-HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

None.

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)
  • 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, 5.3)
  • Venous Thromboembolism: Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. (5.4)
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (5.5, 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: 6/2019

+FULL PRESCRIBING INFORMATION: CONTENTS*

+1 INDICATIONS AND USAGE

+2 DOSAGE AND ADMINISTRATION

+3 DOSAGE FORMS AND STRENGTHS

+4 CONTRAINDICATIONS

+5 WARNINGS AND PRECAUTIONS

+6 ADVERSE REACTIONS

+7 DRUG INTERACTIONS

+8 USE IN SPECIFIC POPULATIONS

+10 OVERDOSAGE

+11 DESCRIPTION

+12 CLINICAL PHARMACOLOGY

+13 NONCLINICAL TOXICOLOGY

+14 CLINICAL STUDIES

+16 HOW SUPPLIED/STORAGE AND HANDLING

+17 PATIENT COUNSELING INFORMATION

+PATIENT PACKAGE INSERT