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INDICATIONS AND SAFETY SUMMARIES
This document contains Consumer Brief Summary information for Inluriyo® (imlunestrant) and Verzenio® (abemaciclib). Review both sections below for complete information on each product.

Inluriyo® (imlunestrant)

Indication and Safety Summary

Inluriyo (en-loo-ree-yoh) is a prescription medicine that is used alone or in combination with the medicine abemaciclib (Verzenio) to treat adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), and whose disease has progressed after at least 1 line of endocrine therapy.

Your healthcare provider will perform a test to make sure Inluriyo is right for you.

When Inluriyo is used in combination with abemaciclib, read the Patient Information for abemaciclib (Verzenio).

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

Before taking Inluriyo, tell your healthcare provider about all your medical conditions, including if you:

  • Have liver problems.
  • Are pregnant or plan to become pregnant. Inluriyo can harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if Inluriyo passes into breastmilk. Do not breastfeed during treatment with Inluriyo and for 1 week after the last dose. Your healthcare provider will tell you how long you should not breastfeed after combination treatment with Inluriyo and abemaciclib.

Females who are able to become pregnant:

  • Your healthcare provider will do a pregnancy test before you start treatment with Inluriyo.
  • Use effective birth control (contraception) during treatment with Inluriyo and for 1 week after the last dose.
  • Your healthcare provider will tell you how long you should use birth control (contraception) after combination treatment with Inluriyo and abemaciclib.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Inluriyo.

Males with female partners who are able to become pregnant:

  • Use effective birth control (contraception) during treatment with Inluriyo and for 1 week after the last dose.

Most common side effects of Inluriyo when taken alone include decreased hemoglobin (anemia), muscle and joint pain, decreased white blood cell counts, increased liver function tests, decreased calcium blood levels, tiredness, diarrhea, increased triglyceride and cholesterol blood levels, nausea, decreased platelet counts, constipation, and stomach-area (abdominal) pain. These are not all the possible side effects of Inluriyo.

Most common side effects of Inluriyo when taken with abemaciclib include decreased white blood cell counts, diarrhea, decreased hemoglobin (anemia), nausea, decreased platelet counts, tiredness, increased triglycerides and cholesterol blood levels, infections, increased liver function tests, increased creatinine blood levels, vomiting, muscle and joint pain, stomach-area (abdominal) pain, decreased appetite, rash, cough, headache, and weight loss. These are not all the possible side effects of Inluriyo in combination with abemaciclib.

Your healthcare provider will check your blood levels, including monitoring your triglyceride and cholesterol blood levels, before and during treatment with Inluriyo.

Your healthcare provider may change your dose, temporarily stop, or completely stop treatment with Inluriyo if you develop certain side effects.

Inluriyo may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Inluriyo and other medicines may affect each other, causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How to take Inluriyo

  • Take Inluriyo exactly as your healthcare provider tells you.
  • Your healthcare provider may change or stop your dose if needed. Do not stop taking Inluriyo or change the dose unless instructed to do so by your healthcare provider.
  • Take Inluriyo once daily, at approximately the same time each day.
  • Take on an empty stomach, at least 2 hours before food or 1 hour after food.
    • Swallow Inluriyo tablets whole. Do not chew, crush, or split the tablets.
  • If you miss a dose by 6 hours or more or vomit after taking Inluriyo, do not take another dose on that day. Take your next dose the following day at your regularly scheduled time.

Learn more

Inluriyo is a prescription medicine available as 200 mg tablets. For more information, call 1-800-545-5979 [or go to www.inluriyo.lilly.com].

This summary provides basic information about Inluriyo 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 Inluriyo and how to take it. Your healthcare provider is the best person to help you decide if Inluriyo is right for you.

VERZENIO® (abemaciclib)

Indication and Safety Summary

Verzenio (ver-ZEN-ee-oh) is a prescription medicine used in adults:

  • In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer with a high risk of coming back as determined by your healthcare provider.
  • In combination with an aromatase inhibitor as the first endocrine-based therapy to treat HR-positive, HER2-negative breast cancer that is advanced or has spread to other parts of the body (metastatic).
  • In combination with fulvestrant to treat HR-positive, HER2-negative breast cancer that is advanced or has spread to other parts of the body (metastatic) and whose disease has progressed after endocrine therapy.
  • In combination with imlunestrant (Inluriyo) to treat estrogen receptor (ER)-positive, HER2-negative, estrogen receptor-1 (ESR1)-mutated advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), and whose disease has progressed after at least 1 line of endocrine therapy. Your health care provider will perform a test to make sure Verzenio in combination with Imlunestrant is right for you.
  • Alone to treat HR-positive, HER2-negative metastatic breast cancer that is advanced or has spread to other parts of the body (metastatic) and whose disease has progressed after endocrine therapy and prior chemotherapy for metastatic disease.

When Verzenio is used in combination with fulvestrant, tamoxifen, imlunestrant, or an aromatase inhibitor, also read the Patient Information or Medication Guide for the prescribed product if available. Ask your healthcare provider if you are not sure.

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

Warnings - Verzenio may cause serious side effects, including:

Diarrhea is common with Verzenio, may sometimes be severe, and may lead to a loss of large amounts of fluid and salt causing dehydration. The most common time to develop diarrhea is during the first month of Verzenio treatment.

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. Tell your healthcare provider right away if you develop signs and symptoms of an infection, such as fever and chills.

Verzenio may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you develop any new or worsening signs or symptoms, including trouble breathing or shortness of breath, cough with or without mucus, or chest pain.

Verzenio can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment. Tell your healthcare provider right away if you develop any of the following signs or symptoms of liver problems including feeling very tired, pain on the upper right side of your stomach area (abdomen), loss of appetite, or 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. Tell your healthcare provider right away if you develop signs and symptoms of a blood clot including pain or swelling in your arms or legs, shortness of breath, chest pain, rapid breathing, or rapid heart rate.

If you develop serious side effects during treatment with Verzenio, your healthcare provider may reduce your dose, temporarily stop, or completely stop treatment with Verzenio.

Most common side effects of Verzenio include diarrhea, infections, low white blood cell counts (neutropenia and leukopenia), tiredness (fatigue), stomach area (abdominal) pain, nausea, low red blood cell counts (anemia), and vomiting. These are not all the possible side effects of Verzenio.

Verzenio may cause fertility problems in males that may affect your ability to father a child.

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

Before you use Verzenio

Tell your healthcare provider about all your medical conditions, including if you:

  • Have fever, chills, or any other signs of infection.
  • Have a history of blood clots in your veins.
  • Have lung or breathing problems.
  • Have liver or kidney problems.
  • Are pregnant, plan to become pregnant, or are breastfeeding. Verzenio can harm your unborn baby.
    • Your healthcare provider will do a pregnancy test before you start treatment with Verzenio.
    • Use effective birth control (contraception) during treatment with Verzenio and for 3 weeks after the last dose of Verzenio.
    • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Verzenio.
  • About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Verzenio may affect the way other medicines work, and other medicines may affect how Verzenio works, causing serious side effects. Especially tell your healthcare provider if you take a medicine that contains ketoconazole. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How to take Verzenio

  • 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 miss a dose of Verzenio, skip the missed dose and take your next dose at your regularly scheduled time.
  • If you vomit after taking a dose of Verzenio, do not take another dose. Take your next dose at your regularly scheduled time.

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 available as 50, 100, 150, and 200 mg tablets. For more information, call 1-800-545-5979 [or go to www.verzenio.lilly.com].

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 doctor. 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.

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Inluriyo® and Verzenio® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.