Semaglutide

Semaglutide may increase the risk that you will develop thyroid gland tumors, including thyroid cancer. Semaglutide caused tumors in rats. It is not known if this medication increases the risk in humans. Tell your doctor if you or anyone in your family has or has ever had thyroid tumors, thyroid cancer, 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.

You will be given the Medication Guide when you begin treatment with semaglutide 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 https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

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Talk to your doctor about the risks of taking semaglutide.

Semaglutide is used for the following:  

• to control blood sugar levels in certain people with type 2 diabetes (condition in which blood sugar is too high because the body does not make or use insulin normally).
• to reduce the risk of a heart attack, stroke, or death in people with heart and blood vessel disease who have type 2 diabetes or who are obese or overweight.
• to assist with weight loss and maintenance in certain people who are obese or overweight and have at least one weight-related medical problem.

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.

Semaglutide comes as a tablet to take by mouth. Take 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.  Your doctor may gradually increase your dose, depending on your response to semaglutide.

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 and weight loss 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 or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• 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,  depression, thoughts about or attempted suicide, changes in behavior, 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 immediately.
• 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 you have diabetes and 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.
• this medication may cause changes in your blood sugar. Signs and symptoms of low blood sugar may include dizziness or lightheadedness, irritability, sweating, hunger, drowsiness, shakiness, weakness, headache, slurred speech, blurred vision, fast heart rate and feeling jittery. You should know the symptoms of low blood sugar and what to do if you have these symptoms.

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
• 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
• severe stomach or intestinal problems

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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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. If you have diabetes, 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.

If you have diabetes, 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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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