Patient information: uses, side effects, how to take - Inluriyo

What is INLURIYO?

INLURIYO is a prescription medicine that is used alone or in combination with the medicine abemaciclib 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 that INLURIYO is right for you.

When INLURIYO is used in combination with abemaciclib, read the Patient Information for abemaciclib.

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

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

have liver problems.
are pregnant or plan to become pregnant. INLURIYO can harm your unborn baby.

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.

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.

Tell your healthcare provider about all of 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 should I take INLURIYO?

Take INLURIYO exactly as your healthcare provider tells you.
Do not stop taking INLURIYO or change the dose unless your healthcare provider tells you to.
Take INLURIYO 1 time a day at about the same time each day.
Take INLURIYO 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 of INLURIYO by 6 or more hours 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.

What are the possible side effects of INLURIYO?

The 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. Your healthcare provider will check your blood levels before and during treatment with INLURIYO.

nausea
decreased platelet counts
constipation
stomach-area (abdominal) pain

The 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. Your healthcare provider will check your blood levels before and during treatment with INLURIYO.
infections

increased liver function tests
increased creatinine blood levels
vomiting
muscle and joint pain
stomach-area (abdominal) pain
decreased appetite
rash
cough
headache
weight loss

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.

How should I store INLURIYO?

Store INLURIYO at room temperature between 68°F to 77°F (20°C to 25°C).
Throw away (dispose of) unused INLURIYO by a medicine take-back program if available. If no take-back program is available, visit www.fda.gov/drugdisposal for instructions on how to throw away medicines in the household trash.
Do not flush INLURIYO down the toilet.

Keep INLURIYO and all medicines out of the reach of children.

General information about the safe and effective use of INLURIYO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INLURIYO for a condition for which it was not prescribed. Do not give INLURIYO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about INLURIYO.

What are the ingredients in INLURIYO?

Active ingredient: imlunestrant

Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The tablet coating contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

For more information, go to www.INLURIYO.com or call 1-800-545-5979

INL-0003-PPI-20260918

Inluriyo (Imlunestrant): Uses, Side Effects and Dosage