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

Stem definition	Drug id	CAS RN
antineoplastics, thalidomide derivatives	3317	191732-72-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: lenalidomide hydrate lenalidomide revimid revlimid	Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including multiple myeloma, mantle cell lymphoma, and del (5q) myelodysplastic syndromes in vitro. Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including multiple myeloma. Immunomodulatory properties of lenalidomide include activation of T cells and natural killer (NK) cells, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-alpha and IL-6) by monocytes. In multiple myeloma cells, the combination of lenalidomide and dexamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis. Molecular weight: 259.27 Formula: C13H13N3O3 CLOGP: -0.41 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 92.50 ALOGS: -2.05 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

lenalidomide hydrate
lenalidomide
revimid
revlimid

Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including multiple myeloma, mantle cell lymphoma, and del (5q) myelodysplastic syndromes in vitro. Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including multiple myeloma. Immunomodulatory properties of lenalidomide include activation of T cells and natural killer (NK) cells, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-alpha and IL-6) by monocytes. In multiple myeloma cells, the combination of lenalidomide and dexamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis.

Molecular weight: 259.27
Formula: C13H13N3O3
CLOGP: -0.41
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 92.50
ALOGS: -2.05
ROTB: 1

Status: OFP

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

Drug dosage:

Dose	Unit	Route
10	mg	O

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	66 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ
S (Water solubility)	2.33 mg/mL	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.38 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

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Date	Agency	Company
Dec. 27, 2005	FDA	CELGENE
June 14, 2007	EMA	CELEGENE EUROPE BV
June 25, 2010	PMDA	Celgene K.K.

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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
Diarrhoea	7108.88	14.77	12327	288649	703039	62485007
Full blood count decreased	6487.50	14.77	2930	298046	23094	63164952
Death	5747.68	14.77	7909	293067	366472	62821574
White blood cell count decreased	4580.51	14.77	4372	296604	134732	63053314
Neuropathy peripheral	4214.63	14.77	3818	297158	109849	63078197
Thrombosis	3519.73	14.77	2715	298261	62040	63126006
Platelet count decreased	2976.86	14.77	3190	297786	112932	63075114
Laboratory test abnormal	2792.65	14.77	1684	299292	25228	63162818
Pneumonia	2624.45	14.77	6302	294674	450465	62737581
Constipation	1785.35	14.77	3541	297435	221402	62966644

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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
Death	5606.01	14.79	11081	283957	386968	34274925
Full blood count decreased	4891.32	14.79	2585	292453	15503	34646390
Neuropathy peripheral	3583.37	14.79	3946	291092	79317	34582576
Thrombosis	3467.72	14.79	3088	291950	47370	34614523
Rash	3283.42	14.79	6342	288696	216410	34445483
White blood cell count decreased	3202.40	14.79	3981	291057	91464	34570429
Pneumonia	2841.29	14.79	8053	286985	354574	34307319
Fatigue	2837.26	14.79	8162	286876	362491	34299402
Laboratory test abnormal	2496.72	14.79	1755	293283	18636	34643257
Platelet count decreased	2468.65	14.79	3956	291082	115761	34546132

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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
Death	7679.70	13.29	10963	347824	555551	78830050
Full blood count decreased	6891.74	13.29	3037	355750	23782	79361819
Pneumonia	5138.08	13.29	9967	348820	650279	78735322
White blood cell count decreased	4824.95	13.29	5043	353744	183245	79202356
Thrombosis	4613.50	13.29	3471	355316	80629	79304972
Neuropathy peripheral	4368.05	13.29	4192	354595	137113	79248488
Diarrhoea	4267.84	13.29	11002	347785	869487	78516114
Platelet count decreased	3998.65	13.29	4644	354143	190020	79195581
Rash	3079.50	13.29	7504	351283	570854	78814747
Deep vein thrombosis	2107.10	13.29	2657	356130	118262	79267339

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AX04	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Other immunosuppressants
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:48422	angiogenesis antagonist
CHEBI has role	CHEBI:50846	Immunologic factor
FDA EPC	N0000184014	Thalidomide Analog
MeSH PA	D020533	Angiogenesis Inhibitors
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D006131	Growth Inhibitors
MeSH PA	D006133	Growth Substances
MeSH PA	D007155	Immunologic Factors

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

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Disease	Relation	SNOMED_ID	DOID
Follicular lymphoma	indication	55150002
Multiple myeloma	indication	109989006	DOID:9538
Myelodysplastic syndrome	indication	109995007
Mantle cell lymphoma	indication	443487006
Marginal zone lymphoma	indication	447100004
Deep venous thrombosis	contraindication	128053003
Impaired renal function disorder	contraindication	197663003
Pulmonary thromboembolism	contraindication	233935004
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.17	acidic
pKa2	3.13	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	7189740	April 11, 2023	USE OF REVLIMID (LENALIDOMIDE) FOR TREATMENT OF PATIENTS WITH TRANSFUSION-DEPENDENT ANEMIA DUE TO LOW-OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES ASSOCIATED WITH A DELETION 5Q ABNORMALITY WITH OR WITHOUT ADDITIONAL CYTOGENETIC ABNORMALITIES
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	8404717	April 11, 2023	USE OF REVLIMID (LENALIDOMIDE) FOR TREATMENT OF PATIENTS WITH TRANSFUSION-DEPENDENT ANEMIA DUE TO LOW-OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES ASSOCIATED WITH A DELETION 5Q ABNORMALITY WITH OR WITHOUT ADDITIONAL CYTOGENETIC ABNORMALITIES
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	9056120	April 11, 2023	USE OF REVLIMID (LENALIDOMIDE) FOR TREATMENT OF PATIENTS WITH TRANSFUSION-DEPENDENT ANEMIA DUE TO LOW-OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES ASSOCIATED WITH A DELETION 5Q ABNORMALITY WITH OR WITHOUT ADDITIONAL CYTOGENETIC ABNORMALITIES
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	8530498	May 15, 2023	USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	8648095	May 15, 2023	USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	9101621	May 15, 2023	USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	9101622	May 15, 2023	USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE, WHEREIN THOSE PATIENTS HAVE NOT RECEIVED PREVIOUS TREATMENT FOR MULTIPLE MYELOMA
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	9155730	May 15, 2023	USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	9393238	May 15, 2023	USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	7468363	Oct. 7, 2023	USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	Feb. 22, 2024	TREATMENT OF MULTIPLE MYELOMA (MM), AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	May 28, 2026	INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
10MG	REVLIMID	CELGENE	N021880	Dec. 27, 2005	RX	CAPSULE	ORAL	May 28, 2026	INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
15MG	REVLIMID	CELGENE	N021880	June 29, 2006	RX	CAPSULE	ORAL	Feb. 22, 2024	TREATMENT OF MULTIPLE MYELOMA (MM), AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)
15MG	REVLIMID	CELGENE	N021880	June 29, 2006	RX	CAPSULE	ORAL	May 28, 2026	INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
15MG	REVLIMID	CELGENE	N021880	June 29, 2006	RX	CAPSULE	ORAL	May 28, 2026	INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
2.5MG	LENALIDOMIDE	DR REDDYS	A209348	Oct. 14, 2021	RX	CAPSULE	ORAL	March 6, 2023	PATENT CHALLENGE
2.5MG	REVLIMID	CELGENE	N021880	Dec. 21, 2011	RX	CAPSULE	ORAL	Feb. 22, 2024	TREATMENT OF MULTIPLE MYELOMA (MM), AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)
2.5MG	REVLIMID	CELGENE	N021880	Dec. 21, 2011	RX	CAPSULE	ORAL	May 28, 2026	INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
2.5MG	REVLIMID	CELGENE	N021880	Dec. 21, 2011	RX	CAPSULE	ORAL	May 28, 2026	INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Protein cereblon	Cytosolic other	Q96SW2	CRBN_HUMAN	MODULATOR	EC50	6.53	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Tumor necrosis factor	Cytokine	P01375	TNFA_HUMAN		IC50	7.89	WOMBAT-PK
Bromodomain-containing protein 4	Unclassified	O60885	BRD4_HUMAN		IC50	5.29	CHEMBL
Cereblon isoform 4	Unclassified		A4TVL0_9PROT		Ki	5.51	CHEMBL

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External reference:

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ID	Source
011171	NDDF
20816	MMSL
216326	PUBCHEM_CID
337535	RXNORM
355195	MMSL
4025089	VUID
4025089	VANDF
421471009	SNOMEDCT_US
421737001	SNOMEDCT_US
7331	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Lenalidomide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1935	CAPSULE	2.50 mg	ORAL	ANDA	33 sections
Lenalidomide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1936	CAPSULE	5 mg	ORAL	ANDA	33 sections
Lenalidomide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1936	CAPSULE	5 mg	ORAL	ANDA	33 sections
Lenalidomide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1937	CAPSULE	10 mg	ORAL	ANDA	33 sections
Lenalidomide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1937	CAPSULE	10 mg	ORAL	ANDA	33 sections
Lenalidomide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1940	CAPSULE	25 mg	ORAL	ANDA	33 sections
Lenalidomide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1940	CAPSULE	25 mg	ORAL	ANDA	33 sections
Lenalidomide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1941	CAPSULE	15 mg	ORAL	ANDA	33 sections
Lenalidomide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1941	CAPSULE	15 mg	ORAL	ANDA	33 sections
Lenalidomide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1942	CAPSULE	20 mg	ORAL	ANDA	33 sections

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