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 when given with 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, when given with Verzenio, is 500 mg administered on days 1, 15, and 29 for the first month and once monthly thereafter. Your doctor will determine your fulvestrant dosing schedule.

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 Care™ Support Program.

Learn how to address side effects

SAFETY SUMMARY

Warnings - Verzenio may cause serious side effects, including:

Diarrhea is common with Verzenio, may sometimes be severe and may cause dehydration or infection. The most common time to develop diarrhea is during the first month of Verzenio treatment. If you develop diarrhea during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, stop your treatment, or decrease your dose.

If you have any loose stools, start taking an antidiarrheal medicine (such as loperamide), drink more fluids, and tell your healthcare provider right away.

Low white blood cell counts (neutropenia) are common with Verzenio and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment. If you develop low white blood cell counts during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, decrease your dose, or wait before starting your next month of treatment. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills.

Verzenio may cause severe or life-threatening inflammation (swelling) of the lungs during treatment that can lead to death. If you develop lung problems during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, decrease your dose, or stop your treatment. Tell your healthcare provider right away if you have any new or worsening symptoms, including:

Trouble breathing or shortness of breath
Cough with or without mucus
Chest pain

Verzenio can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment. If you develop liver problems during treatment with Verzenio, your health care provider may reduce your dose or stop your treatment. Tell your healthcare provider right away if you have any of the following signs or symptoms of liver problems:

Feeling very tired
Pain on the upper right side of your stomach area (abdomen)

Loss of appetite
Bleeding or bruising more easily than normal

Verzenio may cause blood clots in your veins, or in the arteries of your lungs. Verzenio may cause serious blood clots that have led to death. If you develop blood clots during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it. Tell your healthcare provider right away if you have any of the following signs and symptoms of a blood clot:

Pain or swelling in your arms or legs
Shortness of breath
Chest pain

Fast breathing
Fast heart rate

Verzenio can harm your unborn baby. Use effective birth control (contraception) during treatment and for 3 weeks after the last dose of Verzenio and do not breastfeed during treatment with Verzenio and for at least 3 weeks after your last dose. Verzenio may affect the ability of males to father a child.

Common side effects

The most common side effects of Verzenio include:

Nausea
Infections
Low red blood cell counts (anemia)
Decreased appetite
Headache
Hair thinning or hair loss (alopecia)

Abdominal pain
Tiredness
Low white blood cell counts (leukopenia)
Vomiting
Low platelet counts (thrombocytopenia)

These are not all the possible side effects of Verzenio

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using:

Before you use Verzenio, tell your healthcare provider about all your medical conditions, including:

If you have fever, chills, or other signs of infection.
If you have a history of blood clots in your veins.
Have lung or breathing problems.
Have liver or kidney problems.
If you are pregnant, plan to become pregnant, or are breastfeeding.
About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take a medicine that contains ketoconazole.

How to take:

Take Verzenio exactly as your healthcare provider tells you.
Your healthcare provider may change your dose if needed. Do not stop taking Verzenio or change the dose without talking to your healthcare provider.
Verzenio may be taken with or without food.
Swallow Verzenio tablets whole. Do not chew, crush, or split the tablets before swallowing. Do not take Verzenio tablets if they are broken, cracked, or damaged.
Take your doses of Verzenio at about the same time every day.
If you vomit or miss a dose of Verzenio, take your next dose at your regular time. Do not take 2 doses at the same time to make up for the missed dose.

What to avoid during treatment

Avoid taking ketoconazole during treatment with Verzenio. Tell your healthcare provider if you take a medicine that contains ketoconazole
Avoid grapefruit and products that contain grapefruit during treatment with Verzenio. Grapefruit may increase the amount of Verzenio in your blood

Learn more

Verzenio is a prescription medicine. For more information, call 1-800-545-5979.

This summary provides basic information about Verzenio but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Verzenio and how to take it. Your healthcare provider is the best person to help you decide if Verzenio is right for you.

AL CON BS 14SEP2022

Verzenio^® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

INDICATIONS

Verzenio^® (ver-ZEN-ee-oh) is used to treat certain types of breast cancer known as HR+/HER2– (hormone receptor positive/human epidermal growth factor receptor 2 negative) breast cancer.

It is a medicine you can take if:

You have node-positive early breast cancer that has a high risk of coming back as determined by your healthcare provider. Verzenio is given along with hormonal therapy to women and men.
Or, the cancer has spread to other parts of the body (metastasized). If you are postmenopausal, or male, then Verzenio is given with an aromatase inhibitor as initial endocrine-based therapy. If you are a female or male, and the cancer has gotten worse after hormonal therapy, then Verzenio is given with fulvestrant. If you are female or male and the cancer has gotten worse after both hormonal therapy and chemotherapy, then Verzenio is given by itself.

It is not known if Verzenio is safe and effective in children.