From the Guidelines
Rybelsus (oral semaglutide) is recommended for adults with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control, with a standard dosing regimen starting at 3 mg once daily for 30 days, then increasing to 7 mg once daily, and potentially further increasing to 14 mg once daily if needed, as supported by recent guidelines and studies 1.
Key Considerations
- The medication should be taken on an empty stomach when first waking up, with no more than 4 ounces of plain water, and patients should wait at least 30 minutes before consuming food, beverages, or other oral medications, due to the significant reduction in absorption of semaglutide caused by food 1.
- Rybelsus works by mimicking the incretin hormone GLP-1, which stimulates insulin secretion, suppresses glucagon release, and slows gastric emptying, all of which help lower blood glucose levels 1.
- Common side effects include nausea, abdominal pain, diarrhea, and decreased appetite, and patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 should not use this medication, with cautious use recommended in patients with a history of pancreatitis 1.
Evidence-Based Recommendations
- The most recent guidelines and studies, such as those published in Diabetes Care 1 and the Journal of the American College of Cardiology 1, support the use of Rybelsus for improving glycemic control and reducing cardiovascular risk in adults with type 2 diabetes.
- The dosing regimen and administration instructions are based on the highest quality evidence available, including the results of the PIONEER 6 trial, which demonstrated the noninferiority of oral semaglutide compared to placebo for the primary composite outcome of cardiovascular death, nonfatal MI, or nonfatal stroke 1.
From the FDA Drug Label
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. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Semaglutide lowers fasting and postprandial blood glucose and reduces body weight.
The recommended use and dosage of Rybelsus (semaglutide) for patients with type 2 diabetes is once-weekly subcutaneous administration of 0.5 mg or 1 mg.
- The starting dose is 0.5 mg once weekly for 4 weeks, which can be increased to 1 mg once weekly if needed and if the patient tolerates the 0.5 mg dose.
- Steady-state exposure is achieved following 4-5 weeks of once-weekly administration.
- Dose adjustment is not required when co-administered with other oral medications, as no clinically relevant drug-drug interaction with semaglutide was observed. 2
From the Research
Recommended Use of Rybelsus (Semaglutide)
- Rybelsus (semaglutide) is approved for use in conjunction with lifestyle modifications to treat individuals with type 2 diabetes 3.
- It is indicated for use as an add-on combination therapy or as a monotherapy for type 2 diabetes when diet and exercise do not provide adequate glycemic control 4.
- Rybelsus can be used in patients who are intolerant to metformin as a monotherapy 4.
Dosage of Rybelsus (Semaglutide)
- The recommended dosage of Rybelsus is not explicitly stated in the provided studies, but it is mentioned that it is available in 3,7, and 14 mg formulations 5.
- Rybelsus is administered orally, once daily 3, 4.
Safety and Efficacy
- Rybelsus has been shown to be effective in achieving glycemic control, reducing body weight, and decreasing systolic blood pressure 4.
- It has a safety profile consistent with the GLP-1RA drug class, with a low risk of hypoglycemia and common adverse events being gastrointestinal, such as nausea and diarrhea 4.
- Cardiovascular safety has been established, with observations suggesting that the CV profile of oral semaglutide is likely to be similar to that of subcutaneous semaglutide 4.