WARNINGS
What is the most important information I should know about WEGOVY®?
WEGOVY® 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, WEGOVY®
and medicines that work like WEGOVY® caused thyroid tumors, including thyroid cancer.
It is not known if WEGOVY® will cause thyroid tumors or a type of thyroid cancer called
medullary thyroid carcinoma (MTC) in people.
Do not use WEGOVY® 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).
Do not use WEGOVY® 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 2.
you have had a serious allergic reaction to semaglutide or any of the ingredients in WEGOVY®. See the end of this Medication Guide for a complete list of ingredients in WEGOVY®.
USES
What is WEGOVY®?
WEGOVY® 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 excess body weight and keep the weight off.
to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.
WEGOVY® is used with a reduced calorie meal plan and increased physical activity.
WEGOVY® contains semaglutide and should not be used with other semaglutidecontaining products or other GLP-1 receptor agonist medicines.
It is not known if WEGOVY® is safe and effective:
to reduce the risk of major cardiovascular events (death, heart attack, or stroke) in
children under 18 years.
for the treatment of long-term weight loss in children under 12 years.
for the treatment of MASH in children under 18 years.
HOW TO USE
How should I use WEGOVY®?
Read the Instructions for Use that comes with WEGOVY®.
Use WEGOVY® exactly as your healthcare provider tells you to.
Your healthcare provider should show you how to use WEGOVY® before you use it for the first time.
Use WEGOVY® with a reduced-calorie diet and increased physical activity.
WEGOVY® is injected under the skin (subcutaneously) of your stomach (abdomen),
thigh, or upper arm. Do not inject WEGOVY® into a muscle (intramuscularly) or vein
(intravenously).
Change (rotate) your injection site with each injection. Do not use the same site for each
injection.
Use WEGOVY® 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
WEGOVY® was given 2 or more days before.
You can take WEGOVY® with or without food.
What are the possible side effects of WEGOVY®?
WEGOVY® may cause serious side effects, including:
See “What is the most important information I should know about WEGOVY®?”
inflammation of your pancreas (pancreatitis). Stop using WEGOVY® 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 nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.
gallbladder problems. WEGOVY® 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) in patients with type 2 diabetes, 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 WEGOVY® 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 WEGOVY® and while you take WEGOVY®. 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
dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use WEGOVY®. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
serious allergic reactions. Stop using WEGOVY® 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 WEGOVY®.
increased heart rate. WEGOVY® can increase your heart rate while you are at rest. Your healthcare provider should check your heart rate while you take WEGOVY®. 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). WEGOVY® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking WEGOVY® before you are scheduled to have surgery or other procedures.
The most common side effects of WEGOVY® 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 WEGOVY®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of WEGOVY®.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use WEGOVY® for a condition for which it was not prescribed. Do not give WEGOVY® 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 WEGOVY® that is written for health professionals.
What are the ingredients in WEGOVY®?
Active Ingredient: semaglutide
Inactive Ingredients: disodium phosphate dihydrate, 1.42 mg; sodium chloride, 8.25 mg; water for injection, and hydrochloric acid or sodium hydroxide may be added to adjust pH.
OVERDOSE
If you take too much WEGOVY®, 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.
MISSED DOSE
If you miss a dose of WEGOVY® and the next scheduled dose is more than 2 days away (48 hours), take the missed dose as soon as possible. If you miss 1 dose of WEGOVY® 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 WEGOVY® 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.
STORAGE
Store the WEGOVY® pen in the refrigerator between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C).
If needed, before removing the pen cap, WEGOVY® can be stored from 46-degrees F to 86-degrees F (8-degrees C to 30-degrees C) in the original carton for up to 28 days.
Keep WEGOVY® in the original carton to protect it from light.
Do not freeze.
Throw away the pen if WEGOVY® has been frozen, has been exposed to light or temperatures above 86-degrees F(30-degrees C), or has been out of the refrigerator for 28 days or longer.
Keep WEGOVY® and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 08/2025
Prescribing Information: revision date 08/2025
1.) Concomitant Use with Insulin or an Insulin Secretagogue (e.g., Sulfonylurea)
WEGOVY® lowers blood glucose and can cause hypoglycemia. The risk of hypoglycemia is increased when WEGOVY® is used in combination with insulin or insulin secretagogues (e.g., sulfonylureas). The addition of WEGOVY® in patients treated with insulin has not been evaluated. When initiating WEGOVY®, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.
2.) Oral Medications
WEGOVY® causes a delay of gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials with semaglutide 1 mg, semaglutide did not affect the absorption of orally administered medications. Nonetheless, monitor the effects of oral medications concomitantly administered with WEGOVY®
Before using WEGOVY®, 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. WEGOVY® may harm your unborn baby. You should stop using WEGOVY® 2 months before you plan to become pregnant.
Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who use WEGOVY® during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry or you may contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com.
are breastfeeding or plan to breastfeed. It is not known if WEGOVY® passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using WEGOVY®.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. WEGOVY® may affect the way some medicines work and some medicines may affect the way WEGOVY® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. WEGOVY® 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.
