WARNINGS
Do not use RYBELSUS if:
• you or any of your family have ever had a type of thyroid cancer called medullary thyroid
carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine
Neoplasia syndrome type 2 (MEN 2).
• you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS.
See the end of this Medication Guide for a complete list of ingredients in RYBELSUS®.
Symptoms of a serious allergic reaction include:
• swelling of your face, lips, tongue or throat • problems breathing or swallowing
• severe rash or itching • fainting or feeling dizzy
• very rapid heartbeat.
USES
RYBELSUS® is a prescription medicine used:
• along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes
mellitus.
• 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.
It is not known if RYBELSUS® is safe and effective for use in children
HOW TO USE
How should I take RYBELSUS?
• Take RYBELSUS® exactly as your healthcare provider tells you to.
• Do not take more than 1 tablet each day.
• Take RYBELSUS by mouth on an empty stomach in the morning.
• Take RYBELSUS with a sip of plain water (no more than 4 ounces). Do not take RYBELSUS with
any other liquids besides water.
• Do not split, crush or chew. Swallow RYBELSUS whole.
• After 30 minutes, you can eat, drink, or take other oral medicines.
• If you miss a dose of RYBELSUS, skip the missed dose and go back to your regular schedule.
• If you take too much RYBELSUS, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.
Your dose of RYBELSUS and other diabetes medicines may need to change because of: change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, fever, trauma, infection, surgery or because of other medicines you take.
RYBELSUS may cause serious side effects, including:
• See the section WARNINGS and PRECAUTIONS above.
• inflammation of your pancreas (pancreatitis). Stop using RYBELSUS and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.
• changes in vision. Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS.
• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use RYBELSUS with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include:
• dizziness or light-headedness • blurred vision • anxiety, irritability, or mood changes
• sweating • slurred speech • hunger
• confusion or drowsiness • shakiness • weakness
• headache • fast heartbeat • feeling jittery
• dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss
of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids
to help reduce your chance of dehydration. Tell your healthcare provider right away if you have
nausea, vomiting, or diarrhea that does not go away.
• severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use RYBELSUS. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
• serious allergic reactions. Stop using RYBELSUS and get medical help right away, if you
have any symptoms of a serious allergic reaction including:
• swelling of your face, lips, tongue or throat • problems breathing or swallowing
• severe rash or itching • fainting or feeling dizzy
• very rapid heartbeat
• gallbladder problems. Gallbladder problems have happened in some people who take
RYBELSUS. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:
• pain in your upper stomach (abdomen) • yellowing of skin or eyes (jaundice)
• fever
• clay-colored stools
• food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). RYBELSUS may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking RYBELSUS before you are scheduled to have surgery or other procedures. The most common side effects of RYBELSUS may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting and constipation. Nausea, vomiting and diarrhea are most common when you first start RYBELSUS. Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of RYBELSUS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of RYBELSUS®. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RYBELSUS® for a condition for which it was not prescribed. Do not give RYBELSUS® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RYBELSUS® that is written for health professionals.
What are the ingredients in RYBELSUS?
Active ingredient: semaglutide
Inactive ingredients:
RYBELSUS. (formulation R1): magnesium stearate, microcrystalline celluslose, povidone salcaprozate sodium.
RYBELSUS. (formulation R2): salcaprozate sodium and magnesium stearate.
OVERDOSE
In the event of overdose, appropriate supportive treatment should be initiated according to the
patient’s clinical signs and symptoms. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of RYBELSUS® of approximately 1 week
MISSED DOSE
Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
STORAGE
• Store RYBELSUS at room temperature between 68-degrees F and 77-degrees F (20-degrees C to 25-degrees C).
• Store in a dry place away from moisture.
• Store tablets in the original closed RYBELSUS bottle until you are ready to take one. Do not store in any other container.
• Keep RYBELSUS and all medicines out of the reach of children
NOTES
Medication Guide: revision date 10/2025
Prescribing Information: revision date 10/2025
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
RYBELSUS stimulates insulin release in the presence of elevated blood glucose concentrations.
Patients receiving RYBELSUS in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.
When initiating RYBELSUS, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.
Other Oral Drugs
RYBELSUS causes a delay of gastric emptying and thereby has the potential to impact the absorption of other oral drugs. Levothyroxine exposure was increased 33% (90% CI: 1.25-1.42) when administered with RYBELSUS in a drug interaction.
When co-administering RYBELSUS with other oral drugs that have a narrow therapeutic index or that require clinical monitoring, consider increased clinical or laboratory monitoring.
Before using RYBELSUS, tell your healthcare provider if you have any other medical
conditions, including if you:
• have or have had problems with your pancreas or kidneys.
• have a history of vision problems related to your diabetes.
• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep
sedation).
• are pregnant or plan to become pregnant. It is not known if RYBELSUS will harm your unborn baby. You should stop using RYBELSUS 2 months before you plan to become pregnant.
Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
• are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS.
Tell your healthcare provider about all the medicines you take, including prescription
and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS may affect the way some medicines work, and some medicines may affect the way RYBELSUS works.
Before using RYBELSUS, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
