What is the difference between Rybelsus (Semaglutide) formulations?

From the Guidelines

Rybelsus (semaglutide) is available in two formulations: an oral formulation and a subcutaneous formulation, with the oral formulation being taken once daily and the subcutaneous formulation being administered once weekly 1. The main difference between the two formulations is the route of administration and the dosing frequency. The oral formulation is taken at least 30 minutes before the first food or drink of the day, with a gradual dose escalation over 4 weeks to minimize gastrointestinal side effects, starting at 3mg and increasing to a maximum dose of 14mg once daily 1. In contrast, the subcutaneous formulation is initiated at a dose of 0.25 mg per week and titrated up to a maximum dose of 1.0 mg per week 1.

Key Considerations

• The choice between the oral and subcutaneous formulations should be based on individual patient needs and medical history, under the guidance of a qualified healthcare professional.
• Both formulations have been shown to be effective in improving glycemic control and reducing the risk of major adverse cardiovascular events in patients with type 2 diabetes 1.
• The oral formulation may be more convenient for some patients, while the subcutaneous formulation may be more suitable for patients who have difficulty swallowing or have gastrointestinal issues.
• It is essential to consult the prescribing information and the healthcare provider for specific guidance on the use of Rybelsus, as the dosing and administration may vary depending on the individual patient's needs and medical history 1.

Important Factors to Consider

• Dosing and Administration: The oral formulation is taken once daily, while the subcutaneous formulation is administered once weekly.
• Gastrointestinal Side Effects: Both formulations can cause gastrointestinal side effects, such as nausea, vomiting, and diarrhea, which can be minimized with gradual dose escalation and proper administration.
• Cardiovascular Benefits: Both formulations have been shown to reduce the risk of major adverse cardiovascular events in patients with type 2 diabetes.
• Patient Preferences: The choice between the oral and subcutaneous formulations should be based on individual patient needs and preferences, under the guidance of a qualified healthcare professional.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Rybelsus (Semaglutide) Formulations

The difference between Rybelsus (Semaglutide) formulations lies in their dosage and administration.

• Rybelsus is available in three doses: 3,7, and 14 mg 2, 3
• It is a co-formulation of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, with an absorption enhancer, sodium N-(8-[2-hydroxybenzoyl]amino) caprylate (SNAC) 2, 4, 3
• The absorption enhancer facilitates the absorption of semaglutide across the gastric epithelium in a concentration-dependent manner 2

Administration and Dosage

• Rybelsus is administered orally, once daily 5, 2, 4, 3, 6
• The dosage can be gradually increased, with the goal of achieving optimal glycemic control 2
• The medication 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

Clinical Trials and Efficacy

• The safety and efficacy of oral semaglutide were assessed in the PIONEER clinical trial programme, which included 9543 patients with type 2 diabetes 2
• Oral semaglutide provides more effective glycaemic control than common oral glucose-lowering therapies, associated with a clinically relevant reduction in body weight 2
• The medication has been shown to be well tolerated, with a safety profile consistent with the GLP-1RA drug class 4, 6