Japan MSD Rybelsus Semaglutide Oral Semaglutide Somaglutide Rybelsus Tablets 3mg, 7mg, 14mg: 100 tablets Type 2 Diabetes Highly Effective Antidiabetic Drug Stabilizes Blood Sugar Levels Promotes Insulin Secretion

Conditions for Approval: A drug risk management plan must be developed and properly implemented.

Handling Precautions: This product is highly hygroscopic and light-sensitive; it must be stored in PTP blister packs.

This product is a human GLP-1 analog that selectively binds to the GLP-1 receptor targeted by endogenous GLP-1, increasing cAMP release, and acts as a GLP-1 receptor agonist.

It binds to albumin, thereby delaying metabolic breakdown and reducing renal clearance; amino acid substitutions make it resistant to degradation by DPP-4, resulting in prolonged action. Pharmacologically, it promotes insulin secretion in a glucose-dependent manner, inhibits glucagon, lowers blood glucose levels, and delays early postprandial gastric emptying.

Oval tablet. White to pale yellow. Long axis 13.5 mm, short axis 7.5 mm, thickness 6 mm.

Sizes: 3 mg, 7 mg, 14 mg
Identification Code: 3 novo, 7 novo, 14 novo
Weight: 400.7 mg, 404.7 mg, 411.7 mg

3.1 Composition　Each tablet contains semaglutide (recombinant): 3, 7, or 14 mg.

Excipients (same for all strengths): sodium sulcaprozate, polyvinylpyrrolidone, microcrystalline cellulose, magnesium stearate.

This product is made from budding yeast.

19. Molecular formula C₁₈₇H₂₉₁N₄₅O₅₉　Molecular weight 4113.58. A modified peptide consisting of 31 amino acid residues (corresponding to positions 7–37 of human GLP-1; Ala at position 2 and Lys at position 28 are replaced by 2-amino-2-methylpropionic acid and Arg, respectively; 1,18-octadecanedioic acid is linked to Lys at position 20 via Glu and two 8-amino-3,6-dioxooctanoic acid residues).

4. Type 2 Diabetes

5. This treatment should be considered only when adequate results have not been achieved after thoroughly implementing the basic dietary and exercise therapies for diabetes.

For adults, the maintenance dose of semaglutide (recombinant) is typically 7 mg administered orally once daily. However, treatment should begin with a dose of 3 mg once daily, and after at least 4 weeks of administration, the dose should be increased to 7 mg once daily. The dose may be adjusted as appropriate based on the patient’s condition; if the effect of 7 mg once daily is still insufficient after at least 4 weeks of treatment, the dose may be increased to 14 mg once daily.

1. 7.1 Absorption may be reduced by stomach contents. Take one 3 mg, 7 mg, or 14 mg tablet with approximately half a cup of water (less than 120 mL) on an empty stomach, before your first meal or drink of the day. Avoid food, drink, and other oral medications for at least 30 minutes before and after taking this medication. Do not split, crush, or chew the tablet.
2. 7.2 When a 14 mg dose is prescribed, it must not be substituted with two 7 mg tablets.
3. 7.3 If you forget to take a dose on a given day, do not take a double dose; just take it the next day.

21. A drug risk management plan must be developed and implemented.

22. 3 mg/7 mg/14 mg, 100 tablets each [10 tablets (PTP) × 10]

24. Novo Nordisk Pharma Co., Ltd. Customer Service Center TEL 0120-180363
MSD Co., Ltd. MSD Customer Support Center TEL 0120-024961

26. Manufacturer and Distributor: Novo Nordisk Pharma Co., Ltd. / Marketing Partner: MSD Co., Ltd.
Liberサス® and Rybelsus® are registered trademarks of Novo Nordisk A/S.