Foundayo™
A once-daily oral GLP-1 option for adults seeking a non-injection medical weight loss treatment. Schedule Consultation
What is Foundayo™?
Foundayo™ (orforglipron) is a newly approved oral GLP-1 prescription medicine used with a reduced-calorie diet and increased physical activity to help qualifying adults lose excess body weight and keep it off. For patients who want a non-injectable option, Foundayo offers a different path than weekly injectable medications.
Why Foundayo™ Stands Out?
Foundayo is a once-daily oral GLP-1 medicine that can be taken with or without food, and Lilly states it can be taken without food or water restrictions. That convenience is one of the biggest reasons it may attract patients who dislike injections or want a simpler daily routine.
How Foundayo™ Works?
Foundayo works through the GLP-1 pathway to help regulate appetite and reduce calorie intake. It is a small-molecule, non-peptide oral GLP-1 medicine, which distinguishes it from injectable options and from peptide-based products.
What the Clinical Data Show?
In Lilly’s approval announcement, people on the highest Foundayo dose in ATTAIN-1 who stayed on treatment lost an average of 27.3 pounds, or 12.4% of body weight, versus 2.2 pounds with placebo. In the prescribing information, average percent weight change at 72 weeks in the non-diabetes trial was 7.4%, 8.3%, and 11.1% for the 5.5 mg, 9 mg, and 17.2 mg daily doses.
Who May Quality for Foundayo™
Foundayo is approved for adults with obesity, or adults with overweight plus at least one weight-related comorbid condition. It should not be used with another GLP-1 receptor agonist, and it is not known to be safe and effective in children.
What to Expect?
Foundayo is taken once daily by mouth. Tablets should be swallowed whole and should not be crushed, broken, or chewed. Available strengths include 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg, with dose escalation used to reduce GI side effects.
Important Safety Summary
Foundayo carries a warning regarding thyroid C-cell tumors and should not be used in patients with personal or family history of MTC or MEN 2. Important warnings also include pancreatitis, severe GI reactions, acute kidney injury due to volume depletion, hypoglycemia, hypersensitivity, diabetic retinopathy in patients with type 2 diabetes, gallbladder disease, and pulmonary aspiration during anesthesia.
Foundayo™ FAQ
What is Foundayo?
Foundayo is orforglipron, a once-daily oral GLP-1 receptor agonist used with a reduced-calorie diet and increased physical activity to help qualifying adults lose excess weight and keep it off.
Is Foundayo a pill or an injection?
Foundayo is an oral tablet taken once daily by mouth, with or without food. It should be swallowed whole and not crushed, broken, or chewed.
Who should not take Foundayo?
Patients should not take Foundayo if they have a personal or family history of medullary thyroid carcinoma, have MEN 2, or have had a serious allergic reaction to orforglipron or any ingredient in the medication.
What are the most common side effects of Foundayo?
The most common side effects include nausea, constipation, diarrhea, vomiting, indigestion, abdominal pain, headache, abdominal bloating, fatigue, belching, reflux, gas, and hair loss.
Can Foundayo affect birth control pills?
Yes. The label advises that oral hormonal contraceptives may be less effective after starting Foundayo and after each dose increase. Patients using oral birth control should discuss non-oral or backup contraception for 30 days after initiation and 30 days after each escalation.
Can Foundayo be taken with food?
Yes. Foundayo can be taken with or without food.
Can Foundayo be used with other GLP-1 medications?
No. The medication guide states Foundayo should not be used with other GLP-1 receptor agonist medicines.
Is Foundayo safe during pregnancy or breastfeeding?
Weight loss is not recommended during pregnancy, and the label advises discontinuing Foundayo if pregnancy occurs. Breastfeeding is not recommended during treatment.
INDICATION
Foundayo™ should be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults.
LIMITATIONS OF USE
- you or any of your family have a history of Medulary Thyroid Carcinoma (MTC)
- you have MEN 2. This is a disease where people have tumors in more than one gland in their body
- you are allergic. Symptoms of a serious allergic reaction may include: swelling of your face, lips, tongue, or throat, fainting or feeling dizzy, very rapid heartbeat, problems breathing or swallowing, and severe rash or itching.
Lookup your coverage or co-pay for Foundayo™
Foundayo™ Savings Information
Provide the information to look up the cost of Foundayo™ based on your prescription plan. You may need your prescription card to complete your request.
Important Safety Information
Foundayo safety page
What is the most important information I should know about Foundayo™?
Foundayo may cause serious side effects, including a possible risk of thyroid tumors, including cancer. Patients should contact their healthcare provider right away if they develop a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. Foundayo is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Do not take Foundayo™ if:
- you or any family member has ever had medullary thyroid carcinoma (MTC)
- you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- you have had a serious allergic reaction to orforglipron or any ingredient in Foundayo
Before taking Foundayo™, tell your healthcare provider if you:
- have or have had problems with your pancreas or kidneys
- have severe liver problems
- have severe stomach problems, including slowed stomach emptying or difficulty digesting food
- have a history of diabetic retinopathy
- are scheduled to have surgery or other procedures involving anesthesia or deep sedation
- are pregnant or planning to become pregnant
- take oral birth control pills, since Foundayo may reduce how well they work for 30 days after starting treatment and for 30 days after each dose increase
- are breastfeeding or planning to breastfeed, because breastfeeding is not recommended during treatment with Foundayo
Tell your healthcare provider about all the medicines you take
This includes prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Foundayo can affect how some medicines work, and some medicines may affect how Foundayo works. Because it slows stomach emptying, it may also affect absorption of oral medicines. The risk of low blood sugar may be higher when Foundayo is used with insulin or a sulfonylurea.
What are the possible side effects of Foundayo™?
Foundayo may cause serious side effects, including pancreatitis, severe stomach problems, dehydration that can lead to kidney problems, low blood sugar when used with certain diabetes medicines, serious allergic reactions, changes in vision in patients with type 2 diabetes, gallbladder problems, and an increased chance of food or liquid entering the lungs during surgery or other procedures requiring anesthesia or deep sedation. Patients should tell all healthcare providers they are taking Foundayo before any planned procedure.
The most common side effects of Foundayo™ may include:
nausea, constipation, diarrhea, vomiting, indigestion, stomach pain, headache, abdominal bloating or swelling, fatigue, belching, heartburn/reflux, gas, and hair loss.
Additional important note
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. It is taken by mouth once daily, with or without food, and tablets should be swallowed whole.
Foundayo™ is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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Foundayo® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. All other trademarks, registered or unregistered, are the property of their respective owners.