100 Oral Semaglutide Tablets (Japanese Version)

【Product Name】Semaglutide Tablets

【Brand Name】Rybelsus Tablets

【Specifications】7mg × 100 tablets/box; 14mg × 100 tablets/box

【Manufacturer】Novo Nordisk (Japan) / MSD (Japan)

【Indications】

Used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Approved by the US FDA for weight loss indications; it effectively suppresses appetite and aids in weight reduction.

【Dosage and Administration】

Take one Rybelsus tablet on an empty stomach in the morning with no more than 120 ml of water. Avoid consuming food, beverages, or other oral medications for the subsequent 30 minutes. Taking the medication with food, beverages, or other oral medications, or waiting less than 30 minutes, will reduce its efficacy. Waiting longer than 30 minutes before eating may increase drug absorption.

The outer layer of the tablet contains ingredients to neutralize gastric acid; the tablet must be swallowed whole. Do not cut, crush, or chew the tablet.

【Mechanism of Action】

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. It acts as a GLP-1 receptor agonist, selectively binding to and activating the GLP-1 receptor (the target of endogenous GLP-1).

GLP-1 is a physiological hormone that exerts multiple effects on glucose regulation, mediated by the GLP-1 receptor. The primary mechanism extending the half-life of semaglutide is albumin binding, which reduces renal clearance and prevents metabolic degradation. Additionally, semaglutide is stable against degradation by the DPP-4 enzyme.

Semaglutide lowers blood glucose by stimulating insulin secretion and inhibiting glucagon secretion; both processes occur in a glucose-dependent manner. Consequently, when blood glucose levels are high, insulin secretion is stimulated and glucagon secretion is inhibited. The glucose-lowering mechanism also involves a slight delay in gastric emptying during the early postprandial phase. 【Clinical Trials】

Based on the global PIONEER 1–10 clinical trials involving a total of 9,543 patients with type 2 diabetes, oral semaglutide reduced both glycated hemoglobin (HbA1c) levels and body weight compared to the control group. Oral semaglutide resulted in weight loss of 2.0–5.0 kg and demonstrated a favorable safety and tolerability profile.

Individual weight loss results with Rybelsus may vary depending on factors such as age, body weight, metabolism, and adherence to a healthy diet and exercise regimen.

【Adverse Reactions】

Common adverse reactions (incidence >5%) associated with oral semaglutide include nausea, vomiting, diarrhea, and constipation.

Individuals sensitive to the medication may experience nausea and abdominal bloating during the initial phase; vomiting may also occur.

Some users may experience drowsiness or dizziness; these symptoms typically resolve within about a week.

Gastrointestinal reactions peak during the first week, gradually subside over approximately two weeks, and the body generally adapts fully within a month.

A small number of individuals may experience an increased heart rate.

Efficacy is independent of the occurrence of adverse reactions; however, generally speaking, users who experience significant nausea in the early stages tend to see better weight loss results.

【Contraindications】

Populations that should not take GLP-1 receptor agonists:

Pregnant or breastfeeding women, or those planning to become pregnant

Individuals with a history of thyroid cancer or pancreatitis, or those with hepatic or renal impairment

Individuals allergic to semaglutide

Individuals with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Use of weight-loss medication is generally not recommended for individuals with a past or current history of eating disorders

Individuals currently taking other GLP-1 agonists should not take GLP-1 weight-loss medications

| Contraindicated in individuals with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Warning: Risk of thyroid C-cell tumors

In mice and rats, clinically relevant exposure to semaglutide increased the incidence of thyroid C-cell tumors (adenomas and carcinomas), with the incidence correlating to both dosage and duration of treatment. As the clinical relevance of semaglutide-induced thyroid C-cell tumors in rodents to humans has not been established, it is currently unknown whether RYBELSUS causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.

RYBELSUS 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). Patients should be advised of the potential risk of MTC associated with RYBELSUS treatment and informed of the symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, or persistent hoarseness). It is currently undetermined whether routine monitoring of serum calcitonin or thyroid ultrasound in patients treated with RYBELSUS is useful for the early detection of MTC.

[About Novo Nordisk]

Novo Nordisk is a world-renowned pharmaceutical company with a century-long history; founded in 1923, it is headquartered in Denmark. As a global leader in biopharmaceuticals, Novo Nordisk focuses on diabetes care and the management of chronic diseases. The company is dedicated to the research, development, and production of innovative insulin and other diabetes medications to help improve patients' quality of life. Novo Nordisk provides reliable and innovative medical solutions to millions of patients worldwide. For a century, the company has upheld scientific innovation, quality, and sustainability as its core values, striving to improve human health and well-being.

Specifications

Product Name: Semaglutide Oral Tablets (Japanese Version) – 7mg/14mg (100 tablets)