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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 nonoral methods or add a barrier method for 30 days after initiating orforglipron and for 30 days after each dose escalation. Nonoral 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 Data Available on the Effect of Orforglipron on Gastric Emptying and Absorption of Oral Contraceptives?
- What Are the Clinical Recommendations Related to Contraception in Females and Males of Reproductive Potential?
- References
Does Orforglipron Have an Effect on Oral and Nonoral Hormonal Contraceptives?
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 orforglipron and for 30 days after each dose escalation.1
Hormonal contraceptives that are not administered orally should not be affected.1
What Are the Data Available on the Effect of Orforglipron on Gastric Emptying and Absorption of Oral Contraceptives?
Gastric emptying delay caused by glucagon-like peptide-1 (GLP-1) analogs has the potential to alter the absorption rate of orally administered concomitant medications, including oral contraceptives.2-5
The effect of orforglipron on gastric emptying was studied using acetaminophen as a marker of gastric emptying and assessed under various orforglipron dosing regimens in healthy participants and those with obesity or overweight, with or without type 2 diabetes (T2D).6
The effects of orforglipron-induced gastric emptying delay on acetaminophen absorption were concentration dependent and most evident after the first dose of orforglipron. With the starting dose of orforglipron 0.8 mg, acetaminophen maximum concentration (Cmax) was reduced by 28%. This effect diminished over time after repeated dosing of orforglipron 17.2 mg.1
A combination of population pharmacokinetic (PopPK) and physiologically based pharmacokinetic (PBPK) modeling approaches was then used to
- quantify the gastric emptying delay mediated by orforglipron, and
- predict the effect on orally administered small molecules, including a combined oral contraceptive (ethinylestradiol and norelgestromin).6
This approach was conducted as per the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines.7,8
This approach has been verified for the GLP-1 receptor agonist (RA) dulaglutide, against observed drug-drug interaction data with the same small molecules.9
Predictions using the PBPK modeling showed a minor decrease in combined oral contraceptive Cmax, without an effect on the area under the curve (AUC).
The effect of orforglipron on the absorption of oral contraceptives has not been evaluated in a clinical trial.1
In the absence of clinical trial data on oral contraceptive absorption, a precautionary label recommendation was included in the US Foundayo (orforglipron) prescribing information advising patients using oral hormonal contraceptives to switch to a non-oral method or add a barrier method for 30 days after initiation and after each dose escalation. This precautionary label recommendation is consistent with the current Zepbound (tirzepatide) prescribing information.6
What Are the Clinical Recommendations Related to Contraception in Females and Males of Reproductive Potential?
Weight loss offers no benefit to a pregnant patient and may cause fetal harm. When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus and discontinue orforglipron.1
There are no adequate and well-controlled studies of orforglipron during pregnancy.1
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.1
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.1
The US Prescribing Information for orforglipron does not include recommendations for contraceptive use in males of reproductive potential while taking orforglipron.1
In the orforglipron phase 3 clinical trials, no male contraception was required except in compliance with specific local government study requirements.17,18
Enclosed Prescribing Information
FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Jacobsen LV, Vouis J, Hindsberger C, Zdravkovic M. Treatment with liraglutide—a once-daily GLP-1 analog—does not reduce the bioavailability of ethinyl estradiol/levonorgestrel taken as an oral combination contraceptive drug. J Clin Pharmacol. 2011;51(12):1696-703. https://doi.org/10.1177/0091270010389471
- Kothare PA, Seger ME, Northrup J, et al. Effect of exenatide on the pharmacokinetics of a combination oral contraceptive in healthy women: an open-label, randomised, crossover trial. BMC Clin Pharmacol. 2012;12:8. https://doi.org/10.1186/1472-6904-12-8
- Kapitza C, Nosek L, Jensen L, et al. Semaglutide, a once-weekly human GLP-1 analog, does not reduce the bioavailability of the combined oral contraceptive, ethinylestradiol/levonorgestrel. J Clin Pharmacol. 2015;55(5):497-504. https://doi.org/10.1002/jcph.443.
- de la Peña A, Cui X, Geiser J, Loghin C. No dose adjustment is recommended for digoxin, warfarin, atorvastatin or a combination oral contraceptive when coadministered with dulaglutide. Clin Pharmacokinet. 2017;56(11):1415-1427. https://doi.org/10.1007/s40262-017-0531-7
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- Population Pharmacokinetics Guidance for Industry. US Food and Drug Administration. Updated February 3, 2022. Accessed June 5, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/population-pharmacokinetics
- Reporting the results of population pharmacokinetic analyses - scientific guideline. European Medicines Agency. Last updated June 21, 2007. Accessed June 5, 2026. https://www.ema.europa.eu/en/reporting-results-population-pharmacokinetic-analyses-scientific-guideline
- Posada MM, Schneck KB, Morse BL, et al. A combined modeling approach to predict the effect of gastric emptying delay on the pharmacokinetics of small molecules. CPT Pharmacometrics Syst Pharmacol. 2025;14(12):2026-2039. https://doi.org/10.1002/psp4.70101
- Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Ozempic [package insert]. Bagsvaerd, Denmark: Novo Nordisk A/S; 2026.
- Rybelsus [package insert]. Bagsvaerd, Denmark: Novo Nordisk A/S; 2026.
- Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Zepbound [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Wegovy [package insert]. Bagsvaerd, Denmark: Novo Nordisk A/S; 2026.
- Victoza [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2026.
- 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.
Date of Last Review: June 04, 2026