FOUNDAYO- orforglipron tablet, film coated
Eli Lilly and Company
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-BOXED WARNING
(WHAT IS THIS?)
WARNING: RISK OF THYROID C-CELL TUMORS
- In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents [see Nonclinical Toxicology (13.1)]. While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined [see Warnings and Precautions (5.1), Nonclinical Toxicology (13.1)].
- FOUNDAYO is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications (4)]. 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, 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 [see Contraindications (4), Warnings and Precautions (5.1)].
-HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use FOUNDAYO safely and effectively. See full prescribing information for FOUNDAYO.
FOUNDAYO (orforglipron) tablets, for oral use
Initial U.S. Approval: 2026
WARNING: RISK OF THYROID C-CELL TUMORS
See full prescribing information for complete boxed warning.
- In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents (13.1). While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined (5.1, 13.1).
- FOUNDAYO is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors (4, 5.1).
INDICATIONS AND USAGE
FOUNDAYO™ is a GLP-1 receptor agonist 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. (1)
Limitations of Use
Concomitant use with another GLP-1 receptor agonist is not recommended. (1)
DOSAGE AND ADMINISTRATION
- Take FOUNDAYO orally once daily, with or without food. (2.1)
- Swallow tablets whole. Do not break, crush, or chew. (2.1)
- Do not take more than one tablet per day. (2.1)
- Starting dosage is 0.8 mg once daily. After at least 30 days, increase dosage to 2.5 mg once daily. (2.1)
- After at least 30 days on the 2.5 mg dosage, increase dosage to 5.5 mg once daily. (2.1)
- Dosage may be increased to the next dosage level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tolerability. (2.1)
- Maximum dosage is 17.2 mg once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
- Tablets: 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, 17.2 mg of orforglipron (3)
CONTRAINDICATIONS
- Personal or family history of MTC or in patients with MEN 2 (4)
- Known serious hypersensitivity to orforglipron or any of the excipients in FOUNDAYO (4)
WARNINGS AND PRECAUTIONS
- Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including FOUNDAYO. Discontinue if pancreatitis is suspected. (5.2)
- Severe Gastrointestinal Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. FOUNDAYO is not recommended in patients with severe gastroparesis. (5.3)
- Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. (5.4)
- Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. (5.5)
- Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists. If suspected, advise the patient to promptly seek medical attention and discontinue FOUNDAYO. (5.6)
- Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: 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. (5.7)
- Acute Gallbladder Disease: Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated. (5.8)
- Pulmonary Aspiration During General Anesthesia and Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. (5.9)
ADVERSE REACTIONS
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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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. (7.1)
- CYP3A4 Inducers: Avoid concomitant use with strong CYP3A4 inducers. Monitor FOUNDAYO effectiveness and escalate dosage as needed when used concomitantly with moderate CYP3A4 inducers. (7.1)
- Simvastatin: Do not exceed simvastatin 20 mg once daily when used concomitantly with FOUNDAYO. (7.2)
- FOUNDAYO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. (7.3)
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue FOUNDAYO. (8.1)
- Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 30 days after initiation and for 30 days after each dose escalation. (8.3)
- Hepatic impairment: Not recommended for use in patients with severe hepatic impairment. (8.6)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 4/2026
+FULL PRESCRIBING INFORMATION: CONTENTS*
+1 INDICATIONS AND USAGE
+2 DOSAGE AND ADMINISTRATION
+3 DOSAGE FORMS AND STRENGTHS
+4 CONTRAINDICATIONS
+5 WARNINGS AND PRECAUTIONS
+6 ADVERSE REACTIONS
+7 DRUG INTERACTIONS
+8 USE IN SPECIFIC POPULATIONS
+10 OVERDOSAGE
+11 DESCRIPTION
+12 CLINICAL PHARMACOLOGY
+13 NONCLINICAL TOXICOLOGY
+14 CLINICAL STUDIES
+16 HOW SUPPLIED/STORAGE AND HANDLING
+17 PATIENT COUNSELING INFORMATION
+MEDICATION GUIDE
Revised: 4/2026
Document Id: eac65e03-3444-4d6b-acb8-ea4f7a276f03
Set id: 8ac446c5-feba-474f-a103-23facb9b5c62
Version: 5
Effective Time: 20260401
Eli Lilly and Company
