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Verzenio

Addressing Diarrhea

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

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 month. You should be on the lookout for cramping or frequent, loose, or watery stools.

PLAN

PLAN AHEAD OF TIME

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

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 antidiarrheal at the first sign and call your doctor, who may make a dose change.

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

Drink at least 8-12 glasses of clear fluids in the first 24 hours you experience symptoms (and continue any day you experience diarrhea) to avoid dehydration.

Ideally, the antidiarrheal will be able to help resolve your symptoms, but if symptoms continue after the first 24 hours, 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.

Dietary suggestions

Diet may have an impact on your experience with diarrhea, but it doesn’t mean you have to completely change how or what you eat. Before you make any changes to your diet, be sure to talk to your healthcare team. Also note that these tips are not specific to Verzenio.

  • Choose foods that are easy to digest

  • Eat smaller meals more frequently. It is better to eat 5 or 6 small meals a day instead of 3 big meals

  • Look for soft, bland foods: bananas, applesauce, crackers, eggs, white rice, white toast, plain pasta, chicken or turkey (without the skin)

  • Eat foods that are high in sodium and potassium: canned fruits (apricots, peaches, pears), potatoes (baked, boiled, or mashed)

  • When you have diarrhea, your body may lose some of these important minerals, so it’s important to make sure you get enough in your diet

There are many other dietary options to help with diarrhea. This list is just a guide you can refer to when choosing what to eat and drink.

Suggestions for what to avoid:
  • Dairy products—milk, cheese, or sour cream

  • High-fiber foods and foods that cause gas—whole wheat bread, granola, bran cereals, raw fruits and vegetables, nuts, seeds, popcorn, lentils, peas, corn, broccoli, cabbage

  • Fatty or greasy foods—fried foods, bacon, sausage, hamburgers, pizza, salad dressings, pastries

  • Spicy foods—pepper, hot sauce, salsa, chili

  • Sugar-free candy or gum made with sugar alcohol (sorbitol)

  • Food or drinks that have caffeine—regular coffee or tea, some sodas, chocolate

  • Alcoholic drinks—beer, wine, and other types of alcohol

  • Food or drinks that are too hot or too cold—have food or drinks at room temperature

Side effects with Verzenio

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)

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Verzenio. For more information, ask your doctor or pharmacist.

Dose Reductions/Modifications

Most common side effects of Verzenio can be managed with a reduced dose. When a dose reduction is suggested by your doctor, the benefit of Verzenio + hormone therapy is maintained.

Data from the clinical trial was further analyzed to assess the results when dose reduction was needed. These analyses were not pre-planned. Individual results may vary. Take Verzenio exactly as your doctor tells you. Your doctor may change your dose if needed. Do not stop taking Verzenio or change the dose without talking to your doctor. The recommended dose of Verzenio (in combination with hormone therapy) is 150 mg by mouth twice a day, taken once in the morning and once at night.

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 03MAR2023

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

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 03MAR2023

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 female 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.