InluriyoTM (imlunestrant)
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About Inluriyo
Lilly is proud to announce that the U.S. Food and Drug Administration (FDA) approved Inluriyo™ (imlunestrant) 200 mg tablets for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).
Inluriyo is a targeted treatment for ER+, HER2–, ESR1-mutated MBC. Some breast cancers have an ESR1 mutation that leads to overactive estrogen receptors that fuel the growth and division of cancer cells.
The FDA approval is based on the results of the EMBER-3 trial in the patient population harboring ESR1-mutated MBC (n=256). Patients received Inluriyo or ET as first-line treatment for MBC following recurrence on adjuvant aromatase inhibitor (Al), +/- CDK4/6 (cyclin-dependent kinase 4 and 6) inhibitor (21%), or as second-line treatment for MBC following progression on Al, +/- CDK4/6 inhibitor (79%).
Learn more about MBC and how Inluriyo can help appropriate patients:
For more information visit inluriyo.lilly.com. Connect with our Oncology Support Center at lillyoncologysupportcenter.com or by calling 1-866-472-8663.
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 and Patient Information for Inluriyo.
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Inluriyo™ is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
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