RYBELSUS

Rybelsus Generic Name & Formulations

Legal Class

General Description

Semaglutide 3mg, 7mg, 14mg; tablets.

Pharmacological Class

Glucagon-like peptide-1 (GLP-1) receptor agonist.

How Supplied

Tabs—30

Manufacturer

Novo Nordisk

Generic Availability

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

Metabolism

Proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty acid sidechain. >99% plasma protein bound.

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