Important Safety Information — Foundayo™ (orforglipron)

What is this?

This Important Safety Information summarizes key warnings, precautions, contraindications, and possible side effects for Foundayo™ (orforglipron) tablets, a once-daily oral prescription medication used in adults for chronic weight management.

This page does not include all of the information provided in the FDA-approved prescribing information and Medication Guide for Foundayo. Always follow your prescription label, the Medication Guide provided with your prescription, and the instructions provided by your ATHS healthcare provider.

Foundayo is FDA-approved for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight who also have at least one weight-related medical condition. Your provider will determine whether Foundayo is medically appropriate based on your medical history, weight-related conditions, and treatment goals.

Boxed Warning: Risk of Thyroid C-Cell Tumors

In studies with rodents, medications that act on the GLP-1 receptor caused thyroid C-cell tumors, including thyroid cancer. Whether this finding applies to people is not known.

Foundayo should not be used by patients who have:

• A personal or family history of medullary thyroid carcinoma (MTC).
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), an inherited condition that increases the risk of certain endocrine tumors.

Tell your healthcare provider immediately if you develop a lump or swelling in your neck, persistent hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid problems and require evaluation. Routine blood testing for calcitonin or thyroid ultrasound is of uncertain value for early detection of MTC in patients taking Foundayo.

Important Warnings and Precautions

Foundayo may cause or contribute to serious medical problems, including:

• Acute pancreatitis (inflammation of the pancreas), which has been reported in patients taking Foundayo and other GLP-1 receptor agonists. Stop Foundayo and contact your provider immediately if you develop severe abdominal pain, with or without nausea or vomiting, that may radiate to your back.
• Severe gastrointestinal reactions, including severe nausea, vomiting, diarrhea, or constipation. Foundayo is not recommended in patients with severe gastroparesis (delayed stomach emptying).
• Acute kidney injury caused by dehydration from vomiting, diarrhea, or reduced fluid intake. Some patients have required dialysis.
• Low blood sugar (hypoglycemia), particularly in patients who also take insulin or sulfonylureas. Your provider may need to reduce these medications when Foundayo is started.
• Serious allergic reactions, including anaphylaxis and angioedema.
• Worsening of diabetic retinopathy in patients with type 2 diabetes who have a history of retinopathy.
• Acute gallbladder disease, including gallstones (cholelithiasis) and gallbladder inflammation (cholecystitis).
• Pulmonary aspiration during general anesthesia or deep sedation. Foundayo slows stomach emptying, which may increase the risk of food or liquid entering the lungs during procedures requiring anesthesia.

Seek emergency medical care if you experience severe abdominal pain, signs of a serious allergic reaction, severe vomiting or diarrhea with significantly reduced urination, or any symptom that feels severe or rapidly worsening.

Who should not use Foundayo?

Do not use Foundayo if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC).
• Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Have had a serious allergic reaction to orforglipron or to any of the inactive ingredients in Foundayo.

Foundayo should not be used in combination with another GLP-1 receptor agonist medication, including semaglutide, tirzepatide, liraglutide, dulaglutide, or exenatide.

Before using Foundayo, tell your provider if you:

Tell your ATHS provider about your full medical history, especially if you have or have ever had:

• Pancreatitis or other problems with your pancreas.
• Kidney problems.
• Severe liver disease (Child-Pugh Class C). Foundayo is not recommended in this group.
• Severe gastroparesis or significant problems digesting food.
• A history of diabetic retinopathy.
• Type 2 diabetes, especially if you take insulin or a sulfonylurea.
• Gallbladder disease, gallstones, or cholecystitis.
• A serious allergic reaction to another GLP-1 receptor agonist.
• Plans for any surgery or procedure involving anesthesia or deep sedation.

Also tell your provider if you are pregnant, may become pregnant, or are breastfeeding, and tell your provider about all prescription medications, over-the-counter medications, supplements, herbal products, and weight-loss medications you use.

Drug Interactions

Foundayo may interact with other medications. Tell your provider about all prescription medications, over-the-counter medications, vitamins, herbal products, and supplements you take.

Specific interactions include:

• Strong CYP3A4 inhibitors (for example, clarithromycin, itraconazole, ketoconazole). The maximum dose of Foundayo is 9 mg once daily during concomitant use. Strong CYP3A4 inhibitors that also inhibit OATP1B, including ritonavir, should be avoided.
• Strong CYP3A4 inducers (for example, carbamazepine, rifampin, phenytoin, St. John’s wort). Avoid concurrent use, as these medications may reduce the effectiveness of Foundayo.
• Moderate CYP3A4 inducers (for example, efavirenz). Foundayo’s effectiveness should be monitored, and dose escalation may be needed.
• Simvastatin. Do not exceed simvastatin 20 mg once daily while taking Foundayo. Foundayo significantly increases blood levels of simvastatin’s active metabolite.
• Insulin and insulin secretagogues such as sulfonylureas. The risk of low blood sugar may increase. Your provider may reduce these medications when Foundayo is started.
• Other oral medications. Foundayo slows stomach emptying, which may affect how other oral medications are absorbed.

Oral Hormonal Contraceptives

Foundayo may reduce the effectiveness of oral birth control pills. If you use oral hormonal contraceptives, switch to a non-oral method of contraception, or add a barrier method such as condoms, for:

• 30 days after starting Foundayo.
• 30 days after each dose increase.

Talk to your provider about contraceptive options that will work consistently while you are taking Foundayo. Hormonal contraceptives that are not administered by mouth, including injections, implants, intrauterine devices, and transdermal patches, are not expected to be affected.

Common Side Effects

The most common side effects of Foundayo include:

• Nausea
• Constipation
• Diarrhea
• Vomiting
• Indigestion (dyspepsia)
• Abdominal pain
• Headache
• Bloating or abdominal distension
• Fatigue
• Belching (eructation)
• Acid reflux (gastroesophageal reflux disease)
• Gas (flatulence)
• Hair loss

Gastrointestinal side effects are most common during dose escalation and tend to decrease over time. The recommended dose-escalation schedule, with at least 30 days at each dose level before increasing, is designed to reduce these effects.

Other reported side effects include low blood pressure (especially in patients on antihypertensive therapy), increased heart rate (an average increase of 4 to 5 beats per minute), dizziness, changes in taste (dysgeusia), changes in skin sensation (dysesthesia), and laboratory increases in pancreatic amylase and lipase (the clinical significance of which is uncertain in the absence of pancreatitis symptoms).

Tell your provider about any side effect that is persistent, severe, or concerning.

Pancreatitis Warning

Acute pancreatitis has been reported in patients taking Foundayo. Symptoms include:

• Severe abdominal pain that may radiate to the back.
• Persistent nausea or vomiting.
• Pain that is sudden, severe, or does not resolve with normal activity.

Stop taking Foundayo and contact your provider or seek emergency care immediately if you suspect pancreatitis. If pancreatitis is confirmed, Foundayo should not be restarted.

Gallbladder Warning

Foundayo and other GLP-1 receptor agonists have been associated with an increased risk of gallbladder disease, including gallstones and gallbladder inflammation. Some of this risk is associated with weight loss itself.

Contact your provider if you develop:

• Pain in the upper right abdomen.
• Fever.
• Yellowing of the skin or eyes.
• Clay-colored stools.

Acute Kidney Injury Warning

Severe gastrointestinal side effects can cause dehydration, which may lead to acute kidney injury. Stay well hydrated, and contact your provider if you experience persistent vomiting or diarrhea, significantly reduced urination, or lightheadedness on standing.

Surgery, Anesthesia, and Deep Sedation

Because Foundayo slows stomach emptying, food or liquid may remain in your stomach longer than expected even after fasting before a procedure. This may increase the risk of aspiration during general anesthesia or deep sedation.

Tell every member of your surgical or procedural team that you take Foundayo, well in advance of any scheduled procedure. Your providers may give you specific fasting instructions or may pause Foundayo before the procedure.

Hypoglycemia Warning

Foundayo can lower blood sugar, with the highest risk in patients also taking insulin or a sulfonylurea. Hypoglycemia has also been reported in patients without type 2 diabetes.

Symptoms of low blood sugar may include:

• Dizziness or lightheadedness
• Sweating
• Confusion or drowsiness
• Headache
• Blurred vision
• Slurred speech
• Shakiness
• Fast heartbeat
• Anxiety, irritability, or mood changes
• Hunger
• Weakness

Tell your provider if you take any medication that can lower blood sugar before starting Foundayo. If you have type 2 diabetes, your provider may adjust your other diabetes medications.

Diabetic Retinopathy

In patients with type 2 diabetes who have a history of diabetic retinopathy, rapid improvement in blood sugar control may temporarily worsen retinopathy. Contact your provider if you experience changes in vision during treatment with Foundayo.

Pregnancy, Breastfeeding, and Females of Reproductive Potential

Weight loss provides no benefit during pregnancy and may cause harm to a developing fetus. If you become pregnant while taking Foundayo, stop the medication and contact your provider.

A pregnancy exposure registry collects information about pregnancy outcomes in women who took Foundayo during pregnancy. To enroll, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

Foundayo is not recommended during breastfeeding.

If you are of reproductive potential, use effective contraception during treatment with Foundayo. If you take oral hormonal contraceptives, see the contraception guidance above.

Pediatric Use

The safety and effectiveness of Foundayo have not been established in patients under 18 years of age. ATHS does not prescribe Foundayo to patients under 18.

Geriatric Use

Clinical trials of Foundayo included patients aged 65 and older. No overall differences in safety or effectiveness have been observed between older and younger adult patients.

Patients with Liver or Kidney Impairment

• Severe liver impairment (Child-Pugh Class C): Foundayo is not recommended.
• Mild or moderate liver impairment: No dose adjustment is required.
• Renal impairment, including end-stage renal disease: No dose adjustment is required, although kidney function should be monitored if vomiting or diarrhea occur.

Administration

Take Foundayo exactly as prescribed by your provider.

• Take one tablet by mouth once daily, with or without food.
• Swallow the tablet whole. Do not break, crush, or chew it.
• Do not take more than one tablet per day.

Your starting dose is 0.8 mg once daily. Your provider will increase your dose every 30 days or longer based on your response and tolerability. Available dose levels are 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg. The maximum dose is 17.2 mg once daily.

Missed Dose

If you miss a dose, take it as soon as you remember on the same day. Do not take two doses of Foundayo on the same day.

If you miss seven or more consecutive doses, contact your provider before resuming. You may need to restart at a lower dose to reduce the risk of stomach side effects.

Overdose

In case of overdose, contact your provider, call Poison Control at 1-800-222-1222, or go to the nearest emergency room. Foundayo has a long half-life of approximately 29 to 49 hours, so symptoms may persist for an extended period.

Storage

Store Foundayo at room temperature, 68°F to 77°F (20°C to 25°C). Brief excursions to between 59°F and 86°F (15°C and 30°C) are permitted.

Foundayo is sensitive to light. Keep tablets in the original bottle and carton, and replace the cap each time after opening. If the carton is no longer available, store the bottle away from light.

Keep Foundayo and all medications out of the reach of children and pets.

Medication Disposal

Do not flush unused Foundayo down the toilet or pour it into a drain unless specifically instructed.

Preferred disposal methods:

• Use a DEA-authorized drug take-back location when available.
• If no take-back option is available, follow local disposal guidance or ask your pharmacist for instructions.

Ingredients

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. Some tablet strengths also contain ferric oxide red, ferric oxide yellow, or ferrosoferric oxide as coloring agents.

Tell your provider and pharmacist if you have a known allergy or hypersensitivity to any of these ingredients.

Reporting Side Effects

Tell your healthcare provider if you experience side effects or symptoms that concern you. You may report suspected adverse reactions or product quality concerns to:

• Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
• The FDA through MedWatch at 1-800-FDA-1088 or at www.fda.gov/medwatch.

Telemedicine Disclosure

This prescription may be issued through telemedicine after review by a licensed healthcare provider. If you experience concerning symptoms, contact your ATHS provider or seek emergency medical care.

Withholding or providing inaccurate information about your symptoms, medical history, medications, allergies, prior reactions, or lab results may result in serious harm.

Trademark

Foundayo™ is a trademark of Eli Lilly and Company. Alchemical Transformations Health Services, P.C. is not affiliated with or endorsed by Eli Lilly and Company.

Disclaimer

This information is not comprehensive and does not include all possible risks, side effects, interactions, warnings, or precautions associated with Foundayo. This page does not provide medical advice, diagnosis, or treatment.

For questions about your medication, prescription, dosing, side effects, or treatment plan, contact your healthcare provider or pharmacist.

Full Prescribing Information

For the complete FDA-approved prescribing information and Medication Guide for Foundayo, see:

https://uspl.lilly.com/foundayo/foundayo.html#pi