Written by: Jan Montgomery, PharmD, South Carolina Oncology Associates and Jacob Dygert, South UniversitySchool of Pharmacy
To identify when and where to use abemaciclib based on specific prognostic factors.
Abemaciclib is indicated for the treatment of postmenopausal women with HR-Positive, HER2-Negative advanced or metastatic breast cancer with no prior systemic therapy in this disease setting. Abemaciclib may be used as monotherapy or in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy and in combination with fulvestrant with disease progression following endocrine therapy. In an exploratory analysis of the Monarch 3 and Monarch 2 (placebo + fulvestrant vs abemaciclib + fulvestrant) benefit was seen specifically in prognosis concerning: Liver metastases, P-gp negative tumors, or high-grade tumors. The greatest benefit over placebo was seen in Monarch 2 among the subsection of patients with baseline liver metastases; the median PFS increased from 3.09 months (placebo) to 11.64 (abemaciclib). 
- Obtain CBC with differential and platelets at baseline, every 2 weeks for the first 2 months, monthly for the next 2 months, then as clinically indicated.
- Identify patients with prognostic factors that may benefit patient outcomes in areas such as:
- Visceral Liver Metastases
- P-gp Negative Tumors
- High-grade Tumors
- Provide input with medically integrated team as needed to help benefit patient
- Check liver function following the same schedule as CBC
- Abemaciclib should not be given to pregnant women. Assess reproductive potential and manage with LHRH agonist as appropriate.
- Ensure proper use of birth control prior to, and during therapy.
- Monitor and educate patient to be aware of signs and symptoms of diarrhea, dehydration, venous thrombosis, or pulmonary embolism.
Dosing Guideline Summary:
- When used in combination with either an aromatase inhibitor (AI) or fulvestrant, the recommended dose of abemaciclib is 150 mg orally twice daily with or without food.
- When used as monotherapy the recommended dose of abemaciclib is 200 mg orally twice daily with or without food.
- See dose modification based on strong CYP3A4 inhibition
- Be aware of dose adjustments for patients with severe hepatic impairment
- Significant adverse effects to monitor include neutropenia and venous thromboembolism
- Continue treatment until disease progression or unacceptable toxicity.
- Refer to full prescribing information for more information.
Patient Centered Activities :
- Provide Oncology Chemotherapy Education (OCE) Sheet
- Storage: Room temperature; cool dry place
- Disposal: Do not flush. Dispose of unused or expired medications or contact a local pharmacy to inquire about drug-take back programs
- How to take: Swallow whole with or without food, ideally at the same time each day. Drink plenty of non-caffeinated liquids. If vomiting occurs after taking a dose, do NOT repeat the dose; take your next dose at your scheduled time.
- Provide Loperamide (OTC) or RX antidiarrheal and counsel on diarrhea management.
- Please refer to the Abemaciclib Diarrhea Management PQI for more information
- Drink plenty of non-caffeinated fluids per day (6-8 large glasses)
- May be available for uninsured, qualifying patients. Sign up at https://www.verzenio.com/savings-support/savings-card
- The Continuous CareTM program may assist with insurance/ savings. It is available at the site above or by calling: 1-844-837-9364 (1-844-VERZENIO)
- VERZENIO [Package Insert]. Eli Lilly and Company , Indianapolis, IN; 2018. Accessed at: http://uspl.lilly.com/verzenio/verzenio.html#pi
- Lexicomp Online, Hudson, Ohio: Lexi-Comp, Inc.; updated 8/1/18; accessed 8/2/18
- Gold Standard, Inc. Abemaciclib. Clinical Pharmacology [database online]. Available at: http://www.clinicalpharmacology.com. Accessed: 8/2/18
- Goetz MP, O’Shaughnessy J. et al. The benefit of abemaciclib in prognostic subgroups: An exploratory analysis of combined data from the MONARCH 2 and 3 studies. Presented at the San Antonio Breast Cancer Symposium 2017. Poster from Breast Cancer Symposium, Dec. 2017.