What Is Rybelsus (Semaglutide)?

Rybelsus tablets (Semaglutide) are used for adults with type 2 diabetes mellitus to control blood sugar levels. Rybelsus has also been shown in studies to help weight loss, but it is not an FDA-approved weight loss medicine. Rybelsus tablets are a once-a-day tablet that is used along with diet and exercise.

Rybelsus tablets work to lower blood sugar (glucose) levels by increasing how much insulin is released and decreasing glucagon secretion. This medicine also may slow gastric emptying after eating. Rybelsus is from the class of medicines called GLP-1 receptor agonists (glucagon-like peptide-1 receptor agonist).

Rybelsus tablets contain the same active ingredient as Wegovy injection and Ozempic injection. Wegovy is approved for weight management, and Ozempic is approved for type 2 diabetes.

Rybelsus is not for treating type 1 diabetes.

Warnings

You should not use Rybelsus if you have multiple endocrine neoplasia type 2 (tumors in your glands), a personal or family history of medullary thyroid cancer, insulin-dependent diabetes, or diabetic ketoacidosis.

Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

Before Taking Rybelsus (Semaglutide)

You should not use Rybelsus if you are allergic to semaglutide, or if you have:

• multiple endocrine neoplasia type 2 (tumors in your glands); or
• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer).

To make sure Rybelsus is safe for you, tell your doctor if you have:

• a stomach or intestinal disorder;
• gallbladder disease;
• pancreatitis;
• eye problems caused by diabetes (retinopathy); or
• kidney disease.

In animal studies, semaglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people. Ask your doctor about your risk.

Rybelsus is not approved for use by anyone younger than 18 years old.

Pregnancy and Breastfeeding

Stop using Rybelsus at least 2 months before you plan to get pregnant. Ask your doctor for a safer medicine to use during this time. Controlling diabetes is very important during pregnancy, as is gaining the right amount of weight. Even if you are overweight, losing weight during pregnancy could harm the unborn baby.

You should not breastfeed while using Rybelsus.

How Should I Take Rybelsus (Semaglutide)?

Take Rybelsus exactly as prescribed by your doctor by following all directions on your prescription label and read all medication guides or instruction sheets. Rybelsus is usually started at a low dose that is gradually increased every 4 weeks to 30 days. Follow your doctor’s dosing instructions very carefully.

• Rybelsus tablets are taken by mouth, usually once per day.
• Take Rybelsus when you first wake up and at least 30 minutes before you eat or drink anything.
• Take the tablet with a small amount of water (no more than 4 ounces).
• Swallow the tablet whole and do not crush, chew, or break it.
• After 30 minutes of taking the tablet you may eat, drink or take other oral medicines.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

Do not use different brands of semaglutide at the same time.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your dose or medication schedule.

Your treatment may also include diet, exercise, weight control, medical tests, and special medical care.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

Store Rybelsus in the original package at room temperature, away from moisture and heat. Keep out of the reach of children and pets.

Dosing Information

Usual Adult Dose for Diabetes Type 2:
Initial dose: 3 mg taken orally once a day for 30 days, then increase to 7 mg taken orally once a day.
Titration: If additional glycemic control is needed after receiving 7 mg/day for at least 30 days, the dose may increase to 14 mg orally once a day.
Maintenance dose: 7 to 14 mg orally once a day.
Maximum dose: 14 mg/day (taking two 7 mg tablets to achieve a 14 mg dose is not recommended).

What Happens If I Miss A Dose?

Skip the missed dose and use your next dose at the regular time.

Do not use two doses of Rybelsus at one time.

What Happens If I Overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause severe nausea, vomiting, or low blood sugar.

Rybelsus (Semaglutide) Side Effects

Get emergency medical help if you have signs of an allergic reaction to Rybelsus: hives, itching; dizziness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• vision changes;
• unusual mood changes, thoughts about hurting yourself;
• pounding heartbeats or fluttering in your chest;
• a light-headed feeling, like you might pass out;
• signs of a thyroid tumor – swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath;
• symptoms of pancreatitis – severe pain in your upper stomach spreading to your back, nausea with or without vomiting, fast heart rate;
• gallbladder problems – upper stomach pain, fever, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood sugar – headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
• kidney problems – swelling, urinating less, feeling tired or short of breath; or
• stomach flu symptoms – stomach cramps, vomiting, loss of appetite, diarrhea (may be watery or bloody).

Common Rybelsus side effects may include:

• low blood sugar (in people with type 2 diabetes);
• upset stomach, heartburn, burping, gas, bloating;
• nausea, vomiting, stomach pain, loss of appetite;
• diarrhea, constipation;
• runny nose or sore throat;
• stomach flu symptoms; or
• headache, dizziness, tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What Other Drugs Will Affect Rybelsus?

Rybelsus can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

Tell your doctor about all your other medicines, especially insulin or other diabetes medicine, such as dulaglutide, exenatide, liraglutide, Byetta, Trulicity, Victoza, and others.

Other drugs may interact with semaglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

What are the ingredients In Rybelsus (Semaglutide)?

Active Ingredient: semaglutide

Inactive Ingredients: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium (SNAC).

Further Information

• Your doctoror pharmacist can provide more information about Rybelsus.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Rybelsus only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.