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)
Dyspnoea02.11.05.003; 22.02.01.004--
Ear disorder04.03.01.0010.000381%Not Available
Embolism venous24.01.01.0030.000224%Not Available
Epistaxis24.07.01.005; 22.04.03.001--
Eye discharge06.04.05.0010.000381%Not Available
Faeces hard07.01.03.0030.000112%Not Available
Failure to thrive19.07.05.001; 18.04.01.003; 14.03.02.008--Not Available
Fatigue08.01.01.0020.022184%
Feeling abnormal08.01.09.014--Not Available
Feeling cold08.01.09.0080.000246%Not Available
Flatulence07.01.04.0020.001522%
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.002--
Gallbladder disorder09.03.02.0010.000112%Not Available
Gastrooesophageal reflux disease07.02.02.0030.001142%
Gastrointestinal disorder07.11.01.0010.002697%Not Available
Gastrointestinal pain07.01.05.0050.000571%
Genital rash23.03.13.016; 21.10.01.0090.000381%Not Available
Glioblastoma17.20.02.002; 16.30.02.0020.000112%Not Available
Haematemesis24.07.02.011; 07.12.02.0020.000280%Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haemorrhoids24.10.02.002; 07.15.03.0010.000381%
Hair texture abnormal23.02.06.0040.000381%
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.000112%Not Available
Hepatic failure09.01.03.0020.000548%
Hepatic function abnormal09.01.02.0010.001298%Not Available
Hepatitis09.01.07.004--Not Available
Hepatotoxicity09.01.07.009; 12.03.01.0080.000336%Not Available
Hydronephrosis20.01.05.0010.000168%Not Available
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