• Adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence (in combination with tamoxifen or an aromatase inhibitor).
• Advanced or metastatic HR-positive, HER2-negative breast cancer in patients with disease progression following endocrine therapy (in combination with fulvestrant).
• HR-positive, HER2-negative advanced or metastatic breast cancer in patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting (as monotherapy).
• HR-positive, HER2-negative advanced or metastatic breast cancer (as initial endocrine-based therapy in combination with an aromatase inhibitor).

Contraindicated in:

• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Severe renal impairment (CCr <30 mL/min)
• Severe hepatic impairment (↓ dose)
• History of venous thromboembolism
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: peripheral edema, VENOUS THROMBOEMBOLISM.

Derm: alopecia, pruritus, rash.

GI: ↓ appetite, ↑ liver enzymes, abdominal pain, constipation, diarrhea, dry mouth, nausea, stomatitis, vomiting, HEPATOTOXICITY.

GU: ↑ serum creatinine, ↓ fertility (males).

Hemat: anemia, leukopenia, neutropenia, thrombocytopenia.

Metab: ↓ weight.

MS: arthralgia.

Neuro: dizziness, dysgeusia, fatigue, headache.

Resp: cough, INTERSTITIAL LUNG DISEASE/PNEUMONITIS.

Misc: fever, infection.

Drug-Drug:

• Strong CYP3A inhibitors, including itraconazole or ketoconazole may ↑ abemaciclib levels and risk of toxicity; avoid concurrent use with ketoconazole; ↓ abemaciclib dose when using other strong CYP3A4 inhibitors (resume original dose after 3–5 half-lives of offending drug have passed following discontinuation).
• Strong CYP3A inducers, including rifampin may ↓ abemaciclib levels and its effectiveness; avoid concurrent use.

• Tablets: 50 mg; 100 mg; 150 mg; 200 mg;

• PO (Adults): With fulvestrant, tamoxifen, or an aromatase inhibitor: 150 mg twice daily; for early breast cancer, continue for 2 years or until disease progression or unacceptable toxicity; for advanced or metastatic breast cancer, continue until disease progression or unacceptable toxicity. As monotherapy: 200 mg twice daily; continue until disease progression or unacceptable toxicity. Concurrent use of strong CYP3A inhibitor (other then ketoconazole): 100 mg twice daily (with fulvestrant, tamoxifen, an aromatase inhibitor, or as monotherapy); if dose already at 100 mg twice daily due to adverse reactions, ↓ dose to 50 mg twice daily; for early breast cancer, continue for 2 years or until disease progression or unacceptable toxicity; for advanced or metastatic breast cancer, continue until disease progression or unacceptable toxicity.

Verzenio

• Inhibits kinases (cyclin-dependent kinases 4 and 6) that are part of the signaling pathway for cell proliferation.

• Improved survival and decreased spread of breast cancer.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: kinase inhibitors

Absorption: 45% absorbed following oral administration.

Distribution: Extensively distributed to tissues.

Protein Binding: 96%.

Metabolism/Excretion: Primarily metabolized in the liver by CYP3A4 to several active metabolites; 81% excreted in feces, 3% in urine.

Half-life: 18.3 hr.

(blood levels)

• Instruct patient to take abemaciclib at the same times each day as directed. If patient vomits or misses a dose, omit dose and take next dose as scheduled. Do not ingest tablets that are broken, cracked, or not intact. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Advise patient that at first sign of diarrhea, start antidiarrheal therapy (loperamide), increase oral fluids, and notify health care professional.
• Advise patient to notify health care professional if signs and symptoms of infection (fever, chills), liver problems (feeling very tired, pain on upper right side of abdomen, loss of appetite, unusual bleeding or bruising), or venous thromboembolism (pain or swelling in arms or legs, shortness of breath, chest pain, rapid breathing, rapid heart rate) occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and avoid breast feeding during and for at least 3 wk after last dose of therapy. Inform male patient may impair fertility.

a-bem-a-SYE-klib

NDC Code^*

• 0002- Eli Lilly and Company
  • 0002-4483- Verzenio
    • 0002-4483-54- 1 BLISTER PACK in 1 CARTON (0002-4483-54) > 14 TABLET in 1 BLISTER PACK

• 0002- Eli Lilly and Company
  • 0002-4815- Verzenio
    • 0002-4815-54- 1 BLISTER PACK in 1 CARTON (0002-4815-54) > 14 TABLET in 1 BLISTER PACK

• 0002- Eli Lilly and Company
  • 0002-5337- Verzenio
    • 0002-5337-54- 1 BLISTER PACK in 1 CARTON (0002-5337-54) > 14 TABLET in 1 BLISTER PACK

• 0002- Eli Lilly and Company
  • 0002-6216- Verzenio
    • 0002-6216-54- 1 BLISTER PACK in 1 CARTON (0002-6216-54) > 14 TABLET in 1 BLISTER PACK