HIGHLIGHTS OF PRESCRIBING INFORMATION ...

1 1. HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------------- CONTRAINDICATIONS ------------------------------ These HIGHLIGHTS do not include all the INFORMATION needed to use None. (4). VERZENIO safely and effectively. See full PRESCRIBING INFORMATION for VERZENIO. ------------------------ WARNINGS AND PRECAUTIONS ----------------------- Diarrhea: Instruct patients at the first sign of loose stools to initiate VERZENIO (abemaciclib) tablets, for oral use antidiarrheal therapy, increase oral fluids, and notify their Initial Approval: 2017 healthcare provider.

2 ( ). Neutropenia: Monitor complete blood counts prior to the start of --------------------------- RECENT MAJOR CHANGES -------------------------- VERZENIO therapy, every 2 weeks for the first 2 months, monthly Indications and Usage (1) 2/2018 for the next 2 months, and as clinically indicated. ( , ). Dosage and Administration, Hepatotoxicity: Increases in serum transaminase levels have been Recommended Dose and Schedule ( ) 2/2018 observed. Perform liver function tests (LFTs) before initiating Warnings and Precautions, Diarrhea ( ) 2/2018 treatment with VERZENIO.

3 Monitor LFTs every two weeks for the first two months, monthly for the next 2 months, and as clinically Warnings and Precautions, Neutropenia ( ) 2/2018 indicated. ( , ). Warnings and Precautions, Hepatotoxicity ( ) 2/2018 Venous Thromboembolism: Monitor patients for signs and Warnings and Precautions, Venous Thromboembolism ( ) 2/2018 symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. ( ). ---------------------------- INDICATIONS AND USAGE --------------------------- Embryo-Fetal Toxicity: Can cause fetal harm.

4 Advise patients of VERZENIO is a kinase inhibitor indicated: potential risk to a fetus and to use effective contraception. ( , , 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 ------------------------------- ADVERSE REACTIONS ------------------------------ receptor 2 (HER2)-negative advanced or metastatic breast cancer. Most common adverse reactions (incidence 20%) were diarrhea, (1) neutropenia, nausea, abdominal pain, infections, fatigue, anemia, in combination with fulvestrant for the treatment of women with leukopenia, decreased appetite, vomiting, headache, alopecia, and hormone receptor (HR)-positive, human epidermal growth factor thrombocytopenia.

5 (6). receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly as monotherapy for the treatment of adult patients with HR- and Company at 1-800-LillyRx (1-800-545-5979) or FDA at positive, HER2-negative advanced or metastatic breast cancer 1-800-FDA-1088 or with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1) ------------------------------- DRUG INTERACTIONS ------------------------------ CYP3A Inhibitors: Avoid concomitant use of ketoconazole.

6 Reduce ------------------------DOSAGE AND ADMINISTRATION----------------------- the VERZENIO dose with concomitant use of other strong and VERZENIO tablets are taken orally with or without food. ( ) moderate CYP3A inhibitors. ( , ). Recommended starting dose in combination with fulvestrant or an CYP3A Inducers: Avoid concomitant use of strong and moderate aromatase inhibitor: 150 mg twice daily. ( ) CYP3A inducers. ( ). Recommended starting dose as monotherapy: 200 mg twice daily. ------------------------USE IN SPECIFIC POPULATIONS----------------------- ( ).

7 Lactation: Advise not to breastfeed. ( ). Dosing interruption and/or dose reductions may be required based on individual safety and tolerability. ( ). See 17 for PATIENT COUNSELING INFORMATION and ----------------------DOSAGE FORMS AND STRENGTHS--------------------- FDA-approved patient labeling. Tablets: 50 mg, 100 mg, 150 mg, and 200 mg. (3) Revised: 8/2018. full PRESCRIBING INFORMATION : CONTENTS*. 1 INDICATIONS AND USAGE Pediatric Use 2 DOSAGE AND ADMINISTRATION Geriatric Use Recommended Dose and Schedule Renal Impairment Dose Modification Hepatic Impairment 3 DOSAGE FORMS AND STRENGTHS 10 OVERDOSAGE.

8 4 CONTRAINDICATIONS 11 DESCRIPTION. 5 WARNINGS AND PRECAUTIONS 12 CLINICAL PHARMACOLOGY. Diarrhea Mechanism of Action Neutropenia Pharmacodynamics Hepatotoxicity Pharmacokinetics Venous Thromboembolism 13 NONCLINICAL TOXICOLOGY. Embryo-Fetal Toxicity Carcinogenesis, Mutagenesis, Impairment of Fertility 6 ADVERSE REACTIONS 14 CLINICAL STUDIES. Clinical Studies Experience 16 HOW SUPPLIED/STORAGE AND HANDLING. 7 DRUG INTERACTIONS How Supplied Effect of Other Drugs on VERZENIO Storage and Handling 8 USE IN SPECIFIC POPULATIONS 17 PATIENT COUNSELING INFORMATION .

9 Pregnancy Lactation * Sections or subsections omitted from the full PRESCRIBING INFORMATION Females and Males of Reproductive Potential are not listed. 2. full PRESCRIBING INFORMATION . 1 INDICATIONS AND USAGE. VERZENIO (abemaciclib) is 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. 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.

10 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. 2 DOSAGE AND ADMINISTRATION. Recommended Dose and Schedule When used in combination with fulvestrant or an aromatase inhibitor, the recommended dose of VERZENIO is 150 mg taken orally twice daily. When given with VERZENIO, refer to the full PRESCRIBING INFORMATION for the recommended dose of the aromatase inhibitor being used.