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 Not Available
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; 63419-0578; 54893-0098; 0110-4815; 0110-5337; 63419-0554; 0110-6216; 0002-5337; 0002-4815; 0110-4483
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Breast cancer female16.10.01.004; 21.05.01.0110.000533%Not Available
Hepatic enzyme increased13.03.01.0190.001332%Not Available
Hot flush21.02.02.001; 08.01.03.027; 24.03.01.0050.002664%
Bacterial infection11.02.01.0050.000533%Not Available
Blood test abnormal13.18.01.0030.000533%Not Available
Cardiac disorder02.01.01.003--Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000533%Not Available
Inflammation08.01.05.0070.000533%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.014120%
Renal injury12.01.05.001; 20.01.03.0150.000799%Not Available
Ill-defined disorder08.01.03.0490.000533%Not Available
Blood disorder01.05.01.0040.000799%Not Available
Disease progression08.01.03.0380.004031%
Drug intolerance08.06.01.0130.004795%Not Available
Metastasis16.22.01.0010.000208%Not Available
Renal impairment20.01.03.0100.001598%Not Available
Unevaluable event08.01.03.0510.001865%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.001066%Not Available
Blood count abnormal13.01.07.0010.001598%Not Available
Bone marrow failure01.03.03.005--
Cytopenia01.03.03.0120.000533%Not Available
Treatment failure08.06.01.0170.000347%Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Acute kidney injury20.01.03.016--
Skin sensitisation10.02.01.038; 23.03.03.0520.000533%Not Available
Liver function test increased13.03.01.0440.002131%Not Available
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.000139%Not Available
Full blood count abnormal13.01.07.0030.000533%Not Available
Full blood count decreased13.01.07.0040.001066%Not Available
Tumour marker increased13.22.01.0170.001865%Not Available
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