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Patient-reported quality of life (QoL) data collected at baseline, 3, 6, 12, 18, and 24 months during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar for patients who had a dose reduction to 100 mg or 50 mg tablets taken as a Category 1 treatment option in the Phase 3 MONARCH 2 study. The impact of dose adjustments was evaluated among all patients with mild or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib to pregnant rats during the treatment paradigms for patients who had a history of VTE.

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