Read this Medication Guide and Instructions for Use before you start using SEMAGLUTIDE and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

 

What is the most important information I should know about SEMAGLUTIDE?

SEMAGLUTIDE may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, SEMAGLUTIDE and medicines that work like SEMAGLUTIDE caused thyroid tumors, including thyroid cancer. It is not known if SEMAGLUTIDE will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

• Do not use SEMAGLUTIDE if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

 

What is SEMAGLUTIDE?

SEMAGLUTIDE is an injectable prescription medicine:

• to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.

• that may help adults and children aged 12 years and older with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to lose weight and keep the weight off.

• SEMAGLUTIDE should be used with a reduced calorie meal plan and increased physical activity.

• SEMAGLUTIDE contains semaglutide and should not be used with other semaglutide containing products or other GLP-1 receptor agonist medicines.

• It is not known if SEMAGLUTIDE is safe and effective for use in children under 12 years of age.

 

Do not use SEMAGLUTIDE if:

• you or any of your family have ever had a type of thyroid cancer called MTC or if you have an endocrine system condition called MEN you have had a serious allergic reaction to semaglutide or any of the ingredients in SEMAGLUTIDE. See the end of this Medication Guide for a complete list of ingredients in SEMAGLUTIDE. Before using SEMAGLUTIDE, 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 type 2 diabetes and a history of diabetic retinopathy.

• have or have had depression or suicidal thoughts, or mental health issues.

• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). are pregnant or plan to become pregnant. SEMAGLUTIDE may harm your unborn baby. You should stop using SEMAGLUTIDE 2 months before you plan to become pregnant.

• are breastfeeding or plan to breastfeed. It is not known if SEMAGLUTIDE passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using SEMAGLUTIDE.

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SEMAGLUTIDE may affect the way some medicines work and some medicines may affect the way SEMAGLUTIDE works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. SEMAGLUTIDE slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

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How should I use SEMAGLUTIDE?

• Read the Instructions for Use that comes with SEMAGLUTIDE.

• Use SEMAGLUTIDE exactly as your healthcare provider tells you to.

• Use SEMAGLUTIDE with a reduced-calorie diet and increased physical activity.

• SEMAGLUTIDE is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject SEMAGLUTIDE into a muscle (intramuscularly) or vein (intravenously). See detailed instructions here.

• Change (rotate) your injection site with each injection. Do not use the same site for each injection.

• Use SEMAGLUTIDE 1 time each week, on the same day each week, at any time of the day. If you need to change the day of the week, you may do so as long as your last dose of SEMAGLUTIDE was given 2 or more days before.

• If you miss a dose of SEMAGLUTIDE and the next scheduled dose is more than 2 days away (48 hours), take the missed dose as soon as possible. If you miss a dose of SEMAGLUTIDE and the next scheduled dose is less than 2 days away (48 hours), do not administer the dose. Take your next dose on the regularly scheduled day.

• If you miss doses of SEMAGLUTIDE for 2 or more weeks, take your next dose on the regularly scheduled day or call your healthcare provider to talk about how to restart your treatment.

• You can take SEMAGLUTIDE with or without food.

• If you take too much SEMAGLUTIDE, call your healthcare provider or Poison Help line at 1-800-222- 1222 or go to the nearest hospital emergency room right away. Advice is also available online at poisonhelp.org.

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What are the possible side effects of SEMAGLUTIDE?

SEMAGLUTIDE may cause serious side effects, including:

• See "What is the most important information I should know about SEMAGLUTIDE?"

• inflammation of your pancreas (pancreatitis). Stop using SEMAGLUTIDE 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.

• gallbladder problems. SEMAGLUTIDE may cause gallbladder problems including gallstones. Some gallbladder problems need surgery. Call your healthcare provider if you have any of the following symptoms:

  • pain in your upper stomach (abdomen)

  • yellowing of skin or eyes (jaundice)

  • fever

  • clay-colored stools

• increased risk of low blood sugar (hypoglycemia), especially those who also take medicines to treat type 2 diabetes mellitus such as an insulin or a sulfonylureas. Low blood sugar in patients with type 2 diabetes who receive SEMAGLUTIDE can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar. You should check your blood sugar before you start taking SEMAGLUTIDE and while you take SEMAGLUTIDE. Signs and symptoms of low blood sugar may include: dizziness or light-headedness, sweating, shakiness, blurred vision, slurred speech, weakness, anxiety, hunger, headache, irritability, or mood changes, confusion, or drowsiness, fast heartbeat, 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.

• severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use SEMAGLUTIDE. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

• serious allergic reactions. Stop using SEMAGLUTIDE 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 severe rash or itching very rapid heartbeat problems breathing or swallowing fainting or feeling dizzy change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with SEMAGLUTIDE.

• increased heart rate. SEMAGLUTIDE can increase your heart rate while you are at rest. Your healthcare provider should check your heart rate while you take SEMAGLUTIDE. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.

• depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

• food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). SEMAGLUTIDE may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking SEMAGLUTIDE before you are scheduled to have surgery or other procedures.

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The most common side effects of SEMAGLUTIDE in adults or children aged 12 years and older may include:

• nausea

• stomach (abdomen) pain

• dizziness

• gas

• diarrhea

• headache

• feeling bloated

• stomach flu

• vomiting

• tiredness (fatigue)

• belching

• heartburn

• constipation

• upset stomach

• low blood sugar in people with type 2 diabetes

• runny nose or sore throat

 

Talk to your healthcare provider about any side effect that bothers you or does not go away.

 

These are not all the possible side effects of SEMAGLUTIDE. Call your doctor for medical advice about side effects.

 

General information about the safe and effective use of SEMAGLUTIDE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use SEMAGLUTIDE for a condition for which it was not prescribed.

Do not give SEMAGLUTIDE to other people, even if they have the same condition that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SEMAGLUTIDE that is written for health professionals.

 

What are the ingredients in SEMAGLUTIDE?

Active Ingredient: semaglutide

Inactive Ingredients: benzyl alcohol, sodium phosphate dibasic, sterile water for injection.