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Inluriyo ™ (imlunestrant) tablets
200 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What effect does Inluriyo™ (imlunestrant) have on fertility?
Based on its mechanism of action and findings in animals, Inluriyo (imlunestrant) may impair fertility in females and males of reproductive potential.
Imlunestrant and Impairment on Fertility
The effects of imlunestrant on fertility were not assessed in humans. However, based on findings in animals, imlunestrant may impair fertility in females and males of reproductive potential. Findings in animals were reversible.1
Fertility studies with imlunestrant in animals have not been conducted. In repeat-dose toxicity studies up to 6 months in rats and 3 months in cynomolgus monkeys, oral administration of imlunestrant resulted in follicular cysts in the ovary and atrophy in the vagina, cervix, and uterus at doses ≥ 10 mg/kg/day in rats (≥ 4 times the human area under the curve (AUC) at the recommended dose) and ≥ 15 mg/kg/day in cynomolgus monkeys (≥1 times the human AUC at the recommended dose). Decreased sperm and cellular debris in the epididymis and spermatid retention in the testis were observed in male rats at ≥10 mg/kg/day. The effects of imlunestrant on male and female reproductive organs were reversible in rats following a 3-month recovery period. Reversibility was not assessed in cynomolgus monkeys.1
Enclosed Prescribing Information
Reference
1Inluriyo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
Date of Last Review: March 13, 2025