Frequently Asked Questions About RYBELSUS ® (semaglutide) tablets

Rybelsus ® is used along with diet and exercise to improve blood sugar in adults with type 2 diabetes.

There are many reasons that RYBELSUS ® could be right for you. First and foremost, RYBELSUS ® is used along with diet and exercise to improve blood sugar and A1C. So if you’re an adult whose A1C is no longer at goal, you should consider discussing a change in treatment with your healthcare professional.

Ask your healthcare professional if RYBELSUS ® is right for you. Download a discussion guide to help get the conversation started.

RYBELSUS ® , the first and only GLP-1 pill, is a prescription medicine taken once daily that is used along with diet and exercise to improve blood sugar and A1C in adults with type 2 diabetes.

Results are from a 6-month medical study with 703 adults with type 2 diabetes that compared 7 mg RYBELSUS ® and 14 mg RYBELSUS ® with a sugar pill when both were added to diet and exercise. People who took a sugar pill had a 0.3% lowering of A1C, and 31% reached an A1C goal of Will RYBELSUS ® affect my weight? While not for weight loss, RYBELSUS ® may help you lose some weight. Has RYBELSUS ® been studied for cardiovascular risk?

Yes. In a study, RYBELSUS ® did not increase the risk of major cardiovascular (CV) events such as heart attack, stroke, or death. In a cardiovascular safety study, 3183 adults with type 2 diabetes and a high risk of CV events were treated once daily with either 14 mg RYBELSUS ® or a sugar pill in addition to their usual diabetes and CV medications.

RYBELSUS ® works like your body’s naturally occurring GLP-1 to lower blood sugar in the following 3 ways:

1. Stimulates your pancreas to release more insulin when your blood sugar is high 2. Prevents your liver from making and releasing too much sugar 3. Slows down food leaving your stomach after eating

The main ingredient for RYBELSUS ® is semaglutide, a man-made version of the human GLP-1 molecule, with some changes.

The RYBELSUS ® Doctor Discussion Guide can help guide you through a conversation with your healthcare professional about whether RYBELSUS ® is right for you.

Some healthcare professionals may offer telehealth services and virtual consultations to assess treatment options. Check with your healthcare professional to determine the availability of these services.

Yes! If eligible, you may PAY AS LITTLE AS $10 for a 1-, 2-, or 3-month prescription of RYBELSUS ® . a

a To receive offer, 7 mg or 14 mg dose prescription must be for a 1-, 2-, or 3-month supply. For 3 mg dose, pay as little as $10 each month. Eligible, commercially insured patients only. Maximum savings of $300 per 1‑month supply, $600 per 2‑month supply, or $900 per 3‑month supply. Eligibility and other restrictions apply.

b Message and data rates may apply. Check with your mobile service provider. Message frequency will be based on your selections. Text HELP to 21848 for help. Text STOP to 21848 to quit. See Terms and Conditions of Use.

a Message and data rates may apply. Check with your mobile service provider. Message frequency will be based on your selections. Text HELP to 21848 for help. Text STOP to 21848 to quit. See Terms and Conditions of Use.

Give us a call for one-on-one, live support from a Diabetes Health Coach—and to learn more about taking RYBELSUS ® .

You can speak with a Diabetes Health Coach by calling 1-833-ASK-A-CDE (1-833-275-2233) . The Diabetes Health Coach will be happy to answer your questions about RYBELSUS ® .

For RYBELSUS ® to work as planned to lower blood sugar, store RYBELSUS ® tablets at room temperature and keep them in the closed RYBELSUS ® bottle until you are ready to take one.

If you miss a dose, the missed dose should be skipped, and the next dose should be taken the following day.

No. RYBELSUS ® should be taken on an empty stomach when you first wake up. Wait 30 minutes after taking RYBELSUS ® before eating, drinking, or taking other oral medications. Dosing and timing of your other medications may need to be adjusted. You should talk with your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

In order for RYBELSUS ® to be properly absorbed into the body, the RYBELSUS ® tablet needs to rest on the stomach lining undisturbed for at least 30 minutes.

RYBELSUS ® is safe and effective when used as indicated for the treatment of adults with type 2 diabetes to lower blood sugar, along with diet and exercise. Talk to your healthcare professional about RYBELSUS ® .
See the Prescribing Information and Medication Guide. For medical advice about side effects, talk with your healthcare professional if you have questions regarding your treatment plan.

RYBELSUS ® may not work as planned to lower blood sugar if it’s not taken as directed every day. Talk with your healthcare professional if you have any questions about taking RYBELSUS ® .

When taken as directed, RYBELSUS ® , along with diet and exercise, may help improve your blood sugar. However, it's important to know that A1C goals vary from person to person. Make sure to talk to your healthcare professional so you can find out what goal is right for you. Also, keep in mind that you may experience some side effects while taking RYBELSUS ® .

The most common side effects of RYBELSUS ® may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation. Make sure to talk with your healthcare professional if you have any questions about side effects.

Speak with your healthcare professional if you experience nausea or have any questions about side effects. Here are some general nausea tips that may be helpful:

It is not known if RYBELSUS ® will harm your unborn baby. Women should stop taking RYBELSUS ® 2 months before they plan to become pregnant. Talk to your healthcare professional about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.

Please contact your healthcare professional if you are pregnant or intend to become pregnant, or if you are breastfeeding or plan to breastfeed, while taking RYBELSUS ® .

It is not known if RYBELSUS ® passes into breast milk. Breastfeeding is not recommended during treatment with RYBELSUS ® . You should talk to your healthcare professional about the best way to control your blood sugar while you are breastfeeding.

The beginning dose is 3 mg for the first 30 days to help your body get used to the medicine. Your healthcare professional will then prescribe a 7 mg dose to help lower blood sugar. If more blood sugar control is needed after at least 30 days on the 7 mg dose, your healthcare professional may prescribe the 14 mg dose.

Store RYBELSUS ® at room temperature (68 °F to 77 °F). Keep your RYBELSUS ® tablets in the closed RYBELSUS ® bottle until you are ready to take one. Storing the tablets in another container or changing their form before you are ready to take them can reduce how well RYBELSUS ® works.

Store in a dry place away from moisture.
RYBELSUS ® comes in a child-resistant bottle. Keep out of reach of children.

RYBELSUS ® comes in a child-resistant bottle with a blue cap. The bottle lists the name RYBELSUS ® and the dosage, which can be 3 mg, 7 mg, or 14 mg.

• magnesium stearate (pronounced mag-nee-zee-uhm stee-uh-reyt)
• microcrystalline cellulose (pronounced my-kroh-kris-tl-in sel-yuh-lohs)
• povidone (pronounced po-vi-done)
• salcaprozate sodium (pronounced sal-kap-roe-zate sow-dee-uhm)

Everyone has a different wake-up routine. Here's a tip to help you remember to take RYBELSUS ® when you first wake up: Keep your RYBELSUS ® bottle and a small glass of plain water on your nightstand.

When you wake up, take your medicine with a sip of plain water (no more than 4 ounces), and then wait 30 minutes before eating, drinking, or taking any other oral medications. After 30 minutes, you can eat, drink, or take other oral medications, vitamins, or supplements.

Living With Type 2 Diabetes

Type 2 diabetes occurs when the body does not make enough insulin or doesn’t respond to insulin properly. To understand type 2 diabetes, you need to know what insulin is and why your body needs it.

GLP-1, or glucagon-like peptide-1, is a natural hormone that helps your body keep blood sugar in balance. GLP-1 treatments work like this naturally occurring hormone. Until FDA approval of RYBELSUS ® , GLP-1 treatments had only been available in an injectable form. RYBELSUS ® is the first and only GLP-1 in a pill.

See our helpful pieces of information and tips that are available to help you stay active, eat healthy, reduce stress, and more, as you manage your type 2 diabetes.

RYBELSUS ® , along with diet and exercise, can help lower A1C for adults with type 2 diabetes.

Get your A1C DOWN with RYBELSUS ®

Once-daily RYBELSUS ® is proven to significantly lower A1C.

Pay as little as $10 for up to a 3-month RYBELSUS ® prescription a

Check your insurance coverage and learn about ways to save.

a To receive offer, 7 mg or 14 mg dose prescription must be for a 1-, 2-, or 3-month supply. For 3 mg dose, pay as little as $10 each month. Eligible, commercially insured patients with product coverage only. Maximum savings of $300 per 1‑month supply, $600 per 2‑month supply, or $900 per 3‑month supply. Eligibility and other restrictions apply.

a To receive offer, 7 mg or 14 mg dose prescription must be for a 1-, 2-, or 3-month supply. For 3 mg dose, pay as little as $10 each month. Eligible, commercially insured patients with product coverage only. Maximum savings of $300 per 1‑month supply, $600 per 2‑month supply, or $900 per 3‑month supply. Eligibility and other restrictions apply.

b Message and data rates may apply. Check with your mobile service provider. Message frequency will be based on your selections. Text HELP to 21848 for help. Text STOP to 21848 to quit. See Terms and Conditions of Use.

What is RYBELSUS ® ?

Important Safety Information

Important Safety Information

What is the most important information I should know about RYBELSUS ® ?

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS ® and medicines that work like RYBELSUS ® caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS ® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

Do not use RYBELSUS ® if:

• you or any of your family have ever had 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 symptoms of serious allergic reaction in "What are the possible side effects of RYBELSUS ® ?"

What is RYBELSUS ® ?

RYBELSUS ® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.

• It is not known if RYBELSUS ® can be used in people who have had pancreatitis
• RYBELSUS ® is not for use in people with type 1 diabetes
• It is not known if RYBELSUS ® is safe and effective for use in children under 18 years of age

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 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.

How should I take RYBELSUS ® ?

• Take RYBELSUS ® exactly as your healthcare provider tells you to
• Take RYBELSUS ® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)
• 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

What are the possible side effects of RYBELSUS ® ?

RYBELSUS ® may cause serious side effects, including:

• 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 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 lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery
• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
• 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; or 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, and clay-colored stools

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 ® .

Please see Prescribing Information and Medication Guide for RYBELSUS ® .

RYBELSUS ® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is RYBELSUS ® ?

RYBELSUS ® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.

• It is not known if RYBELSUS ® can be used in people who have had pancreatitis
• RYBELSUS ® is not for use in people with type 1 diabetes
• It is not known if RYBELSUS ® is safe and effective for use in children under 18 years of age

What is RYBELSUS ® ?

RYBELSUS ® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.

• It is not known if RYBELSUS ® can be used in people who have had pancreatitis
• RYBELSUS ® is not for use in people with type 1 diabetes
• It is not known if RYBELSUS ® is safe and effective for use in children under 18 years of age

Important Safety Information

What is the most important information I should know about RYBELSUS ® ?

RYBELSUS ® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS ® and medicines that work like RYBELSUS ® caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS ® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

Do not use RYBELSUS ® if:

• you or any of your family have ever had 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 symptoms of serious allergic reaction in "What are the possible side effects of RYBELSUS ® ?"

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 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.

How should I take RYBELSUS ® ?

• Take RYBELSUS ® exactly as your healthcare provider tells you to
• Take RYBELSUS ® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)
• 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

What are the possible side effects of RYBELSUS ® ?

RYBELSUS ® may cause serious side effects, including:

• 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 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 lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery
• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
• 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; or 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, and clay-colored stools

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 ® .

Please see Prescribing Information and Medication Guide for RYBELSUS ® .

RYBELSUS ® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is RYBELSUS ® ?

Important Safety Information

What is RYBELSUS ® ?

RYBELSUS ® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.

• It is not known if RYBELSUS ® can be used in people who have had pancreatitis
• RYBELSUS ® is not for use in people with type 1 diabetes
• It is not known if RYBELSUS ® is safe and effective for use in children under 18 years of age

What is RYBELSUS ® ?

RYBELSUS ® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.

• It is not known if RYBELSUS ® can be used in people who have had pancreatitis
• RYBELSUS ® is not for use in people with type 1 diabetes
• It is not known if RYBELSUS ® is safe and effective for use in children under 18 years of age

Important Safety Information

What is the most important information I should know about RYBELSUS ® ?

RYBELSUS ® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS ® and medicines that work like RYBELSUS ® caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS ® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

Do not use RYBELSUS ® if:

• you or any of your family have ever had 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 symptoms of serious allergic reaction in "What are the possible side effects of RYBELSUS ® ?"

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 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.

How should I take RYBELSUS ® ?

• Take RYBELSUS ® exactly as your healthcare provider tells you to
• Take RYBELSUS ® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)
• 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

What are the possible side effects of RYBELSUS ® ?

RYBELSUS ® may cause serious side effects, including:

• 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 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 lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery
• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
• 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; or 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, and clay-colored stools

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 ® .

Please see Prescribing Information and Medication Guide for RYBELSUS ® .

What is the most important information I should know about RYBELSUS ® ?

RYBELSUS ® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS ® and medicines that work like RYBELSUS ® caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS ® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

Do not use RYBELSUS ® if:

• you or any of your family have ever had 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 symptoms of serious allergic reaction in "What are the possible side effects of RYBELSUS ® ?"

Important Safety Information

What is the most important information I should know about RYBELSUS ® ?

RYBELSUS ® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS ® and medicines that work like RYBELSUS ® caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS ® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

Do not use RYBELSUS ® if:

• you or any of your family have ever had 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 symptoms of serious allergic reaction in "What are the possible side effects of RYBELSUS ® ?"

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 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.

How should I take RYBELSUS ® ?

• Take RYBELSUS ® exactly as your healthcare provider tells you to
• Take RYBELSUS ® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)
• 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

What are the possible side effects of RYBELSUS ® ?

RYBELSUS ® may cause serious side effects, including:

• 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 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 lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery
• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
• 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; or 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, and clay-colored stools

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 ® .

What is RYBELSUS ® ?

RYBELSUS ® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.

• It is not known if RYBELSUS ® can be used in people who have had pancreatitis
• RYBELSUS ® is not for use in people with type 1 diabetes
• It is not known if RYBELSUS ® is safe and effective for use in children under 18 years of age

Please see Prescribing Information and Medication Guide for RYBELSUS ® .

RYBELSUS ® is a prescription medication.