Rybelsus

Rybelsus tablets (semaglutide) are used for adults with type 2 diabetes to control blood sugar levels and reduce A1C levels. Rybelsus is also used to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes mellitus who are at high risk for these events. Rybelsus has also been shown in studies to help with 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, slowing gastric emptying, and decreasing glucagon secretion. Rybelsus is from the class of medicines called GLP-1 receptor agonists (glucagon-like peptide-1 receptor agonists).

Rybelsus tablets contain the same active ingredient, semaglutide, as Ozempic pill and injection, and Wegovy injection. Wegovy is FDA-approved for weight management, and the serious liver condition MASH, and Ozempic is approved for type 2 diabetes and other conditions.

Rybelsus tablets (semaglutide formulation R1) and Ozempic pill (semaglutide formulation R2) are not interchangeable on a dose-per-dose basis because they are different formulations that influence how the drug is absorbed.

Rybelsus patients should continue their medication as directed and speak with their healthcare professionals about transitioning to the Ozempic pill, as appropriate.

There is no Rybelsus generic available.

This medicine is not for treating type 1 diabetes.

• Take Rybelsus tablets once a day.
• Take tablets 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). Do not take the tablet with any other liquids besides water.
• 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.

Take tablets exactly as prescribed by your doctor by following all directions on your prescription label and reading all medication guides or instruction sheets. This medicine 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.

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.

Rybelus has a boxed warning for risk of thyroid C-cell tumours, as in laboratory studies semaglutide caused thyroid C-cell tumors in rodents. It is unknown whether this medicine causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.

You should not use this medicine 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.

You should not use this medicine 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;
• are planning surgery or other procedures that use anesthesia or deep sedation;
• 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.

This medicine 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 this medication

Common side effects

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.

Serious Rybelsus side effects

Get emergency medical help if you have signs of an allergic reaction, including hives, itching, dizziness, fast heartbeats, difficulty breathing, or swelling of your face, lips, tongue, or throat.

This medicine may increase the chance of food or liquid getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking this medicine before you are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness.

This medicine may cause other serious side effects. 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).

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.

The Rybelsus cost will depend on your insurance plan and which pharmacy you use. Refer to our Rybelsus Prices, Coupons, Copay Cards & Patient Assistance page for more information about the cost.

A coupon or a savings card may help you save money on your prescription. Ask your doctor or pharmacist if you qualify or see the Rybelsus Copay Card: Do I qualify? Savings explained page has more information.

Usual Adult Dose for Diabetes Type 2 and Cardiovascular Risk Reduction:Initial dose: Rybelsus (R1 formulation) 3mg 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 mg to 14 mg orally once a day.Maximum dose: 14 mg/day

Tablets are available as:

• Rybelsus 3 mg
• Rybelsus 7 mg
• Rybelsus 14 mg

A new formulation of Rybelsus has been approved, called R2. Both contain semaglutide, but they are not interchangeable on a dose-per-dose basis because they differ in their inactive ingredients, which influence how the drug is absorbed.

Switching Between Rybelsus and Ozempic Pills

You can only switch between Rybelsus and Ozempic tablets after the initiation phase (days 1 to 30). When switching between Rybelsus and Ozempic tablets, start the new semaglutide tablet product the day after stopping the previous semaglutide tablet product.

Dose conversion from Rybelsus to Ozempic Pills (escalation or maintenance phase)

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

Do not use two doses of this medicine at one time.

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 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.

• Store at room temperature between 68°F and 77°F (20°C to 25°C).
• Store in a dry place away from moisture.
• Store tablets in the original closed bottle until you are ready to take one. Do not store in any other container.
• Keep all medicines out of the reach of children.

Rybelsus manufacturer Novo Nordisk A/S DK-2880 Bagsvaerd Denmark

Active Ingredient: semaglutide

Inactive Ingredients: 3 mg, 7 mg, 14 mg: magnesium stearate, microcrystalline cellulose, povidone, and salcaprozate sodium (SNAC).