Indications for RYBELSUS:
As adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus (T2DM).
Limitations of Use:
Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Not studied with a history of pancreatitis. Not for treating type 1 diabetes or diabetic ketoacidosis.
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.
<18yrs: not established.
History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.
Risk of thyroid C-cell tumors.
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. Monitor renal function when initiating or escalating dose. History of anaphylaxis or angioedema with other GLP-1 receptor agonist. Discontinue if hypersensitivity reactions occur. Pregnancy. Females of reproductive potential: discontinue ≥2 months prior to planned pregnancy. Nursing mothers: not recommended.
Glucagon-like peptide-1 (GLP-1) receptor agonist.
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.
Nausea, abdominal pain, diarrhea, decreased appetite, vomiting, constipation; rare: pancreatitis, hypersensitivity reactions.