Rybelsus Semaglutide Tablets

1. Indications and Usage
Glycemic Control: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Cardiovascular Risk Reduction: To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
2. Dosage and Administration
Administration: Take once daily in the morning, at least 30 minutes before the first food, beverage, or oral medication of the day. Swallow the tablet whole with a glass of water (up to 4 ounces).
Starting Dose:
R1 Formulation: 3 mg once daily for the first 30 days.
R2 Formulation: 1.5 mg once daily for the first 30 days.
Titration:
R1 Formulation: Increase to 7 mg once daily for days 31-60. If further glycemic control is needed, increase to 14 mg once daily thereafter.
R2 Formulation: Increase to 4 mg once daily for days 31-60. If further glycemic control is needed, increase to 9 mg once daily thereafter.
Missed Dose: If a missed dose is more than 3 days (72 hours) ago, skip the missed dose and resume the next scheduled dose.
3. Mechanism of Action
GLP-1 Receptor Agonism: Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.
Glucose-Dependent Effects: It stimulates glucose-dependent insulin secretion and suppresses glucagon secretion.
Gastric Emptying: It delays gastric emptying, which helps reduce postprandial glucose excursions.
4. Safety and Warnings
Thyroid C-Cell Tumors: In rodent studies, semaglutide caused thyroid C-cell tumors. It is unknown whether it causes such tumors in humans. It 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).
Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been reported. Discontinue if suspected.
Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported.
Hepatic Disorders: Hepatocellular injury, including cases of liver failure, has been reported.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Nausea, diarrhea, vomiting, constipation, abdominal pain, and headache.
Hypoglycemia: The risk of hypoglycemia is increased when used in combination with sulfonylureas or insulin.
Diabetic Retinopathy Complications: An increase in the incidence of diabetic retinopathy complications was observed in patients treated with semaglutide, particularly in those with severe retinopathy at baseline.
Acute Renal Failure: Acute renal failure and acute kidney injury, including cases requiring dialysis, have been reported, often in association with gastrointestinal adverse reactions.
6. Drug Interations
Oral Medications: Semaglutide may decrease the rate and extent of oral drug absorption due to delayed gastric emptying. Oral medications should be taken at least 30 minutes before taking Semaglutide.
CYP Enzymes: Semaglutide does not inhibit or induce CYP enzymes and is unlikely to cause interactions with drugs metabolized by these enzymes.
Digoxin: No clinically significant interaction has been observed.
7. Pharmaceutical Information
Active Ingredient: Semaglutide.
Strengths:
R1 Formulation: 3 mg, 7 mg, and 14 mg tablets.
R2 Formulation: 1.5 mg, 4 mg, and 9 mg tablets.
Appearance: White to pale yellow oval film-coated tablets.
Storage: Store in the original blister packaging to protect from light and moisture. Do not store above 30°C.