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Foundayo ™ (orforglipron) tablet
0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 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.
Can Foundayo™ (orforglipron) be used with contraceptives?
Advise patients on oral hormonal contraceptives to switch to non-oral methods or add a barrier method for 30 days after initiating orforglipron and for 30 days after each dose escalation. Non-oral hormonal contraceptives should not be affected.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Does Orforglipron Have an Effect on Oral and Nonoral Hormonal Contraceptives?
- What Are the Clinical Recommendations Related to Contraception in Females and Males of Reproductive Potential?
- Enclosed Prescribing Information
- References
Does Orforglipron Have an Effect on Oral and Nonoral Hormonal Contraceptives?
This response presents safety data from the investigational orforglipron capsule formulation (1 mg, 3 mg, 6 mg, 12 mg, 24 mg, and 36 mg) shown as equivalent doses of once daily orforglipron tablets (0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg) approved in the United States.1-3
Orforglipron delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications.3
The gastric emptying delay effect of orforglipron on acetaminophen maximum plasma concentration (Cmax) was largest after the first dose of orforglipron 0.8 mg with acetaminophen Cmax decreased by 28%. The effect diminished after repeated dosing of orforglipron 17.2 mg.3
The effect of orforglipron on the absorption of oral contraceptives has not been evaluated in a clinical trial.3
Use of orforglipron may reduce the efficacy of oral hormonal contraceptives. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 30 days after initiation with FOUNDAYO and for 30 days after each dose escalation.
Hormonal contraceptives that are not administered orally should not be affected.3
What Are the Clinical Recommendations Related to Contraception in Females and Males of Reproductive Potential?
Based on animal reproduction studies, there may be risks to the fetus from exposure to orforglipron during pregnancy. Advise women of childbearing potential to use effective contraception during treatment with orforglipron.3
Because delayed gastric emptying may affect the absorption of oral medications, advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 30 days after initiation with orforglipron and for 30 days after each dose escalation.3
The US Prescribing Information for orforglipron does not include recommendations for contraceptive use in males of reproductive potential while taking orforglipron.3
In the orforglipron phase 3 clinical trials, no male contraception was required except in compliance with specific local government study requirements.1,2
Enclosed Prescribing Information
FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly
References
- Wharton S, Aronne LJ, Stefanski A, et al; ATTAIN-1 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist for obesity treatment. N Engl J Med. 2025;393(18):1796-1806. https://doi.org/10.1056/NEJMoa2511774
- Horn DB, Ryan DH, Giljanovic Kis S, et al; ATTAIN-2 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial. Lancet. 2025;406(10522):2927-2944. https://doi.org/10.1016/S0140-6736(25)02165-8.
- Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Date of Last Review: April 01, 2026