How long do you take Verzenio for?
Key Points
What is Verzenio?
Verzenio (abemaciclib) is an oral medicine used to treat a type of breast cancer known as HR+/HER2– (hormone receptor positive/human epidermal growth factor receptor 2–negative) in certain patients. HR+, HER2– breast cancer makes up approximately 70% of all breast cancers. Men and women of all ages can be diagnosed with breast cancer.
Verzenio is considered a targeted drug treatment, not a chemotherapy. It is known as a CDK 4 & 6 inhibitor and is given as an oral tablet taken twice a day. It works by blocking cyclin-dependent kinases 4 and 6 involved in promoting the growth of cancer cells.
Verzenio is given:
How long did people take Verzenio in clinical studies?
Studies looking at the effectiveness of Verzenio looked at different endpoints, such as overall survival (OS) and profession-free survival (PFS).
Verzenio in combination with an Aromatase Inhibitor (AI)
Verzenio was studied in combination with an AI (letrozole or anastrozole) as the first endocrine-based therapy in 493 postmenopausal women with newly diagnosed HR+/HER2– advanced or metastatic breast cancer (MBC). Overall, 328 patients were treated with Verzenio + AI and 165 were treated with an AI alone. Median duration of treatment was 15.1 months for the group taking Verzenio plus an AI.
Verzenio plus fulvestrant
Verzenio was studied in a clinical trial of 669 women with HR+/HER2- MBC, whose disease had progressed after hormone treatment (such as with letrozole or anastrozole). In this study, 446 patients were treated with Verzenio plus fulvestrant, and 223 were treated with fulvestrant alone. The median duration of treatment with Verzenio plus fulvestrant was 12 months.
Verzenio alone (monotherapy)
In this study, 132 patients with HR+/HER2– MBC were only treated with Verzenio. These patients, whose cancer had spread in the body, had progressed on or after prior hormone treatments, a taxane, and 1 or 2 chemotherapy regimens. The median duration of treatment with Verzenio was 4.5 months.
Verzenio in early breast cancer
The monarchE study looked at 2,003 eligible women and men with HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence.
Patients were randomized to receive two years of Verzenio 150 mg twice daily plus physician's choice of hormone therapy, or hormone therapy alone. Patients in both treatment arms were instructed to continue to receive hormone therapy for up to 5 to 10 years as recommended by their doctor.
The primary endpoint of the study (still ongoing) is invasive disease-free survival (IDFS). IDFS is the length of time before breast cancer comes back, any new cancer develops, or death.
Common side effects with Verzenio treatment
Various types of side effects can occur frequently with Verzenio treatment. Discuss the risk of side effects with your doctor prior to treatment.
The most common side effects, occuring in more than 20% of patients, include:
Diarrhea
In studies with Verzenio, diarrhea was a common side effect and can sometimes be severe. In most cases, diarrhea occurs during the first month, then decreases. However, the diarrhea can lead to dehydration or infection. Overall, roughly 81% to 90% of patients experienced diarrhea among the various clinical studies with Verzenio.
In most cases, the median time until patients had the first symptoms of diarrhea was about seven to eight days. Moderate to more significant diarrhea lasted between roughly 5 to 11 days, but was variable based on studies.
At the first sign of loose stools, tell your doctor. Diarrhea can be managed by your doctor with an anti-diarrhea medication such as loperamide (Imodium). Your doctor may also decide to reduce your dose. About 15% to 25% of patients may need a dose omission or lowering of a dose due to diarrhea, but this can vary between patients.
Be sure you have an over-the-counter anti-diarrhea medicine, such as loperamide (Imodium) available at home before you start taking Verzenio. Work out an action plan with your doctor about how to address diarrhea if it occurs.
Hair thinning or hair loss
On average, 12% to 27% of patients who received Verzenio experienced hair thinning or loss. Patients taking Verzenio plus an aromatase inhibitor (such as letrozole or anastrozole) experienced the greatest risk of hair thinning or loss at 27% of patients.
These are not all the possible side effects of Verzenio. Speak to your doctor about the possibility of serious and common side effects with Verzenio.
Verzenio and grapefruit Juice
Avoid grapefruit products while taking Verzenio. Grapefruit may increase the amount of Verzenio in your blood due to a drug-food interaction.
Other serious side effects
Other serious side effects that can occur with Verzenio treatment include: neutropenia (low neutrophils, a type of white blood cell), a severe type of lung disease (Interstitial Lung Disease (ILD)/Pneumonitis), liver toxicity, blood clots, and harm to an unborn baby.
Learn more about serious side effects with Verzenio here.
Bottom Line
This is not all the information you need to know about Verzenio for safe and effective use. Review the full Verzenio product information here, and discuss this information with your doctor or other health care provider.
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