Rybelsus Available Strengths
Rybelsus (oral semaglutide) is available in three tablet strengths: 3 mg, 7 mg, and 14 mg, designed for gradual dose escalation to optimize glycemic control while minimizing gastrointestinal side effects. 1, 2
Approved Dosage Forms
The oral formulation of semaglutide is co-formulated with an absorption enhancer (SNAC) that facilitates gastric absorption, distinguishing it from the injectable forms (Ozempic and Wegovy). 1, 2
Available Tablet Strengths:
- 3 mg tablets - Initial starting dose 1, 2
- 7 mg tablets - Intermediate maintenance dose 1, 2
- 14 mg tablets - Maximum maintenance dose 1, 2
Dosing Algorithm
The recommended titration schedule begins with 3 mg once daily for 30 days, then escalates to 7 mg once daily, with optional further increase to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose. 1, 2
Titration Schedule:
- Start: 3 mg once daily for 30 days (treatment initiation dose) 1, 2
- Escalate: 7 mg once daily after 30 days (first maintenance dose) 1, 2
- Maximum: 14 mg once daily if needed after at least 30 days on 7 mg (maximum maintenance dose) 1, 2
Critical Administration Requirements
Rybelsus must be taken on an empty stomach with no more than 4 ounces of plain water, at least 30 minutes before any food, beverage, or other oral medications to ensure adequate absorption. 2, 3
Administration Pitfalls to Avoid:
- Taking with food or beverages other than plain water significantly reduces absorption 2, 3
- Taking with other oral medications within 30 minutes impairs bioavailability 2, 3
- Using more than 4 ounces of water decreases drug absorption 2, 3
Comparison with Injectable Semaglutide
Unlike the injectable formulations (Ozempic: 0.25 mg, 0.5 mg, 1 mg; Wegovy: 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg), oral semaglutide requires daily administration and has different dosing strengths due to lower bioavailability from oral absorption. 4, 1
Clinical Context
Oral semaglutide demonstrated glycemic efficacy across the PIONEER trial program (9,543 patients), showing superiority to common oral glucose-lowering therapies with clinically relevant weight reduction, though it lacks the robust cardiovascular outcome data seen with injectable semaglutide. 1, 3
The PIONEER 6 trial demonstrated cardiovascular safety (non-inferiority to placebo) and suggested mortality benefits, though this differs from the proven cardiovascular risk reduction seen with injectable semaglutide in SUSTAIN-6. 3, 5