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

Stem definitionDrug idCAS RN
interleukin-2 analogues and derivatives 5011 110942-02-4

Description:

MoleculeDescription

Synonyms:

  • BAY 50-4798
  • aldesleukin
  • proleukin
  • aldesleukine
a recombinant human IL-2, marketed for the treatment of metastatic renal cell carcinoma; BAY 50-4798 is a variant
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.20 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
May 5, 1992 FDA CHIRON

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
Pyrexia 63.25 33.37 55 943 380148 50223978
Device related bacteraemia 42.84 33.37 6 992 83 50604043
Hypotension 40.81 33.37 35 963 235434 50368692

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
Capillary leak syndrome 70.17 26.44 18 2098 1881 29570530
Cardiotoxicity 61.96 26.44 20 2096 4724 29567687
Device related bacteraemia 57.10 26.44 10 2106 161 29572250
Autoimmune myocarditis 43.26 26.44 8 2108 177 29572234
Metastases to lung 38.20 26.44 16 2100 7839 29564572
Hypotension 37.76 26.44 57 2059 194297 29378114
Chills 37.72 26.44 35 2081 71265 29501146
Pyrexia 34.40 26.44 68 2048 287554 29284857
Vitiligo 26.93 26.44 7 2109 769 29571642

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
Device related bacteraemia 94.30 25.53 16 3120 319 64495277
Pyrexia 82.34 25.53 117 3019 558527 63937069
Capillary leak syndrome 67.19 25.53 18 3118 3279 64492317
Cardiotoxicity 65.66 25.53 23 3113 10251 64485345
Hypotension 47.51 25.53 74 3062 380900 64114696
Device related infection 47.10 25.53 25 3111 30601 64464995
Autoimmune myocarditis 43.26 25.53 8 3128 264 64495332
Malignant neoplasm progression 43.15 25.53 39 3097 112832 64382764
Hypophosphataemia 40.81 25.53 18 3118 14702 64480894
Vitiligo 32.96 25.53 9 3127 1759 64493837
Thrombocytopenia 32.86 25.53 47 3089 223754 64271842
Metastases to lung 30.87 25.53 15 3121 15249 64480347
Chills 28.15 25.53 34 3102 137230 64358366
Off label use 27.61 25.53 80 3056 632726 63862870
Lymphopenia 26.11 25.53 16 3120 25641 64469955

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L03AC01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSTIMULANTS
IMMUNOSTIMULANTS
Interleukins
FDA CS M0011506 Interleukin-2
FDA PE N0000009391 Increased Lymphocyte Cell Production
MeSH PA D019380 Anti-HIV Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D044966 Anti-Retroviral Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000998 Antiviral Agents
FDA EPC N0000175667 Lymphocyte Growth Factor
FDA PE N0000178328 Increased Lymphocyte Activation

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Acute myeloid leukemia, disease indication 91861009
Metastatic malignant melanoma indication 443493003
Metastatic renal cell carcinoma indication 702392008




🐶 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
Interleukin-2 receptor Membrane receptor AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
D00748 KEGG_DRUG
4019994 VUID
N0000148066 NUI
4019994 VANDF
CHEMBL1201438 ChEMBL_ID
C082598 MESH_SUPPLEMENTAL_RECORD_UI
6510 INN_ID
DB00041 DRUGBANK_ID
M89N0Q7EQR UNII
203760 RXNORM
3242 MMSL
4145 MMSL
d01375 MMSL
108804009 SNOMEDCT_US
386917000 SNOMEDCT_US
C0218986 UMLSCUI
003655 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Proleukin HUMAN PRESCRIPTION DRUG LABEL 1 65483-116 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1.10 mg INTRAVENOUS BLA 24 sections
Proleukin HUMAN PRESCRIPTION DRUG LABEL 1 76310-022 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1.10 mg INTRAVENOUS BLA 24 sections