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

Stem definition	Drug id	CAS RN
interleukin-2 analogues and derivatives	5011	110942-02-4

Description:

Molecule

Description

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:

Dose	Unit	Route
0.20	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
May 5, 1992	FDA	CHIRON

FDA Adverse Event Reporting System (Female)

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
Pyrexia	73.75	36.15	62	1029	470416	63017515
Cardiotoxicity	41.20	36.15	12	1079	8426	63479505
Hypotension	40.50	36.15	35	1056	272569	63215362
Device related bacteraemia	38.60	36.15	6	1085	201	63487730

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
Capillary leak syndrome	73.58	25.00	19	2259	2239	34952414
Cardiotoxicity	64.39	25.00	21	2257	5627	34949026
Device related bacteraemia	48.92	25.00	10	2268	416	34954237
Chills	42.51	25.00	38	2240	81005	34873648
Autoimmune myocarditis	42.10	25.00	8	2270	227	34954426
Metastases to lung	37.00	25.00	16	2262	9304	34945349
Hypotension	36.10	25.00	57	2221	221592	34733061
Pyrexia	33.02	25.00	69	2209	332944	34621709
Restrictive cardiomyopathy	28.14	25.00	7	2271	708	34953945
Vitiligo	26.21	25.00	7	2271	937	34953716
Disease progression	25.16	25.00	33	2245	108044	34846609
Device related infection	25.04	25.00	15	2263	17222	34937431

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
Pyrexia	88.22	25.74	125	3275	678584	79062404
Cardiotoxicity	88.16	25.74	29	3371	12210	79728778
Device related bacteraemia	84.57	25.74	16	3384	686	79740302
Capillary leak syndrome	71.13	25.74	19	3381	3906	79737082
Device related infection	50.38	25.74	26	3374	34268	79706720
Hypotension	46.73	25.74	74	3326	440243	79300745
Malignant neoplasm progression	41.30	25.74	39	3361	135951	79605037
Autoimmune myocarditis	40.86	25.74	8	3392	411	79740577
Hypophosphataemia	37.87	25.74	18	3382	19895	79721093
Thrombocytopenia	35.85	25.74	50	3350	265209	79475779
Vitiligo	32.56	25.74	9	3391	2100	79738888
Chills	32.47	25.74	37	3363	160197	79580791
Metastases to lung	30.26	25.74	15	3385	18148	79722840
Restrictive cardiomyopathy	28.70	25.74	7	3393	1001	79739987
Ejection fraction decreased	26.08	25.74	17	3383	34560	79706428

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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 | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Interleukin-2 receptor	Membrane receptor	P01589 P14784 P31785	IL2RA_HUMAN IL2RB_HUMAN IL2RG_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

External reference:

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

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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
Proleukin	HUMAN PRESCRIPTION DRUG LABEL	1	76310-022	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