Important Safety Information

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