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Important Safety Information

Foundayo® Pill

Orforglipron oral tablet

Boxed Warning

Boxed Warning: Risk of thyroid C-cell tumors

Orforglipron, like other GLP-1 receptor agonists, has shown thyroid C-cell tumors in rodent studies at clinically relevant exposures. It is unknown whether orforglipron causes such tumors, including medullary thyroid carcinoma, in humans. Foundayo is contraindicated in patients with a personal or family history of MTC and in patients with MEN 2.

About this product

Foundayo (orforglipron) is a once-daily oral GLP-1 receptor agonist indicated for chronic weight management in adults with obesity, or overweight with at least one weight-related condition, as an adjunct to a reduced-calorie diet and increased physical activity.

Important safety information

Orforglipron may cause serious side effects, including:

  • Possible thyroid tumors, including medullary thyroid carcinoma (MTC). Tell your provider about any neck lump, hoarseness, trouble swallowing, or shortness of breath.
  • Inflammation of the pancreas (pancreatitis). Stop and call your provider for severe abdominal pain that does not go away.
  • Gallbladder problems, including gallstones.
  • Low blood sugar (hypoglycemia), especially with insulin or sulfonylureas.
  • Acute kidney injury from dehydration related to nausea, vomiting, or diarrhea.
  • Serious allergic reactions, including anaphylaxis.
  • Increased heart rate.
  • Depression or thoughts of suicide.
  • Possible delayed gastric emptying — tell anesthesia providers about Foundayo use before surgery or sedation.

Do not use Foundayo if you

  • Or any of your family members have ever had medullary thyroid carcinoma (MTC).
  • Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Have had a serious allergic reaction to orforglipron or any of the ingredients.

Most common side effects

  • Nausea, vomiting, diarrhea, constipation
  • Indigestion, abdominal pain, decreased appetite
  • Belching, eructation
  • Headache, fatigue

Before starting Foundayo, tell your provider if you

  • Have or have had pancreatitis, gallbladder, kidney, or severe stomach problems
  • Have a history of diabetic retinopathy
  • Have a history of depression or suicidal thoughts
  • Are pregnant, plan to become pregnant, or are breastfeeding
  • Are taking other prescription, over-the-counter, vitamin, or herbal products

Reporting side effects

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to the manufacturer or to your NowYou care team.

Important

This summary does not include all information about this medication. It is not a substitute for the full Prescribing Information or for talking with your healthcare provider. Please read the full Prescribing Information and Medication Guide before starting treatment, and discuss any questions with your provider.

This safety summary is provided for educational purposes and does not replace the full Prescribing Information, Medication Guide, or professional medical advice. Always discuss benefits, risks, and alternatives with your licensed provider.