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Highlights About Foundayo™ (fown-DAY-oh) or orforglipron 😊

What is Foundayo? 💊

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.

Important limitations: ⚠️

• 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 👶.


What are the results with Foundayo?

People taking the 17.2 mg dose of Foundayo lost up to 25 pounds (~11%)†‡

†Along with diet and exercise.
‡Individual results may vary.


How much weight did people lose in clinical studies? 📊

TreatmentAverage weight loss (without diabetes)Average weight loss (with type 2 diabetes)
Placebo2.1% (5.3 lbs)2.5% (5.9 lbs)
Foundayo 5.5 mg7.4% (17.2 lbs)5.1% (11.7 lbs)
Foundayo 9 mg8.3% (18.9 lbs)7.0% (15.9 lbs)
Foundayo 17.2 mg11.1% (24.9 lbs)9.6% (21.2 lbs)

Study details: 📝

• 72-week study without diabetes: Average starting weights were 225–229 lbs
• 72-week study with type 2 diabetes: Average starting weights were 220–226 lbs

Foundayo is not for cosmetic weight loss 🚫.


Does Foundayo have food & water restrictions? 🍽️💧

No 😊. Foundayo is a once-daily pill that can be taken on your schedule—without the hassle of food or water restrictions.

• 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 more than 1 tablet per day.


How can I save on Foundayo? 💰

There are saving options for Foundayo regardless of your insurance status. Ask your healthcare provider or pharmacist for details.


Why weight loss can be hard — and how Foundayo may help 😟➡️😊

Here are some possible reasons why you may have lost weight previously, but it came back:

You’ve been eating healthy. Working out. But it’s still hard to lose weight. And if you lose a few pounds, it’s hard to keep that weight off.

If this cycle sounds familiar, you may be surprised to learn it’s not your lack of willpower — your biology may be working against you 🧬.

When you start to lose weight, your body can react by:

• Making you feel hungrier throughout the day 🍔
• Increasing your appetite and cravings 😋
• Making you feel less satisfied after you eat 😕

The good news is there are more options than ever before — with many treatments that work with your body to help you lose weight, along with diet and exercise 💪.

It’s a great time to discuss a new approach with your doctor — one that may help break the cycle 👨‍⚕️.


You may need help on your weight journey 🤝

Did you know that people who partner with a weight management doctor could lose more weight than those who don’t?

If you haven’t been reaching your weight goals on your own, it might be time to work with a weight management doctor on a plan made just for you 😊.

Options could include:

• Lifestyle changes: A reduced-calorie meal plan and physical activity are an important part of any weight management plan 🥗🏃‍♂️.
• Weight management medicines: There are treatment options available to help control appetite and reduce hunger along with a healthy diet and physical activity 💊.
• Weight loss surgery: For some people living with an excess of body fat, this surgery (also called bariatric surgery) makes changes to the digestive system. It may control hunger and feelings of fullness 🏥.

The fact is, you don’t have to figure things out by yourself 💙.


How to Take Foundayo 💊

• Take Foundayo exactly as your healthcare provider tells you.
• 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.
• If you miss a dose, take it as soon as possible. Do not take 2 doses 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 🚨.


DOSAGE AND ADMINISTRATION 📌

Foundayo is available as a 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg tablet.

Recommended Dosage Escalation to Reduce Risk of GI Adverse Reactions: ⚠️

• Initiate with the 0.8 mg dosage.
• After at least 30 days, increase to the 2.5 mg dosage.
• After at least 30 days, increase to the 5.5 mg dosage.
• Adjust as needed to the next dosage (9 mg, 14.5 mg, 17.2 mg) after at least 30 days on the current dosage.
• The maximum dosage of Foundayo is 17.2 mg.
• Consider treatment response and tolerability when selecting treatment dosage.

For adults with obesity, or with overweight in the presence of at least one weight-related comorbid condition, as an adjunct to reduced-calorie diet and increased physical activity.

Storage: Protect from light ☀️.


Additional Safety Notes: ⚠️

• Avoid strong CYP3A4 inhibitors that also inhibit OATP1B when taking Foundayo.
• The maximum dosage of Foundayo is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor.
• Avoid strong CYP3A4 inducers when taking Foundayo.
• Monitor Foundayo effectiveness when concomitantly using moderate CYP3A4 inducers and escalate Foundayo dosage as needed.


Safety Summary with Warnings for Foundayo™ (orforglipron) 🚨

WARNING: Possible Thyroid Tumors ⚠️

Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms:

• A lump or swelling in the neck
• Hoarseness
• Trouble swallowing
• Shortness of breath

If you have any of these symptoms, tell your healthcare provider immediately 🏥.


Do not use Foundayo if: 🚫

• You or any of your family have ever had a type of thyroid cancer called 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 of the ingredients in Foundayo


Foundayo may cause serious side effects, including: ⚠️

• Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe stomach-area pain that will not go away, with or without nausea or vomiting.
• Severe stomach problems. 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 fluid loss. Drink fluids to help reduce your chance of dehydration 💧.
• Low blood sugar (hypoglycemia). Your risk may be higher if you also take insulin or sulfonylurea. Symptoms include dizziness, sweating, confusion, headache, blurred vision, shakiness, fast heartbeat, hunger, and weakness.
• Serious allergic reactions. Stop using Foundayo and get medical help right away if you have swelling of face/lips/tongue/throat, trouble breathing, severe rash, fainting, or very rapid heartbeat 🚨.
• Changes in vision in patients with type 2 diabetes.
• Gallbladder problems. Tell your provider right away if you have upper stomach pain, fever, yellow skin/eyes, or clay-colored stools.
• Food or liquid getting into the lungs during surgery or procedures that use anesthesia or deep sedation. Tell your healthcare providers that you are taking Foundayo before any surgery 🏥.


Common side effects 😷

The most common side effects include: nausea, constipation, diarrhea, vomiting, indigestion, stomach pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss.

These are not all the possible side effects. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Before taking Foundayo, tell your healthcare provider: 📝

• All medicines you take
• If you are pregnant or plan to become pregnant (Foundayo may harm your unborn baby) 🤰
• If you are breastfeeding or plan to breastfeed (not recommended during treatment) 🍼
• If you have pancreas, kidney, liver, or stomach problems (including gastroparesis)
• If you have a history of diabetic retinopathy
• If you are scheduled for surgery


Birth control pills 💊⚠️

If you take birth control pills by mouth, talk to your healthcare provider. Birth control pills may not work as well while taking Foundayo. Your provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase.


Pregnancy Exposure Registry 📌

There is a registry for women who have taken Foundayo during pregnancy. Talk to your healthcare provider about how to take part, or call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979.


References: 📚

https://www.lilly.com/news/stories/what-to-know-about-orforglipron
https://pmc.ncbi.nlm.nih.gov/articles/PMC12922244/
https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program
https://clinicaltrials.gov/study/NCT05872620
https://www.youtube.com/watch?v=wyhYexXFQ-U