How effective is Verzenio by itself?
Verzenio was studied in 132 adult patients with hormone receptor‑positive (HR+), human epidermal growth factor receptor 2‑negative (HER2–) advanced or metastatic breast cancer (MBC) who had progressed on or after prior hormone treatments, a taxane, and 1 or 2 chemotherapy regimens in the metastatic setting. All patients were treated with only Verzenio.
Verzenio shrinks tumors and delays the spread of cancer
When other advanced or metastatic breast cancer treatments (hormonal treatments and prior chemotherapy) stopped working, Verzenio helped delay the growth and spread of cancer in a clinical study.
19.7% of women taking Verzenio alone saw their tumors shrink by 30% or more. In the same study, an independent review found similar results (17.4% of women).
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 by itself
The recommended dose for Verzenio by itself is 200 mg twice daily, taken once in the morning and once at night.
You will receive 4 individual packs, each one containing your dose of 200-mg tablets for 7 days.
- Multiple tablet strengths (50 mg, 100 mg, 150 mg, and 200 mg) allow your doctor to make dose adjustments based on your tolerability
- 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:
Side effects with Verzenio by itself
Most common side effects
- Decreased appetite
- Abdominal pain
- Low white blood cell count (neutropenia)
- Low red blood cell count (anemia)
- Low platelet count (thrombocytopenia)
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 + fulvestrant, it was common for patients to experience diarrhea that was sometimes severe. In some cases, it led to dehydration or infection. Diarrhea was greatest during the first month, and then decreased.
- The median time to first symptoms was about a week (the median duration of moderate and more significant diarrhea was 7.5 days and 4.5 days, respectively). However, some patients experienced this earlier or later in therapy
- The diarrhea was managed by their doctor with an anti-diarrhea medicine, like loperamide (sometimes sold under the brand name Imodium®), and/or by reducing the dose.* One patient stopped participating in the trial due to diarrhea. You should call your doctor right away if your diarrhea does not go away or gets worse
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, 132 patients who progressed on or after prior hormone treatments, a taxane, and 1 or 2 chemotherapy regimens in the metastatic setting received Verzenio by itself
- In the same study, 12% of patients who received Verzenio by itself experienced hair thinning or loss