Indication

Foundayo is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.

Limitations of Use

Concomitant use with another GLP-1 receptor agonist is not recommended.

Important Safety Information for Foundayo™ (orforglipron) Tablets

Contraindications

Foundayo is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2 and patients with known serious hypersensitivity to orforglipron or any of the excipients in Foundayo. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with GLP-1 receptor agonists.

Risk of Thyroid C-cell Tumors

Counsel patients regarding the potential risk for MTC with the use of Foundayo and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, or persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Foundayo. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

Acute Pancreatitis

Acute pancreatitis has been reported in patients treated with Foundayo. Fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with GLP-1 receptor agonists. After initiation of Foundayo, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue Foundayo and initiate appropriate management.

Severe Gastrointestinal Reactions

Use of Foundayo has been associated with gastrointestinal adverse reactions, sometimes severe. In clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients treated with orforglipron (approximately 3%) than patients who received placebo (1%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Foundayo is not recommended in patients with severe gastroparesis.

Acute Kidney Injury Due to Volume Depletion

There have been reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists or Foundayo. The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Foundayo that could lead to volume depletion, especially during dosage initiation and escalation of Foundayo.

Hypoglycemia

Foundayo lowers blood glucose and can cause hypoglycemia. In a trial of adults with type 2 diabetes mellitus and BMI ≥27 kg/m² (Trial 2), hypoglycemia (plasma glucose <54 mg/dL) was reported in 2% of patients treated with orforglipron versus 0.2% of patients receiving placebo. One patient treated with orforglipron and no patients receiving placebo reported severe hypoglycemia in Trial 2. In Trial 2, 7% of patients treated with orforglipron once daily in combination with sulfonylurea reported hypoglycemia compared with 0.5% of patients not taking a sulfonylurea. There is also increased risk of hypoglycemia in patients treated with Foundayo in combination with insulin. Hypoglycemia has also been associated with Foundayo and GLP-1 receptor agonists in adults without type 2 diabetes. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes, monitor blood glucose prior to starting Foundayo and during Foundayo treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or sulfonylurea (or other concomitantly administered insulin secretagogue).

Hypersensitivity Reactions

Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists. If hypersensitivity reactions occur, advise the patients to promptly seek medical attention and discontinue use of Foundayo. Foundayo is contraindicated in patients with a prior serious hypersensitivity reaction to orforglipron or to any of the excipients in Foundayo. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with Foundayo.

Diabetic Retinopathy Complications in Patients with Type 2 Diabetes

Temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control. Foundayo has not been studied in patients with diabetic retinopathy and/or macular edema requiring acute treatment. Monitor patients with a history of diabetic retinopathy for progression of diabetic retinopathy.

Acute Gallbladder Disease

Treatment with Foundayo and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease. In a pool of two clinical trials for weight reduction (Trials 1 and 2), cholelithiasis was reported in 1% of patients treated with orforglipron once daily and 0.7% of placebo-treated patients, and acute cholecystitis was reported in 0.4% of patients treated with orforglipron once daily and 0.3% of placebo-treated patients. Acute gallbladder events were associated with weight reduction. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.

Pulmonary Aspiration During General Anesthesia or Deep Sedation

Foundayo delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking Foundayo, including whether modifying preoperative fasting recommendations or temporarily discontinuing Foundayo could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Foundayo.

Most Common Adverse Reactions

The most common adverse reactions, reported in ≥5% of patients treated with Foundayo, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and hair loss.

Drug Interactions

Strong CYP3A4 Inhibitors: The maximum dosage of Foundayo is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor. Avoid concomitant use with strong CYP3A4 inhibitors that also inhibit OATP1B. Concomitant use may increase the risk of adverse reactions.

CYP3A4 Inducers: Avoid concomitant use with strong CYP3A4 inducers. Monitor Foundayo effectiveness and escalate dosage as needed when used concomitantly with moderate CYP3A4 inducers.

Simvastatin: Do not exceed simvastatin 20 mg once daily when concomitantly used with Foundayo. Use of Foundayo with simvastatin increased exposure of the active metabolite simvastatin acid two-fold. A two-fold increase in simvastatin acid exposure at the highest simvastatin dose could be clinically meaningful.

Foundayo delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications.

Pregnancy

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 Foundayo. There are no adequate and well-controlled studies of Foundayo during pregnancy. Based on animal reproduction studies, there may be risks to the fetus from exposure to orforglipron during pregnancy. There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Foundayo during pregnancy. Pregnant patients exposed to Foundayo and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

Lactation

There are no data on the presence of orforglipron or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Orforglipron was present in the milk of lactating rats in in vivo testing. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Foundayo is not recommended for nursing women. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Foundayo and any potential adverse effects on the breastfed child from Foundayo or from the underlying maternal condition.

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 Foundayo. The effect of Foundayo on the absorption of oral contraceptives has not been evaluated in a clinical trial. 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 30 days after initiation with Foundayo and for 30 days after each dose escalation.

Pediatric Use:

The safety and effectiveness of Foundayo have not been established in pediatric patients.

Hepatic Impairment

Foundayo is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). No dosage adjustment of Foundayo is recommended in patients with mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively).

Foundayo is available as a 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg tablet.

Please click to access Prescribing Information, including Boxed Warning about possible thyroid tumors, including thyroid cancer, and Medication Guide.

OG HCP ISI 01APR2026

GLP-1 RA=glucagon-like peptide-1 receptor agonist

Foundayo™ is a trademark of Eli Lilly and Company. Foundayo is available by prescription only.

CMAT-04535 04/2026 ©Lilly USA, LLC 2026. All rights reserved.