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Rybelsus®: New Oral Treatment for Type 2 Diabetes

Posted by Amanda Dexter on February 21, 2020 at 11:57 AM
Amanda Dexter
Dr. Amanda K. Dexter received her optometric training at Southern California College of Optometry in Fullerton, California, where she was Class of 2010 Valedictorian. She also completed a residency in Primary Care and Ocular Disease at the Veteran's Affairs Hospital in San Diego, California. Dr. Dexter is the Manager and Program Coordinator for OptoPrep, the premiere online study resource for the NBEO Part I & II.

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The U.S. Food and Drug Administration (FDA) recently approved a new oral medication for blood glucose management in adult patients with type 2 diabetes. Manufactured by Novo Nordisk, Rybelsus® (semaglutide) is the first drug in a class of medications known as GLP-1 (glucagon-like peptide) inhibitors that do not need to be injected.

This is very exciting news in that many patients with type 2 diabetes are not able to be adequately managed with oral medications alone, and often need to add injectables into their treatment regimen. Rybelsus® gives patients a new option for treating their diabetes without potentially needing to go down that path. Below we will outline the important factors you should know about this new medication.

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GLP-1 Receptor Agonist Mechanism of Action

  • Action is based on incretins, which are gut hormones that work to increase insulin secretion following ingestion of food
  • Incretin hormones work in several ways; they increase satiety, slow stomach emptying, increase insulin release from the pancreas, and decrease glucagon release

Indications and Usage

  • Rybelsus® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 
  • It is not recommended as first-line therapy for patients inadequately controlled with diet and exercise 
  • It is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of ketoacidosis; it has also not been studied in patients with a history of pancreatitis 

Dosage and Administration

  • Rybelsus® should be taken at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only 
  • Rybelsus® is typically initiated with a dosage of 3 mg once daily for 30 days; after 30 days the dose can be increased to 7 mg once daily 
  • Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose 
  • Prior to Rybelsus®, GLP-1 agonists were only available as an injection that was taken either twice daily, or once weekly depending on the drug 

Contraindications

  • Patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2
  • Known hypersensitivity to semaglutide or any components in Rybelsus®

Warnings and Precautions

  • Pancreatitis: was reported in clinical trials; patients should discontinue immediately if pancreatitis is suspected and it should not be restarted if confirmed
  • Diabetic retinopathy complications: was reported in trials with semaglutide injections; patients with history of diabetic retinopathy should be monitored
  • Hypoglycemia: if used with an insulin secretagogue or insulin, the dosage of the insulin or secretagogue may need to be lowered to reduce the risk of hypoglycemia
  • Acute kidney injury: patients with renal impairment should have renal function monitored if reporting severe adverse gastrointestinal reactions
  • Hypersensitivity reactions: Rybelsus® should be discontinued if hypersensitivity is suspected 
  • The most common adverse reactions of Rybelsus® include: nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation 

Black Box Warning

  • Risk of thyroid c-cell tumors 
    • In rodents, semaglutide causes thyroid c-cell tumors; it is unknown whether Rybelsus® causes c-cell tumors, including medullary thyroid carcinoma (MTC)
    • Patients should be counseled regarding the potential risk of MTC and the symptoms of thyroid tumors

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Topics: Oral Medications, Rybelsus

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