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

Stem definition	Drug id	CAS RN
chimeric origin	4940	179045-86-4

Description:

Molecule	Description
Synonyms: basiliximab simulect chRFT5 SDZ-CHI-621	Basiliximab functions as an IL-2 receptor antagonist by binding with high affinity to the alpha chain of the high affinity IL-2 receptor complex and inhibiting IL-2 binding. Basiliximab is specifically targeted against IL-2Ralpha, which is selectively expressed on the surface of activated T-lymphocytes. This specific high affinity binding of basiliximab to IL-2Ralpha competitively inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

basiliximab
simulect
chRFT5
SDZ-CHI-621

Basiliximab functions as an IL-2 receptor antagonist by binding with high affinity to the alpha chain of the high affinity IL-2 receptor complex and inhibiting IL-2 binding. Basiliximab is specifically targeted against IL-2Ralpha, which is selectively expressed on the surface of activated T-lymphocytes. This specific high affinity binding of basiliximab to IL-2Ralpha competitively inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
40	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
May 12, 1998	FDA	NOVARTIS
Oct. 9, 1998	EMA

FDA Adverse Event Reporting System (Female)

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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
Kidney transplant rejection	806.11	29.90	179	10792	4092	63473959
Cytomegalovirus infection	714.16	29.90	226	10745	20726	63457325
Transplant rejection	646.08	29.90	180	10791	10600	63467451
Complications of transplanted kidney	467.81	29.90	104	10867	2382	63475669
Polyomavirus-associated nephropathy	407.13	29.90	88	10883	1760	63476291
Thrombotic microangiopathy	359.75	29.90	114	10857	10447	63467604
Post transplant lymphoproliferative disorder	233.89	29.90	69	10902	4962	63473089
Multiple organ dysfunction syndrome	208.70	29.90	127	10844	56625	63421426
Delayed graft function	207.07	29.90	46	10925	1047	63477004
Cytomegalovirus viraemia	196.53	29.90	62	10909	5587	63472464

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FDA Adverse Event Reporting System (Male)

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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
Kidney transplant rejection	1017.53	19.93	303	18169	7194	34931265
Transplant rejection	652.70	19.93	234	18238	10077	34928382
Cytomegalovirus infection	581.39	19.93	281	18191	25854	34912605
Complications of transplanted kidney	508.52	19.93	159	18313	4450	34934009
Polyomavirus-associated nephropathy	446.70	19.93	138	18334	3706	34934753
Delayed graft function	267.57	19.93	82	18390	2139	34936320
Renal tubular necrosis	236.58	19.93	130	18342	15550	34922909
Mucormycosis	198.69	19.93	85	18387	5857	34932602
Strongyloidiasis	196.04	19.93	68	18404	2643	34935816
Thrombotic microangiopathy	185.19	19.93	97	18375	10533	34927926

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FDA Adverse Event Reporting System (Geriatric)

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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
Kidney transplant rejection	1569.67	21.22	416	27393	9830	79706749
Transplant rejection	1208.02	21.22	392	27417	19045	79697534
Cytomegalovirus infection	1143.99	21.22	462	27347	42182	79674397
Complications of transplanted kidney	863.79	21.22	235	27574	6131	79710448
Polyomavirus-associated nephropathy	811.67	21.22	218	27591	5409	79711170
Delayed graft function	478.13	21.22	130	27679	3377	79713202
Thrombotic microangiopathy	463.85	21.22	196	27613	19973	79696606
Post transplant lymphoproliferative disorder	355.05	21.22	138	27671	11326	79705253
Renal tubular necrosis	343.90	21.22	170	27639	24869	79691710
Multiple organ dysfunction syndrome	343.38	21.22	305	27504	119941	79596638

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AC02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Interleukin inhibitors
FDA EPC	N0000175622	Interleukin-2 Receptor Blocking Antibody
FDA MoA	N0000010279	Interleukin 2 Receptor Antagonists
FDA MoA	N0000175621	Interleukin 2 Receptor-directed Antibody Interactions
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive Agents

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

Disease	Relation	SNOMED_ID	DOID
Renal transplant rejection	indication	236570004

🐶 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:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Interleukin-2 receptor subunit alpha	Membrane receptor	P01589	IL2RA_HUMAN	ANTIBODY BINDING	Kd	10		DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
007552	NDDF
109135008	SNOMEDCT_US
11703	MMSL
196102	RXNORM
386978004	SNOMEDCT_US
4021113	VUID
4021113	VANDF
4246	MMSL
6879	IUPHAR_LIGAND_ID
7578	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Simulect	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0331	INJECTION, POWDER, FOR SOLUTION	20 mg	INTRAVENOUS	BLA	24 sections
Simulect	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0331	INJECTION, POWDER, FOR SOLUTION	20 mg	INTRAVENOUS	BLA	24 sections
Simulect	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0331	INJECTION, POWDER, FOR SOLUTION	20 mg	INTRAVENOUS	BLA	24 sections
Simulect	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0393	INJECTION, POWDER, FOR SOLUTION	10 mg	INTRAVENOUS	BLA	24 sections
Simulect	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0393	INJECTION, POWDER, FOR SOLUTION	10 mg	INTRAVENOUS	BLA	24 sections
Simulect	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0393	INJECTION, POWDER, FOR SOLUTION	10 mg	INTRAVENOUS	BLA	24 sections

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