Warnings – Foundayo™ may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your clinician.
- Do not use Foundayo™ if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Foundayo™ if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Foundayo™ if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo™.
Foundayo™ may cause serious side effects, including:
- Inflammation of the pancreas (pancreatitis). Stop taking Foundayo™ and tell your clinician right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.
- Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo™. Tell your clinician if you have stomach problems that are severe or will not go away.
- Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your clinician right away if you have nausea, vomiting, or diarrhea that does not go away.
- Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo™ with medicines that can cause low blood sugar, such as insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.
- Serious allergic reactions. Stop using Foundayo™ and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.
- Changes in vision in patients with type 2 diabetes. Tell your clinician if you have changes in vision during treatment with Foundayo™.
- Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo™. Tell your clinician right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.
- Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo™ may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo™ before you are scheduled to have surgery or other procedures.
Common side effects
The most common side effects of Foundayo™ include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdomen) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo™. Talk to your clinician about any side effect that bothers you or doesn’t go away.
Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before taking Foundayo™
- Tell your clinician about all the medicines you take. Foundayo™ may affect the way some medicines work, and some medicines may affect the way Foundayo™ works.
- Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo™ during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your clinician about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
- If you take birth control pills by mouth, talk to your clinician before you take Foundayo™. Birth control pills may not work as well while taking Foundayo™. Your clinician may recommend another type of birth control for 30 days after starting Foundayo™ and for 30 days after each dose increase of Foundayo™.
- Talk to your clinician about low blood sugar and how to manage it. Tell your clinician if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
- Talk to your clinician if you are taking the cholesterol-lowering medication, simvastatin. While taking Foundayo™, your simvastatin dose should not exceed 20 mg once daily.
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