Breast cancer:
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.
Adult Dosage:
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.
Children Dosage:
Not established.
VERZENIO Warnings/Precautions:
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).
VERZENIO Classification:
Kinase inhibitor.
VERZENIO Interactions:
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.
Adverse Reactions:
Diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, thrombocytopenia; venous thrombosis, pulmonary embolism, ILD/pneumonitis, hepatotoxicity.
Drug Elimination:
Fecal (~81%), renal (~3%). Half-life: 18.3 hours. Geometric mean hepatic clearance: 26.0 L/h (51% CV).
Generic Drug Availability:
NO
How Supplied:
Tabs—14 (blister pack)
