Important Foundayo™ Safety Information

Important Foundayo™ Safety Information

Warning: Risk of Thyroid C-Cell Tumors

In animal studies, medications in the GLP-1 receptor agonist class, including Foundayo™ (orforglipron), caused thyroid C-cell tumors. It is not known whether Foundayo™ causes these tumors, including medullary thyroid carcinoma (MTC), in humans.

Contact your healthcare provider promptly if you notice a lump or swelling in your neck, persistent hoarseness, difficulty swallowing, or shortness of breath, as these may be symptoms of thyroid disease.

Do not take Foundayo™ if you or any member of your immediate family has ever been diagnosed with medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is the FDA-approved use of Foundayo™?

Foundayo™ (orforglipron) is an oral glucagon-like peptide-1 (GLP-1) receptor agonist approved by the U.S. Food and Drug Administration (FDA) for chronic weight management.

Foundayo™ is intended to be used together with a reduced-calorie diet and increased physical activity for adults with:

  • A body mass index (BMI) of 30 kg/m² or greater (obesity), or
  • A BMI of 27 kg/m² or greater (overweight) who also have at least one weight-related medical condition, such as:
    • High blood pressure
    • Type 2 diabetes
    • High cholesterol
    • Obstructive sleep apnea

Limitations of Use

  • The safety and effectiveness of combining Foundayo™ with other GLP-1 receptor agonists or weight-loss medications have not been established.
  • Foundayo™ should not be used together with another GLP-1 receptor agonist unless specifically directed by your healthcare provider.
  • Foundayo™ has not been adequately studied in some patient populations, including certain individuals with a history of pancreatitis.

Who should not use Foundayo™?

Do not take Foundayo™ if you:

  • Have a personal or family history of medullary thyroid carcinoma (MTC).
  • Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Have experienced a serious allergic reaction to orforglipron or any ingredient contained in Foundayo™.

How should Foundayo™ be administered?

Foundayo™ is an oral tablet taken once daily.

Unlike some other oral GLP-1 medications, Foundayo™ may be taken with or without food and with or without water.

Your healthcare provider will usually begin treatment with a lower dose and gradually increase the dose over several weeks to improve tolerability and reduce gastrointestinal side effects.

To obtain the greatest benefit:

  • Take your medication exactly as prescribed.
  • Take it at approximately the same time each day.
  • Do not skip doses or change your dose without discussing it with your healthcare provider.
  • Continue following your nutrition, exercise, and lifestyle recommendations while taking Foundayo™.

What should I tell my healthcare provider before using Foundayo™?

Before beginning treatment, tell your healthcare provider about all of your medical conditions.

Be sure to discuss if you have ever had:

  • Pancreatitis
  • Gallbladder disease or gallstones
  • Kidney disease
  • Liver disease
  • Diabetic eye disease (retinopathy)
  • Severe gastrointestinal disorders or delayed stomach emptying
  • Depression or other mental health conditions
  • Suicidal thoughts or behaviors
  • Thyroid disorders

Tell your provider about all medications you take, including:

  • Prescription medications
  • Over-the-counter medicines
  • Vitamins
  • Herbal supplements

Foundayo™ slows stomach emptying, which may affect how certain oral medications are absorbed.

Women using oral birth control pills should discuss contraceptive options with their healthcare provider, as Foundayo™ may temporarily reduce the effectiveness of oral hormonal contraceptives during dose escalation.

Tell your provider if you:

  • Are pregnant
  • Plan to become pregnant
  • Are breastfeeding
  • Are planning surgery or procedures requiring anesthesia or deep sedation

Weight-loss medications are generally not recommended during pregnancy.

What are the most serious side effects that I or a caregiver should watch for?

Seek emergency medical attention or call 911 if you experience symptoms of a medical emergency.

  • Thyroid Tumors- Notify your healthcare provider immediately if you develop neck swelling, hoarseness, difficulty swallowing, or persistent throat discomfort
  • Pancreatitis- Stop taking Foundayo™ and seek immediate medical care if you develop severe abdominal pain, pain radiating into the back, persistent nausea or vomiting
  • Gallbladder Disease- Contact your healthcare provider immediately if you experience severe pain in the upper right abdomen, fever, yellowing of the skin or eyes, pale or clay-colored stools.
  • Low Blood Sugar (Hypoglycemia) – The risk is increased when Foundayo™ is used together with insulin or medications called sulfonylureas. Symptoms include sweating, trembling, rapid heartbeat, hunger, confusion, blurred vision, or dizziness.
  • Kidney Problems – Persistent vomiting or diarrhea may cause dehydration, which can worsen kidney function. Drink adequate fluids and contact your provider if gastrointestinal symptoms become severe.
  • Serious Allergic Reactions – Stop taking Foundayo™ immediately and seek emergency care if you develop swelling of the face, lips, tongue, or throat, difficulty breathing, severe rash or hives or fainting.
  • Vision Changes- Patients with diabetes should promptly report any new or worsening vision changes.
  • Pulmonary Aspiration During Anesthesia – Because Foundayo™ slows stomach emptying, food may remain in the stomach longer than expected. Inform your surgeon, anesthesiologist, dentist, or procedural physician that you are taking Foundayo™ before any procedure requiring sedation or general anesthesia.

What are the most common side effects of Foundayo™?

The most frequently reported side effects include:

  • Nausea
  • Diarrhea
  • Vomiting
  • Constipation
  • Decreased appetite
  • Abdominal discomfort
  • Indigestion
  • Heartburn
  • Bloating
  • Fatigue
  • Headache
  • Dizziness

Reporting Side Effects

If you believe you are experiencing a side effect from Foundayo™, contact your healthcare provider promptly.

You may also report adverse events to the U.S. Food and Drug Administration (FDA) through the MedWatch Safety Information and Adverse Event Reporting Program.

Important Reminder

This summary highlights important safety information about Foundayo™ but does not include every possible side effect, precaution, or drug interaction.

Always read the Medication Guide provided with your prescription and discuss any questions with your healthcare provider.

Never take Foundayo™ unless it has been prescribed specifically for you, and never share your medication with another person.

This information is not comprehensive. Please see the full prescribing information for complete safety instructions. (https://uspl.lilly.com/foundayo/foundayo.html#pi)

Disclaimer: Foundayo ™ is a registered trademark of Eli Lilly. Ivim Health has no affiliation with Eli Lilly. The compounded products available as part of Ivim Health’s Weight Loss Program are not made by Eli Lilly or any company affiliated with Eli Lilly.