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Most common adverse reactions (≥10%) reported in EMBER-3 (n=651)1

Adverse reactionsa (≥10%) in patients who received Inluriyo in EMBER-31

Inluriyo (n=327)Fulvestrant (n=292) or Exemestane (n=32)
Adverse ReactionbAll Grades %Grade 3 or 4 %All Grades %Grade 3 or 4 %
Musculoskeletal Disorders
Musculoskeletal Pain303.7291.9
General Disorders and Administration Site Conditions
Fatiguec230.3140.6
Gastrointestinal Disorders
Diarrhea220.6120
Nausea170.3130
Constipation10060.3
Abdominal painc100.360.6

aThe safety population included all the patients who received ≥1 dose of Inluriyo, fulvestrant, or exemestane.2

bAdverse reactions were graded using NCI CTCAE version 5.0.1

cIncludes other related terms.1

Prescribe with confidence—Inluriyo has a safety profile that is similar to fulvestrant or exemestane.1

  • 10% of patients experienced serious ARs with Inluriyo vs 11% with fulvestrant or exemestane1,2
  • Fatal events occurred in 1.8% of patients who received Inluriyo vs 1.9% with fulvestrant or exemestane1,2

Serious adverse reactions in >1% of patients receiving Inluriyo included pleural effusion (1.2%). Fatal adverse reactions with Inluriyo included cardiac arrest, acute myocardial infarction, right ventricular failure, hypovolemic shock, and upper gastrointestinal hemorrhage (each 0.3%).1

AR=adverse reaction; CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute.

Select lab abnormalities (≥10%) that worsened from baseline in patients treated with Inluriyo in EMBER-31

InluriyobFulvestrant or exemestaneb
Lab AbnormalityaAll Grades %Grade 3 or 4 %All Grades %Grade 3 or 4 %
Hematology
Hemoglobin decreased301.2353.4
Neutrophils decreased264294.7
Platelets decreased161.8141.3
Chemistry
Calcium decreased260190.6
AST increased251.9272.3
ALT increased211.3231
Triglycerides increased210221.2
Cholesterol increased100120

aGraded according to NCI CTCAE version 5.0.1

bThe denominator used to calculate the rate varied from 252 to 325 based on the number of patients with a baseline value and at least one posttreatment value.1

ALT=alanine aminotransferase; AST=aspartate aminotransferase; CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute.

In the safety population of the EMBER-3 trial (n=651)1

The majority of ARs with Inluriyo were low grade (Grade 1-2)1

  • 2.4% of patients had dose reductions with Inluriyo due to an AR vs 0% with fulvestrant or exemestane1,2
  • 10% of patients had dosage interruptions with Inluriyo due to an AR vs 0.6% with fulvestrant or exemestane1,2

Inform patients that lipid profile monitoring will be performed prior to starting and periodically while taking Inluriyo.1

Adverse reactions for Inluriyo which resulted in:

  • Permanent discontinuation included increased alanine aminotransferase (0.9%), abdominal pain, fatigue, fractured sacrum, hepatotoxicity, neuropathy peripheral, and pyrexia (each 0.3%)1
  • Dosage interruption in >0.5% were vomiting (1.5%); increased aspartate aminotransferase and COVID-19 (each 0.9%); and increased alanine aminotransferase, anemia, diarrhea, decreased neutrophil count, and pyrexia (each 0.6%)1
  • Dose reductions were increased aspartate aminotransferase (0.6%); and increased alanine aminotransferase, anemia, fatigue, interstitial lung disease, nausea, neutropenia, and vomiting (each 0.3%)1

AR=adverse reaction; ECG=electrocardiogram.

References:

  1. Inluriyo. Prescribing Information. Lilly USA, LLC.
  2. Jhaveri KL, Neven P, Casalnuovo ML, et al. Imlunestrant with or without abemaciclib in advanced breast cancer. N Engl J Med. 2025;392(12):1189-1202. doi:101056/NEJMoa2410858

INDICATION

Inluriyo™ is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.1

IMPORTANT SAFETY INFORMATION FOR INLURIYO™ (imlunestrant)

Warnings and Precautions - Embryo-Fetal Toxicity

Based on findings in animals and its mechanism of action, Inluriyo can cause fetal harm when administered to a pregnant woman. In an animal reproduction study, oral administration of imlunestrant to pregnant rats during the period of organogenesis led to embryo-fetal mortality and structural abnormalities at maternal exposures that were below the human exposure at the recommended dose based on area under the curve (AUC). Avoid the use of imlunestrant in pregnant women. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Inluriyo and for 1 week after the last dose.

Serious and Fatal Adverse Reactions

Serious adverse reactions occurred in 10% of patients who received Inluriyo. Serious adverse reactions in >1% of patients included pleural effusion (1.2%). Fatal adverse reactions occurred in 1.8% of patients who received Inluriyo, including cardiac arrest, acute myocardial infarction, right ventricular failure, hypovolemic shock, and upper gastrointestinal hemorrhage (each 0.3%).

Most Common Adverse Reactions

The most common adverse reactions (incidence ≥10%), including laboratory abnormalities, in patients who received Inluriyo were: hemoglobin decreased (30%), musculoskeletal pain (30%), calcium decreased (26%), neutrophils decreased (26%), AST increased (25%), fatigue (23%), diarrhea (22%), ALT increased (21%), triglycerides increased (21%), nausea (17%), platelets decreased (16%), constipation (10%), cholesterol increased (10%), and abdominal pain (10%).

Drug Interactions

Imlunestrant is a CYP3A substrate. Avoid concomitant use of Inluriyo with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce the dosage of Inluriyo. Avoid concomitant use of Inluriyo with strong CYP3A inducers. If concomitant use cannot be avoided, increase the dosage of Inluriyo.

Imlunestrant inhibits both P-gp and BCRP. Avoid concomitant use unless otherwise recommended in the Prescribing Information for P-gp or BCRP substrates where minimal concentration changes may lead to serious adverse reactions.

Use in Specific Populations - Lactation

Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment with Inluriyo and for 1 week after the last dose.

Use in Specific Populations - Hepatic Impairment

Reduce the dose of Inluriyo for patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. No dosage adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A).

Inluriyo (imlunestrant) is available as 200 mg tablets.

Please click to access Prescribing Information for Inluriyo.

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