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)
Feeding disorder19.09.01.003; 14.03.02.0030.000302%Not Available
Embolism24.01.01.0090.000224%
Gastrointestinal motility disorder07.02.03.0010.000112%Not Available
Haematotoxicity01.05.01.007; 12.03.01.0250.000246%Not Available
Inflammation10.02.01.089; 08.01.05.0070.000437%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.012424%
Renal injury20.01.03.015; 12.01.05.0010.000492%Not Available
Blood disorder01.05.01.0040.000437%Not Available
Adverse drug reaction08.06.01.0090.003515%Not Available
Autoimmune disorder10.04.04.0030.000381%
Disease progression08.01.03.0380.019722%
Drug intolerance08.06.01.0130.006637%Not Available
Metastasis16.22.01.0010.000302%Not Available
Renal impairment20.01.03.0100.001802%Not Available
Unevaluable event08.01.03.0510.001690%Not Available
Poor quality sleep19.02.05.005; 17.15.04.002--Not Available
Hypophagia07.01.06.010; 19.09.01.004; 14.03.01.0060.000985%Not Available
Cytopenia01.03.03.0120.001007%Not Available
Liver injury12.01.17.012; 09.01.07.0220.000526%Not Available
Adverse reaction08.06.01.0180.000437%Not Available
Oral disorder07.05.01.005--Not Available
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.0070.000381%Not Available
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.000381%Not Available
Breast cancer recurrent21.05.01.017; 16.10.01.0090.000381%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.000548%Not Available
Recurrent cancer16.16.01.0150.000571%Not Available
Lymphangiosis carcinomatosa24.09.02.007; 16.22.02.009; 01.09.01.0270.000168%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.0080.000168%Not Available
Disease complication08.01.03.0870.000112%Not Available
Illness08.01.03.0910.001388%Not Available
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