Verzenio

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Verzenio (chemical name: abemaciclib) is used in combination with an aromatase inhibitor as the first hormonal therapy to treat advanced-stage or metastatic, hormone-receptor-positive, HER2-negative breast cancer in postmenopausal women. Arimidex (chemical name: anastrozole), Aromasin (chemical name: exemestane), and Femara (chemical name: letrozole) are aromatase inhibitors.

Verzenio also is used in combination with Faslodex (chemical name: fulvestrant) to treat women diagnosed with hormone-receptor-positive, HER2-negative metastatic or advanced-stage breast cancer if the cancer grew after hormonal therapy treatment.

Verzenio is used alone to treat women and men diagnosed with hormone-receptor-positive, HER2-negative metastatic or advanced-stage breast cancer if the cancer grew after hormonal therapy treatment and earlier chemotherapy for metastatic disease.

Verzenio is a pill taken by mouth.

Learn more about:

How Verzenio works

Cancer cells grow in uncontrolled fashion. Like Ibrance (chemical name: palbociclib) and Kisqali (chemical name: ribociclib), Verzenio is a cyclin-dependent kinase (CDK) 4/6 inhibitor. A kinase is a type of protein in the body that helps control cell division. CDK4/6 inhibitors work by interfering with the kinase and stopping cancer cells from dividing and growing.

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Is Verzenio right for you?

Verzenio can be used:

  • in combination with Faslodex (chemical name: fulvestrant) to treat women diagnosed with hormone-receptor-positive, HER2-negative metastatic or advanced-stage breast cancer if the cancer grew after hormonal therapy treatment
  • alone — called monotherapy by doctors — to treat women and men diagnosed with hormone-receptor-positive, HER2-negative metastatic or advanced-stage breast cancer if the cancer grew after hormonal therapy treatment and earlier chemotherapy for metastatic disease
  • in combination with an aromatase inhibitor to treat postmenopausal women diagnosed with metastatic or advanced-stage hormone-receptor-positive, HER2-negative breast cancer that has not been treated with hormonal therapy yet

Advanced-stage breast cancer is cancer that has come back (recurred) or spread beyond the breast to the chest wall below the breast. Metastatic breast cancer is advanced-stage cancer that has spread to parts of the body away from the breast, such as the bones or liver.

Hormonal therapy medicines treat hormone-receptor-positive breast cancers in two ways:

  • by lowering the amount of the hormone estrogen in the body
  • by blocking the action of estrogen on breast cancer cells

There are several types of hormonal therapy medicines, including aromatase inhibitors, selective estrogen receptor modulators, and estrogen receptor downregulators.

To find out if a cancer is hormone-receptor-positive, most testing labs use a special staining process that makes the hormone receptors show up in a tissue sample. The test is called an immunohistochemical staining assay, or ImmunoHistoChemistry (IHC). Not all labs use the same method for analyzing the results of the test, and they do not have to report the results in exactly the same way. So you may see any of the following on your pathology report:

  • A percentage that tells you how many cells out of 100 stain positive for hormone receptors. You will see a number between 0% (none have receptors) and 100% (all have receptors).
  • An Allred score between 0 and 8. This scoring system is named for the doctor who developed it. The system looks at what percentage of cells test positive for hormone receptors, along with how well the receptors show up after staining (this is called “intensity”). This information is then combined to score the sample on a scale from 0 to 8. The higher the score, the more receptors were found and the easier they were to see in the sample.
  • The word “positive” or “negative.”

Learn more about how to read hormone receptor test results.

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What to expect when taking Verzenio

Verzenio is a pill taken by mouth. The recommended starting doses of Verzenio are 150 mg twice per day in combination with Faslodex or an aromatase inhibitor, or 200 mg twice per day used alone.

There are certain medicines, supplements, and foods you should not take or eat if you are taking Verzenio:

  • You should not take a type of medicine called a strong CYP3A inhibitor because it increases the effects of Verzenio. This class of medicines includes antifungal medicines such as Nizoral (chemical name: ketoconazole).
  • You should not take a type of medicine called a strong CYP3A inducer because it decreases the effects of Verzenio. This class of medicines includes Rifamate (chemical name: rifampin), an antibiotic used to treat tuberculosis.
  • You should not eat grapefruit or drink grapefruit juice because they can increase the effects of Verzenio.

It's important to know that women who are pregnant or planning to get pregnant should not take Verzenio. Verzenio can harm the developing fetus. If there is any chance you can become pregnant, you must use effective birth control while you're taking Verzenio and for at least 3 weeks after your last dose. Visit Treatment for Breast Cancer During Pregnancy for more information.

Also, women who are breastfeeding or plan to breastfeed shouldn't take Verzenio. Together, you and your doctor will decide if you should take Verzenio or breastfeed.

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Paying for Verzenio

If your doctor prescribes Verzenio and you have problems getting it covered by insurance or have problems paying for the treatment, Eli Lilly and Company, the company that makes Verzenio, may be able to help you.

If you live in the United States, you may be eligible for one of these patient assistance options:

  • Lilly offers a savings card program for eligible, commercially insured patients to assist with out-of-pocket costs. The savings card program provides first 3 months of Verzenio for free, then the patient pays no more than $10 per month. The patient can use the savings card for up to 12 months ($25,000 annual cap). For more information, please visit www.verzenio.com.
  • Through the Verzenio Continuous Care Program, patients can enroll in the Lilly Benefits Investigation support program that helps patients navigate their insurance benefits to learn how they may be able to pay the lowest out-of-pocket cost. To learn more about the support available, visit verzenio.com or call 1-844-VERZENIO (1-844-837-9364).
  • Lilly also donates medicines to the Lilly Cares Foundation, a separate nonprofit organization, that provides Lilly medicines to qualifying patients at no cost. Learn more about Lilly Cares at www.lillycares.com or by calling 1-800-545-6962.

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Verzenio side effects

The most common side effects of Verzenio are:

Verzenio also may cause serious side effects, including:

Diarrhea: Diarrhea is a common side effect of Verzenio. Still, some women may have such severe diarrhea that they have to decrease the dose of Verzenio or stop treatment. Tell your doctor immediately if you have any diarrhea.

Liver problems: Tell your doctor right away if you have any of the following signs of liver problems:

  • yellowing of the skin or the whites of the eyes
  • dark or brown urine
  • feeling very tired
  • loss of appetite
  • pain on the upper right side of the abdomen
  • bleeding or bruising more easily than normal

Neutropenia (low white blood cell count): Low white blood cell counts are a common side effect of Verzenio. Still, some women’s white blood cell counts may drop so low that they have to decrease the dose of Verzenio or stop treatment. Your doctor will check your white blood cell count before and during treatment with Verzenio.

Blood clots: Verzenio may cause serious or life-threatening blood clots in your arteries or lungs. Tell your doctor right away if you have shortness of breath, rapid heart rate, rapid breathing, or a sudden sharp chest pain.

Rare but severe lung inflammation: In some people, Ibrance may lead to severe pneumonia or interstitial lung disease. Interstitial lung disease describes a large group of conditions that cause scarring of the lungs. The scarring makes the lungs stiff, which makes it difficult to breathe. Tell your doctor right away if you have difficulty breathing or discomfort when you breathe or have shortness of breath when you’re resting or doing an activity that requires little exertion.

Because Verzenio is given with Faslodex or an aromatase inhibitor, you also may have side effects caused by those medicines. Common side effects of Faslodex are hot flashes, nausea, and vomiting. Common side effects of an aromatase inhibitor are joint stiffness and joint pain.

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References

  1. Verzenio (abemaceclib) prescribing information. Eli Lilly and Company. Indianapolis, IN. 2018. Available at http://pi.lilly.com/us/verzenio-uspi.pdf.
  2. Verzenio (abemaceclib) patient information. Eli Lilly and Company. Indianapolis, IN. 2018. Available at http://uspl.lilly.com/verzenio/verzenio.html#ppi.

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