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abemaciclib (Verzenio)
Indications:
- early breast cancer in certain patients* [4]
- ER+, HER2- metastatic breast cancer
* high-risk, node-positive with a Ki-67 score of > 19 [4]
Dosage:
- 200 mg BID
- 150 mg BID in combination with fulvestrant
- fulvestrant dose is 500 mg IM on days 1, 15, & 29, & once monthly thereafter [3]
Tabs: 50 mg, 100 mg, 150 mg, & 200 mg
Pharmacokinetics:
- metabolized by CYP3A
Adverse effects:
- diarrhea, nausea, vomiting, abdominal pain, decreased appetite
- leukopenia, neutropenia, thrombocytopenia, anemia
- infections
- fatigue, headache
Mechanism of action:
- inhibits CDK4 & CDK6
General
small inhibitory antineoplastic agent (ib drug)
cyclin-dependent kinase inhibitor (CDKI, CDKN)
References
- Wikipedia: Abemaciclib
https://en.wikipedia.org/wiki/Abemaciclib
- Windle ML.
FDA New Drug and Biologic Approvals -- 2017 Year-in-Review
Medscape - Jan 11, 2018.
https://reference.medscape.com/viewarticle/890871
- U.S. Food and Drug Administration.
Novel Drug Approvals for 2017.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
- Dickler MN, Tolaney SM, Rugo HS et al
MONARCH 1, A Phase II Study of Abemaciclib, a CDK4 and CDK6
Inhibitor, as a Single Agent, in Patients with Refractory
HR+/HER2- Metastatic Breast Cancer.
Clin Cancer Res. 2017 Sep 1;23(17):5218-5224. Epub 2017 May 22.
PMID: 28533223
- Sledge GW Jr, Toi M, Neven P et al
MONARCH 2: Abemaciclib in Combination With Fulvestrant in
Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed
While Receiving Endocrine Therapy.
J Clin Oncol. 2017 Sep 1;35(25):2875-2884. Epub 2017 Jun 3.
PMID: 28580882
- Chustecka Z
New Approval in Early Breast Cancer: First Advance in 20 Years.
Medscape. October 13, 2021
https://www.medscape.com/viewarticle/960784
- HIGHLIGHTS OF PRESCRIBING INFORMATION. VERZENIO
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716s000lbl.pdf