How effective is Verzenio + fulvestrant?

Verzenio was studied in a clinical trial of 669 patients with HR+, HER2– metastatic breast cancer (MBC) who progressed following prior hormone treatments. 446 patients were treated with Verzenio + fulvestrant and 223 were treated with fulvestrant alone.

16.4 months

Delayed disease progression

Patients taking Verzenio + fulvestrant, on average, lived without their cancer getting worse for 16.4 months versus 9.3 months with fulvestrant alone.

48.1% of patients

Tumor shrinkage

48.1% of patients* on Verzenio + fulvestrant saw their tumors shrink versus 21.3% of patients on fulvestrant alone.

  • Partial Response: 44.7% (142 out of 318) of patients receiving Verzenio + fulvestrant saw a partial response compared to 21.3% (35 of 164) of patients receiving fulvestrant alone
  • Complete Response: 3.5% (11 of 318) of patients on Verzenio + fulvestrant even had a complete response compared to 0% of patients on fulvestrant alone. This means that tumors were not detected (this does not mean that patients were cured)

*Whose disease could be measured (72%).

Taking Verzenio + fulvestrant

Dosing

  • The recommended dose for Verzenio + fulvestrant is 150 mg twice daily, taken once in the morning and once at night
  • moon and sun 150-mg tabletmoon and sun 150-mg tablet
  • 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

If your doctor prescribes:

50-mg dose

You will receive
4 red packs.

100-mg dose

You will receive
4 green packs.

150-mg dose

You will receive
4 purple packs.

Fulvestrant dosing

  • The recommended starting dose of fulvestrant is 500 mg on days 1, 15, and 29 for the first month and once monthly thereafter
fulvestrant dosing month 1 and month 2+

Side effects with Verzenio + fulvestrant

Most common side effects

side effects with Verzenio + fulvestrant
  • 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 (also known as Faslodex®), it was common for patients to experience diarrhea that was sometimes severe. In some cases, it led to dehydration or infection. Diarrhea was most common 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

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.

*22% of patients required a dose omission and 22% required a dose reduction.

Addressing side effects

Addressing diarrhea

Diarrhea is a common side effect with Verzenio and may sometimes be severe, but you and your doctor may be able to manage it. Diarrhea may cause dehydration and infection.

  • Notify your doctor right away at the first sign of diarrhea. This can include cramping or frequent, loose, or watery stools
  • Your doctor may start you on an anti-diarrhea medicine like loperamide, or may reduce your dose of Verzenio to help manage your diarrhea symptoms

Staying hydrated is one of the ways to help prevent the complications of diarrhea.

Drink at least 8 glasses of clear fluids every day, like:

8 glasses of clear fluids
  • Water
  • Sports Drinks
  • Broth
  • Weak decaffeinated teas
  • Caffeine-free soft drinks
  • Clear juices (no grapefruit juice)
  • Gelatin

You should call your doctor right away if your diarrhea does not go away or gets worse.

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 check for liver problems before and during treatment

Indication

Verzenio is a prescription medicine used:

  • In combination with fulvestrant to treat women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), whose disease has progressed after hormonal therapy
  • Alone to treat adults with HR–positive, HER2–negative advanced breast cancer or metastatic breast cancer whose disease has progressed after hormonal therapy and prior chemotherapy

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 and vomiting.

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 Safety Summary for Verzenio.

AL DTC ISI 02OCT2017