Inluriyo
Pronunciation: en-loo-ree-yoh
Generic name: Imlunestrant
Brand name: Inluriyo
Dosage form: tablet (200 mg)
What is Inluriyo? ESR1-Mutated Breast Cancer Treatment
Inluriyo (imlunestrant) is an oral SERD therapy (selective estrogen receptor degrader) used to treat adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine therapy.
This hormone receptor-positive breast cancer treatment is specifically designed for patients with endocrine therapy-resistant breast cancer who have developed ESR1 mutations - a common cause of resistance to other hormone treatments.
Inluriyo for ESR1-Mutated Breast Cancer
ESR1 mutation testing is required before starting Inluriyo. This biomarker-driven therapy targets a specific genetic change that occurs in approximately 20-40% of patients with hormone therapy-resistant breast cancer.
Key Benefits for ESR1-Mutated Breast Cancer:
- Proven effectiveness against ESR1 mutation breast cancer treatment
- Oral breast cancer medication, with convenient once-daily dosing
- Alternative when other second-line endocrine therapy options fail
EMBER-3 Clinical Trial Results - Proven Survival Benefits
In the EMBER-3 Phase 3 study (NCT04975308), Inluriyo demonstrated significant progression-free survival data:
- 38% reduction in progression or death risk compared to standard endocrine therapy
- Superior progression-free survival vs fulvestrant/exemestane for patients with ESR1-mutated metastatic breast cancer
- Median PFS: 5.5 months (Inluriyo) vs 3.8 months (comparator)
- Hazard ratio 0.62 (95% CI: 0.46-0.82), p=0.0008
How Does Inluriyo Work? Mechanism of Action
Inluriyo is an oral SERD therapy that works through estrogen receptor degradation:
- Imlunestrant attaches to estrogen receptors (ERα) on cancer cells
- Causes receptor breakdown and disappearance
- Blocks estrogen growth signals to cancer cells
- Stops cancer cell multiplication and growth
This mechanism is particularly effective against hormone therapy resistance caused by ESR1 mutations.
Inluriyo vs Fulvestrant and Other Treatments
Advantages over traditional therapies:
- Oral administration vs injection-based treatments
- Effective against ESR1 mutations where other therapies may fail
- Alternative to CDK4/6 inhibitors in certain patient populations
- Proven survival benefits in clinical trials.
Inluriyo Side Effects
Common Side Effects
- Decreased hemoglobin (anemia)
- Muscle and joint pain
- Decreased white blood cell counts
- Increased liver function tests
- Decreased calcium blood levels
- Nausea
- Decreased platelet counts
- Constipation
- Stomach-area (abdominal) pain
- Tiredness
- Diarrhea
- Increased triglyceride and cholesterol blood levels.
Your healthcare provider will monitor your blood levels before and during treatment and may adjust dosing if needed.
Warnings: Inluriyo may cause harm to an unborn baby (see pregnancy and breastfeeding considerations below).
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 the FDA at 1-800-FDA-1088.
Before taking
Tell your healthcare provider about all your medical conditions, including if you have:
- Liver disease
- Are pregnant or planning a pregnancy
- Are breastfeeding
Pregnancy and Breastfeeding Considerations
Inluriyo can harm an unborn baby.
Females with childbearing potential:
- Pregnancy test required before starting treatment
- Use effective birth control during treatment and for 1 week after the last dose
- Tell your provider immediately if you become pregnant
Males with female partners who can become pregnant:
- Use effective birth control during treatment and for 1 week after the last dose
Breastfeeding: Do not breastfeed during treatment and for 1 week after the last dose.
Fertility: May affect fertility in males and females - discuss concerns with your provider.
How Should I Take Inluriyo?
- Take exactly as prescribed by your healthcare provider
- Once daily at the same time each day
- On an empty stomach (at least 2 hours before food or 1 hour after food)
- Swallow tablets whole. Do not chew, crush, or split
- Do not stop or change dose without provider approval
Missed Dose Instructions
- If you miss a dose by 6+ hours or vomit after taking Inluriyo
- Do not take another dose that day
- Resume normal schedule the following day
Dosing Information
Recommended Dosage for ER+, HER2-, ESR1-mutated Breast Cancer:
- 400 mg once daily
- Take on an empty stomach
- Reduce dosage in moderate to severe liver impairment
What other drugs will affect Inlurio?
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about:
- Strong CYP3A Inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, or nefazodone. Avoid concomitant use with Inluriyo. If concomitant use cannot be avoided, decrease the Inluriyo dosage
- Strong CYP3A Inducers, such as rifampin, carbamazepine, phenytoin, St. John's Wort, and phenobarbital: Avoid concomitant use with Inluriyo. If concomitant use cannot be avoided, increase the Inluriyo dosage.
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 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.
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.
Manufacturer
Inluriyo is a trademark of Eli Lilly and Company and is marketed by Lilly USA, LLC, Indianapolis, IN 46285, USA.
Frequently Asked Questions
How long does Inluriyo take to work?
Inluriyo survival benefits were demonstrated in clinical trials with median progression-free survival of 5.5 months. Individual response may vary.
What is the frequency of ESR1 mutations in breast cancer?
ESR1 mutations occur in approximately 20-40% of patients with metastatic breast cancer who have received prior endocrine therapy.
What are advanced breast cancer symptoms?
Advanced breast cancer symptoms may include bone pain, shortness of breath, abdominal swelling, and persistent fatigue. Consult your healthcare provider for proper evaluation.
What is the metastatic breast cancer prognosis with Inluriyo?
Metastatic breast cancer prognosis varies by individual factors. Clinical trials showed improved progression-free survival compared to standard treatments.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.