Rybelsus 14 mg 10 tablets

Rebelsus 14 mg 10 tablets

Composition:
Each tablet contains:
Semaglutide 14 mg.
Excipients:
Sodium salcaprozate, povidone K90, microcrystalline cellulose, magnesium stearate, human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA biotechnology using a genetically modified strain.
Properties:
Pharmacotherapeutic group:
Hypoglycemic agent – GLP-1 receptor analogue.
Semaglutide lowers blood glucose concentrations through glucose-dependent stimulation of insulin secretion and inhibition of glucagon secretion at high blood glucose levels.
The mechanism of glucose reduction is also associated with a slight delay in gastric emptying during the early postprandial phase.
During hypoglycemia, semaglutide reduces insulin secretion and does not inhibit glucagon secretion. The mechanism of action of semaglutide is independent of the route of administration.
Semaglutide reduces body weight and fat mass by lowering energy intake, including a general reduction in appetite. In addition, semaglutide decreases preference for high-fat foods.
Indications for use:
For use in adult patients with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and physical activity to improve glycemic control:
- As monotherapy, when metformin use is inappropriate due to intolerance or contraindications;
- In combination therapy with other hypoglycemic medicinal products.
Method of administration and dosage:
Rebelsus is administered orally in tablet form.
The medication 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 any other oral medicinal products. Failure to comply with this recommendation may reduce semaglutide absorption.
The initial dose of Rebelsus is 3 mg once daily for one month.
After one month, the dose should be increased to 7 mg once daily.
For further glycemic control, the dose may be increased to the maintenance dose of 14 mg once daily, after at least one month of treatment at 7 mg.
The maximum recommended daily dose of Rebelsus is 14 mg once daily.
Taking two 7 mg tablets to achieve a 14 mg dose has not been studied and is therefore not recommended.
Self-monitoring of blood glucose is not required for adjusting the dose of Rebelsus.
Blood glucose self-monitoring may be necessary to adjust the dose of sulfonylureas or insulin, especially at the start of semaglutide treatment and when reducing the insulin dose.
A gradual approach to insulin dose reduction is recommended.
If a dose is missed, the patient should not take an extra dose, but should continue with the next scheduled dose the following day.
Adverse reactions:
Rare:
Anaphylactic reactions, acute pancreatitis, increased lipase activity, increased amylase activity.
Uncommon:
Increased heart rate, vomiting, abdominal pain, abdominal bloating, constipation, cholelithiasis, belching, dyspepsia, gastritis, weight loss.
Common:
Decreased appetite, complications of diabetic retinopathy, gastroesophageal reflux disease, flatulence, fatigue.
Very common:
Nausea, diarrhea, hypoglycemia (when used in combination with insulin or sulfonylureas), hypoglycemia with other GLP-1 receptor agonists.
Contraindications:
Hypersensitivity to semaglutide or any excipients
Type 1 diabetes mellitus (T1DM)
Diabetic ketoacidosis
Personal or family history of medullary thyroid carcinoma (MTC)
Multiple endocrine neoplasia syndrome type 2 (MEN 2)
Pregnancy and breastfeeding
Age under 18 years
Severe hepatic impairment
End-stage renal disease (creatinine clearance < 15 ml/min)
Chronic heart failure, class IV (NYHA classification)
History of pancreatitis.
Warnings and precautions:
Cases of acute pancreatitis have been reported with the use of GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, treatment with semaglutide must be discontinued. If pancreatitis is confirmed, treatment must not be resumed. Use with caution in patients with a history of pancreatitis.
Patients treated with semaglutide in combination with sulfonylureas or insulin may be at an increased risk of hypoglycemia.
Women of childbearing potential should use effective contraception during treatment with semaglutide.
Pregnancy:
There are limited data on the use of semaglutide in pregnant women.
Therefore, the use of semaglutide is contraindicated during pregnancy. If a patient is planning a pregnancy or becomes pregnant, semaglutide therapy must be discontinued.
Treatment with semaglutide should be stopped at least 2 months prior to a planned pregnancy, due to its long half-life.
Effect on ability to drive and use machines:
Semaglutide has no or negligible influence on the ability to drive and use machines.
However, patients using semaglutide in combination with sulfonylureas and/or insulin should be advised to take precautions to avoid hypoglycemia while driving or operating machinery.
Storage conditions:
Store at temperatures up to 25°C (77°F).
Packaging:
Carton box containing 1 blister of 10 tablets and a paper leaflet (package insert).