ADReCS

Pharmaceutical Information

Drug Name	Lenalidomide
Drug ID	BADD_D01253
Description	Lenalidomide (previously referred to as CC-5013) is an immunomodulatory drug with potent antineoplastic, anti-angiogenic, and anti-inflammatory properties.[A228553] It is a 4-amino-glutamyl analogue of [thalidomide] [A228543] and like thalidomide, lenalidomide exists as a racemic mixture of the active S(-) and R(+) forms.[A228708] However, lenalidomide is much safer and potent than thalidomide, with fewer adverse effects and toxicities.[A714, A228543] Thalidomide and its analogues, including lenalidomide, are referred to as immunomodulatory imide drugs (also known as cereblon modulators), which are a class of immunomodulatory drugs that contain an imide group. Lenalidomide works through various mechanisms of actions that promote malignant cell death and enhance host immunity.[A228708] Available as oral capsules, lenalidomide is approved by the FDA and EU for the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma in selected patients.[L16028] Lenalidomide is available only under a special restricted distribution program.[A228708]
Indications and Usage	Lenalidomide is indicated for the treatment of adult patients with multiple myeloma (MM) in combination with dexamethasone. It is also indicated as maintenance therapy in multiple myeloma following autologous hematopoietic stem cell transplantation (auto-HSCT). It is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Lenalidomide is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In combination with a rituximab product, lenalidomide is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL) or previously treated marginal zone lymphoma (MZL).[L16028]
Marketing Status	approved
ATC Code	L04AX04
DrugBank ID	DB00480
KEGG ID	D04687
MeSH ID	D000077269
PubChem ID	216326
TTD Drug ID	D0Q5NX
NDC Product Code	54893-0061; 65015-772; 82991-402; 31722-257; 43598-512; 59572-410; 59572-425; 60505-4534; 0378-1941; 70710-1033; 53104-7720; 68554-0090; 82245-0101; 43598-516; 47781-486; 63304-044; 0378-1936; 70710-1032; 70710-1034; 70710-1035; 14096-131; 55111-911; 59651-733; 31722-260; 31722-262; 43598-514; 43598-515; 59572-420; 59651-342; 63304-042; 63304-043; 70771-1676; 0378-1935; 0480-1241; 0480-1242; 65727-084; 71796-026; 31722-261; 43598-511; 47781-484; 47781-487; 47781-488; 59572-405; 59651-346; 59651-347; 63304-045; 0378-1937; 0480-1246; 70771-1681; 0378-1942; 0480-1244; 70710-1031; 76282-697; 76282-699; 76282-701; 59116-4710; 31722-258; 59572-402; 59651-344; 0378-1940; 69097-604; 0480-1245; 70710-1030; 76282-698; 43598-513; 47781-483; 59572-415; 59651-345; 60505-4533; 63304-041; 69097-381; 69097-382; 69097-383; 69097-384; 69097-385; 70771-1680; 59651-343; 60505-4536; 63304-046; 0480-1243; 70771-1679; 55488-0700; 47781-485; 60505-4532; 60505-4535; 60505-4537; 70771-1677; 70771-1678; 53104-7726; 31722-259
UNII	F0P408N6V4
Synonyms	Lenalidomide \| 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione \| 2,6-Piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2H- isoindol-2-yl)- \| IMiD3 Cpd \| CC 5013 \| CC5013 \| CC-5013 \| Revlimid \| Revimid

Chemical Information

Molecular Formula	C13H13N3O3
CAS Registry Number	191732-72-6
SMILES	C1CC(=O)NC(=O)C1N2CC3=C(C2=O)C=CC=C3N
Chemical Structure

ADRs Induced by Drug

*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..

ADR Term	ADReCS ID	ADR Frequency (FAERS)	ADR Severity Grade (FAERS)	ADR Severity Grade (CTCAE)
Anaplastic large cell lymphoma T- and null-cell types	16.17.02.002; 01.11.02.002	0.000241%		Not Available
Angiosarcoma	24.03.06.003; 16.16.03.001	0.000241%		Not Available
B precursor type acute leukaemia	16.01.01.004; 01.10.01.004	0.003496%		Not Available
B-cell small lymphocytic lymphoma	01.15.06.001; 16.28.06.001	0.000241%		Not Available
Bladder cancer recurrent	20.03.04.005; 16.08.01.003	0.000362%		Not Available
Bladder obstruction	20.03.01.012	0.000362%		Not Available
Blood blister	23.03.01.028; 12.01.06.013	0.003713%		Not Available
Bone cancer	16.29.02.002; 15.09.03.012	0.002049%		Not Available
Bone cyst	16.11.03.001; 15.02.04.026	0.000241%		Not Available
Breast cancer in situ	21.05.01.015; 16.10.01.007	0.000362%		Not Available
Breast cancer stage I	21.05.01.018; 16.10.01.010	0.000723%		Not Available
Carcinoid tumour of the gastrointestinal tract	16.24.04.005; 07.21.04.010; 05.08.01.010	0.000241%		Not Available
Cardiac aneurysm	24.02.02.004; 02.04.02.030	0.000482%		Not Available
Central nervous system lymphoma	18.04.04.013; 17.02.10.028; 16.20.01.005; 01.12.01.005	0.001688%		Not Available
Chronic lymphocytic leukaemia recurrent	01.10.06.003; 16.01.06.003	0.000362%		Not Available
Chronic lymphocytic leukaemia refractory	16.01.06.004; 01.10.06.004	0.000241%		Not Available
Colon cancer stage IV	16.13.01.014; 07.21.01.012	0.000482%		Not Available
Diffuse large B-cell lymphoma recurrent	01.15.02.002; 16.28.02.002	0.001953%		Not Available
Diffuse large B-cell lymphoma refractory	16.28.02.003; 01.15.02.003	0.001808%		Not Available
Diffuse large B-cell lymphoma stage IV	16.28.02.004; 01.15.02.004	0.000482%		Not Available
Faeces pale	07.01.03.005	0.002580%		Not Available
Hypergammaglobulinaemia benign monoclonal	16.23.01.004; 01.14.01.004	0.000651%		Not Available
Incarcerated hernia	08.01.04.004	0.000482%		Not Available
Jugular vein thrombosis	24.01.02.007	0.000723%		Not Available
Large granular lymphocytosis	16.01.11.001; 01.10.11.001	0.000362%		Not Available
Lentigo maligna	23.08.01.003; 16.03.01.003	0.000362%		Not Available
Liposarcoma	16.33.05.001; 15.09.03.005	0.000241%		Not Available
Lung adenocarcinoma	22.08.01.007; 16.19.01.002	0.002652%		Not Available
Lung squamous cell carcinoma stage IV	22.08.01.020; 16.19.01.008	0.000362%		Not Available
Magnesium deficiency	14.04.02.003	0.000820%		Not Available

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