Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Abemaciclib
Drug ID BADD_D02498
Description Abemaciclib is an antitumor agent and dual inhibitor of cyclin-dependent kinases 4 (CDK4) and 6 (CDK6) that are involved in the cell cycle and promotion of cancer cell growth in case of unregulated activity. On September 28, 2017, FDA granted approval of abemaciclib treatment under the market name Verzenio for the treatment of HR-positive and HER2-negative advanced or metastatic breast cancer that has progressed after unsuccessful endocrine therapy. It is either given alone in patients who has undergone endocrine therapy and chemotherapy after the metastasis of cancer, or in combination with [DB00947]. Following oral treatment in patients with HR-positive, HER2-negative breast cancer, abemaciclib demonstrated increased progression-free survival rates and objective response rates. Abemaciclib has been used in trials studying the treatment of melanoma, lymphoma, neoplasm, solid tumor, and glioblastoma.
Indications and Usage * Indicated in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. * Inidicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Marketing Status approved; investigational
ATC Code L01EF03
DrugBank ID DB12001
KEGG ID D10688
MeSH ID C000590451
PubChem ID 46220502
TTD Drug ID D05SBO
NDC Product Code 0002-6216; 0002-4483; 0002-4815; 0110-4483; 0110-6216; 0110-4815; 0002-5337; 63419-0554; 0110-5337; 54893-0098; 63419-0578
UNII 60UAB198HK
Synonyms abemaciclib | 5-(4-ethylpiperazin-1-ylmethyl)pyridin-2-yl)-(5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3H-benzoimidazol-5-yl)pyrimidin-2-yl)amine | 5-(4-ethylpiperazin-1-ylmethyl)pyridin-2-yl)-(5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3H-benzimidazol-5-yl)pyrimidin-2-yl)amine | LY2835219 | LY-2835219 | LY2385219 | abemaciclib mesylate | LY2835210 | Verzenio
Chemical Information
Molecular Formula C27H32F2N8
CAS Registry Number 1231929-97-7
SMILES CCN1CCN(CC1)CC2=CN=C(C=C2)NC3=NC=C(C(=N3)C4=CC5=C(C(=C4)F)N=C(N5C(C)C)C)F
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)
Pulmonary embolism22.06.02.001; 24.01.06.0010.001220%-
Pulmonary oedema02.05.02.003; 22.01.03.0030.000907%
Pulmonary thrombosis22.06.02.003; 24.01.06.0020.000795%-
Pyoderma gangrenosum10.04.02.009; 16.32.03.005; 23.07.03.0010.000112%-
Renal disorder20.01.02.0020.002205%-
Renal failure20.01.03.0050.001052%-
Retching07.01.07.0020.000683%-
Scab23.03.03.0040.000381%-
Skin discolouration23.03.03.0050.001142%-
Skin irritation23.03.04.0090.000951%-
Skin ulcer23.07.03.003; 24.04.03.0070.000302%
Somnolence17.02.04.006; 19.02.05.003--
Stomatitis07.05.06.0050.001824%
Swelling face08.01.03.100; 10.01.05.018; 23.04.01.0180.000873%-
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.0140.000851%-
Syncope02.11.04.015; 17.02.04.008; 24.06.02.012--
Thrombosis24.01.01.0060.002608%-
Transient ischaemic attack17.08.04.001; 24.04.06.0050.000470%
Vomiting07.01.07.0030.015424%
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.000302%-
Onychoclasis23.02.05.0050.000437%-
Peripheral swelling02.05.04.015; 08.01.03.0530.003212%-
Musculoskeletal chest pain15.03.04.012; 22.09.01.001--
Deep vein thrombosis24.01.02.0030.000839%-
Malignant neoplasm progression16.16.01.0050.005462%-
Skin burning sensation17.02.06.009; 23.03.03.0210.000381%-
Faecaloma07.01.03.0040.000246%-
Urine odour abnormal20.02.01.0200.000381%-
Breast cancer female16.10.01.004; 21.05.01.0110.000627%-
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.0050.001959%
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