Rybelsus 7 mg 10 tablets

Trade Name:

Rybelsus 7 mg

10 tablets

Composition:

Each 1 tablet contains:

Semaglutide 7 mg

Inactive ingredients:

Sodium salcaprozate, povidone K90, microcrystalline cellulose, magnesium stearate, human glucagon-like peptide-1 analog (GLP-1), produced by recombinant DNA biotechnology using a strain

Properties:

Pharmacotherapeutic group

hypoglycemic agent – an analogue of glucagon-like peptide-1.

Semaglutide reduces blood glucose concentrations through glucose-dependent stimulation of insulin secretion and suppression of glucagon secretion at high blood glucose concentrations. The mechanism for lowering blood glucose concentrations is also associated with a slight delay in gastric emptying in the early postprandial phase. During hypoglycemia, semaglutide reduces insulin secretion and does not interfere with glucagon secretion. The mechanism of action of semaglutide does not depend on the route of administration.

Semaglutide reduces body weight and adipose tissue mass by reducing energy intake, including a general decrease in appetite. In addition, semaglutide reduces the preference for high-fat meals.

Indications:

• for use in adult patients with poor control of T2DM in addition to diet and exercise to improve glycemic control:
• as monotherapy, when the use of metformin is not possible due to intolerance or contraindications;
• in combination with other hypoglycemic drugs.

Dosage and administration:

Rybelsus® is a tablet for oral administration.

• The drug should be taken on an empty stomach at any time of the day.
• The tablet must be swallowed whole with water.
• Patients should wait at least 30 minutes before eating or drinking or taking other oral medications. Failure to comply with this condition will lead to a decrease in the absorption of semaglutide.
• The initial dose of Rybelsus® is 3 mg once a day for one month. After 1 month of use, the dose should be increased to 7 mg once a day. To further improve glycemic control after at least 1 month of use at a dose of 7 mg once a day, the dose can be increased to a maintenance dose of 14 mg once a day.
• The maximum recommended dose of Rybelsus® once daily is 14 mg. Taking two 7 mg tablets to achieve the effect of a 14 mg dosage has not been studied and is therefore not recommended.
• Dose adjustment of Rybelsus® does not require self-monitoring of blood glucose levels. Self-monitoring of blood glucose concentration is necessary to adjust the dose of sulfonylurea and insulin, especially at the beginning of treatment with semaglutide and when reducing the dose of insulin. A stepwise approach to reducing the insulin dose is recommended.
• In case of missing a dose of the drug, the missed dose does not need to be taken additionally, you should continue taking the drug as usual the next day.

Side effects:

-Rare:

anaphylactic reactions, acute pancreatitis, increased lipase activity.increased amylase activity

-Uncommon:

increased heart rate (HR), vomiting, abdominal pain, bloating, constipation, cholelithiasis, belching, dyspepsia, gastritis, weight loss

-Common:

loss of appetite, complications of diabetic retinopathy, gastroesophageal reflux disease, flatulence, fatigue,

-Very common:

nausea, diarrhea, hypoglycemia when used together with insulin or sulfonylurea derivatives, hypoglycemia

Contraindications:

– Hypersensitivity to semaglutide or to any of the excipients of the drug;

– type 1 diabetes mellitus (DM1);

– diabetic ketoacidosis;

– history of medullary thyroid cancer, including family history;

– multiple endocrine neoplasia (MEN) type 2;

– pregnancy and breastfeeding period;

– age up to 18 years;

– severe liver failure;

– end-stage renal failure (creatinine clearance (CC) < 15 ml / min);

– chronic heart failure IV functional class

– history of pancreatitis

Warnings and Precautions:

• When using rGLP-1 agonists, cases of acute pancreatitis were observed. Patients should be informed about the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, semaglutide therapy should be discontinued. If acute pancreatitis is confirmed, semaglutide therapy should not be restarted. Caution should be exercised in patients with a history of pancreatitis.
• Patients on therapy with semaglutide in combination with sulfonylurea derivatives or insulin may have an increased risk of developing hypoglycemia
• Women of childbearing potential are advised to use contraception during therapy with semaglutide.
• Pregnancy:

Data on the use of semaglutide in pregnant women are limited. In this regard, the use of semaglutide during pregnancy is contraindicated. If the patient is preparing for pregnancy, or pregnancy has already occurred, semaglutide therapy should be discontinued.Treatment with semaglutide should be discontinued at least 2 months before planned pregnancy due to the long half-life

• Semaglutide does not affect or slightly affects the ability to drive vehicles or work with mechanisms. When using semaglutide in combination with sulfonylurea derivatives and / or insulin, patients should be warned that they should take precautions to avoid developing hypoglycemia while driving and operating machinery.

Storage:

Store at a temperature not exceeding 25°C

Package:

The carton box contains 1 strip of 10 tablets, and paper instructions.