Verzenio(Abemaciclib Tablets)
VERZENIO Rx
Generic Name and Formulations:
Abemaciclib 50mg, 100mg, 150mg, 200mg; tabs.
Company:
Lilly, Eli and Company
RECENT UPDATES
Monograph added.
Indications for VERZENIO:
In combination with fulvestrant for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. As monotherapy for the treatment of 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:
Swallow whole. Take at the same time every day. Combination with fulvestrant (see full labeling): initially 150mg twice daily; in pre/perimenopausal women: also treat with a gonadotropin-releasing hormone agonist according to current practice standards. Monotherapy: initially 200mg twice daily. Both: 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:
Not established.
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. Monitor CBCs and LFTs prior to initiation and every 2 weeks for the first 2 months, then monthly for the next 2 months, and as clinically indicated. Dose interruption/reduction/discontinuation or delay in starting treatment cycles if Grade 3/4 neutropenia, recurrent Grade 2 or Grade 3/4 transaminase elevation occurs. Monitor for signs/symptoms of venous thromboembolic events; treat appropriately. Severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during therapy and for at least 3 weeks after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for at least 3 weeks after the last dose).
Interactions:
Avoid concomitant ketoconazole, grapefruit products. Concomitant other strong CYP3A inhibitors: reduce abemaciclib dose. Avoid concomitant strong CYP3A inducers (eg, rifampin): consider alternative agents.
Pharmacological Class:
Kinase inhibitor.
Adverse Reactions:
Diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, thrombocytopenia; venous thromboembolism, hepatotoxicity.
Generic Availability:
NO
How Supplied:
Blister pack—14 |
