Orforglipron

FOUNDAYO TM is indicated 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 adults with overweight in the presence of at least one weight-related comorbid condition. FOUNDAYO™ is a GLP-1 receptor agonist indicated 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 adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended.

FOUNDAYO is a GLP-1 receptor agonist that binds to and activates the human GLP-1 receptor. GLP-1 is a physiological regulator of appetite and caloric intake. GLP-1 receptors are present in brain regions that regulate appetite. In animal studies, orforglipron distributed to and activated neurons in brain regions that regulate appetite and food intake.

Take FOUNDAYO orally once daily, with or without food. Swallow tablets whole. Do not break, crush, or chew. Do not take more than one tablet per day. Starting dosage is 0.8 mg once daily. After at least 30 days, increase dosage to 2.5 mg once daily. After at least 30 days on the 2.5 mg dosage, increase dosage to 5.5 mg once daily. Dosage may be increased to the next dosage level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tolerability. Maximum dosage is 17.2 mg once daily.

FOUNDAYO is contraindicated in patients with: A personal or family history of MTC or in patients with MEN 2. Known serious hypersensitivity to orforglipron or any of the excipients in FOUNDAYO. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with GLP-1 receptor agonists. Personal or family history of MTC or in patients with MEN 2.

Boxed warning (risk of thyroid c-cell tumors): In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents. Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including FOUNDAYO. Discontinue if pancreatitis is suspected. Severe Gastrointestinal Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. FOUNDAYO is not recommended in patients with severe gastroparesis.

The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-Cell Tumors Acute Pancreatitis Severe Gastrointestinal Reactions Acute Kidney Injury Due to Volume Depletion Hypoglycemia Hypersensitivity Reactions Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Acute Gallbladder Disease Pulmonary Aspiration During General Anesthesia or Deep Sedation Most common adverse reactions, reported in ≥5% of patients treated with FOUNDAYO, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and hair loss.

Strong CYP3A4 Inhibitors: The maximum dosage of FOUNDAYO is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor. Avoid concomitant use with strong CYP3A4 inhibitors that also inhibit OATP1B. CYP3A4 Inducers: Avoid concomitant use with strong CYP3A4 inducers. Monitor FOUNDAYO effectiveness and escalate dosage as needed when used concomitantly with moderate CYP3A4 inducers. Simvastatin: Do not exceed simvastatin 20 mg once daily when used concomitantly with FOUNDAYO. FOUNDAYO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications.

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