Rybelsus

u3000u3000 [English drug name of origin]:

u3000u3000semaglutide

u3000u3000 [Chinese reference product translation name]:

u3000u3000Rybelsus

u3000u3000 [Chinese reference drug translation name]:

u3000u3000 Semaglutide

u3000u3000 [Introduction]:

u3000u3000 Recently, the U.S. Food and Drug Administration approved Rybelsus|semaglutide tablets 7 mg or 14 mg for use in adults with type 2 diabetes and when diet and exercise may improve blood sugar (glucose). Rybelsus is the first and only glucagon-like peptide 1 (GLP-1) analog in a pill and a new option for adults with type 2 diabetes who are not meeting their A1C goals Current antidiabetic treatments.

u3000u3000Type 2 diabetes is a global public health problem, affecting more than 28 million people in the United States alone. Despite existing treatment options, many adults with type 2 diabetes have poor blood sugar control, which may increase their risk of serious diabetes-related complications.

u3000u3000 approval date: September 21, 2019 Company: Novo Nordisk

u3000u3000RYBELSUS (semaglutide) Tablets, Oral

u3000u3000 Initial US Approval: 2017

u3000u3000【Semaglutide Tablets Warning】:

u3000u3000 Risk of Thyroid C-Cell Tumors For complete boxed warnings, see full prescribing information.

u3000u30001. In rodents, semaglutide can cause thyroid C-cell tumors. It is unknown whether RYBELSUS causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the relevance of semaglutide-induced rodent thyroid thyrocytomas to humans has not been established.

u3000u30002. Have a personal family history of MTC or suffer from multiple endocrine hyperplasia syndrome type 2 (MEN 2) RYBELSUS is contraindicated in patients. Counsel patients about the potential risks of MTC and the symptoms of thyroid tumors.

u3000u3000 [Mechanism of action of semaglutide tablets]

u3000u3000Semaglutide is a GLP-1 analog with a sequence homology of 94% to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist, selectively binding to and activating the GLP-1 receptor (the target of natural GLP-1).

u3000u3000GLP-1 is a physiological hormone with multiple effects on glucose mediated by the GLP-1 receptor.

The primary mechanism by which u3000u3000 prolongs the half-life of semaglutide is albumin binding, resulting in reduced renal clearance and prevention of metabolic degradation. In addition, semaglutide is stable against degradation by the DPP-4 enzyme.

u3000u3000Semaglutide lowers blood glucose through mechanisms that stimulate insulin secretion and decrease glucagon secretion, both of which occur in a glucose-dependent manner. Therefore, when blood sugar is high, insulin secretion is stimulated and glucagon secretion is suppressed. The mechanism of hypoglycemia also involves a slight delay in gastric emptying during the early postprandial period.

u3000u3000 [Indications and Usage of Semaglutide Tablets]

u3000u3000RYBELSUS is a glucagon-like peptide 1 (GLP-1) receptor agonist that can be used as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.

u3000u3000【Restrictions on the use of semaglutide tablets】

u3000u3000•For patients with insufficient diet and exercise control, it is not recommended as a first-line treatment.

u3000u3000•Patients with a history of pancreatitis have not yet been studied.

u3000u3000•Not suitable for use in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

u3000u3000【Semaglutide Dosage and Administration】

u3000u3000 • Instruct patients to take rebesauce at least 30 minutes before consuming any food, beverage, or other oral medication for the first time of the day, with no more than 4 ounces of plain water. Waiting less than 30 minutes, or taking it with food, drinks (not pure water), or other oral medications will reduce the effectiveness of RYBELSUS. Waiting longer than 30 minutes to eat may increase the absorption of RYBELSUS.

u3000u3000•Swallow the tablet whole. Do not cut, crush, or chew tablets.

u3000u3000• Start taking RYBELSUS at 3 mg once daily for 30 days. After 30 days of taking the 3 mg dose, increase the dose to 7 mg once daily.

u3000u3000 • If additional glycemic control is required after at least 30 days at the 7 mg dose, the dose may be increased to 14 mg once daily.

u3000u3000•For instructions on switching between OZEMPIC® and RYBELSUS, see Full Prescribing Information.

u3000u3000 [Semaglutide tablets dosage form and strength]

u3000u3000 tablets: 3mg, 7mg and 14mg

u3000u3000【Contraindications of semaglutide tablets】

u3000u3000•Personal or family history of patients with medullary thyroid cancer or multiple endocrine neoplasia type 2.

u3000u3000• Known allergy to semaglutide or any ingredient in RYBELSUS.

u3000u3000【Semaglutide Tablets Warnings and Precautions】

u3000u3000•Pancreatitis: Has been reported in clinical trials. If pancreatitis is suspected, discontinue medication immediately. If pancreatitis is confirmed, do not restart.

u3000u3000• Complications of diabetic retinopathy: semaglutide injection has been reported in a cardiovascular outcomes trial. Patients with a history of diabetic retinopathy should be monitored.

u3000u3000•Hypoglycemia: When using RYBELSUS with an insulin secretagogue or insulin, consider reducing the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.

u3000u3000•Acute kidney injury: Monitor renal function in patients with renal insufficiency who have severe gastrointestinal adverse effects.

u3000u3000•Anaphylaxis: If in doubt, discontinue treatment with Rebaeus and seek medical attention immediately.

u3000u3000 [Adverse reactions of semaglutide tablets]

u3000u3000 In ≥5% of RYBELSUS patients, the most common adverse reactions are: nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

u3000u3000【Semaglutide drug interactions】

u3000u3000 Oral medicine: RYBELSUS delays gastric emptying. When coadministered, instruct patients to strictly follow the dosing instructions for RYBELSUS. Consider adding clinical or laboratory monitoring protocols where the therapeutic range is narrow or where clinical monitoring is required.

u3000u3000[Semaglutide tablets are used in specific populations]

u3000u30001. Pregnancy: May cause fetal harm.

u3000u30002. Lactation period: Breastfeeding is not recommended.

u3000u30003. Females and males of reproductive potential: Due to the long washout period of semaglutide, discontinue RYBELSUS in pregnant women at least 2 months before a planned pregnancy.

u3000u3000 [Semaglutide tablets packaging supply/storage and handling methods]

u3000u3000RYBELSUS tablets are available in the following types:

u3000u3000 tablet strength package configuration NDC

u3000u30003 mg 30 tablets in carton (3x10 count blister packaging) 0169-4303-13

u3000u30007 mg 30 tablets in carton (3 x10 count blister packs) 0169-4307-13

u3000u300014 mg 30 tablets in carton (3 x10 count blister packs) 0169-4314-13

u3000u3000【Semaglutide tablets storage and handling】

u3000u3000 Store at 20 to 25°C (68 to 77°F); The allowed temperature excursion range is 15° to 30°C (59° to 86°F). Stored and distributed in original carton. Store the tablet in the original blister card until used to protect the tablet from moisture. Store product in a dry place away from moisture.