Rybelsus Generic Name & Formulations
Legal Class
Rx
General Description
Semaglutide 3mg, 7mg, 14mg; tablets.
Pharmacological Class
Glucagon-like peptide-1 (GLP-1) receptor agonist.
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Rybelsus Indications
Indications
As adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus (T2DM).
Limitations of Use
Not studied in those with a history of pancreatitis. Not for treating type 1 diabetes.
Rybelsus Dosage and Administration
Adult
Swallow whole. Take at least 30mins before first food, beverage, or other oral medications with max 4oz of plain water only. ≥18yrs: Initially 3mg once daily for 30 days, then increase to 7mg once daily; may increase to 14mg once daily if additional glycemic control needed after ≥30 days on 7mg dose. Taking two 7mg tabs to achieve a 14mg dose: not recommended. Switching between Ozempic and Rybelsus: see full labeling.
Children
<18yrs: not established.
Rybelsus Contraindications
Contraindications
History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.
Rybelsus Boxed Warnings
Boxed Warning
Risk of thyroid C-cell tumors.
Rybelsus Warnings/Precautions
Warnings/Precautions
Risk of thyroid C-cell tumors; inform patients of potential risk and symptoms. History of pancreatitis; consider other antidiabetics. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. History of diabetic retinopathy; monitor for progression. History of anaphylaxis or angioedema with other GLP-1 receptor agonist. Discontinue if hypersensitivity reactions occur. Acute gallbladder disease (eg, cholelithiasis, cholecystitis). Perform gallbladder studies and clinical follow-up if cholelithiasis is suspected. Monitor renal function when initiating or escalating dose. Pregnancy. Females of reproductive potential: discontinue ≥2 months prior to planned pregnancy. Nursing mothers: not recommended.
Rybelsus Pharmacokinetics
Elimination
Renal, fecal. Half-life: ~1 week.
Rybelsus Interactions
Interactions
Increased risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas) or insulin; may need lower dose of these. May affect absorption of concomitant oral drugs (delayed gastric emptying); caution.
Rybelsus Adverse Reactions
Adverse Reactions
Nausea, abdominal pain, diarrhea, decreased appetite, vomiting, constipation; rare: pancreatitis, acute renal injury, hypersensitivity reactions.
Rybelsus Clinical Trials
See Literature
Rybelsus Note
Not Applicable
Rybelsus Patient Counseling
See Literature