Frequently Asked Questions
Browse answers to common questions about Inluriyo. Explore the list below to learn more. If you do not find the answer you are looking for, we recommend calling Lilly Support ServicesTM at 1-800-LillyRx or speaking directly with your healthcare provider.
About Inluriyo
Inluriyo is an oral prescription medication approved for adults with advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic) whose disease was previously treated with endocrine therapy. The breast cancer must be ER+, HER2–, and ESR1-mutated.
Inluriyo may cause serious side effects. Inluriyo can harm your unborn baby. Women who are able to become pregnant and males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with Inluriyo and for 1 week after the last dose of Inluriyo. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Inluriyo. Do not breastfeed during treatment with Inluriyo and for 1 week after the last dose.
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.
ER+=estrogen receptor-positive; ESR1=estrogen receptor-1; HER2–=human epidermal growth factor receptor 2-negative.
A blood test will determine if your ER+, HER2– metastatic breast cancer has an ESR1 mutation. The results of the blood test may help you and your doctor decide the next course of treatment.
Learn more about testing for ESR1 mutations.
ER+=estrogen receptor-positive; ESR1=estrogen receptor-1; HER2–=human epidermal growth factor receptor 2-negative.
Inluriyo is a targeted endocrine (hormone) treatment for ER+, HER2–, ESR1-mutated metastatic breast cancer. Some breast cancers have an ESR1 mutation that leads to overactive estrogen receptors that fuel the growth and division of cancer cells. Inluriyo binds to and blocks these overactive estrogen receptors, slowing the growth of breast cancer cells.
Inluriyo affects healthy cells and breast cancer cells, which can result in side effects, some of which can be serious.
Inluriyo may cause serious side effects. Inluriyo can harm your unborn baby. Women who are able to become pregnant and males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with Inluriyo and for 1 week after the last dose of Inluriyo. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Inluriyo. Do not breastfeed during treatment with Inluriyo and for 1 week after the last dose.
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.
ER+=estrogen receptor-positive; ESR1=estrogen receptor-1; HER2–=human epidermal growth factor receptor 2-negative.
No, Inluriyo is an oral treatment that can be taken at home.
Results for Inluriyo
Inluriyo provided more time without disease progression after endocrine therapy* stopped working. In a clinical study, Inluriyo kept ER+, HER2–, ESR1-mutated metastatic breast cancer from growing or spreading for a median† of 5.5 months versus 3.8 months with fulvestrant or exemestane.
Inluriyo was studied in a clinical trial of adults with ER+, HER2– metastatic breast cancer whose disease was previously treated with endocrine therapy. The study included 256 adults whose breast cancer had an ESR1 mutation. Of those 256 adults, 138 were treated with Inluriyo and 118 were treated with fulvestrant or exemestane.
Inluriyo showed a longer progression-free survival (PFS) compared with fulvestrant or exemestane. PFS is how long cancer growth is delayed from the time a treatment is started.
Learn more about the results of this study.
Inluriyo may cause serious side effects. Inluriyo can harm your unborn baby. Women who are able to become pregnant and males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with Inluriyo and for 1 week after the last dose of Inluriyo. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Inluriyo. Do not breastfeed during treatment with Inluriyo and for 1 week after the last dose.
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.
*Specifically aromatase inhibitors.
†The median is the middle number in a range of numbers.
AI=aromatase inhibitor; ER+=estrogen receptor-positive; ESR1=estrogen receptor-1; HER2–=human epidermal growth factor receptor 2-negative; PFS=progression-free survival.
Inluriyo is for adults with ER+, HER2–, ESR1-mutated metastatic breast cancer whose cancer progressed after endocrine therapy. Talk to your healthcare provider before receiving Inluriyo to discuss your specific health situation and treatment plan.
ER+=estrogen receptor-positive; ESR1=estrogen receptor-1; HER2–=human epidermal growth factor receptor 2-negative.
Dosing & Administration
A daily oral treatment, Inluriyo is 2 tablets (200 mg each) taken once a day. When taking Inluriyo, follow the directions given by your healthcare provider.
Take 2 tablets (200 mg each) at about the same time every day.
Take on an empty stomach, at least 2 hours before food or 1 hour after food.
Swallow tablets whole. Do not chew, crush, or split the tablets.
Your healthcare provider may change or stop your dose if needed. Do not stop taking Inluriyo or change your dose unless instructed to do so by your healthcare provider.
If you miss a dose by more than 6 hours or vomit after taking a dose, do not take another dose on that day. Take your next dose the following day at your regularly scheduled time.
Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep Inluriyo and all medicines out of the reach of children.
Take Inluriyo on an empty stomach, at least 2 hours before food or 1 hour after food.
Store Inluriyo at room temperature between 68°F to 77°F (20°C to 25°C). Keep Inluriyo and all medicines out of the reach of children.
Yes, Inluriyo can be taken while away from home but must be stored at room temperature between 68°F to 77°F (20°C to 25°C). Keep Inluriyo and all medicines out of the reach of children.
Safety & Side Effects
The most common side effects reported by people taking Inluriyo were 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.
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.
These are not all of the possible side effects of Inluriyo.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Your healthcare provider will check your blood levels, including monitoring your triglyceride and cholesterol blood levels, before and during treatment with Inluriyo.
Muscle or joint pain can occur while taking Inluriyo. If muscle pain, joint pain, or other side effects develop, contact your healthcare provider, who may change or stop your dose if needed. Do not stop taking Inluriyo or change your dose unless instructed to do so by your healthcare provider.
Before taking Inluriyo, 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. Keep a list of your current medications, vitamins, and supplements to show your healthcare provider or pharmacist when you get a new medicine.
Talk to your healthcare provider before receiving a vaccine to discuss your specific health situation and treatment plan.
Savings & Support
From the start of treatment, the Inluriyo Savings Card is available to help with out-of-pocket expenses if you are eligible and commercially insured with coverage for Inluriyo. Governmental beneficiaries excluded, terms and conditions apply.
Lilly Support Services™ aims to offer support for eligible patients prescribed Lilly’s cancer treatments. Those who qualify can get help with understanding insurance coverage, reviewing financial assistance options, and more.
If you have questions about Lilly Support Services for Inluriyo, please call 1-800-LillyRx (1-800-545-5979) from Monday to Friday between 8 am and 10 pm ET.