Lilly reissues Foundayo medication guide with a seven-day missed-dose restart rule
Lilly's reissued Foundayo guide sets a clear seven-day cutoff for missed doses, but it does not say whether treatment restarts at the same dose or a lower one.
Eli Lilly has reissued the Medication Guide for Foundayo (orforglipron), its once-daily oral GLP-1 tablet, with patient-facing instructions for missed doses [1]. The guide says to take a missed dose as soon as possible, not to take two doses in the same day, and to call a healthcare provider to talk about how to restart treatment if seven or more days in a row are missed [1]. The reissued document carries the number OFG-0002-MG-20260729 [1].
What the guide says about missed doses
Foundayo is a prescription medicine used along with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, lose excess body weight and keep it off [1]. It is taken as a tablet by mouth once a day, with or without food, and the tablets are meant to be swallowed whole rather than broken, crushed, or chewed [1].
The guide sets two limits around missed doses: no more than one tablet a day, and no two doses in the same day [1]. It also sets a seven-day threshold for contacting a prescriber. If a person misses seven or more days in a row, the guide says to call a healthcare provider to talk about how to restart treatment [1]. The guide does not describe what a restart involves, so whether treatment resumes at the same dose or at a lower one has not been disclosed in the patient labeling [1].
If someone takes too much Foundayo, the guide says to call a healthcare provider or the Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away [1].
Other safety information in the guide
The guide leads with a warning about thyroid tumors. In studies with rodents, medicines that work like Foundayo caused thyroid tumors, including thyroid cancer; the guide states that it is not known whether Foundayo will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma in people [1]. People with a personal or family history of that cancer, or with an endocrine condition called MEN 2, are told not to take the drug [1].
Other serious side effects listed include inflammation of the pancreas, severe stomach problems, dehydration that can lead to kidney problems, low blood sugar, serious allergic reactions, vision changes in people with type 2 diabetes, gallbladder problems, and food or liquid getting into the lungs during surgery or procedures that use anesthesia or deep sedation [1]. The risk of low blood sugar is higher for people who also take insulin or a sulfonylurea, according to the guide [1]. Common side effects listed include nausea, stomach pain, constipation, heartburn, headache, diarrhea, gas, swollen belly, vomiting, hair loss, indigestion, feeling tired, and belching [1].
The guide also says that birth control pills taken by mouth may not work as well during treatment; a healthcare provider may recommend another birth control method for 30 days after starting Foundayo and for 30 days after each dose increase [1]. Breastfeeding is not recommended during treatment, and Lilly says there will be a pregnancy exposure registry for women who take Foundayo during pregnancy [1]. The guide says Foundayo should not be used with other GLP-1 receptor agonist medicines, and that it is not known whether the drug is safe and effective in children [1].
Why it matters for patients
Foundayo is a daily pill rather than a weekly injection, so a missed dose is an ordinary event rather than a rare one. The reissued guide gives a specific cutoff, seven consecutive days, at which patients are directed to involve a healthcare provider before continuing [1].
What a restart looks like is the open question. The guide does not state whether treatment begins again at the previous dose or at a lower strength, and it does not explain why seven days was chosen [1]. Restart decisions are made in the clinic, not in the label, so anyone who has missed a week or more has a concrete question to bring to a prescriber or pharmacist.
The instruction not to combine Foundayo with other GLP-1 receptor agonist medicines also matters for people who are moving from an injectable product, because the guide does not lay out a switching schedule [1].
What happens next
Lilly lists a pregnancy exposure registry for people who take Foundayo during pregnancy, with information available from the company at 1-800-LillyRx (1-800-545-5979) [1]. The guide also points to the product website, and no further changes to the Foundayo labeling have been announced [1].
Sources
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