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Rybelsus semaglutide semaglutide tablets 7mg 100 tablets Japanese version

Rybelsus semaglutide semaglutide tablets 7mg 100 tablets Japanese version

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Rybelsus® (Semaglutide) 7 mg Tablets – Japanese Version

 


 

 

Product Overview

 

 

  • Product Name: Rybelsus® 7 mg Tablets

  • Japanese Name: リベルサス錠7mg

  • Active Ingredient: Semaglutide (genetically recombined)

  • Manufacturer: Novo Nordisk Pharma Ltd., Tokyo, Japan

  • Packaging: 100 tablets per box

  • Dosage Form: Oral tablet

  • Tablet Appearance: White to light yellow, oval-shaped

  • Approval in Japan: Approved by the Japanese Ministry of Health, Labour and Welfare on June 29, 2020, for the treatment of type 2 diabetes mellitus 

 

 


 

 

Indications

 


Rybelsus® is indicated for the improvement of glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise.

 


 

 

Mechanism of Action

 


Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that enhances glucose-dependent insulin secretion, suppresses inappropriate glucagon secretion, and slows gastric emptying. These actions contribute to improved glycemic control.

 


 

 

Dosage and Administration

 

 

  • Initial Dose: 3 mg once daily for the first 4 weeks

  • Maintenance Dose: Increase to 7 mg once daily after 4 weeks

  • Further Adjustment: If additional glycemic control is needed, the dose may be increased to 14 mg once daily after at least 4 weeks on the 7 mg dose

  • Administration Instructions:

     

    • Take once daily on an empty stomach with no more than 120 mL (approximately half a glass) of water

    • Do not eat, drink, or take other oral medications for at least 30 minutes after taking Rybelsus®

    • Swallow tablets whole; do not split, crush, or chew

     

 

 


 

 

Storage

 

 

  • Storage Conditions: Store in a sealed container, away from moisture and high temperatures, and out of reach of children

  • Handling Instructions: Due to its hygroscopic nature, remove tablets from the packaging immediately before use and avoid handling with wet hands 

 

 


 

 

Contraindications

 

 

  • Patients with a personal or family history of medullary thyroid carcinoma (MTC)

  • Patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

  • Patients with type 1 diabetes mellitus

  • Patients with a history of pancreatitis

  • Patients with severe gastrointestinal disorders such as gastroparesis

  • Pregnant or breastfeeding women

 

 


 

 

Precautions

 

 

  • Hypoglycemia: Increased risk when used with insulin or insulin secretagogues

  • Renal Impairment: Monitor renal function in patients experiencing dehydration due to gastrointestinal side effects

  • Pancreatitis: Discontinue use if pancreatitis is suspected

  • Thyroid Tumors: Monitor for symptoms of thyroid tumors, such as a neck mass, dysphagia, dyspnea, or persistent hoarseness

 

 


 

 

Adverse Reactions

 

 

  • Common Adverse Reactions:

     

    • Nausea, vomiting, diarrhea, abdominal pain, decreased appetite

     

  • Serious Adverse Reactions:

     

    • Pancreatitis, acute kidney injury, hypersensitivity reactions, thyroid C-cell tumors

     

 

 


 

 

Clinical Studies

 


Clinical trials have demonstrated that Rybelsus® significantly reduces HbA1c levels and body weight in patients with type 2 diabetes mellitus. Additionally, semaglutide has been shown to reduce the risk of major adverse cardiovascular events .

 


 

 

Additional Information

 


Rybelsus® is the first and only oral GLP-1 receptor agonist approved for the treatment of type 2 diabetes mellitus. Its oral administration offers an alternative to injectable GLP-1 receptor agonists, potentially improving patient adherence and convenience.

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