LOsem Semaglutide Tablets 3mg/7mg/14mg

【Chinese Name】Semaglutide Tablets

【English Name】Semaglutide Tablets

【Brand Name】Rybelsus / Nuohexin / L'Osem-3 / L'Osem-7 / L'Osem-14

【Specifications】3mg × 30 tablets/box; 7mg × 30 tablets/box; 14mg × 30 tablets/box

【Manufacturer】Lao United Pharmaceutical Group Co., Ltd.

【Lao FDA Registration No.】06 L 1121/24 / 06 L 1122/24 / 06 L 1123/24

【Indications】

Can be 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; effective for suppressing appetite and reducing body weight.

【Dosage and Administration】

Administration: Take once daily on an empty stomach, at least 30 minutes before breakfast. Swallow the tablet whole with approximately 120mL of plain water (do not chew, crush, or split the tablet, as this damages the drug structure and affects absorption). Avoid eating, drinking other liquids (except water), or taking other oral medications within 30 minutes after administration (to prevent food or other drugs from interfering with absorption).

Dosage for Long-term Weight Management

Oral semaglutide therapy for weight loss requires a gradual dose escalation to improve tolerability.

Initial Dose (3mg): Once daily for weeks 1–4; this is an adaptation period for the body, and significant weight loss effects are not typically observed.

First Dose Adjustment (7mg): Once daily starting from week 5; increase to 7mg after tolerating the 3mg dose. If weight loss is suboptimal after at least 4 weeks of 7mg treatment and tolerability is good, further adjustment may be considered.

Second Dose Adjustment (14mg): Once daily starting from week 9; increase to 14mg (the maximum recommended dose for weight loss therapy). If 14mg is not tolerated, revert to 7mg (do not increase the dose further). For maintenance therapy, the 7 mg or 14 mg dose is selected for long-term use based on weight loss efficacy and tolerability; if there is no significant weight loss (e.g., <5% reduction) after 12 weeks at the maximum dose, a physician should evaluate whether to continue treatment.

Dosage and administration for Type 2 Diabetes (blood glucose control)

Oral semaglutide therapy for blood glucose lowering should begin at a low dose and be gradually adjusted to an effective dose to minimize gastrointestinal adverse reactions (such as nausea and diarrhea).

Starting dose: 3 mg once daily for the first 1–4 weeks of treatment to allow the body to adapt to the medication; this dose is not effective for lowering blood glucose and serves only as a transitional step for dose adjustment.

First dose adjustment: 7 mg once daily. Starting from week 5, if the 3 mg dose is tolerated (without severe gastrointestinal reactions), the dose may be increased to 7 mg; 7 mg is the primary effective dose for lowering blood glucose, and most patients achieve glycemic control at this level.

Second dose adjustment: 14 mg once daily. If blood glucose targets are not met (e.g., HbA1c has not dropped to the target value) after taking 7 mg for at least 4 weeks, and the 7 mg dose is tolerated, the dose may be increased to 14 mg (the maximum recommended dose for blood glucose lowering) under a physician's guidance.

Handling missed doses: If a dose is missed, take it as soon as remembered on the same day (maintaining the fasting state and waiting 30 minutes after taking the medication before eating); if it is close to the time for the next day's dose, skip the missed dose and take the medication at the usual time the next day—do not take a double dose.

[Mechanism of Action]

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide 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 metabolism, mediated through the GLP-1 receptor. The primary mechanism extending the half-life of semaglutide is albumin binding, which reduces renal clearance and protects against 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 mechanism for lowering blood glucose also involves a slight delay in gastric emptying during the early postprandial phase.

[Clinical Trials]

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

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

[Adverse Reactions]

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

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

Some individuals may experience drowsiness or dizziness; these symptoms generally subside within about a week.

Gastrointestinal reactions typically peak during the first week, gradually subside over the next 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, among those who respond well to the treatment, those who experience significant nausea in the early stages often see better results. [Contraindications]

Individuals who should not take GLP-1 receptor agonists include:

Those who are pregnant, breastfeeding, or planning a pregnancy

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

Those allergic to Semaglutide

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

Weight-loss medications are generally not recommended for individuals with a past or current history of eating disorders

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