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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
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Product Name: Rybelsus® 7 mg Tablets
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Japanese Name: リベルサス錠7mg
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Active Ingredient: Semaglutide (genetically recombined)
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Manufacturer: Novo Nordisk Pharma Ltd., Tokyo, Japan
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Packaging: 100 tablets per box
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Dosage Form: Oral tablet
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Tablet Appearance: White to light yellow, oval-shaped
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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
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Initial Dose: 3 mg once daily for the first 4 weeks
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Maintenance Dose: Increase to 7 mg once daily after 4 weeks
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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
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Administration Instructions:
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Take once daily on an empty stomach with no more than 120 mL (approximately half a glass) of water
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Do not eat, drink, or take other oral medications for at least 30 minutes after taking Rybelsus®
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Swallow tablets whole; do not split, crush, or chew
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Storage
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Storage Conditions: Store in a sealed container, away from moisture and high temperatures, and out of reach of children
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Handling Instructions: Due to its hygroscopic nature, remove tablets from the packaging immediately before use and avoid handling with wet hands
Contraindications
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Patients with a personal or family history of medullary thyroid carcinoma (MTC)
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Patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
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Patients with type 1 diabetes mellitus
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Patients with a history of pancreatitis
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Patients with severe gastrointestinal disorders such as gastroparesis
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Pregnant or breastfeeding women
Precautions
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Hypoglycemia: Increased risk when used with insulin or insulin secretagogues
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Renal Impairment: Monitor renal function in patients experiencing dehydration due to gastrointestinal side effects
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Pancreatitis: Discontinue use if pancreatitis is suspected
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Thyroid Tumors: Monitor for symptoms of thyroid tumors, such as a neck mass, dysphagia, dyspnea, or persistent hoarseness
Adverse Reactions
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Common Adverse Reactions:
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Nausea, vomiting, diarrhea, abdominal pain, decreased appetite
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Serious Adverse Reactions:
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Pancreatitis, acute kidney injury, hypersensitivity reactions, thyroid C-cell tumors
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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.
