Foundayo®
Your safety is our first priority. Learn more about key medication details, side effects, and other important info about your treatment.
Prescribing information
Common side effects
Nausea
Stomach (abdominal) pain
Heartburn
Constipation
Headache
Gas
Diarrhea
Swollen belly
Hair loss
Vomiting
Feeling tired
Indigestion
Belching
Important safety information
FOUNDAYO is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
Limitations of Use:
• 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.
WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning.
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 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.
Do not use 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 MEN 2.
you have had a serious allergic reaction to orforglipron or any of the ingredients in FOUNDAYO. Inactive ingredients include: 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.
Before taking FOUNDAYO, tell your healthcare provider about all of your medical conditions, including if you:
have or have had problems with your pancreas or kidneys.
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.
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.
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.
What are the possible side effects of 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.
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.
How should I store FOUNDAYO?
• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• 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.
Do not use FOUNDAYO for a condition for which it was not prescribed. Do not give FOUNDAYO to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or healthcare provider for information about FOUNDAYO that is written for health professionals.