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Generic Name: abemaciclib

Trade Name: Verzenio™

For which conditions Verzenio drug approved? Verzenio is indicated for use:

  • In combination with fulvestrant in women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer who have experienced progression of their disease following endocrine therapy, or
  • As monotherapy for adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer who have experienced progression of their disease following endocrine therapy and prior chemotherapy.

What is the mechanism of action? Verzenio is a kinase inhibitor. A kinase is a type of protein in the body that helps control cell division. Cancer cells grow in an uncontrolled fashion, and Verzenio works by interfering with the kinase to stop cancer cells from dividing and growing**.**

How is Verzenio typically given (administered)? Verzenio is taken orally with or without food twice daily as either monotherapy or in combination with fulvestrant. You should take Verzenio at approximately the same times every day and swall whole. If you miss a dose or vomit following a dose, take the next prescribed dose at the usual time.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Verzenio. Typically, blood will be drawn before and after treatment to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans, or other measures to assess side effects and response to therapy. Verzenio can harm an unborn baby, so women should not become pregnant while taking this drug. Do not breastfeed during treatment with Verzenio and for at least 3 weeks after the last dose of Verzenio.

What are the most common (occur in 20% or more of patients) side effects of treatment with Verzenio?

  • Diarrhea
  • Neutropenia
  • Nausea
  • Abdominal pain
  • Infections
  • Fatigue
  • Anemia
  • Decrease in white blood cells (leukopenia)
  • Decreased appetite
  • Vomiting
  • Headache
  • Decrease in platelets (thrombocytopenia)

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

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Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

Tell your healthcare provider about all the medicines you take, including prescription and over­-the-counter medicines, vitamins, and herbal supplements.

Are there any special precautions patients should be aware of before starting treatment?

Because Verzenio may cause diarrhea which can be severe in some cases, at the first sign of loose stools, talk to your doctor about initiating antidiarrheal therapy and further instructions and follow up. You should increase your intake of oral fluids. Avoid grapefruit and grapefruit products while taking Verzenio.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Contact your healthcare professional right away if you experience any of the following:

  • Diarrhea/loose stools
  • You have symptoms of low white blood cell counts. These include: signs of infections such as fever of chills.
  • Feeling very tired
  • Pain on the upper right side of your abdomen
  • Loss of appetite
  • Bleeding or bruising more easily than normal
  • Pain or swelling in your arms or legs
  • Shortness of breath
  • Chest pain
  • Rapid breathing
  • Rapid heart rate
  • You become pregnant.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.