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VERZENIO
Breast cancer
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Drug Name:

VERZENIO Rx

Generic Name and Formulations:
Abemaciclib 50mg, 100mg, 150mg, 200mg; tabs.

Company:
Lilly, Eli and Company

Therapeutic Use:

Indications for VERZENIO:

In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. 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. In combination with fulvestrant or an aromatase inhibitor (see full labeling): 150mg twice daily; 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. All: 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 to ≤Grade 1, then resume at next lower dose. 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, persistent/recurrent Grade 2 or Grade 3/4 transaminase elevation occurs. Monitor for signs/symptoms of venous thromboembolic events; treat appropriately. Severe hepatic impairment (Child-Pugh C): see Adult. 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).

Pharmacological Class:

Kinase inhibitor.

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, hepatotoxicity.

Generic Availability:

NO

How Supplied:

Blister pack—14

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