Verzenio + Aromatase Inhibitor

Explore the effectiveness of Verzenio + an AI, dosing, and how to address side effects

How effective is Verzenio + an aromatase inhibitor (AI)?

Verzenio was studied in combination with an AI as initial endocrine-based therapy in 493 patients with newly diagnosed hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2−) advanced or metastatic breast cancer (MBC). In the study, 328 patients were treated with Verzenio + an 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.

Live longer without cancer getting worse

Verzenio + AI delayed disease progression for over 2 years

Verzenio + an AI delayed disease progression for over 2 years (a median of 28.2 months) vs 14.8 months with an AI alone

More than half of the women saw their tumors shrink

Verzenio + AI Tumor Shrinkage

55.4% of women on Verzenio + an AI saw their tumors shrink vs 40.2% on an AI alone

Complete response: no detectable signs of cancer

Verzenio + AI had a complete response or no detectable signs of cancer

3.4% of women on Verzenio + an AI had a complete response, or no detectable sign of cancer, vs 0% with an AI alone

Partial response: tumor shrinkage of 30% or more

Verzenio + AI saw a tumor shrinkage of 30% or more

52.1% of women on Verzenio + an AI had a partial response with tumor shrinkage of 30% or more vs 40.2% with an AI alone

Taking Verzenio + an AI

Dosing

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.

150-mg tablet by mouth in the morning.
150-mg tablet by mouth in the evening

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:

50-mg dose

You will receive
4 red packs.

100-mg dose

You will receive
4 purple packs.

150-mg dose

You will receive
4 light blue packs.

Aromatase inhibitor dosing

Prescription pill bottle

The recommended dose of an AI is 1 tablet taken by mouth once daily. The recommended doses for letrozole and anastrozole are 2.5 mg and 1 mg, respectively

Side effects with Verzenio + an AI

Most common side effects

Most common side effects with Verzenio plus an AI
  • Diarrhea
  • Low white blood cell count (leukopenia/neutropenia)
  • Infections
  • Nausea
  • Low red blood cell count (anemia)
  • Vomiting
  • Hair loss or thinning (alopecia)
  • Decreased appetite
  • Tiredness
  • 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 negative 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.

*19% had to have their dose omitted, and 13% had to have their dose lowered.

Addressing side effects

Addressing diarrhea

Overall, the key information to know about diarrhea: it can be managed with the appropriate steps so EXPECT, PLAN, and ACT.

Addressing Side Effects - Addressing Diarrhea – EXPECT

EXPECT — DIARRHEA IS A COMMON SIDE EFFECT

Diarrhea is a common side effect with Verzenio and may sometimes be severe, but you and your doctor can take steps to manage it. If diarrhea occurs, it will most likely happen in the first week. You should be on the lookout for cramping or frequent, loose, or watery stools.

Addressing Side Effects - Addressing Diarrhea – PLAN

PLAN — PLAN AHEAD OF TIME

It is important to plan ahead of time with your doctor. Make sure you have an over-the-counter anti-diarrheal medicine, such as loperamide (also known as Imodium®) available at home before you start taking Verzenio.

Addressing Side Effects - Addressing Diarrhea – ACT

ACT – IMMEDIATE 24-HOUR ACTION PLAN

If you begin experiencing diarrhea, it is very important that you take action immediately at the first signs of symptoms. The best way to manage diarrhea is to start an anti-diarrheal at the first sign and call your doctor, who may make a dose change.

  • STEP 1: Start an anti-diarrheal and call your doctor

    If you are experiencing diarrhea, you need to start taking an anti-diarrheal as directed on the packaging and call your doctor or nurse immediately so they are aware and can help you manage the diarrhea.

  • STEP 2: Stay hydrated and drink clear fluids

    Drink at least 8-10 glasses of clear fluids in the first 24 hours you experience symptoms (and continue any day you experience diarrhea) to avoid dehydration.

  • STEP 3: Watch for improvement and follow up with doctor

    Ideally, the anti-diarrheal will be able to help resolve your symptoms, but if symptoms continue after the first 24 hrs, you need to talk to your doctor or nurse that day. He or she may consider adjusting your dose, with the ultimate goal of finding which dose is right for you. Verzenio is effective at different doses, so it is important to find what dose is right for your body.

Monitoring blood counts and liver function

Some patients experienced low white blood cell counts (neutropenia) and/or liver problems.

Your doctor will do blood tests to monitor your blood cell counts and to check for liver problems before and during treatment

Indication

Verzenio is a prescription medicine used to treat a type of breast cancer. It is a medicine you can take if:

  • You have a type of breast cancer called HR+/HER2− (hormone receptor positive/human epidermal growth factor receptor 2 negative) and the cancer has spread to other parts of the body (metastasized)
  • Verzenio is given in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, in combination with fulvestrant in women whose disease has progressed after hormonal therapy, or alone in women whose disease has progressed after hormone therapy and prior chemotherapy

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

Important Safety Information

Verzenio may cause serious side effects, including:

Diarrhea. Diarrhea is common with Verzenio and may sometimes be severe. Diarrhea may cause you to develop 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

Low white blood cell counts (neutropenia). Low white blood cell counts are common when taking Verzenio and may cause serious infections that can lead to death. Your doctor should check your white blood cell counts before and during treatment.

If you develop low white blood cell counts during treatment with Verzenio, your doctor may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your doctor right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills.

Liver problems. Your doctor should do blood tests before and during treatment to check your liver. Your doctor may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle if you develop liver problems. Tell your doctor right away if you have any of the following:

  • Feeling very tired
  • Pain on the upper right side of your stomach area (abdomen)
  • Loss of appetite
  • Bleeding or bruising more easily than normal

Blood clots in your veins or in the arteries of your lungs. Verzenio may cause serious blood clots that have led to death. Talk to your doctor if you have 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. If you are able to become pregnant, you should use effective birth control during treatment with Verzenio and for at least 3 weeks after the last dose of Verzenio. Verzenio may affect the ability of males to father a child.

What are the possible side effects of Verzenio?

The most common side effects of Verzenio include: nausea, infections, decreased appetite, headache, abdominal pain, tiredness, vomiting, hair thinning or loss.

The most common changes to blood tests were low red blood cell count (anemia), low white blood cell counts (leukopenia) and low platelet count (thrombocytopenia).

You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What should I tell my doctor before taking Verzenio?

Tell your doctor if you:

  • are pregnant or plan to become pregnant. If you become pregnant during your treatment, discuss this with your doctor.
  • are breastfeeding or plan to breastfeed. It is not known if Verzenio passes into your breast milk. Do not breastfeed during treatment with Verzenio and for at least 3 weeks after your last dose. You and your doctor should decide if you will take Verzenio or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Verzenio and certain other medicines can affect each other, causing serious side effects and may require you to change your dose. Especially tell your doctor if you take a medicine that contains ketoconazole. Avoid grapefruit products while taking Verzenio. Grapefruit may increase the amount of Verzenio in your blood.

Verzenio is available by prescription only.

Please see full Prescribing Information for Verzenio.

AL DTC ISI 27FEB2018