Foundayo™ (orforglipron) Important Safety Information

What Is Foundayo™?

Foundayo™ (orforglipron) is a prescription medicine used along with a reduced-calorie diet and increased physical activity to reduce and maintain weight in adults with obesity, or with overweight plus a weight-related condition. Foundayo is the first non-peptide oral GLP-1 receptor agonist FDA-approved for chronic weight management, manufactured by Eli Lilly.

Limitations of Use

Foundayo should not be used in combination with other GLP-1 receptor agonists.

Who Should Not Use Foundayo™?

Do not use Foundayo if:

• You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You have a known allergic reaction to Foundayo or any of its ingredients.

How Should I Take Foundayo™?

Take one Foundayo tablet by mouth every day. Swallow the tablet whole. Do not cut, crush, or chew the tablet.

You can take Foundayo with or without food. There are no restrictions on water or other liquid intake. Do not change your dosing regimen or stop taking Foundayo without first discussing with your provider. Your provider will guide you on a treatment regimen that may include a dose increase every four weeks.

What Should I Tell My Provider Before Using Foundayo™?

Foundayo has certain drug interactions. Tell your provider all medications you are currently taking, including prescription medications, over-the-counter medications, vitamins, and herbal or dietary supplements. Foundayo may interact with other medicines, affecting how they or Foundayo work. Your provider can guide you on how to take your medications.

Medications to Watch For

• Zocor® (simvastatin): If you are taking Zocor® while taking Foundayo, do not take more than 20 mg per day.
• Diabetes medications: Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl® or Glucotrol XL®). Foundayo may increase the risk of low blood sugar if taken together.
• Other oral medications: Foundayo causes a delay in gastric emptying, which may affect the absorption of other oral medications.
• Hormonal birth control: If you are using oral hormonal contraceptives (birth control pills), Foundayo may decrease their effectiveness, especially after the first dose. Switch to a non-oral contraceptive method, or use a barrier method of contraception, for 4 weeks after starting Foundayo and for 4 weeks after each dose escalation, until you reach the maintenance dose.
• Other GLP-1 medications: Including Mounjaro®, Zepbound®, Wegovy®, Ozempic®, or Saxenda®. These medications should not be taken with Foundayo.
• Other weight loss products: Including dietary supplements.

Share Your Medical History

Tell your provider if you have or have ever had any of the following:

• Thyroid cancer
• Type 1 or type 2 diabetes
• Gastrointestinal disease
• Pancreatitis
• Liver disease
• Kidney disease
• Diabetic retinopathy

Pregnancy & Breastfeeding

Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.

• If you are pregnant: Foundayo should not be used during pregnancy. Animal studies suggest potential risks to the unborn baby from exposure to Foundayo during pregnancy. Intentional weight loss is not recommended during pregnancy and may cause harm to the unborn baby.
• If you are of reproductive potential: Foundayo may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception, for 4 weeks after starting medication and for 4 weeks after each dose escalation, until you reach a maintenance dose.
• If you are breastfeeding: Foundayo is not recommended for breastfeeding women. Talk to your provider first about the benefits and risks of using Foundayo while breastfeeding.

Pregnancy registry: Pregnant patients exposed to Foundayo and healthcare providers are encouraged to contact the manufacturer at 1-800-LillyRx (1-800-545-5979).

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

Serious Side Effects to Monitor

If you are experiencing a medical emergency, call 911 or seek immediate medical attention. The following serious side effects are rarer but can occur with Foundayo. You or a caregiver should carefully monitor for these side effects, especially at the start of treatment and with dose changes.

Thyroid C-Cell Tumors

In rats and mice, certain GLP-1 medications caused thyroid C-cell tumors. Foundayo did not produce these tumors in rats and mice. However, it is unknown whether Foundayo causes these tumors in people. Foundayo is contraindicated in patients with a personal or family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

Inflammation of the Pancreas (Acute Pancreatitis)

Acute pancreatitis has been reported in patients using Foundayo. Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.

Severe Gastrointestinal Disease

Foundayo is associated with gastrointestinal side effects such as nausea, diarrhea, vomiting, constipation, and stomach pain, which can sometimes be severe. Foundayo is not recommended in patients with severe gastroparesis.

Acute Kidney Injury

Gastrointestinal side effects of Foundayo, such as diarrhea, nausea, and vomiting, may cause loss of fluids (dehydration), which may lead to kidney problems if dehydration is severe. Drink plenty of water to help reduce the chance of dehydration.

Low Blood Sugar (Hypoglycemia)

Foundayo lowers blood glucose. It can cause low blood sugar in patients with type 2 diabetes who also take another glucose-control medication. Monitor your blood sugar and watch for signs of low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.

Allergic Reactions

Stop using Foundayo right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; severe rash or itching; very rapid heartbeat; problems breathing or swallowing; or fainting or feeling dizzy.

Diabetic Retinopathy Complications

Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.

Acute Gallbladder Disease

Foundayo and other GLP-1 receptor agonists are associated with an increased chance of acute gallbladder disease. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.

Pulmonary Aspiration During General Anesthesia or Deep Sedation

Foundayo causes a delay in gastric emptying. There have been reports of pulmonary aspiration (food or liquid from the stomach entering the lungs) in people taking GLP-1 medications while undergoing surgery requiring sedation, even when instructed to fast before the surgery. If you have a planned major surgery requiring sedation, contact your provider for instructions on how to prepare.

Common Side Effects

The most common side effects of Foundayo include:

• Nausea
• Constipation
• Diarrhea
• Vomiting
• Indigestion
• Stomach (abdominal) pain
• Headache
• Bloating
• Fatigue
• Belching
• Gastroesophageal reflux disease
• Flatulence
• Hair loss

These are not all the possible side effects of Foundayo. Talk to your provider about any side effect that bothers you or does not go away.

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Additional Resources

This information is not comprehensive. Please refer to the full Prescribing Information for complete safety information. The official manufacturer Important Safety Information is available at www.foundayo.com. For the complete clinical breakdown of Foundayo, including dosing, candidacy, and access pathways, see the Foundayo program page.