1. Breast cancer, advanced or metastatic
2. Breast cancer, early, high risk

Antineoplastic Agent, Cyclin-Dependent Kinase Inhibitor:
Abemaciclib is a potent small molecule cyclin-dependent kinase (CDK) inhibitor which is selective for CDK 4 and 6; it blocks retinoblastoma tumor suppressor protein phosphorylation and prevents progression through the cell cycle, resulting in arrest at the G1 phase.

Absorption
1. Bioavailability:45%
2. Time to peak:8 hours
Distribution
1. Vd:~690.3 L
2. Protein binding:~96%
Excretion
Feces (~81%; primarily as metabolites); Urine (~3%)
Pharmakodynamics
Half-life Elimination:18.3 hours

Hypersensitivity to abemaciclib or any component of the formulation.

Use during pregnancy may cause fetal harm.

Due to the potential for adverse events in the breastfed infant, the manufacturer does not recommend breastfeeding during therapy and for 3 weeks after the last abemaciclib dose.

Common( > 10%):
Dermatologic: Alopecia
Endocrine & metabolic: Weight loss
Gastrointestinal: Abdominal pain , constipation , decreased appetite , diarrhea , dysgeusia , nausea, stomatitis, vomiting , xerostomia
Hematologic & oncologic: Anemia , decreased neutrophils , decreased platelet count , decreased white blood cell count , lymphocytopenia
Hepatic: Increased serum alanine aminotransferase , increased serum aspartate aminotransferase
Infection: Infection
Nervous system: Dizziness , fatigue, headache
Neuromuscular & skeletal: Arthralgia
Renal: Increased serum creatinine
Respiratory: Cough
Miscellaneous: Fever
1% to 10%:
Endocrine & metabolic: Dehydration
Frequency not defined:
Cardiovascular: Arterial thrombosis
Respiratory: Interstitial pulmonary disease, pneumonitis

1.Breast cancer, advanced or metastatic, HR-positive, HER2-negative:
150 mg twice daily(Initial endocrine-based therapy in postmenopausal females and in males), 200 mg twice daily(Progressive disease following endocrine therapy and prior chemotherapy),150 mg twice daily (Progressive disease on prior endocrine therapy)
2.Breast cancer, early, high risk, HR-positive, HER2-negative, node-positive:
150 mg twice daily

Safety and effectiveness not established in pediatric patients.

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

1.Mild or moderate impairment (Child-Pugh class A or B):
No dosage adjustment necessary.
2.Severe impairment (Child-Pugh class C):
Reduce the abemaciclib frequency to once daily.

Store below 30°C