Verzenio + fulvestrant
Explore the effectiveness, dosing, and common side effects of Verzenio + fulvestrant.
How effective is Verzenio + fulvestrant?
Verzenio was studied in a clinical trial of 669 women with hormone receptor‑positive (HR+), human epidermal growth factor receptor 2‑negative (HER2–) metastatic breast cancer (MBC), whose disease had progressed after hormone treatment: 446 patients were treated with Verzenio + fulvestrant, and 223 were treated with fulvestrant alone.
Verzenio is helping to raise the bar of what is possible in HR+, HER2− metastatic breast cancer treatment.
Proven to help women live significantly longer
In a clinical study, women taking Verzenio + fulvestrant lived for a median of 46.7 months vs 37.3 months on fulvestrant alone, regardless of menopausal status
More time without disease progression
In the same study, Verzenio + fulvestrant delayed disease progression for a median of 16.4 months vs 9.3 months with fulvestrant alone
What is overall survival?
Overall survival (OS) is how long someone lives with cancer, either after being diagnosed or starting treatment. When taking treatment, OS is the days, months, or years that treatment may add to life.
What is progression-free survival?
Progression-free survival (PFS) is the amount of time during and after treatment that the cancer doesn’t get worse. In other words, PFS is how long cancer growth is delayed from the time a treatment is started.
What is the difference between progression-free survival and overall survival?
Progression-free survival (PFS) is the amount of time during and after treatment that the cancer doesn’t get worse. Overall survival (OS) is how long someone lives with cancer after being diagnosed or starting treatment.
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.
Twice as many women saw their tumors shrink
48.1% of patients on Verzenio + fulvestrant saw their tumors shrink vs 21.3% with fulvestrant alone
Complete response: no detectable signs of cancer
In a clinical study, 3.5% of women on Verzenio + fulvestrant had a complete response, or no detectable sign of cancer, vs 0% with fulvestrant alone
Partial response: tumor shrinkage of 30% or more
In a clinical study, 44.7% of women on Verzenio + fulvestrant had a partial response with tumor shrinkage of 30% or more vs 21.3% with fulvestrant alone
SELECT SAFETY INFORMATION
Verzenio may cause serious side effects, including:
Low white blood cell counts (neutropenia) are common with Verzenio and may cause serious infections that can lead to death. Your doctor should check your white blood cell counts before and during treatment. Tell your doctor right away if you have fever or chills.
Taking Verzenio + fulvestrant
The recommended dose for Verzenio + fulvestrant is 150 mg twice daily, 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.
- Multiple tablet strengths (50 mg, 100 mg, and 150 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:
Fulvestrant dosing
The recommended starting dose of fulvestrant is 500 mg administered on days 1, 15, and 29 for the first month and once monthly thereafter
If you have questions about Verzenio, or need more information on how to take it, you should talk to your doctor. You can also call us at 1-844-VERZENIO (1-844-837-9364) or sign up for our Verzenio Continuous CareTM Support Program.
Side effects with Verzenio + fulvestrant
Most common side effects
- Diarrhea
- Nausea
- Infections
- Low white blood cell count (leukopenia/neutropenia)
- Abdominal pain
- Low red blood cell count (anemia)
- Tiredness
- Decreased appetite
- Vomiting
- Headache
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 9 and 6 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.* You should call your doctor right away if your diarrhea does not go away or gets worse
*22% of patients required a dose omission, and 22% required a dose reduction.
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, 446 patients who progressed following prior hormone treatments received Verzenio + fulvestrant
- In the same study, 16% of patients who received Verzenio + fulvestrant experienced hair thinning or loss