Rybelsus contains semaglutide, which is a GLP-1 receptor agonist. It is developed as an oral tablet for use, and semaglutide's action is enhanced through albumin binding and specific modifications for increased stability. The formulation process includes a peptide backbone produced by yeast fermentation.

How should I use this medication?

Take this medication by mouth with a sip of water (no more than 4 ounces). Take it in the morning right after waking up every day. Take it on an empty stomach, at least 30 minutes before food, drink, or other medications. Do not cut, crush, or chew this medication. Swallow the tablets whole. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Change in vision -Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine -Fast or irregular heartbeat -Fast or irregular heartbeat -Gallbladder problems—severe stomach pain, nausea, vomiting, fever -Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet -Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting -Thyroid cancer—new mass or lump in the neck, pain or trouble swallowing, trouble breathing, hoarseness -Constipation -Constipation -Diarrhea -Loss of appetite -Nausea -Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Endocrine tumors (MEN 2) or if someone in your family had these tumors -Eye disease -History of pancreatitis -Kidney disease -Stomach or intestine problems -Thyroid cancer or if someone in your family had thyroid cancer -Vision problems -An unusual or allergic reaction to semaglutide, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

-Digoxin -Levothyroxine -Warfarin Some medications may affect your blood sugar levels or hide the symptoms of low blood sugar (hypoglycemia). Talk with your care team about all the medications you take. They may suggest changes to your insulin dose or checking your blood sugar levels more often. Medications that may affect your blood sugar levels include: -Alcohol -Certain antibiotics, such as ciprofloxacin, levofloxacin, sulfamethoxazole; trimethoprim -Certain medications for blood pressure or heart disease, such as benazepril, enalapril, lisinopril, losartan, valsartan -Certain medications for mental health conditions, such as fluoxetine or olanzapine -Diuretics, such as hydrochlorothiazide (HCTZ) -Estrogen and progestin hormones -Other medications for diabetes -Steroid medications, such as prednisone or cortisone -Testosterone -Thyroid hormones Medications that may mask symptoms of low blood sugar include: -Beta blockers, such as atenolol, metoprolol, propranolol -Clonidine -Guanethidine -Reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medication. Your care team will monitor your HbA1C (A1C). This test shows what your average blood sugar (glucose) level was over the past 2 to 3 months. Know the symptoms of low blood sugar and know how to treat it. Always carry a source of quick sugar with you. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink if your blood sugar is too low and you are unable to care for yourself. Get medical help at once. Tell your care team if you have high blood sugar. Your medication dose may change if your body is under stress. Some types of stress that may affect your blood sugar include fever, infection, and surgery. Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card. Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication. Talk to your care team right away if you have a lump or swelling in your neck, hoarseness that does not go away, trouble swallowing, shortness of breath, or trouble breathing. Make sure you stay hydrated while taking this medication. Drink water often. Eat fruits and veggies that have a high water content. Drink more water when it is hot or you are active. Talk to your care team right away if you have fever, infection, vomiting, diarrhea, or if you sweat a lot while taking this medication. The loss of too much body fluid may make it dangerous for you to take this medication. If you are going to need surgery or a procedure, tell your care team that you are taking this medication. Do not take this medication without first talking to your care team if you may be or could become pregnant. Your care team can help you find the option that works for you. Weight loss is not recommended during pregnancy. Maintaining healthy blood sugar levels can help reduce the risk of pregnancy complications. Talk to your care team if you are breastfeeding. When recommended, this medication may be taken. Its use during breastfeeding has not been well studied. Lactation may help lower your blood sugar levels. Your care team may recommend changes to your treatment plan.

What are the most serious risks of this medication?

This medication may increase the risk of thyroid tumors or cancer. Do not take this medication if you or a family member has or have had multiple endocrine neoplasia (MEN) 2 or a type of thyroid cancer called medullary thyroid carcinoma (MTC). Talk to your care team right away if you have a lump or swelling in the neck, pain or trouble swallowing, trouble breathing, or hoarseness.