What is Rybelsus (semaglutide)?
Rybelsus is a prescription medication used to treat and improve blood sugar control in people with type 2 diabetes.
Rybelsus belongs to the drug class, glucagon-like peptide-1 (GLP-1) receptor agonists. It is the first and only GLP-1 receptor agonist that can be taken by mouth, making it a convenient alternative to the traditional injectable form of this medication.
What are the Indications for Rybelsus?
Rybelsus is indicated for the treatment of type 2 diabetes mellitus in adults. It is used to improve glycemic control in people who have not achieved adequate blood sugar control with diet and exercise alone or with other oral antidiabetic medications.
The drug can be used as monotherapy, meaning it can be taken alone, or in combination with other medications such as metformin, sulfonylureas, and insulin. It is important to note that Rybelsus is not recommended for the treatment of type 1 diabetes or diabetic ketoacidosis.
How is Rybelsus used?
Rybelsus should be stored at room temperature, between 68°F and 77°F (20°C and 25°C), in its original container.
Keep Rybelsus out of reach of children and pets.
Take Rybelsus once daily, preferably in the morning, with or without food. The tablet should be swallowed whole with a glass of water and should not be chewed, crushed, or split.
Rybelsus is available in tablet form in the following strengths: 3mg, 7mg, 14mg.
The starting dose of Rybelsus is 3 mg once daily, and the dose can be increased to 7 mg once daily after 30 days if needed. Your doctor may increase your dose to 14 mg once daily after an additional 30 days if your blood sugar is still not adequately controlled.
It’s important to understand that although Rybelsus is FDA-approved, it comes with side effects that may or may not affect you.
Before starting Rybelsus, you should discuss possible side effects with your doctor or pharmacist.
Common Side Effects
Not all side effects require medical attention. As your body adjusts to Rybelsus, side effects may go away.
Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:
- Abdominal pain
- Decreased appetite
Serious Side Effects
Severe adverse reactions while using Rybelsus can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:
- Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
- Pancreatitis: Inflammation of the pancreas, which can cause severe abdominal pain, nausea, vomiting, and fever.
- Hypoglycemia: Low blood sugar levels, which can cause symptoms such as sweating, dizziness, confusion, and fainting.
- Acute kidney injury: A sudden and severe decline in kidney function, which can cause symptoms such as swelling, fatigue, and changes in urine output.
- Diabetic retinopathy complications: May cause vision changes, including sudden vision loss, and blindness.
- Thyroid cancer: Increased risk of developing thyroid cancer, especially if you have a history of thyroid cancer
The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.
Warnings & Precautions
Before using Rybelsus, tell your doctor or pharmacist:
- If you are allergic to any medications such as Rybelsus
- If you have thyroid cancer or have a family history of medullary thyroid carcinoma (MTC)
- If you have kidney problems
- If you have pancreatitis or have had pancreatitis
- If you have gallbladder problems or a history of gallbladder problems
- If you are pregnant or expect to become pregnant
- If you are breastfeeding or plan to breastfeed
Taking Rybelsus can cause your pancreas to swell and become inflamed resulting in pancreatitis. Signs of pancreatitis include back pain and severe stomach pain that causes you to throw up. Contact your doctor right away if you experience any symptoms that do not go away.
Taking Rybelsus increases your risk for a certain type of cancer known as medullary thyroid carcinoma (MTC). You should not take Rybelsus if you’ve had thyroid cancer or have a family history of thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Taking Rybelsus can cause a worsening of kidney function, especially if you have pre-existing kidney disease or are taking medications that affect the kidneys such as ACE inhibitors. Signs of kidney failure include vomiting, nausea, and diarrhea. Contact your doctor if you experience any symptoms that do not go away.
Taking Rybelsus may increase your risk of hypoglycemia, especially if taken in combination with other medications that lower blood sugar levels such as insulin. Signs of low blood sugar include sweating, confusion, headache, fast heartbeat, hunger, irritability, dizziness, blurred vision, and shaking. Contact your doctor if you experience any symptoms that do not go away.
Taking Rybelsus can increase your risk of complications with diabetic retinopathy. Your doctor will monitor your eyes regularly if you have a history of diabetic retinopathy.
Taking Rybelsus can increase your risk of developing gallbladder issues especially if you have a history of gallbladder problems. Signs of gallbladder problems include fever or chills, jaundice or yellowing of the skin, pain in your upper stomach, diarrhea, or abnormal stool and urine colors. Contact your doctor if you experience any symptoms that do not go away.
Taking Rybelsus may cause gastroparesis, a condition in which the stomach does not empty properly. If you have or have had a history of gastroparesis, do not take Rybelsus.
Pregnant or Planning to Become Pregnant
It is not known if Rybelsus affects the unborn child. If you are pregnant or plan to become pregnant while taking Rybelsus, talk to your doctor for the best course of action before taking Rybelsus.
It is not known if Rybelsus passes into breast milk. If you are breastfeeding or considering breastfeeding while taking Rybelsus, talk to your doctor for the best course of action before taking Rybelsus.
Interactions & Contraindications
Before using Rybelsus, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.
Taking Rybelsus with insulin may increase your risk of hypoglycemia or low blood sugar. Do not take Rybelsus until you’ve consulted with your doctor to determine if change of therapy is needed.
Other Antidiabetic Medications
Taking Rybelsus with other antidiabetic medications may increase your risk of hypoglycemia or low blood sugar. Do not take Rybelsus until you’ve consulted with your doctor to determine if change of therapy is needed.
Taking Rybelsus with Warfarin can increase the effects of warfarin, a blood thinner medication, which can increase the risk of bleeding. Consult with your doctor to determine if change of therapy is needed.
Drugs that Affect the Gastrointestinal System
Taking Rybelsus with medications that affect the gastrointestinal system such as antibiotics or proton pump inhibitors (PPI), can affect the effectiveness of Rybelsus. Consult with your doctor to determine if change of therapy is needed.