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)
Swelling08.01.03.0150.001066%Not Available
Swelling face23.04.01.018; 10.01.05.0180.000799%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.001066%Not Available
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Tachycardia02.03.02.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombosis24.01.01.0060.001865%Not Available
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection11.01.14.004; 20.08.02.001--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.06.008--Not Available
Vomiting07.01.07.0030.013853%
Weight decreased13.15.01.0050.004795%
Weight increased13.15.01.006--
White blood cell count abnormal13.01.06.0280.000533%Not Available
White blood cell count decreased13.01.06.0120.009324%
Onychoclasis23.02.05.0050.000533%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.003197%Not Available
Abasia17.02.05.035; 08.01.02.0070.000533%Not Available
Balance disorder17.02.02.0070.001066%Not Available
Contusion24.07.06.001; 23.03.11.002; 15.03.01.008; 12.01.06.0010.001332%
Deep vein thrombosis24.01.02.003--Not Available
Malignant neoplasm progression16.16.01.0050.001876%Not Available
Musculoskeletal stiffness15.03.01.005--Not Available
Haemorrhage24.07.01.002--Not Available
Gastric disorder07.11.01.0030.001066%Not Available
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