How effective is Verzenio + aromatase inhibitor (AI)?
Verzenio was studied in combination with an AI as initial endocrine-based therapy in 493 postmenopausal women with newly diagnosed hormone receptor‑positive (HR+), human epidermal growth factor receptor 2‑negative (HER2–) advanced or metastatic breast cancer (MBC). 328 patients were treated with Verzenio + AI and 165 were treated with an AI alone.
Clinical trials are still ongoing to determine if there is an overall survival benefit with Verzenio.
SELECT SAFETY INFORMATION
Verzenio may cause serious side effects, including:
Diarrhea is common with Verzenio, may be severe and may cause dehydration or infection. The most common time to develop diarrhea is during the first month of Verzenio treatment. Your doctor may stop your treatment, lower your dose, or tell you to wait to begin your treatment cycle if you have diarrhea.
At the first sign of loose stools, tell your doctor. You may be advised to start taking an antidiarrheal medicine (such as loperamide) and drink more fluids.
Taking Verzenio + AI
The recommended dose of Verzenio in combination with an AI is 150 mg by mouth twice a day, taken once in the morning and once at night.
You will receive 4 individual packs, each one containing your dose of 150-mg tablets for 7 days. Each of these packs includes 14 individual 150-mg tablets.
- Multiple tablet strengths (50 mg, 100 mg, and 150 mg) allow your doctor to make dose adjustments based on your tolerance
- If you need to reduce your dose due to tolerability, Verzenio is approved to be dosed as low as 50 mg twice daily, as directed by your doctor
- No matter what dose you are prescribed, you will take 1 tablet, 2 times a day, unless your doctor tells you otherwise
If your doctor prescribes:
Live longer without cancer getting worse
Verzenio + an AI delayed disease progression for over 2 years (a median of 28.2 months) vs 14.8 months with an AI alone
Side effects with Verzenio + AI
Most common side effects
- Low white blood cell count (leukopenia/neutropenia)
- Low red blood cell count (anemia)
- Hair loss or thinning (alopecia)
- Decreased appetite
- Abdominal pain
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Verzenio. For more information, ask your doctor or pharmacist.
In a study of Verzenio taken with an AI, it was common for women to experience diarrhea, which was sometimes severe. In some cases, diarrhea led to dehydration or infection. Diarrhea was greatest during the first month and then decreased.
- The median time to first symptoms was 8 days. The median duration for moderate and more significant diarrhea was 11 days and 8 days, respectively. However, some patients experienced this earlier or later in therapy
- The diarrhea was managed by their doctor with an anti-diarrhea medicine (for example, loperamide, which is sometimes sold under the brand name Imodium®) and/or by reducing the dose*
Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
You may also report side effects to Eli Lilly and Company at 1‑800‑545‑5979.
Will my hair fall out with Verzenio?
- In a clinical study of patients with HR+, HER2− metastatic breast cancer, 328 patients with no prior system therapy for metastatic breast cancer received Verzenio + an AI
- In the same study, 27% of patients who received Verzenio + an AI experienced hair thinning or loss