Foundayo 36 mg 30 Capsule

Foundayo (Orforglipron)

Foundayo (Orforglipron) is a once-daily oral GLP-1 capsule indicated for weight loss and long-term weight management for adults with obesity or overweight and at least one obesity-related comorbid condition, alongside a healthy diet and physical activity. Foundayo supports weight loss by reducing appetite and food intake, with greater fat mass loss than lean mass loss. People experienced significant weight loss with Foundayo, achieving an average weight reduction of 12.4% (12.4 kg) on the highest dose of Foundayo. Results were seen as early as 4 weeks, with Foundayo leading to 10 times more weight loss than diet and exercise alone. Consult your healthcare professional to determine whether Foundayo is appropriate for you.

How to Use

• Foundayo is a capsule for once-daily oral use at any time of day, with or without food.
• Swallow capsules whole and do not open, break, crush, or chew as it is not known whether this impacts absorption of Orforglipron.
• The starting dose for Foundayo is 1 mg once daily.
• After at least 30 days, increase the dose to 3 mg.
• After at least 30 days on the current dose, the dose may be increased to the next dose (6 mg, 12 mg, 24 mg, or 36 mg).
• The maximum daily dose is 36 mg once daily.
• Taking more than one capsule a day should not be done to achieve the effect of a higher dose.
• If a dose is missed, resume dosing as soon as possible.
• Do not take more than one capsule per day.

Product Details

• Available strengths: Foundayo 1 mg hard capsules, Foundayo 3 mg hard capsules, Foundayo 6 mg hard capsules, Foundayo 12 mg hard capsules, Foundayo 24 mg hard capsules, Foundayo 36 mg hard capsules.
• Pack size: 30 capsules.
• Shelf life: 2 years.
• Storage: Store at or below 30°C. Store in the original package in order to protect from light. This medicinal product is light sensitive.

Common Side Effects

The most frequently reported adverse reactions were gastrointestinal disorders, and these were mostly mild or moderate in severity. The incidence of nausea, vomiting, and diarrhea was higher during the dose escalation period and decreased over time.

Caution and Warning

Contraindications

Foundayo is contraindicated in patients with:

• A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Hypersensitivity to the active substance or to any of the excipients.

Risk of Thyroid C-Cell Tumors

• Foundayo is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2.
• Counsel patients regarding the potential risk for MTC with the use of Foundayo and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, or persistent hoarseness).

Acute Pancreatitis

Orforglipron has not been studied in patients with a history of pancreatitis and should be used with caution in these patients.

Severe Gastrointestinal Adverse Reactions

Orforglipron has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and should be used with caution in these patients.

Severe Hepatic Impairment

Orforglipron is not recommended for use in patients with severe hepatic impairment.

Paediatric Population

• The safety and efficacy of Orforglipron in children aged less than 18 years have not yet been established.
• No data are available.

Women of Childbearing Potential

Women of childbearing potential should use effective contraception during treatment with Orforglipron.

Pregnancy

• There are limited data from the use of Orforglipron in pregnant women.
• Studies in animals have shown reproductive toxicity.
• Orforglipron should not be used for weight reduction during pregnancy.
• Orforglipron may cause fetal harm.

Breast-feeding

• It is unknown whether Orforglipron is excreted in human milk.
• A risk to the newborn/infant cannot be excluded.
• Orforglipron should not be used during breast-feeding.

Drug Interactions

• For patients taking a strong CYP3A4 inhibitor, consider an alternative medicine to the strong CYP3A4 inhibitor or consider an Orforglipron dose reduction.
• The maximum Orforglipron dose should be the 12 mg capsule dose when co-administered with a strong CYP3A4 inhibitor.
• Avoid strong CYP3A4 inhibitors that also inhibit OATP1B when taking Orforglipron.
• Coadministration of a moderate or strong CYP3A4 inducer may reduce the effectiveness of Orforglipron.
• Drugs for which oral absorption is known to be sensitive to elevated gastric pH should not be taken within 2 hours of swallowing an Orforglipron capsule.