Rybelsus® is the first FDA-approved oral medication in the class of glucagon-like peptide-1 (GLP-1) receptor agonists, primarily indicated for managing type 2 diabetes.
An additional effect observed with GLP-1 medications is weight loss, which may benefit some patients when prescribed appropriately.
This article will tell you what you need to know about Rybelsus and its effects on type 2 diabetes and weight.
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What is Rybelsus?
Rybelsus belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. The generic name for Rybelsus is semaglutide.
If this sounds familiar, it's because semaglutide is also marketed under the brand names Ozempic® and Wegovy®. Rybelsus is unique because it is the only GLP-1 approved by the Food and Drug Administration (FDA) for oral use.
Understanding GLP-1 and Rybelsus' Mechanism
GLP-1 receptor agonists stimulate insulin secretion through a pathway known as the incretin effect in response to oral glucose.
GLP-1 receptor agonists act on the GLP-1 receptor, activating it and leading to a decrease in glucagon production and increased insulin production. In addition, they decrease appetite and slow gastric emptying, which promotes weight loss.
GLP-1 medications also show potential benefits for other diseases, such as cardiovascular disease.
Traditionally, GLP-1 medications have been injectable due to their poor oral absorption. Rybelsus is the first oral GLP-1 medication specifically formulated to be absorbed through the GI tract.
Rybelsus is unique among oral medications because its absorption occurs in the stomach rather than in the intestines, like most oral medications.
FDA Approval and Usage Guidelines
In 2019, the FDA approved Rybelsus as a treatment for type 2 diabetes to be used in conjunction with diet and exercise.
In 2023, the FDA label was updated to make Rybelsus a first-line medication, which is approved for people not treated with other diabetic medications.
The drug has also been approved for cardiovascular risk reduction for adults with type 2 diabetes. It has also been shown to reduce the severity of metabolic dysfunction-associated steatotic liver disease (MASLD).
Benefits of Rybelsus for Diabetes and Weight Loss
Rybelsus and other GLP-1 medications are approved to treat type 2 diabetes but may also help with weight loss. While Rybelsus is not specifically approved for weight loss, it does have weight loss as a known side effect.
Blood Sugar Control
In studies, Rybelsus resulted in a decrease in hemoglobin A1c of 1.2 to 3.8%, depending on the dose used. Fasting blood sugars dropped an average of 21-36 points.
Rybelsus can help maintain the stability of blood sugars over time, leading to improved A1c.
Weight Loss Support
Rybelsus is not FDA-approved for weight loss but can positively affect weight. It is associated with weight loss of up to 10 lbs over 26 weeks.
Cardiovascular Benefits
Rybelsus and other GLP-1 medications have also been shown to have benefits for cardiovascular disease.
Studies showed a 14% decrease in cardiovascular events in patients with type 2 diabetes on Rybelsus.
How to Take Rybelsus Correctly
Like any medication, Rybelsus has specific instructions for proper usage.
Dosage and Administration
Rybelsus comes in 3 mg, 7 mg, and 14 mg doses. It should be taken with 4 ounces of water (or less) on an empty stomach at least 30 minutes before eating, drinking, or taking other medication. Rybelsus should be swallowed whole and not crushed or split.
Guidelines for Missed Doses
If you miss a dose of Rybelsus, you should skip the dose and go back to your regular schedule unless instructed otherwise by your healthcare provider.
Monitoring and Adjusting Dosage
It is generally started at 3mg and then increased to 7 mg after a month if tolerated well. If needed, the dose can be increased to 14 mg to achieve goal A1c.
You should not change your dose of Rybelsus unless instructed to by your healthcare provider.
Comparing Rybelsus to Other Type 2 Diabetes Medications
Rybelsus is the only oral GLP-1 medication available for type 2 diabetes, but how does it compare to other medicines?
Rybelsus vs. Injectable GLP-1 Agonists
Rybelsus and the other GLP-1 medications (e.g., Ozempic) are all indicated for type 2 diabetes.
However, some of the other GLP-1 medications also carry an indication for weight loss. Wegovy (semaglutide), Saxenda (liraglutide), and Zepbound (tirzepatide) are all FDA-approved for obesity.
For patients interested in switching between Rybelsus or Ozempic, patients on 14mg of Rybelsus can be transitioned to 0.5mg of Ozempic or vice versa. If the dose of Ozempic is 1 mg or greater, it may not be possible to make that transition.
Rybelsus vs. SGLT2 Inhibitors and DPP-4 Inhibitors
A head-to-head study of Rybelsus vs. other medications showed no significant difference between semaglutide and liraglutide or empagliflozin for cardiovascular events. However, semaglutide did show a reduced risk for cardiovascular disease over sitagliptin.
Cost Comparison and Insurance Coverage
Costs and insurance coverage for Rybelsus can vary, as can the cost of Rybelsus compared to other medications used for diabetes. The best way to know how much the medication may cost is to check with your insurance provider and your pharmacy.
Generally, however, oral semaglutide is more expensive than some of the other diabetic medications, such as empagliflozin and metformin.
Side Effects, Risks, and Precautions with Rybelsus
Rybelsus has several possible side effects ranging from mild to severe.
Common Side Effects and Tips for Management
Clinical trials have identified common side effects of Rybelsus, including:
- Diarrhea
- Decreased appetite
- Nausea
- Vomiting
- Abdominal pain
Patients experiencing these effects should consult their healthcare provider for guidance. Some things you can do to help control the symptoms, such as eating small meals, avoiding spicy foods, and staying well hydrated, can offset some of the medication's side effects.
Serious Risks and Warnings
Some of the more serious side effects of Rybelsus include:
- Allergic reactions
- Vision changes
- Dehydration
- Problems with the gallbladder
- Kidney problems
- Pancreatitis
- Thyroid cancer
If you experience severe stomach pain, fever, rapid heartbeat, swelling, itching, rashes, or a lump in your neck, you should seek emergency care from your healthcare provider.
Contraindications and Who Should Avoid Rybelsus
Rybelsus should not be used in people with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2.
Rybelsus is also not approved for use in pregnancy. Rybelsus can interact with other medications, so it is essential to ensure that your healthcare provider knows all the medicines you are taking.
Rybelsus Cost, Accessibility, and Savings Options
Rybelsus is a newer medication, and a generic option is not currently available.
Average Cost of Rybelsus
The approximate cost of Rybelsus is around $850 for a 30-day supply (as of 2020).
Insurance Coverage and Copay Programs
Insurance coverage varies. Copay cards may be available for people who have private insurance.
Where to Buy Rybelsus
Rybelsus is available from most pharmacies. The medication requires a prescription.
Frequently Asked Questions About Rybelsus
You may have many questions about Rybelsus. Here are some answers to some of the frequently asked questions.
Is Rybelsus Effective for Weight Loss?
Rybelsus is not approved for weight loss alone, but studies have shown that Rybelsus may cause up to 10 lbs of weight loss at 26 weeks.
Can Rybelsus Be Taken with Other Diabetes Medications?
Rybelsus can be taken with other diabetic medications under the direction of a healthcare provider. There may be an increased risk of low blood sugar when Rybelsus is combined with other medicines.
How Long Does It Take to See Results?
Rybelsus may take up to 30 days to start improving your blood sugar. The starting dose of medication is usually 3 mg and is increased to 7 mg after 30 days.
Is Rybelsus Safe for Long-Term Use?
Rybelsus can be used long-term for the treatment of diabetes if recommended by your healthcare provider.
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Key Takeaways
- Rybelsus is the first oral GLP-1 medication for treating type 2 diabetes.
- Rybelsus may have positive effects on cardiovascular risk and weight control.
- Rybelsus should not be used in people with a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia 2, or those who are pregnant.
- Common side effects of Rybelsus can usually be managed with fluid intake, smaller meals, and avoiding spicy foods.
- You and your healthcare provider should decide whether Rybelsus is right for you based on your overall risk factors and other health concerns.
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