For: Breast Cancer
Verzenio (abemaciclib) is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.
VERZENIO 50 mg tablets are oval beige tablet with “Lilly” debossed on one side and “50” on the other side.
VERZENIO 100 mg tablet are oval white to practically white tablet with “Lilly” debossed on one side and “100” on the other side.
VERZENIO 150 mg tablets are oval yellow tablet with “Lilly” debossed on one side and “150” on the other side.
VERZENIO 200 mg tablets are oval beige tablet with “Lilly” debossed on one side and “200” on the other side.
VERZENIO tablets are supplied in 7-day dose pack configurations as follows:
200 mg dose pack (14 tablets) �" each blister pack contains 14 tablets (200 mg per tablet) (200 mg twice daily)
NDC 0002-6216-54
150 mg dose pack (14 tablets) �" each blister pack contains 14 tablets (150 mg per tablet) (150 mg twice daily)
NDC 0002-5337-54
100 mg dose pack (14 tablets) �" each blister pack contains 14 tablets (100 mg per tablet) (100 mg twice daily)
NDC 0002-4815-54
50 mg dose pack (14 tablets) �" each blister pack contains 14 tablets (50 mg per tablet) (50 mg twice daily)
NDC 0002-4483-54
16.2 Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
These highlights do not include all the information needed to use VERZENIO safely and effectively. See full prescribing information for VERZENIO.
VERZENIO® (abemaciclib) tablets, for oral use
Initial U.S. Approval: 2017
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 9/2019
Warnings and Precautions (5.3) 9/2019
INDICATIONS AND USAGE
VERZENIO® is a kinase inhibitor indicated:
in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1)
in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1)
as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1)
DOSAGE AND ADMINISTRATION
VERZENIO tablets are taken orally with or without food. (2.1)
Recommended starting dose in combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily. (2.1)
Recommended starting dose as monotherapy: 200 mg twice daily. (2.1)
Dosing interruption and/or dose reductions may be required based on individual safety and tolerability. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg, 100 mg, 150 mg, and 200 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Diarrhea: Instruct patients at the first sign of loose stools to initiate antidiarrheal therapy, increase oral fluids, and notify their healthcare provider. (5.1)
Neutropenia: Monitor complete blood counts prior to the start of VERZENIO therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. (2.2, 5.2)
Interstitial Lung Disease (ILD)/Pneumonitis: Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for clinical symptoms or radiological changes indicative of ILD/pneumonitis. Permanently discontinue VERZENIO in all patients with Grade 3 or 4 ILD or pneumonitis. (2.2, 5.3)
Hepatotoxicity: Increases in serum transaminase levels have been observed. Perform liver function tests (LFTs) before initiating treatment with VERZENIO. Monitor LFTs every two weeks for the first two months, monthly for the next 2 months, and as clinically indicated. (2.2, 5.4)
Venous Thromboembolism: Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. (5.5)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (5.6, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥20%) were diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A Inhibitors: Avoid concomitant use of ketoconazole. Reduce the VERZENIO dose with concomitant use of other strong and moderate CYP3A inhibitors. (2.2, 7.1)
CYP3A Inducers: Avoid concomitant use of strong and moderate CYP3A inducers. (7.1)
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 9/2019
Lilly MONARCH 3 Study Published in Journal of Clinical Oncology Demonstrates Benefit of Verzenio� (abemaciclib) Plus NSAI in Advanced Breast Cancer
- Verzenio, used in combination with a nonsteroidal aromatase inhibitor (NSAI), reduced the risk of progression or death by 46 percent in patients with HR+, HER2- advanced breast cancer
- Results showed more than half of patients with measurable disease treated with Verzenio plus an NSAI achieved a greater degree of tumor shrinkage compared to an NSAI alone
