Active ingredient: Abemaciclib.
Indication: Monotherapy for adult patients w/ hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer w/ disease progression following endocrine therapy & prior chemotherapy in the metastatic setting. In combination w/ an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women w/ HR-positive, HER2-negative advanced or metastatic breast cancer; w/ fulvestrant for women w/ HR-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer w/ disease progression following endocrine therapy.
Dosage & Administration: Monotherapy 200 mg bid.
Combination therapy 150 mg bid w/ aromatase inhibitor, or 500 mg fulvestrant given on Days 1, 15, 29 mthly.
Dose Modifications for Adverse Reactions: Reduce dose every 50 mg from current dosing.
Concomitant use w/ strong CYP3A inhibitors other than ketoconazole Initially 200 mg or 150 mg bid, then reduce dose to 100 mg bid.
Severe hepatic impairment (Child Pugh-C) Reduce frequency to once daily.
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