(sem" a gloo' tide)
Semaglutide injection 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 use semaglutide injection. 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 injection.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with semaglutide injection 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 ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking semaglutide injection.
WHY is this medicine prescribed?
Semaglutide injection 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) when other medications did not control the sugar levels well enough. Semaglutide injection 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 injection is not used instead of insulin to treat people with diabetes who need insulin. Semaglutide injection 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 injection 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.
HOW should this medicine be used?
Semaglutide injection comes as a solution (liquid) in a prefilled dosing pen to inject subcutaneously (under the skin). It is usually injected once a week without regard to meals. Use semaglutide injection on the same day each week at any time of day. You may change the day of the week that you use semaglutide as long as it has been 2 or more days (48 or more hours) since you used your last dose. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use semaglutide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Your doctor will probably start you on a low dose of semaglutide injection and increase your dose after 4 weeks. Your doctor may increase your dose again after another 4 weeks based on your body's response to the medication.
Semaglutide injection controls diabetes but does not cure it. Continue to use semaglutide injection even if you feel well. Do not stop using semaglutide injection without talking to your doctor.
Carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to inject a dose of semaglutide injection. Be sure to ask your pharmacist or doctor if you have any questions about how to inject this medication.
Always look at the semaglutide solution before you inject it. It should be clear, colorless, and free of particles. Do not use semaglutide if it is colored, cloudy, thickened, or contains solid particles, or if the expiration date on the bottle has passed.
Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Dispose of needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture resistant container.
You can inject semaglutide in your upper arm, thigh, or stomach area. Change (rotate) the injection site with each injection. You can inject semaglutide and insulin in the same body area, but you should not give the injections right next to each other. Allow the pen to warm to room temperature before injecting if the pen was stored in the refrigerator.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking semaglutide injection,
- tell your doctor and pharmacist if you are allergic to semaglutide, albiglutide (Tanzeum; no longer available in the US), dulaglutide (Trulicity), exenatide (Bydureon, Byetta), liraglutide (Saxenda, Victoza), lixisenatide (Adlyxin, in Soliqua), any other medications, or any of the ingredients in semaglutide injection. 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. Also be sure to mention insulin and sulfonylureas such as chlorpropamide (Diabinese, Glucamide), glimepiride (Amaryl, in Duetact), glipizide (Glucotrol), glyburide (DiaBeta, Glynase), tolazamide, and tolbutamide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had pancreatitis (inflammation of the pancreas), diabetic retinopathy (damage to the eyes caused by diabetes), 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 using semaglutide injection for 2 months before a planned pregnancy.
- tell your doctor if you are pregnant, or are breastfeeding. If you become pregnant while using semaglutide injection, call your doctor.
- 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 injection you may need.
What SPECIAL DIETARY instructions should I follow?
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian.
What should I do IF I FORGET to take a dose?
Inject the missed dose as soon as you remember it. However, if more than 5 days passed since the missed dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Semaglutide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- abdominal pain
Some side effects can be serious. If you experience any of these symptoms 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
Semaglutide injection 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 ( Web Site ) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in and out of reach of children. Store it away from light and heat, with the pen cap on. Store unused semaglutide pens in the refrigerator (36°F to 46°F [2°C to 8°C]) but do not place them near the refrigerator cooling element. Once a semaglutide pen is in use you can store it at room temperature (59°F to 86°F [15°C to 30°C]) or in the refrigerator. Do not freeze. Do not use semaglutide if it has been frozen.
When traveling pens that are in use can be stored at room temperature (59°F to 86°F [15°C to 30°C]) (not in a car glove compartment or other hot place).
Make a note of the date you first use a semaglutide pen, and dispose of the pen after 56 days, even if there is some solution left in the pen.
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. Web Site
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 ( Web Site) for more information if you do not have access to a take-back program.
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What OTHER INFORMATION should I know?
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.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: November 15, 2019.