Semaglutide

Semaglutide may increase the risk that you will develop tumors of the thyroid gland, including medullary thyroid carcinoma (MTC; a type of thyroid cancer). Laboratory animals who were given semaglutide developed tumors, but it is not known if this medication increases the risk of tumors in humans. Tell your doctor if you or anyone in your family has or has ever had MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2; condition that causes tumors in more than one gland in the body). If so, your doctor will probably tell you not to take semaglutide. If you experience any of the following symptoms, call your doctor immediately: a lump or swelling in the neck, hoarseness, difficulty swallowing, or shortness of breath.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to semaglutide.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with semaglutide tablets and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of taking semaglutide.

Semaglutide is used along with a diet and exercise program to control blood sugar levels in adults with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Semaglutide is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). Semaglutide is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Semaglutide also works by slowing the movement of food through the stomach.

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Semaglutide comes as a tablet to take by mouth. It is usually taken on an empty stomach once a day when you wake up. Take semaglutide with a sip of water (no more than 4 ounces [120 mL]) at least 30 minutes before eating a meal or snack, drinking, or taking any other medications. The drug works best if you eat a meal or snack 30 minutes after you take the drug. Your doctor may gradually increase your dose, depending on your response to semaglutide. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take semaglutide exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Semaglutide controls diabetes but does not cure it. Continue to take semaglutide even if you feel well. Do not stop taking semaglutide without talking with your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking semaglutide,

• tell your doctor and pharmacist if you are allergic to semaglutide (Ozempic, Rybelsus, Wegovy), albiglutide (Tanzeum; no longer available in US); dulaglutide (Trulicity), exenatide (Bydureon, Byetta), liraglutide (Saxenda, Victoza, in Xultophy), lixisenatide (Adlyxin, in Soliqua), any other medications, or any of the ingredients in semaglutide tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. It is especially important to tell your doctor about all the medications you take by mouth because semaglutide may change the way your body absorbs these medications.
• tell your doctor if you have or have ever had pancreatitis (inflammation of the pancreas), diabetic retinopathy (damage to the eyes caused by diabetes), gall bladder disease, or kidney disease. Also tell your doctor if you have recently had diarrhea, nausea, or vomiting or if you cannot drink liquids by mouth, which may cause dehydration (loss of a large amount of body fluids).
• tell your doctor if you plan to become pregnant. Your doctor may tell you to stop taking semaglutide for 2 months before a planned pregnancy.
• tell your doctor if you are pregnant, or are breastfeeding. If you become pregnant while taking semaglutide, call your doctor.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking semaglutide.
• ask your doctor what to do if there is a large change in your diet, exercise, or weight; or if you get sick, develop an infection or fever, experience unusual stress, or are injured. These changes and conditions can affect your blood sugar and the amount of semaglutide you may need.

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help semaglutide work more effectively.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Semaglutide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• abdominal pain
• constipation
• decreased appetite
• heartburn
• burping

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• ongoing pain that begins in the upper left or middle of the stomach but may spread to the back, with or without vomiting
• rash; itching; swelling of the eyes, face, mouth, tongue, or throat; difficulty breathing or swallowing
• decreased urination; swelling of legs, ankles, or feet
• vision changes
• dizziness, light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anixety or irritability or mood changes, hunger, weakness, or feeling jittery

Semaglutide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to semaglutide. Your doctor will also tell you how to check your response to this medication by measuring your blood sugar levels at home. Follow these instructions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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