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degarelix 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| gonadotropin-releasing-hormone (GnRH) inhibitors, peptides | 4379 | 214766-78-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
FE-200486 is the acetate salt
|
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2.70 | mg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.74 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 0.68 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.10 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 18.60 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 24, 2008 | FDA | FERRING | |
| June 26, 2012 | PMDA | Astellas Pharma Inc. | |
| Sept. 29, 2023 | EMA | ACCORD HEALTHCARE S.L.U. |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Injection site erythema | 317.39 | 19.64 | 125 | 7829 | 20070 | 42593311 |
| Injection site pain | 283.70 | 19.64 | 160 | 7794 | 57638 | 42555743 |
| Prostatic specific antigen increased | 235.47 | 19.64 | 96 | 7858 | 16829 | 42596552 |
| Hot flush | 216.09 | 19.64 | 98 | 7856 | 22253 | 42591128 |
| Injection site swelling | 208.17 | 19.64 | 88 | 7866 | 16885 | 42596496 |
| Injection site induration | 154.94 | 19.64 | 47 | 7907 | 3440 | 42609941 |
| Osteonecrosis of jaw | 142.45 | 19.64 | 70 | 7884 | 18979 | 42594402 |
| Injection site mass | 96.94 | 19.64 | 42 | 7912 | 8533 | 42604848 |
| Injection site nodule | 82.77 | 19.64 | 26 | 7928 | 2135 | 42611246 |
| Injection site reaction | 72.81 | 19.64 | 42 | 7912 | 15679 | 42597702 |
| Injection site cellulitis | 71.70 | 19.64 | 18 | 7936 | 648 | 42612733 |
| Metastases to bone | 69.74 | 19.64 | 40 | 7914 | 14769 | 42598612 |
| Interstitial lung disease | 62.39 | 19.64 | 75 | 7879 | 78387 | 42534994 |
| Injection site warmth | 61.75 | 19.64 | 22 | 7932 | 2661 | 42610720 |
| Prostatic specific antigen abnormal | 61.24 | 19.64 | 17 | 7937 | 907 | 42612474 |
| Hypocalcaemia | 50.14 | 19.64 | 43 | 7911 | 30130 | 42583251 |
| Injection site inflammation | 45.01 | 19.64 | 14 | 7940 | 1112 | 42612269 |
| Prostate cancer metastatic | 42.59 | 19.64 | 22 | 7932 | 6607 | 42606774 |
| Necrotising retinitis | 37.81 | 19.64 | 12 | 7942 | 1018 | 42612363 |
| Injection site abscess | 37.79 | 19.64 | 12 | 7942 | 1020 | 42612361 |
| Blood testosterone abnormal | 35.56 | 19.64 | 10 | 7944 | 559 | 42612822 |
| Malignant neoplasm progression | 34.81 | 19.64 | 68 | 7886 | 108332 | 42505049 |
| Hormone-dependent prostate cancer | 32.93 | 19.64 | 6 | 7948 | 43 | 42613338 |
| Blood testosterone increased | 32.87 | 19.64 | 12 | 7942 | 1555 | 42611826 |
| Toxicity to various agents | 31.89 | 19.64 | 3 | 7951 | 229133 | 42384248 |
| Infusion site plaque | 31.82 | 19.64 | 5 | 7949 | 12 | 42613369 |
| Prescribed underdose | 31.19 | 19.64 | 21 | 7933 | 10261 | 42603120 |
| Hormone-refractory prostate cancer | 29.97 | 19.64 | 10 | 7944 | 994 | 42612387 |
| Drug ineffective | 28.75 | 19.64 | 46 | 7908 | 630151 | 41983230 |
| Injection site discomfort | 28.18 | 19.64 | 12 | 7942 | 2334 | 42611047 |
| Hepatic function abnormal | 28.11 | 19.64 | 41 | 7913 | 51526 | 42561855 |
| Product administered at inappropriate site | 28.06 | 19.64 | 13 | 7941 | 3085 | 42610296 |
| Prostate cancer | 28.05 | 19.64 | 38 | 7916 | 44605 | 42568776 |
| Decreased appetite | 24.99 | 19.64 | 86 | 7868 | 193051 | 42420330 |
| Fatigue | 24.10 | 19.64 | 151 | 7803 | 435490 | 42177891 |
| Urethral obstruction | 23.82 | 19.64 | 6 | 7948 | 219 | 42613162 |
| Urinary retention | 23.64 | 19.64 | 34 | 7920 | 42180 | 42571201 |
| Wrong technique in product usage process | 23.38 | 19.64 | 34 | 7920 | 42601 | 42570780 |
| Toxic cataract | 23.18 | 19.64 | 4 | 7950 | 20 | 42613361 |
| Bone pain | 22.67 | 19.64 | 25 | 7929 | 23767 | 42589614 |
| Metastases to liver | 22.61 | 19.64 | 21 | 7933 | 16305 | 42597076 |
| Syringe issue | 22.48 | 19.64 | 16 | 7938 | 8540 | 42604841 |
| Cerebral amyloid angiopathy | 22.39 | 19.64 | 6 | 7948 | 280 | 42613101 |
| Postrenal failure | 22.26 | 19.64 | 7 | 7947 | 576 | 42612805 |
| Metastases to spine | 22.06 | 19.64 | 11 | 7943 | 3066 | 42610315 |
| Spinal cord infarction | 21.35 | 19.64 | 7 | 7947 | 659 | 42612722 |
| Product lot number issue | 20.86 | 19.64 | 4 | 7950 | 39 | 42613342 |
| Metastases to lymph nodes | 20.01 | 19.64 | 13 | 7941 | 5985 | 42607396 |
| Mucocutaneous disorder | 20.00 | 19.64 | 5 | 7949 | 177 | 42613204 |
FDA Adverse Event Reporting System (Geriatric)
| 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 |
|---|---|---|---|---|---|---|
| Prostatic specific antigen increased | 275.85 | 19.92 | 76 | 6582 | 12435 | 110570206 |
| Injection site erythema | 184.74 | 19.92 | 97 | 6561 | 94079 | 110488562 |
| Injection site pain | 169.50 | 19.92 | 115 | 6543 | 177807 | 110404834 |
| Hot flush | 161.55 | 19.92 | 79 | 6579 | 65957 | 110516684 |
| Osteonecrosis of jaw | 140.52 | 19.92 | 65 | 6593 | 47952 | 110534689 |
| Injection site swelling | 127.82 | 19.92 | 66 | 6592 | 61724 | 110520917 |
| Injection site induration | 111.37 | 19.92 | 37 | 6621 | 11346 | 110571295 |
| Interstitial lung disease | 78.78 | 19.92 | 66 | 6592 | 139268 | 110443373 |
| Injection site mass | 74.09 | 19.92 | 34 | 6624 | 24579 | 110558062 |
| Injection site cellulitis | 62.21 | 19.92 | 16 | 6642 | 2004 | 110580637 |
| Injection site nodule | 61.46 | 19.92 | 19 | 6639 | 4627 | 110578014 |
| Hypocalcaemia | 59.13 | 19.92 | 41 | 6617 | 65325 | 110517316 |
| Prostate cancer metastatic | 56.16 | 19.92 | 18 | 6640 | 4925 | 110577716 |
| Prostate cancer | 55.06 | 19.92 | 32 | 6626 | 37609 | 110545032 |
| Metastases to bone | 54.91 | 19.92 | 30 | 6628 | 31342 | 110551299 |
| Necrotising retinitis | 46.04 | 19.92 | 12 | 6646 | 1584 | 110581057 |
| Prostatic specific antigen abnormal | 45.05 | 19.92 | 10 | 6648 | 669 | 110581972 |
| Injection site abscess | 43.32 | 19.92 | 12 | 6646 | 1994 | 110580647 |
| Urinary retention | 39.32 | 19.92 | 33 | 6625 | 69650 | 110512991 |
| Hormone-refractory prostate cancer | 36.98 | 19.92 | 9 | 6649 | 901 | 110581740 |
| Infusion site plaque | 36.66 | 19.92 | 5 | 6653 | 15 | 110582626 |
| Malignant neoplasm progression | 35.52 | 19.92 | 48 | 6610 | 174519 | 110408122 |
| Hepatic function abnormal | 34.15 | 19.92 | 34 | 6624 | 89261 | 110493380 |
| Injection site warmth | 31.44 | 19.92 | 17 | 6641 | 17388 | 110565253 |
| Hormone-dependent prostate cancer | 30.88 | 19.92 | 6 | 6652 | 208 | 110582433 |
| Injection site inflammation | 29.40 | 19.92 | 11 | 6647 | 4760 | 110577881 |
| Decreased appetite | 28.96 | 19.92 | 78 | 6580 | 475768 | 110106873 |
| Urethral obstruction | 28.74 | 19.92 | 6 | 6652 | 300 | 110582341 |
| Prostatic specific antigen decreased | 28.62 | 19.92 | 5 | 6653 | 95 | 110582546 |
| Syringe issue | 28.16 | 19.92 | 13 | 6645 | 9512 | 110573129 |
| Toxic cataract | 27.71 | 19.92 | 4 | 6654 | 20 | 110582621 |
| Postrenal failure | 27.27 | 19.92 | 7 | 6651 | 869 | 110581772 |
| Rhabdomyolysis | 25.85 | 19.92 | 34 | 6624 | 120367 | 110462274 |
| Spinal cord infarction | 25.71 | 19.92 | 7 | 6651 | 1091 | 110581550 |
| Intercepted product preparation error | 25.59 | 19.92 | 11 | 6647 | 6809 | 110575832 |
| Cerebral amyloid angiopathy | 25.18 | 19.92 | 6 | 6652 | 549 | 110582092 |
| Metastases to spine | 24.70 | 19.92 | 10 | 6648 | 5333 | 110577308 |
| Mucocutaneous disorder | 24.66 | 19.92 | 5 | 6653 | 216 | 110582425 |
| Wrong technique in product usage process | 24.12 | 19.92 | 28 | 6630 | 87320 | 110495321 |
| Blood testosterone increased | 24.01 | 19.92 | 7 | 6651 | 1395 | 110581246 |
| Retinal detachment | 23.33 | 19.92 | 12 | 6646 | 11088 | 110571553 |
| Cerebral infarction | 22.18 | 19.92 | 21 | 6637 | 51817 | 110530824 |
| Drug ineffective | 22.18 | 19.92 | 36 | 6622 | 1520504 | 109062137 |
| Disseminated intravascular coagulation | 22.15 | 19.92 | 19 | 6639 | 41267 | 110541374 |
| Fall | 20.42 | 19.92 | 81 | 6577 | 603401 | 109979240 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L02BX02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ENDOCRINE THERAPY HORMONE ANTAGONISTS AND RELATED AGENTS Other hormone antagonists and related agents |
| FDA PE | N0000008638 | Decreased GnRH Secretion |
| FDA MoA | N0000175084 | Gonadotropin Releasing Hormone Receptor Antagonists |
| FDA EPC | N0000175839 | Gonadotropin Releasing Hormone Receptor Antagonist |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Related Drugs by ATC class:
L02BX Other hormone antagonists and related agents 3 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Advanced hormone-dependent prostate cancer | indication | 722103009 | |
| Advanced Prostatic Carcinoma | indication | ||
| Torsades de pointes | contraindication | 31722008 | |
| Hypokalemia | contraindication | 43339004 | |
| Chronic heart failure | contraindication | 48447003 | |
| Prolonged QT interval | contraindication | 111975006 | |
| Liver function tests abnormal | contraindication | 166603001 | |
| Hypomagnesemia | contraindication | 190855004 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Pregnancy, function | contraindication | 289908002 | |
| Osteopenia | contraindication | 312894000 | |
| Congenital long QT syndrome | contraindication | 442917000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.99 | acidic |
| pKa2 | 11.49 | acidic |
| pKa3 | 12.21 | acidic |
| pKa4 | 12.25 | acidic |
| pKa5 | 12.82 | acidic |
| pKa6 | 13.11 | acidic |
| pKa7 | 13.11 | acidic |
| pKa8 | 13.39 | acidic |
| pKa9 | 13.47 | acidic |
| pKa10 | 13.85 | acidic |
| pKa11 | 9.64 | Basic |
| pKa12 | 5.35 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 120MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 10729739 | Feb. 10, 2029 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 120MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 10973870 | Feb. 10, 2029 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 120MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 9579359 | Feb. 10, 2029 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 80MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 10729739 | Feb. 10, 2029 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 80MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 10973870 | Feb. 10, 2029 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 80MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 9579359 | Feb. 10, 2029 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 120MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 12514898 | Feb. 20, 2029 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 120MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 12533387 | Feb. 20, 2029 | TREATMENT OF ADVANCED PROSTATE CANCER |
| EQ 80MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 12514898 | Feb. 20, 2029 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 80MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 12533387 | Feb. 20, 2029 | TREATMENT OF ADVANCED PROSTATE CANCER |
| EQ 120MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 10695398 | April 27, 2032 | METHOD OF TREATING PROSTATE CANCER |
| EQ 120MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 11766468 | April 27, 2032 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 120MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 11826397 | April 27, 2032 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 120MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 9415085 | April 27, 2032 | METHOD OF TREATING PROSTATE CANCER |
| EQ 80MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 10695398 | April 27, 2032 | METHOD OF TREATING PROSTATE CANCER |
| EQ 80MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 11766468 | April 27, 2032 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 80MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 11826397 | April 27, 2032 | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT |
| EQ 80MG BASE/VIAL | FIRMAGON | FERRING | N022201 | Dec. 24, 2008 | RX | POWDER | SUBCUTANEOUS | 9415085 | April 27, 2032 | METHOD OF TREATING PROSTATE CANCER |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Gonadotropin-releasing hormone receptor | GPCR | ANTAGONIST | Ki | 8.77 | IUPHAR | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D08635 | KEGG_DRUG |
| 4028567 | VUID |
| N0000178334 | NUI |
| 934246-14-7 | SECONDARY_CAS_RN |
| 4028567 | VANDF |
| C1455035 | UMLSCUI |
| CHEMBL415606 | ChEMBL_ID |
| CHEMBL2028987 | ChEMBL_ID |
| DB06699 | DRUGBANK_ID |
| C431566 | MESH_SUPPLEMENTAL_RECORD_UI |
| 5585 | IUPHAR_LIGAND_ID |
| 8192 | INN_ID |
| SX0XJI3A11 | UNII |
| 16136245 | PUBCHEM_CID |
| 475230 | RXNORM |
| 164686 | MMSL |
| 168716 | MMSL |
| 26319 | MMSL |
| d07411 | MMSL |
| 012979 | NDDF |
| 012980 | NDDF |
| 16526211000001104 | SNOMEDCT_US |
| 441758000 | SNOMEDCT_US |
| 441864003 | SNOMEDCT_US |
| CHEBI:135961 | CHEBI |
| SX0XJI3A11 | INXIGHT DRUGS |
Pharmaceutical products:
None