876 29514168
Colon cancer stage III 45.18 14.00 14 46469 118 29527926
Product preparation issue 43.77 14.00 16 46467 233 29527811
Blood urea abnormal 43.48 14.00 22 46461 731 29527313
Reproductive toxicity 42.89 14.00 9 46474 9 29528035
Intercepted product prescribing error 42.88 14.00 13 46470 101 29527943
Radiation proctitis 42.54 14.00 12 46471 70 29527974
Back pain 42.03 14.00 290 46193 101994 29426050
Foetal exposure during pregnancy 41.63 14.00 3 46480 33864 29494180
Drug administered in wrong device 41.01 14.00 10 46473 29 29528015
Blood creatinine increased 40.92 14.00 44 46439 85058 29442986
Product colour issue 40.83 14.00 17 46466 356 29527688
Occupational exposure to product 40.31 14.00 16 46467 295 29527749
Stress urinary incontinence 40.07 14.00 12 46471 89 29527955
Metastases to lung 39.54 14.00 55 46428 7800 29520244
Suicide attempt 39.26 14.00 4 46479 34106 29493938
Vomiting 39.18 14.00 186 46297 212074 29315970
Bone lesion 38.90 14.00 33 46450 2671 29525373
Drug abuse 38.75 14.00 41 46442 79842 29448202
Metastatic salivary gland cancer 38.20 14.00 7 46476 0 29528044
White blood cell count decreased 38.01 14.00 45 46438 83317 29444727
Pneumonia 37.81 14.00 322 46161 319850 29208194
Intentional dose omission 37.75 14.00 29 46454 2037 29526007
Injection site swelling 37.41 14.00 59 46424 9358 29518686
Agitation 37.22 14.00 17 46466 51287 29476757
Blood electrolytes abnormal 37.14 14.00 21 46462 876 29527168
Injection site inflammation 36.62 14.00 19 46464 666 29527378
Infection 36.55 14.00 40 46443 76711 29451333
Dyspnoea 36.21 14.00 334 46149 326398 29201646
Angioedema 36.07 14.00 4 46479 31911 29496133
Malignant transformation 35.82 14.00 20 46463 814 29527230
Seizure 35.70 14.00 57 46426 93066 29434978
Prostatic specific antigen decreased 35.47 14.00 11 46472 93 29527951
Cardiac arrest 35.12 14.00 50 46433 85541 29442503
Febrile neutropenia 34.86 14.00 78 46405 112162 29415882
Metastases to spine 34.30 14.00 28 46455 2148 29525896
Psoriasis 34.10 14.00 5 46478 32222 29495822
Condition aggravated 34.03 14.00 117 46366 146178 29381866
Abscess sterile 33.67 14.00 8 46475 20 29528024
Haematuria 33.58 14.00 148 46335 43991 29484053
Rash 33.47 14.00 169 46314 189650 29338394
Gynaecomastia 33.36 14.00 52 46431 8165 29519879
Renal impairment 32.89 14.00 48 46435 81285 29446759
Pituitary haemorrhage 32.56 14.00 12 46471 179 29527865
Asthma 32.03 14.00 7 46476 33842 29494202
Coma 32.01 14.00 11 46472 39439 29488605
Asthenia 31.97 14.00 495 45988 214755 29313289
International normalised ratio increased 31.72 14.00 15 46468 44357 29483687
Product dosage form issue 31.45 14.00 8 46475 29 29528015
Metabolic acidosis 31.44 14.00 10 46473 37652 29490392
Bone cancer metastatic 31.30 14.00 11 46472 142 29527902
Somnolence 31.08 14.00 63 46420 93892 29434152
Incorrect dose administered 30.94 14.00 118 46365 32866 29495178
Sepsis 30.61 14.00 118 46365 142564 29385480
Product prescribing error 30.51 14.00 79 46404 17897 29510147
Epidural lipomatosis 30.40 14.00 17 46466 694 29527350
Hip fracture 30.20 14.00 57 46426 10435 29517609
Intercepted product selection error 29.90 14.00 7 46476 16 29528028
Fracture 29.89 14.00 42 46441 6011 29522033
Infusion related reaction 29.63 14.00 16 46467 43870 29484174
Pancreatitis 29.10 14.00 9 46474 34505 29493539
Tachycardia 29.01 14.00 43 46440 72367 29455677
Abdominal pain 29.00 14.00 112 46371 135245 29392799
Cancer pain 28.47 14.00 26 46457 2321 29525723
Urinary retention 28.20 14.00 112 46371 31786 29496258
Foreign body reaction 28.17 14.00 8 46475 48 29527996
Off label use 28.13 14.00 320 46163 300480 29227564
Rheumatoid arthritis 27.81 14.00 8 46475 32144 29495900
Gastrointestinal haemorrhage 27.45 14.00 52 46431 79481 29448563
Injection site abscess sterile 27.29 14.00 5 46478 0 29528044
Septic shock 27.22 14.00 35 46448 62525 29465519
Sinusitis 27.15 14.00 10 46473 34340 29493704
Product quality issue 27.13 14.00 70 46413 15825 29512219
Femur fracture 26.67 14.00 43 46440 6948 29521096
Urticaria 26.56 14.00 28 46455 54632 29473412
Metastases to soft tissue 26.48 14.00 11 46472 229 29527815
Male sexual dysfunction 26.39 14.00 11 46472 231 29527813
Disease progression 26.17 14.00 219 46264 81697 29446347
Urinary tract obstruction 26.13 14.00 29 46454 3268 29524776
Loss of libido 25.09 14.00 24 46459 2272 29525772
Macroenzyme creatine kinase 24.97 14.00 6 46477 16 29528028
Product storage error 24.96 14.00 40 46443 6430 29521614
Renal failure 24.84 14.00 99 46384 118500 29409544
Nocturia 24.78 14.00 46 46437 8316 29519728
Hypersensitivity 24.71 14.00 28 46455 52875 29475169
C-reactive protein increased 24.66 14.00 20 46463 44243 29483801
Induration 24.62 14.00 16 46467 860 29527184
Blood creatine phosphokinase increased 24.40 14.00 17 46466 40627 29487417
Bradycardia 24.37 14.00 41 46442 65588 29462456
Dementia 23.79 14.00 55 46428 11603 29516441
Radical prostatectomy 23.72 14.00 7 46476 49 29527995
Mucosal inflammation 23.65 14.00 10 46473 31585 29496459
Nausea 23.53 14.00 317 46166 288938 29239106
Anti-androgen withdrawal syndrome 23.35 14.00 5 46478 6 29528038
Radiotherapy 22.50 14.00 11 46472 339 29527705
Breast tenderness 22.35 14.00 14 46469 706 29527338
Haemoptysis 22.34 14.00 10 46473 30540 29497504
Bone cancer 22.17 14.00 17 46466 1191 29526853
Platelet count decreased 22.15 14.00 87 46396 104585 29423459
Chest pain 21.88 14.00 96 46387 111877 29416167
Inappropriate schedule of product administration 21.86 14.00 132 46351 44340 29483704
Neuroendocrine carcinoma of prostate 21.83 14.00 4 46479 0 29528044
Rib fracture 21.69 14.00 56 46427 12662 29515382
Respiratory arrest 21.31 14.00 7 46476 25826 29502218
Product dispensing error 21.31 14.00 34 46449 5446 29522598
Spinal compression fracture 21.25 14.00 36 46447 6058 29521986
Pruritus 21.16 14.00 103 46380 116746 29411298
Bone density decreased 21.14 14.00 19 46464 1661 29526383
Pancytopenia 21.06 14.00 64 46419 83104 29444940
Bladder neck obstruction 21.02 14.00 8 46475 131 29527913
Injection site reaction 20.90 14.00 51 46432 11137 29516907
Chest discomfort 20.76 14.00 25 46458 45958 29482086
Product administered at inappropriate site 20.76 14.00 19 46464 1701 29526343
Oxygen saturation decreased 20.75 14.00 24 46459 44913 29483131
Drug reaction with eosinophilia and systemic symptoms 20.73 14.00 9 46474 27983 29500061
Pollakiuria 20.61 14.00 66 46417 16850 29511194
Tremor 20.53 14.00 54 46429 73484 29454560
Lower respiratory tract infection 20.47 14.00 8 46475 26494 29501550
Cardiogenic shock 20.25 14.00 3 46480 19187 29508857
Product size issue 20.06 14.00 12 46471 557 29527487
Juvenile idiopathic arthritis 20.02 14.00 17 46466 1377 29526667
Metastases to liver 20.01 14.00 52 46431 11804 29516240
Blood pressure increased 20.00 14.00 55 46428 73748 29454296
Respiratory distress 19.85 14.00 13 46470 32093 29495951
White blood cell count increased 19.63 14.00 18 46465 37498 29490546
Thrombocytopenia 19.46 14.00 128 46355 134695 29393349
Traumatic fracture 19.11 14.00 9 46474 255 29527789
Liver function test abnormal 18.86 14.00 11 46472 28907 29499137
Injection site discomfort 18.79 14.00 16 46467 1301 29526743
Aggression 18.65 14.00 17 46466 35524 29492520
Injection site extravasation 18.60 14.00 21 46462 2412 29525632
Meningioma 18.55 14.00 16 46467 1324 29526720
Testicular atrophy 18.47 14.00 11 46472 506 29527538
Eye haematoma 18.45 14.00 6 46477 60 29527984
Intercepted product dispensing error 18.45 14.00 6 46477 60 29527984
Neutrophil count decreased 18.31 14.00 25 46458 43542 29484502
Leukopenia 18.26 14.00 37 46446 55166 29472878
Hyperkalaemia 17.97 14.00 44 46439 61348 29466696
Hepatic enzyme increased 17.94 14.00 16 46467 33783 29494261
Osteoporosis 17.94 14.00 47 46436 10722 29517322
Metastases to breast 17.79 14.00 4 46479 7 29528037
Respiratory failure 17.36 14.00 86 46397 97045 29430999
Nasopharyngitis 17.28 14.00 43 46440 59622 29468422
Transitional cell carcinoma 17.05 14.00 18 46465 1917 29526127
Product availability issue 16.94 14.00 14 46469 1093 29526951
Dysuria 16.87 14.00 75 46408 22365 29505679
Urethral intrinsic sphincter deficiency 16.56 14.00 4 46479 11 29528033
Bone marrow tumour cell infiltration 16.56 14.00 4 46479 11 29528033
Hospice care 16.44 14.00 29 46454 5039 29523005
Anaplastic meningioma 16.37 14.00 3 46480 0 29528044
Blood testosterone normal 16.37 14.00 3 46480 0 29528044
Metastases to penis 16.37 14.00 3 46480 0 29528044
Coagulopathy 16.35 14.00 4 46479 17903 29510141
Hypoglycaemia 16.33 14.00 32 46451 48314 29479730
Hypoxia 16.32 14.00 31 46452 47348 29480696
Metastases to spinal cord 16.30 14.00 4 46479 12 29528032
Pancreatitis acute 16.30 14.00 9 46474 24376 29503668
Intentional product use issue 16.28 14.00 26 46457 42472 29485572
Headache 16.26 14.00 185 46298 173822 29354222
Eye colour change 16.23 14.00 8 46475 251 29527793
Vipoma 16.06 14.00 4 46479 13 29528031
Pelvic pain 15.98 14.00 18 46465 2061 29525983
Injection site discharge 15.95 14.00 6 46477 95 29527949
Product physical issue 15.92 14.00 18 46465 2070 29525974
Plasma cell myeloma 15.89 14.00 21 46462 37094 29490950
Diabetes mellitus 15.78 14.00 112 46371 39719 29488325
Mental status changes 15.75 14.00 19 46464 34908 29493136
Bronchitis 15.65 14.00 21 46462 36847 29491197
Premature baby 15.50 14.00 4 46479 17276 29510768
Culture positive 15.33 14.00 11 46472 696 29527348
Muscular weakness 15.31 14.00 157 46326 61895 29466149
Breast cancer male 15.20 14.00 8 46475 289 29527755
Urinary tract infection 15.07 14.00 177 46306 72177 29455867
Eosinophilia 15.07 14.00 8 46475 22153 29505891
Injection site infection 15.06 14.00 12 46471 889 29527155
Encephalopathy 14.96 14.00 16 46467 31027 29497017
Respiratory depression 14.90 14.00 51 46432 13472 29514572
Abnormal behaviour 14.79 14.00 9 46474 23118 29504926
Blood testosterone decreased 14.75 14.00 24 46459 3906 29524138
Lymphocyte count decreased 14.58 14.00 6 46477 19265 29508779
Euthanasia 14.53 14.00 4 46479 21 29528023
Anxiety 14.45 14.00 77 46406 85288 29442756
Product solubility abnormal 14.44 14.00 9 46474 450 29527594
Cardiac ventricular scarring 14.30 14.00 3 46480 3 29528041
Extradural neoplasm 14.30 14.00 3 46480 3 29528041
Multiple organ dysfunction syndrome 14.30 14.00 51 46432 63065 29464979
Neovascular age-related macular degeneration 14.27 14.00 6 46477 129 29527915
Hypervolaemia 14.04 14.00 5 46478 17540 29510504
Wheezing 14.04 14.00 19 46464 33221 29494823
Lymphadenopathy 14.04 14.00 77 46406 24972 29503072
Metastases to bone marrow 14.03 14.00 9 46474 473 29527571

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
Intercepted product preparation error 8488.81 12.55 1409 41708 499 64455116
Syringe issue 7456.08 12.55 1426 41691 2860 64452755
Device leakage 4551.66 12.55 1064 42053 7202 64448413
Wrong technique in product usage process 2093.20 12.55 969 42148 64005 64391610
Prostatic specific antigen increased 2081.30 12.55 577 42540 8183 64447432
Hot flush 1337.77 12.55 641 42476 45594 64410021
Product physical consistency issue 995.14 12.55 188 42929 334 64455281
Intercepted medication error 659.56 12.55 142 42975 613 64455002
Blood testosterone increased 436.03 12.55 102 43015 684 64454931
Prostate cancer metastatic 435.03 12.55 138 42979 3166 64452449
Death 421.86 12.55 967 42150 481738 63973877
Blood testosterone abnormal 404.31 12.55 74 43043 99 64455516
Prostate cancer 356.76 12.55 200 42917 19595 64436020
Intercepted product administration error 338.57 12.55 64 43053 114 64455501
Metastases to bone 313.69 12.55 186 42931 20249 64435366
Needle issue 293.51 12.55 137 42980 9135 64446480
Osteonecrosis of jaw 293.06 12.55 230 42887 39595 64416020
Product leakage 265.21 12.55 66 43051 592 64455023
Malignant neoplasm progression 240.59 12.55 335 42782 112536 64343079
Prostate cancer recurrent 194.90 12.55 53 43064 692 64454923
Prostatic specific antigen abnormal 190.39 12.55 41 43076 177 64455438
Hormone-refractory prostate cancer 189.19 12.55 45 43072 327 64455288
Pelvic pain 171.84 12.55 101 43016 10809 64444806
Toxicity to various agents 152.89 12.55 29 43088 363484 64092131
Injection site abscess 142.03 12.55 48 43069 1350 64454265
Ovarian hyperstimulation syndrome 135.36 12.55 56 43061 2789 64452826
Occupational exposure to product 116.38 12.55 34 43083 584 64455031
Abscess sterile 112.50 12.55 22 43095 51 64455564
Product preparation error 110.93 12.55 54 43063 3951 64451664
Injection site pain 109.82 12.55 235 42882 111173 64344442
Product administration error 99.48 12.55 107 43010 27536 64428079
Completed suicide 98.42 12.55 16 43101 224398 64231217
Vaginal haemorrhage 97.61 12.55 90 43027 19254 64436361
Hydronephrosis 94.09 12.55 77 43040 14048 64441567
Victim of child abuse 88.85 12.55 30 43087 841 64454774
Intercepted product storage error 86.84 12.55 21 43096 165 64455450
Injection site granuloma 85.33 12.55 17 43100 45 64455570
Drug hypersensitivity 79.14 12.55 30 43087 237785 64217830
Fatigue 77.70 12.55 802 42315 747928 63707687
Injection site mass 76.94 12.55 75 43042 17195 64438420
Rheumatoid arthritis 75.98 12.55 10 43107 164284 64291331
Marasmus 69.67 12.55 25 43092 843 64454772
Incorrect route of product administration 66.53 12.55 80 43037 23218 64432397
Injection site abscess sterile 64.64 12.55 11 43106 6 64455609
Injection site induration 64.39 12.55 51 43066 8881 64446734
Interstitial lung disease 62.90 12.55 175 42942 97557 64358058
Terminal state 61.84 12.55 38 43079 4406 64451209
Heavy menstrual bleeding 60.56 12.55 56 43061 12021 64443594
Pelvic mass 60.39 12.55 24 43093 1076 64454539
Infusion related reaction 59.47 12.55 18 43099 164449 64291166
Sinusitis 56.45 12.55 14 43103 145914 64309701
Joint swelling 55.49 12.55 38 43079 215344 64240271
Haematuria 55.49 12.55 124 42993 60347 64395268
Hysterectomy 54.74 12.55 37 43080 5048 64450567
Extra dose administered 54.01 12.55 41 43076 6709 64448906
Cystitis radiation 52.91 12.55 13 43104 110 64455505
Cough 52.87 12.55 75 43042 302073 64153542
Metastases to lymph nodes 52.83 12.55 45 43072 8672 64446943
Product reconstitution quality issue 52.33 12.55 14 43103 171 64455444
Overdose 51.63 12.55 21 43096 159545 64296070
Underdose 51.00 12.55 74 43043 25755 64429860
Oestradiol increased 50.59 12.55 12 43105 86 64455529
Nasopharyngitis 49.97 12.55 35 43082 196038 64259577
Blood urea abnormal 48.24 12.55 21 43096 1187 64454428
Injection site haemorrhage 47.12 12.55 69 43048 24209 64431406
Malignant transformation 46.10 12.55 20 43097 1121 64454494
Infection 45.80 12.55 34 43083 184846 64270769
Mood swings 45.07 12.55 57 43060 17411 64438204
Circumstance or information capable of leading to medication error 45.05 12.55 28 43089 3312 64452303
Metastatic salivary gland cancer 44.18 12.55 7 43110 0 64455615
Lower respiratory tract infection 43.16 12.55 6 43111 94608 64361007
Male sexual dysfunction 43.03 12.55 12 43105 173 64455442
Metastases to lung 42.91 12.55 52 43065 15212 64440403
Pituitary haemorrhage 41.43 12.55 13 43104 287 64455328
Radiation proctitis 40.98 12.55 10 43107 82 64455533
Epidural lipomatosis 40.83 12.55 17 43100 860 64454755
Metastases to liver 40.74 12.55 64 43053 23877 64431738
Product prescribing error 40.14 12.55 79 43038 35190 64420425
Epiphysiolysis 40.05 12.55 10 43107 91 64455524
Diarrhoea 39.61 12.55 302 42815 722402 63733213
Urinary retention 38.70 12.55 95 43022 49106 64406509
Expired product administered 38.54 12.55 32 43085 5955 64449660
Gynaecomastia 38.40 12.55 32 43085 5984 64449631
Urinary tract obstruction 38.01 12.55 27 43090 3990 64451625
Disease progression 37.79 12.55 191 42926 141489 64314126
Swelling 37.74 12.55 31 43086 160187 64295428
Bone pain 37.57 12.55 92 43025 47480 64408135
Blood electrolytes abnormal 37.52 12.55 20 43097 1771 64453844
Hypersensitivity 37.16 12.55 46 43071 196406 64259209
Blood luteinising hormone increased 37.06 12.55 11 43106 200 64455415
Blood testosterone decreased 36.99 12.55 21 43096 2104 64453511
Condition aggravated 36.65 12.55 127 42990 372299 64083316
Drug intolerance 36.64 12.55 43 43074 187949 64267666
Rash 36.53 12.55 170 42947 458379 63997236
Drug administered in wrong device 36.52 12.55 8 43109 38 64455577
Product dosage form issue 36.35 12.55 8 43109 39 64455576
Bone lesion 36.32 12.55 29 43088 5108 64450507
Hypotension 36.10 12.55 132 42985 380842 64074773
Hepatic enzyme increased 36.10 12.55 21 43096 129922 64325693
Arthropathy 35.87 12.55 18 43099 120949 64334666
Metastasis 35.75 12.55 30 43087 5665 64449950
Maternal exposure during pregnancy 35.55 12.55 10 43107 95874 64359741
Intercepted product selection error 35.44 12.55 6 43111 3 64455612
Back pain 35.40 12.55 287 42830 249884 64205731
Coma 34.67 12.55 8 43109 87607 64368008
Device connection issue 34.19 12.55 15 43102 864 64454751
Injury associated with device 33.71 12.55 22 43095 2831 64452784
Injection site nodule 33.58 12.55 23 43094 3207 64452408
Uterine leiomyoma 33.12 12.55 28 43089 5341 64450274
Product quality issue 33.01 12.55 66 43051 29733 64425882
Menstrual disorder 32.73 12.55 23 43094 3342 64452273
Wound 32.29 12.55 6 43111 76471 64379144
Somnolence 32.28 12.55 54 43063 203591 64252024
Endometrial stromal sarcoma 31.63 12.55 6 43111 11 64455604
Asthenia 31.11 12.55 429 42688 427615 64028000
Metastases to spine 31.09 12.55 23 43094 3620 64451995
Pericarditis 30.91 12.55 3 43114 62513 64393102
Intentional dose omission 29.88 12.55 27 43090 5625 64449990
Loss of libido 29.54 12.55 19 43098 2385 64453230
Drug interaction 28.95 12.55 134 42983 361949 64093666
Systemic lupus erythematosus 28.95 12.55 8 43109 77604 64378011
Asthma 28.48 12.55 14 43103 95211 64360404
Prostatic specific antigen decreased 28.30 12.55 7 43110 61 64455554
Bronchitis 28.23 12.55 19 43098 108724 64346891
Intermenstrual bleeding 28.12 12.55 25 43092 5100 64450515
Diabetes mellitus 28.06 12.55 103 43014 66371 64389244
Injection site ulcer 27.96 12.55 12 43105 655 64454960
Erectile dysfunction 27.62 12.55 38 43079 12589 64443026
Anti-androgen withdrawal syndrome 27.62 12.55 5 43112 6 64455609
Therapeutic product effect decreased 27.55 12.55 22 43095 115329 64340286
Dyspnoea 27.52 12.55 328 42789 718346 63737269
Night sweats 26.67 12.55 68 43049 35978 64419637
Intercepted product prescribing error 26.63 12.55 9 43108 253 64455362
Dysmenorrhoea 26.48 12.55 18 43099 2479 64453136
Psoriasis 25.63 12.55 8 43109 71695 64383920
Meningioma 25.51 12.55 21 43096 3861 64451754
Bladder neck obstruction 25.35 12.55 7 43110 97 64455518
Product colour issue 25.26 12.55 11 43106 622 64454993
Neuroendocrine carcinoma of prostate 25.25 12.55 4 43113 0 64455615
Adnexa uteri pain 25.04 12.55 9 43108 305 64455310
Focal nodular hyperplasia 24.87 12.55 11 43106 646 64454969
Macroenzyme creatine kinase 24.64 12.55 5 43112 15 64455600
Palliative care 24.41 12.55 11 43106 675 64454940
Foreign body reaction 24.31 12.55 7 43110 114 64455501
Dental fistula 24.21 12.55 10 43107 496 64455119
Vomiting 24.06 12.55 244 42873 550873 63904742
Acute kidney injury 23.94 12.55 189 42928 449051 64006564
Dysuria 23.84 12.55 72 43045 41985 64413630
Metabolic acidosis 23.49 12.55 9 43108 70949 64384666
Intercepted product dispensing error 23.35 12.55 7 43110 132 64455483
International normalised ratio increased 23.14 12.55 12 43105 79155 64376460
Metastases to soft tissue 23.09 12.55 9 43108 383 64455232
Intentional product use issue 23.01 12.55 18 43099 95346 64360269
Tachycardia 22.48 12.55 41 43076 149538 64306077
Abdominal discomfort 22.38 12.55 56 43061 182266 64273349
Cancer pain 21.85 12.55 20 43097 4237 64451378
Lipid metabolism disorder 21.77 12.55 8 43109 289 64455326
Prosopagnosia 21.71 12.55 5 43112 31 64455584
Laparoscopy 21.58 12.55 4 43113 6 64455609
Respiratory depression 21.41 12.55 48 43069 23395 64432220
Adnexal torsion 21.02 12.55 7 43110 188 64455427
Transitional cell carcinoma 21.01 12.55 15 43102 2234 64453381
Pollakiuria 20.80 12.55 57 43060 31473 64424142
Nocturia 20.61 12.55 31 43086 11134 64444481
Pyrexia 20.57 12.55 257 42860 558387 63897228
Product preparation issue 20.51 12.55 10 43107 734 64454881
Oxygen saturation decreased 20.35 12.55 25 43092 107151 64348464
Urine flow decreased 20.30 12.55 11 43106 1006 64454609
Angioedema 20.20 12.55 8 43109 61813 64393802
Injection site necrosis 20.16 12.55 12 43105 1313 64454302
Metastases to spinal cord 20.07 12.55 5 43112 45 64455570
Product dispensing error 20.02 12.55 31 43086 11419 64444196
Breast enlargement 20.02 12.55 12 43105 1330 64454285
Incorrect dose administered 19.91 12.55 87 43030 60678 64394937
Eye haematoma 19.87 12.55 6 43111 116 64455499
Hospice care 19.86 12.55 25 43092 7600 64448015
Ovarian cyst 19.50 12.55 30 43087 10988 64444627
Juvenile idiopathic arthritis 19.47 12.55 18 43099 3861 64451754
Prostatic mass 19.47 12.55 4 43113 13 64455602
Vipoma 19.47 12.55 4 43113 13 64455602
Radical prostatectomy 19.47 12.55 4 43113 13 64455602
Lymphadenopathy 19.42 12.55 72 43045 46614 64409001
Product size issue 19.31 12.55 9 43108 597 64455018
Uterine haemorrhage 19.18 12.55 15 43102 2564 64453051
Urethral intrinsic sphincter deficiency 19.02 12.55 4 43113 15 64455600
Pancreatitis 19.01 12.55 8 43109 59599 64396016
Anaplastic meningioma 18.93 12.55 3 43114 0 64455615
Blood testosterone normal 18.93 12.55 3 43114 0 64455615
Rib fracture 18.46 12.55 46 43071 23992 64431623
Loss of personal independence in daily activities 18.35 12.55 13 43104 72441 64383174
Pruritus 18.25 12.55 128 42989 312272 64143343
Injection site inflammation 18.25 12.55 16 43101 3205 64452410
Blood pressure fluctuation 18.16 12.55 6 43111 51865 64403750
Vulvovaginal dryness 18.03 12.55 12 43105 1596 64454019
Drug dependence 17.92 12.55 56 43061 33256 64422359
Spinal compression fracture 17.91 12.55 34 43083 14741 64440874
Nausea 17.61 12.55 396 42721 785404 63670211
Neuroendocrine carcinoma 17.48 12.55 8 43109 509 64455106
Bone cancer metastatic 17.38 12.55 6 43111 180 64455435
Testicular atrophy 17.18 12.55 7 43110 335 64455280
Respiratory arrest 17.08 12.55 7 43110 52978 64402637
Acute coronary syndrome 17.04 12.55 39 43078 19271 64436344
Lactic acidosis 16.94 12.55 10 43107 61400 64394215
Renal impairment 16.93 12.55 41 43076 134976 64320639
Cardiac ventricular scarring 16.86 12.55 3 43114 3 64455612
Drug abuse 16.76 12.55 40 43077 132334 64323281
Pulmonary embolism 16.58 12.55 160 42957 146196 64309419
Stomatitis 16.50 12.55 30 43087 109575 64346040
Child abuse 16.40 12.55 6 43111 214 64455401
Blood follicle stimulating hormone abnormal 16.39 12.55 3 43114 4 64455611
Suicide attempt 16.39 12.55 14 43103 70993 64384622
Breast cancer male 16.37 12.55 6 43111 215 64455400
Tremor 16.33 12.55 48 43069 148182 64307433
Hypervolaemia 16.17 12.55 3 43114 38282 64417333
Drug reaction with eosinophilia and systemic symptoms 16.17 12.55 8 43109 54209 64401406
Neovascular age-related macular degeneration 15.79 12.55 6 43111 238 64455377
Stress urinary incontinence 15.72 12.55 11 43106 1587 64454028
Oophorectomy 15.65 12.55 6 43111 244 64455371
Myomectomy 15.64 12.55 3 43114 6 64455609
Bone marrow tumour cell infiltration 15.59 12.55 4 43113 41 64455574
Product storage error 15.35 12.55 30 43087 13288 64442327
Inappropriate schedule of product administration 15.33 12.55 110 43007 92176 64363439
Induration 15.32 12.55 11 43106 1653 64453962
Pathological fracture 15.22 12.55 24 43093 8981 64446634
Urethral stenosis 15.19 12.55 9 43108 977 64454638
Hypoglycaemia 15.02 12.55 23 43094 89869 64365746
Gastrointestinal disorder 14.94 12.55 23 43094 89686 64365929
Haematocolpos 14.94 12.55 4 43113 49 64455566
Blood creatinine increased 14.93 12.55 44 43073 135738 64319877
Pneumonia 14.89 12.55 274 42843 559302 63896313
Radiation injury 14.82 12.55 8 43109 726 64454889
Calcium deficiency 14.78 12.55 8 43109 730 64454885
Bradycardia 14.74 12.55 36 43081 118183 64337432
Liver function test abnormal 14.60 12.55 11 43106 59390 64396225
Euthanasia 14.58 12.55 4 43113 54 64455561
Culture positive 14.57 12.55 9 43108 1053 64454562
Agitation 14.39 12.55 23 43094 88344 64367271
Polyneuropathy in malignant disease 14.33 12.55 5 43112 155 64455460
Injection site infection 14.20 12.55 11 43106 1854 64453761
Injection site swelling 14.15 12.55 60 43057 41293 64414322
Therapeutic product effect incomplete 14.13 12.55 30 43087 103452 64352163
Inner ear disorder 14.13 12.55 7 43110 532 64455083
Traumatic fracture 14.07 12.55 8 43109 804 64454811
Inguinal hernia 14.06 12.55 18 43099 5563 64450052
Prostatic obstruction 14.01 12.55 4 43113 63 64455552
Chest discomfort 13.98 12.55 36 43081 116070 64339545
Ill-defined disorder 13.91 12.55 6 43111 44046 64411569
Pituitary apoplexy 13.84 12.55 5 43112 172 64455443
Blood pressure increased 13.68 12.55 64 43053 172488 64283127
Oropharyngeal pain 13.67 12.55 24 43093 88843 64366772
Ovarian cyst ruptured 13.63 12.55 8 43109 853 64454762
Cardiac arrest 13.52 12.55 55 43062 154009 64301606
Psoriatic arthropathy 13.50 12.55 6 43111 43275 64412340
Placenta accreta 13.47 12.55 5 43112 186 64455429
Bone density decreased 13.45 12.55 24 43093 9928 64445687
Maternal exposure before pregnancy 13.44 12.55 14 43103 3469 64452146
Exposed bone in jaw 13.43 12.55 14 43103 3473 64452142
Extradural neoplasm 13.41 12.55 3 43114 16 64455599
Hysteroscopy 13.41 12.55 3 43114 16 64455599
Eye colour change 13.29 12.55 6 43111 370 64455245
Breast tenderness 13.29 12.55 11 43106 2038 64453577
Metastases to pleura 13.14 12.55 9 43108 1255 64454360
Tongue discomfort 13.06 12.55 11 43106 2088 64453527
Injection site discomfort 12.83 12.55 15 43102 4226 64451389
Cardiogenic shock 12.75 12.55 3 43114 32424 64423191
Arthritis 12.56 12.55 23 43094 83791 64371824

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L02AE02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ENDOCRINE THERAPY
HORMONES AND RELATED AGENTS
Gonadotropin releasing hormone analogues
ATC L02AE51 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ENDOCRINE THERAPY
HORMONES AND RELATED AGENTS
Gonadotropin releasing hormone analogues
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:50751 anti-estrogenic drug
CHEBI has role CHEBI:63533 gonadotropin releasing hormone agonists
FDA MoA N0000175654 Gonadotropin Releasing Hormone Receptor Agonists
FDA EPC N0000175655 Gonadotropin Releasing Hormone Receptor Agonist
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018931 Antineoplastic Agents, Hormonal
MeSH PA D005300 Fertility Agents, Female
MeSH PA D012102 Reproductive Control Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Endometriosis indication 129103003
Precocious puberty indication 400179000
Advanced Prostatic Carcinoma indication
Anemia due to Bleeding Uterine Leiomyoma indication
Malignant tumor of ovary off-label use 363443007 DOID:2394
Urinary tract obstruction contraindication 7163005 DOID:5200
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Hypertensive disorder contraindication 38341003 DOID:10763
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Cerebrovascular accident contraindication 230690007
Pregnancy, function contraindication 289908002
Osteopenia contraindication 312894000
Cardiovascular event risk contraindication 395112001
Breastfeeding (mother) contraindication 413712001
Obesity contraindication 414916001 DOID:9970
Smokes tobacco daily contraindication 449868002
Vertebral Metastases contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.65 acidic
pKa2 11.9 acidic
pKa3 12.73 acidic
pKa4 13.09 acidic
pKa5 13.39 acidic
pKa6 13.69 acidic
pKa7 10.75 Basic
pKa8 6.69 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
22.5MG ELIGARD KIT TOLMAR THERAP N021379 July 24, 2002 RX POWDER SUBCUTANEOUS 8470359 Oct. 15, 2023 METHOD OF TREATING CANCER
30MG ELIGARD KIT TOLMAR THERAP N021488 Feb. 13, 2003 RX POWDER SUBCUTANEOUS 8470359 Oct. 15, 2023 METHOD OF TREATING CANCER
45MG ELIGARD KIT TOLMAR THERAP N021731 Dec. 14, 2004 RX POWDER SUBCUTANEOUS 8470359 Oct. 15, 2023 METHOD OF TREATING CANCER
45MG FENSOLVI KIT TOLMAR N213150 May 1, 2020 RX POWDER SUBCUTANEOUS 8470359 Oct. 15, 2023 METHOD OF TREATING PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY
45MG/VIAL LUPRON DEPOT ABBVIE ENDOCRINE INC N020517 June 17, 2011 RX INJECTABLE INJECTION 8921326 Feb. 5, 2031 PALLIATIVE TREATMENT OF PROSTATE CANCER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
45MG FENSOLVI KIT TOLMAR N213150 May 1, 2020 RX POWDER SUBCUTANEOUS May 1, 2023 TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY (CPP)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Gonadotropin-releasing hormone receptor GPCR AGONIST IC50 9.52 WOMBAT-PK CHEMBL
Gonadotropin-releasing hormone receptor GPCR IC50 9.30 CHEMBL

External reference:

IDSource
4019800 VUID
N0000147889 NUI
D00989 KEGG_DRUG
74381-53-6 SECONDARY_CAS_RN
4018977 VANDF
4019800 VANDF
C0085272 UMLSCUI
CHEBI:6427 CHEBI
CHEMBL1201199 ChEMBL_ID
CHEMBL1200775 ChEMBL_ID
DB00007 DRUGBANK_ID
C493311 MESH_SUPPLEMENTAL_RECORD_UI
1175 IUPHAR_LIGAND_ID
37JNS02E7V UNII
657181 PUBCHEM_CID
203217 RXNORM
11929 MMSL
43716 MMSL
4966 MMSL
8763 MMSL
d01353 MMSL
002675 NDDF
004751 NDDF
008314 NDDF
008315 NDDF
350364005 SNOMEDCT_US
397198002 SNOMEDCT_US
70562007 SNOMEDCT_US
D016729 MESH_DESCRIPTOR_UI
5025 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Leuprolide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0185-7400 INJECTION, SOLUTION 1 mg SUBCUTANEOUS ANDA 25 sections