VERZENIO (Abemaciclib) Tablets.

Basic Drug Information
Generic Name‌: abemaciclib
Brand Name‌: VERZENIO
Dosage Form & Strength‌: immediate-release tablet for oral use; 50mg / 100mg / 150mg
Initial U.S. Approval‌: 2017
Packager‌: Eli Lilly and Company
Drug Class‌: Kinase inhibitor (targets CDK4/6)
Indications and Usage

VERZENIO (abemaciclib) is indicated:

In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with ‌early breast cancer (HR-positive, HER2-negative, node-positive, high risk of recurrence)‌.
In combination with fulvestrant for the treatment of adult patients with ‌hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer‌ who have experienced disease progression after endocrine therapy.
Dosage and Administration
Recommended dose for adjuvant combination therapy‌: 150 mg orally twice daily
Recommended dose when used in combination with fulvestrant‌: 150 mg orally twice daily
Monotherapy recommended dose‌: 200 mg orally twice daily
Can be taken ‌with or without food‌, at the same time every day; swallow the tablet whole, do not split, chew, crush or take broken/damaged tablets.
Hepatic impairment adjustment‌: No dose adjustment needed for mild/moderate (Child-Pugh A/B) impairment; reduce the dosing frequency for severe (Child-Pugh C) hepatic impairment.
If vomiting after taking the dose, do not take an extra dose; continue the regular scheduled dosing schedule.
Treatment duration:
Early breast cancer: continue treatment until 2 years or until disease recurrence/unacceptable toxicity
Advanced/metastatic breast cancer: continue as long as clinical benefit is observed
Contraindications

None (only contraindicated in patients with hypersensitivity to abemaciclib or any excipients of the product).

Warnings and Precautions
Diarrhea‌: Severe diarrhea can occur and lead to dehydration. Start antidiarrheal treatment (e.g. loperamide) at the first onset of loose stools, interrupt or reduce dose if needed.
Hematologic toxicity‌: Neutropenia, anemia, thrombocytopenia can occur. Monitor complete blood counts before initiation, every 2 weeks for the first 2 months, monthly thereafter. Adjust dose based on severity.
Hepatotoxicity‌: Monitor ALT, AST and total bilirubin before initiation, every 2 weeks for the first 2 months, monthly thereafter.
Interstitial Lung Disease (ILD)/Pneumonitis‌: Severe and fatal cases can occur. Monitor for pulmonary symptoms, permanently discontinue for grade 3/4 ILD.
Embryo-Fetal Toxicity‌: Can cause fetal harm. Advise patients of fetal risk and use effective contraception during treatment and for 3 weeks after the last dose.