Abeclib™ 150 Tablet: Each tablet contains Abemaciclib INN 150 mg.
Abeclib™ 200 Tablet: Each tablet contains Abemaciclib INN 200 mg.
Abeclib™ is a preparation of Abemaciclib. Abemaciclib is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). These kinases are activated upon binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation. In vitro, continuous exposure to Abemaciclib inhibited Rb phosphorylation and blocked progression from G1 into S phase of the cell cycle, resulting in senescence and apoptosis. In breast cancer xenograft models, Abemaciclib dosed daily without interruption as a single agent or in combination with antiestrogens resulted in reduction of tumor size.
Abeclib™ tablets are taken orally with or without food.
Based on findings in animals and its mechanism of action, Abemaciclib can cause fetal harm when administered to a pregnant woman. There are no available human data informing the drug-associated risk. Advise pregnant women of the potential risk to a fetus. In animal reproduction studies, administration of Abemaciclib during organogenesis was teratogenic and caused decreased fetal weight at maternal exposures that were similar to human clinical exposure based on AUC at the maximum recommended human dose.
There are no data on the presence of Abemaciclib in human milk, or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Abemaciclib, advise lactating women not to breastfeed during Abemaciclib treatment and for at least 3 weeks after the last dose.
Store below 30°C temperature. Keep away from light and wet place. Keep out of reach of children.