Indications for: VERZENIO
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.
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.
Advise patients to initiate antidiarrheal (eg, loperamide) and increase fluids at first sign of loose stools; discontinue if Grade 3/4 diarrhea occurs or hospitalization required, until resolves to ≤Grade 1, then resume at next lower dose. Monitor CBCs and LFTs prior to initiation, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Monitor for interstitial lung disease (ILD)/pneumonitis. Dose interruption/reduction/discontinuation or delay in starting treatment cycles if Grade 3/4 neutropenia, persistent/recurrent Grade 2 or Grade 3/4 transaminase elevation or ILD/pneumonitis occurs. Monitor for venous thromboembolic events (VTE); treat appropriately. Dose interruption for early breast cancer patients with any grade VTE or for advanced or metastatic breast cancer patients with a Grade 3/4 VTE. Severe hepatic impairment (Child-Pugh C): see Adult. Severe renal impairment (CrCl <30mL/min), ESRD, or on dialysis. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during therapy and for ≥3 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥3 weeks after the last dose).
Avoid concomitant ketoconazole, grapefruit products. Concomitant other strong CYP3A inhibitors: reduce abemaciclib dose; moderate inhibitors: monitor and consider reducing dose. Avoid concomitant strong or moderate CYP3A inducers (eg, rifampin): consider alternative agents.
Diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, thrombocytopenia; venous thrombosis, pulmonary embolism, ILD/pneumonitis, hepatotoxicity.
Fecal (~81%), renal (~3%). Half-life: 18.3 hours. Geometric mean hepatic clearance: 26.0 L/h (51% CV).
Generic Drug Availability:
Tabs—14 (blister pack)