Foundayo™ Details
FOUNDAYO may cause serious side effects including:
• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, medicines that work like FOUNDAYO caused thyroid tumors, including thyroid cancer. It is not known if FOUNDAYO will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
• Do not take FOUNDAYO if you or any of your family have ever had a type of thyroid cancer called MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• FOUNDAYO should not be used with other GLP-1 receptor agonist medicines.
• It is not known if FOUNDAYO is safe and effective for use in children.
• you have had a serious allergic reaction to orforglipron or any of the ingredients in FOUNDAYO. See the end of this Medication Guide for a complete list of ingredients in FOUNDAYO. See “What are the possible side effects of FOUNDAYO?” for symptoms of a serious allergic reaction.
• have severe problems with your liver.
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• have a history of diabetic retinopathy.
• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).
• are pregnant or plan to become pregnant. FOUNDAYO may harm your unborn baby. Tell your healthcare provider if you become pregnant while taking FOUNDAYO.
• 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 healthcare provider 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).
• Birth control pills by mouth may not work as well while taking FOUNDAYO. If you take birth control pills by mouth, your healthcare provider may recommend another type of birth control for 30 days after you start FOUNDAYO and for 30 days after each increase in your dose of FOUNDAYO. Talk to your healthcare provider about birth control methods that may be right for you while using FOUNDAYO.
• are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with FOUNDAYO. Talk to your healthcare provider about the best way to feed your baby while using FOUNDAYO.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FOUNDAYO may affect the way some medicines work, and some medicines may affect the way FOUNDAYO works.
Before using FOUNDAYO, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
• Use FOUNDAYO with a reduced-calorie diet and increased physical activity.
• Take FOUNDAYO by mouth 1 time each day, with or without food.
• Swallow tablets whole. Do not break, crush, or chew the tablet.
• If you miss a dose, take it as soon as possible. Do not take 2 doses of FOUNDAYO in the same day.
• Do not take more than 1 tablet per day.
• If you miss taking FOUNDAYO for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.
• If you take too much FOUNDAYO, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
FOUNDAYO may cause serious side effects, including:
• See “What is the most important information I should know about FOUNDAYO?”
• inflammation of the pancreas (pancreatitis). Stop taking FOUNDAYO and call your healthcare provider 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 healthcare provider 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 healthcare provider 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 an insulin or sulfonylurea.
Signs and symptoms of low blood sugar may include:
• dizziness or light-headedness • blurred vision • anxiety, irritability, or mood changes
• sweating • slurred speech • hunger
• confusion or drowsiness • shakiness • weakness
• headache • fast heartbeat • feeling jittery
• serious allergic reactions. Stop taking 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 • fainting or feeling dizzy
• problems breathing or swallowing • very rapid heartbeat
• severe rash or itching
• changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with FOUNDAYO.
• gallbladder problems. Gallbladder problems have happened in some people who use FOUNDAYO. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:
• pain in your upper stomach (abdomen) • yellowing of skin or eyes (jaundice)
• fever • 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 all your healthcare providers that you are taking FOUNDAYO before you are scheduled to have surgery or other procedures.
The most common side effects of FOUNDAYO include:
• nausea • stomach (abdominal) pain • heartburn
• constipation • headache • gas
• diarrhea • swollen belly • hair loss
• vomiting • feeling tired
• indigestion • belching
Talk to your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of FOUNDAYO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
• FOUNDAYO is sensitive to light. Protect FOUNDAYO from light by keeping it in the original bottle and carton and replacing the cap each time after opening.
• If you no longer have the carton, store the bottle away from light.Keep FOUNDAYO and all medicines out of the reach of children.
Active ingredient: orforglipron
Inactive ingredients: Copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The film coating contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The film coating of the 0.8 mg and 9 mg tablets also contains ferric oxide red and ferric oxide yellow; 2.5 mg and 14.5 mg tablets also contains ferric oxide yellow; and 5.5 mg and 17.2 mg tablets also contains ferrosoferric oxide and ferric oxide red.
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