Verzenio Generic Name & Formulations
Mechanism of Action
In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with HR-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence. In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer. In combination with fulvestrant for treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. As monotherapy for adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Verzenio Dosage and Administration
Swallow whole. Take at the same time every day. In combination with fulvestrant, tamoxifen, or an aromatase inhibitor (see full labeling): 150mg twice daily; in pre/perimenopausal women and men (in combination with aromatase inhibitor) or in pre/perimenopausal women (in combination with fulvestrant): also treat with a gonadotropin-releasing hormone agonist according to current practice standards. Monotherapy: 200mg twice daily. Early breast cancer: continue until completion of 2yrs of treatment or until disease recurrence, or unacceptable toxicity. Advanced or metastatic breast cancer: continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions, concomitant strong CYP3A4 inhibitors: see full labeling. Severe hepatic impairment: reduce frequency to once daily.
Verzenio Boxed Warnings
The absolute bioavailability of abemaciclib after a single oral dose of 200 mg is 45% (19% CV). The median Tmax of abemaciclib is 8.0 hours (range: 4.1-24.0 hours).
A high-fat, high-calorie meal (~800 to 1000 calories with 150 calories from protein, 250 calories from carbohydrate, and 500 to 600 calories from fat) administered to healthy subjects increased the AUC of abemaciclib plus its active metabolites by 9% and increased Cmax by 26%.
Human plasma protein bound: 96.3%. Geometric mean systemic volume of distribution: ~690.3 L (49% CV).
Fecal (~81%), renal (~3%). Half-life: 18.3 hours. Geometric mean hepatic clearance: 26.0 L/h (51% CV).
Verzenio Adverse Reactions
Verzenio Clinical Trials
Verzenio Patient Counseling