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Author: Admin | 2025-04-28
Is recommended for patients with hepatic impairment. Overdose Information for RybelsusIn the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of RYBELSUS of approximately 1 week.Contraindications for RybelsusRYBELSUS 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) [see WARNINGS AND PRECAUTIONS]. A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in RYBELSUS. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with RYBELSUS [see WARNINGS AND PRECAUTIONS]. Clinical Pharmacology for RybelsusMechanism Of ActionSemaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme.Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.PharmacodynamicsAll pharmacodynamic evaluations were performed after 12 weeks of treatment (including dose escalation) at steady state semaglutide injection 1 mg.Fasting And Postprandial GlucoseSemaglutide reduces fasting and postprandial glucose concentrations. In patients with type 2 diabetes, treatment with semaglutide injection 1 mg resulted in reductions in glucose in terms of absolute change from baseline and relative reduction compared to placebo of 29 mg/dL (22%) for fasting glucose, 74 mg/dL (36%) for 2 hour postprandial glucose, and 30 mg/dL (22%) for mean 24 hour glucose concentration.Insulin SecretionBoth first- and second-phase insulin secretion are increased in patients with type 2 diabetes treated with semaglutide compared with placebo.Glucagon SecretionSemaglutide lowers the fasting and postprandial glucagon concentrations.Glucose Dependent Insulin And Glucagon SecretionSemaglutide lowers high blood glucose concentrations by stimulating insulin secretion and lowering glucagon secretion in a glucose-dependent manner.During induced hypoglycemia, semaglutide did not alter the counter regulatory responses of increased glucagon compared to placebo and did not impair the decrease of C-peptide in patients with type 2 diabetes.Gastric EmptyingSemaglutide causes a delay of early postprandial gastric emptying, thereby reducing the rate at which glucose appears in the circulation postprandially.Cardiac Electrophysiology (QTc)The effect of subcutaneously administered
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