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)
Hypersomnia19.02.05.001; 17.15.01.0010.000437%
Hypotension24.06.03.002--
Impaired healing08.03.02.0010.000381%Not Available
Injection site bruising08.02.03.042; 12.07.03.042; 24.07.06.017; 23.03.11.015--Not Available
Injection site mass12.07.03.010; 08.02.03.009--Not Available
Interstitial lung disease22.01.02.003; 10.02.01.0330.001410%Not Available
Intestinal obstruction07.13.01.002--Not Available
Lacrimation increased06.08.02.0040.000571%
Liver disorder09.01.08.0010.000907%Not Available
Lung disorder22.02.07.0010.000526%Not Available
Malaise08.01.01.003--
Mass08.03.05.0030.000302%Not Available
Metastases to liver16.22.02.001; 09.04.02.0040.000381%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.000381%Not Available
Mouth ulceration07.05.06.004--Not Available
Nausea07.01.07.0010.023281%
Necrosis24.04.02.006; 08.03.03.0010.000112%Not Available
Neoplasm16.16.02.0010.000246%Not Available
Nephrolithiasis20.04.01.0020.000302%
Neuralgia17.02.07.0050.000381%
Neutropenia01.02.03.0040.005160%Not Available
Nonspecific reaction08.01.03.0400.000437%Not Available
Oesophagitis07.08.05.0010.000246%
Oral pain07.05.05.0340.000437%
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pain of skin23.03.03.0030.000381%
Pleural effusion22.05.02.0020.000582%
Pneumonitis22.01.01.0060.003067%
Pneumothorax22.05.02.0030.000604%
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