Foundayo 14.5 — Orforglipron 14.5 mg Tablets, 30 Tablets

Foundayo 14.5 mg is supplied in the form of film-coated tablets for oral administration.

Qualitative and Quantitative Composition per Tablet:

• • Active Ingredient: Orforglipron — 14.5 mg.
• • Excipients: Microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, coloring agents.

Packaging and Presentation: Round, biconvex film-coated tablets bearing "14.5" debossing. Each box contains 30 tablets. The outer carton reflects official Eli Lilly branding displaying the INN orforglipron, brand name Foundayo, strength 14.5 mg, and administration instructions Oral use / Once daily.

Pharmacodynamics:
Orforglipron is a highly selective non-peptide GLP-1 receptor agonist. It binds to and activates GLP-1 receptors, initiating glucose-dependent intracellular signaling cascades. The agent stimulates glucose-dependent insulin secretion from pancreatic beta cells while concurrently suppressing inappropriately elevated glucagon secretion from alpha cells. Delayed gastric emptying helps smooth postprandial glucose excursions. Central hypothalamic mechanisms suppress appetite and enhance satiety, reducing overall caloric intake.

Pharmacokinetics:

• • Absorption: Rapidly absorbed from the gastrointestinal tract following oral intake. Peak plasma concentrations are achieved within 1 to 3 hours. Food intake does not exert clinically significant effects on systemic bioavailability.
• • Distribution: Exhibits moderate volume of distribution. Plasma protein binding is high, predominantly binding to serum albumins.
• • Metabolism: Minimally metabolized in the liver via cytochrome P450 enzymatic pathways.
• • Elimination: Terminal elimination half-life is approximately 30 to 40 hours, ensuring steady-state plasma exposure under once-daily dosing regimens. Excretion occurs via feces and urine.

Foundayo 14.5 mg is indicated in adult patients for the following conditions:

• • Type 2 Diabetes Mellitus: As monotherapy (when metformin is inappropriate) or as part of combination antihyperglycemic therapy to improve glycemic control alongside diet and exercise.
• • Weight Management: For chronic weight control in adult patients with obesity (Body Mass Index BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, cardiovascular disease).

Foundayo 14.5 mg is intended for oral administration once daily at any time of day, with or without food, accompanied by water. Tablets must be swallowed whole without crushing or chewing.

Titration Schedule and 14.5 mg Administration:
The 14.5 mg dose is administered during the fifth step of titration (month 5, weeks 17–20) following sequential completion of prior titration steps (0.8 mg → 2.5 mg → 5.5 mg → 9 mg for 4 weeks each). Dose escalation follows this regimen: 0.8 mg (first 4 weeks) → 2.5 mg (weeks 5–8) → 5.5 mg (weeks 9–12) → 9 mg (weeks 13–16) → 14.5 mg (from week 17 / maintenance dose).

Maintenance Therapy:
The 14.5 mg once-daily dose serves as a target maintenance dose for sustained long-term efficacy or as a step prior to escalating to the maximum 17.2 mg dose.

Administration of Foundayo 14.5 mg is contraindicated in:

• • Hypersensitivity: Known hypersensitivity to orforglipron or any inactive excipient.
• • Type 1 Diabetes Mellitus: Not indicated for treating type 1 diabetes or diabetic ketoacidosis.
• • Oncological History: Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• • Severe GI Disorders: Severe gastroparesis or acute inflammatory bowel disease flare-ups.
• • Pregnancy and Lactation: Contraindicated in pregnant or nursing women.
• • Pediatric Population: Safety and efficacy in individuals under 18 years of age have not been established.

Potential drug interactions should be evaluated during Foundayo therapy:

• • Delayed Gastric Emptying: Orforglipron slows gastric emptying, which may potentially impact the absorption rate of concomitant oral medications.
• • Insulin and Insulin Secretagogues (Sulfonylureas): Co-administration increases the risk of hypoglycemia, potentially requiring dose reduction of insulin or secretagogues.
• • CYP450 Inhibitors and Inducers: Clinical studies indicate a minimal risk of significant pharmacokinetic drug-drug interactions via cytochrome P450 pathways.

Pregnancy:
Foundayo 14.5 mg is contraindicated during pregnancy. Animal reproductive toxicity studies have demonstrated adverse fetal outcomes. If a patient plans pregnancy or pregnancy is detected, treatment must be discontinued immediately (at least 2 months prior to planned conception due to the prolonged elimination half-life).

Lactation:
Data regarding the excretion of orforglipron in human breast milk are unavailable. The drug is contraindicated during breastfeeding.

The most frequent adverse events associated with GLP-1 receptor agonists involve the gastrointestinal tract, diminishing as the body adapts to the maintenance dose:

• • Gastrointestinal Tract (Very Common): Nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, gastroesophageal reflux. These events are predominantly mild to moderate in severity and subside over time.
• • Metabolic Disorders: Decreased appetite, hypoglycemia (when combined with insulin or sulfonylureas).
• • Nervous System: Dizziness, fatigue, headache.
• • Cardiovascular System: Increase in resting heart rate (tachycardia).
• • Other: Elevations in pancreatic enzymes, rare reports of cholelithiasis.

Symptoms:
Overdose with orforglipron may result in an exaggeration of pharmacological effects, leading to severe gastrointestinal adverse reactions (intense nausea, persistent vomiting, pronounced diarrhea) and an increased risk of symptomatic hypoglycemia.

Treatment:
No specific antidote exists. Supportive and symptomatic care should be administered, focusing on fluid-electrolyte balance restoration and management of hypoglycemia. Hemodialysis is ineffective due to high plasma protein binding.

Storage Requirements for Foundayo 14.5 mg:

• 🌡️ Temperature Range: Store in a dry place at controlled room temperature not exceeding 25–30 °C (77–86 °F). Do not freeze.
• ☀️ Environmental Protection: Keep in original manufacturer packaging to protect from moisture and direct sunlight.
• 👶 Safety Precautions: Keep out of reach of children.
• ⏳ Shelf Life: Stated on the outer carton. Do not use past expiration date. Prescription-only medicine.

To verify the authenticity of original Foundayo 14.5 mg manufactured by Eli Lilly (Lilly), check the following visual and security features:

• ✅ Eli Lilly Corporate Logo: Recognizable cursive red "Lilly" logo located in the bottom right corner of the carton face.
• ✅ Product Branding: Brand name "Foundayo" printed in dark blue with a registered trademark symbol, accompanied by strength "14.5 mg" set inside a proprietary sector graphic element.
• ✅ Carton Layout: Clean white background featuring generic ingredient orforglipron, administration text Oral use / Once daily, and pack count 30 film-coated tablets.
• ✅ Strength Verification: Clear "14.5 mg" designation printed on the box face and corresponding "14.5" debossing on each tablet.
• ✅ Security Measures: Presence of 2D barcodes, serial numbers, and tamper-evident sealing features on carton flaps.