WEGOVY semaglutide .25 mg/.5mL Injection, Solution, 4 syringes

1 INDICATIONS AND USAGE WEGOVY is indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight. • to reduce excess body weight and maintain weight reduction long term in: o Adults and pediatric patients aged 12 years and older with obesity o Adults with overweight in the presence of at least one weight-related comorbid condition.

Limitations of Use • WEGOVY contains semaglutide. Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended. WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight (1) . • to reduce excess body weight and maintain weight reduction long term in: o Adults and pediatric patients aged 12 years and older with obesity o Adults with overweight in the presence of at least one weight-related comorbid condition (1) .

Limitations of Use: • Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended (1).

2 DOSAGE AND ADMINISTRATION • Administer WEGOVY once weekly as an adjunct to diet and increased physical activity, on the same day each week, at any time of day, with or without meals (2.1). • Inject subcutaneously in the abdomen, thigh or upper arm (2.1). • In patients with type 2 diabetes, monitor blood glucose prior to starting and during WEGOVY treatment (2.1). • Initiate at 0.25 mg once weekly for 4 weeks. Then follow the dosage escalation schedule, titrating every 4 weeks to achieve the maintenance dosage (2.2 , 2.3). • The maintenance dosage of WEGOVY in adults is either 2.4 mg (recommended) or 1.7 mg once weekly (2.2) . • The maintenance dosage of WEGOVY in pediatric patients aged 12 years and older is 2.4 mg once weekly (2.3).

2.1Important Monitoring and Administration Instructions • In patients with type 2 diabetes, monitor blood glucose prior to starting WEGOVY and during WEGOVY treatment [see Warnings and Precautions (5.4 )]. • Prior to initiation of WEGOVY, train patients on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. • Inspect WEGOVY visually prior to each injection. Only use if solution is clear, colorless, and contains no particles. • Administer WEGOVY in combination with a reduced-calorie diet and increased physical activity. • Administer WEGOVY once weekly, on the same day each week, at any time of day, with or without meals. • Inject WEGOVY subcutaneously in the abdomen, thigh, or upper arm.

The time of day and the injection site can be changed without dose adjustment.

2.2Recommended Dosage in Adults Dosage Initiation and Escalation • Initiate WEGOVY with a dosage of 0.25 mg injected subcutaneously once weekly. Then follow the dose escalation schedule presented in Table 1 to minimize gastrointestinal adverse reactions [see Adverse Reactions ( 6.1 )] . • If patients do not tolerate a dose during dosage escalation, consider delaying dosage escalation for 4 weeks. Table 1.

Recommended Dosage Regimen for Adults Treatment Weeks Once weekly Subcutaneous Dosage Initiation 1 through 4 0.25 mg Escalation 5 through 8 0.5 mg 9 through 12 1 mg 13 through 16 1.7 mg Maintenance 17 and onward 1.7 mg or 2.4 mg Maintenance Dosage • The maintenance dosage of WEGOVY in adults is either 2.4 mg (recommended) or 1.7 mg once weekly. Consider treatment response and tolerability when selecting the maintenance dosage [see Clinical Studies (14.2) ] .

2.3Recommended Dosage in Pediatric Patients Aged 12 Years and Older Dosage Initiation and Escalation • Initiate WEGOVY according to the dosage escalation schedule in Table 2 to minimize gastrointestinal adverse reactions [see Adverse Reactions (6.1) ] . • If patients do not tolerate a dose during dosage escalation, consider delaying dosage escalation for 4 weeks. • The 0.25 mg, 0.5 mg, and 1 mg once-weekly dosages are initiation and escalation dosages and are not approved as maintenance dosages. Table 2. Recommended Dosage Regimen for Pediatric Patients Aged 12 Years and Older Treatment Weeks Once weekly Subcutaneous Dosage Initiation 1 through 4 0.25 mg a Escalation 5 through 8 0.5 mg a 9 through 12 1 mg a 13 through 16 1.7 mg b Maintenance 17 and onward 2.4 mg a Not approved as maintenance dosages b See Dosage Modifications for Adverse Reactions Maintenance Dosage • The maintenance dosage of WEGOVY in pediatric patients aged 12 years and older is 2.4 mg once weekly.

Dosage Modifications for Adverse Reactions • If patients do not tolerate the 2.4 mg once weekly maintenance dosage, the maintenance dosage may be reduced to 1.7 mg once weekly. • Discontinue WEGOVY if the patient cannot tolerate the 1.7 mg once-weekly dosage.

2.4Recommendations Regarding Missed Dose • If one dose is missed and the next scheduled dose is more than 2 days away (48 hours), administer WEGOVY as soon as possible. If one dose is missed and the next scheduled dose is less than 2 days away (48 hours), do not administer th…

3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless solution available in 5 pre-filled, disposable, single-dose pens: • 0.25 mg/0.5 mL • 0.5 mg/0.5 mL • 1 mg/0.5 mL • 1.7 mg/0.75 mL • 2.4 mg/0.75 mL Injection: pre-filled, single-dose pen that delivers doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg ( 3 ).

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Risk of Thyroid C-cell Tumors Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician [see Boxed Warning and Warnings and Precautions ( 5.1 )] .

Acute Pancreatitis Inform patients of the potential risk for acute pancreatitis. Instruct patients to discontinue WEGOVY promptly and contact their physician if pancreatitis is suspected (severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting) [see Warnings and Precautions ( 5.2 )] . Acute Gallbladder Disease Inform patients of the risk of acute gallbladder disease.

Advise patients that substantial or rapid weight loss can increase the risk of gallbladder disease, but that gallbladder disease may also occur in the absence of substantial or rapid weight loss. Instruct patients to contact their healthcare provider for appropriate clinical follow-up if gallbladder disease is suspected [see Warnings and Precautions ( 5.3 )]. Hypoglycemia Inform patients of the risk of hypoglycemia and educate patients on the signs and symptoms of hypoglycemia.

Advise patients with diabetes mellitus on glycemic lowering therapy that they may have an increased risk of hypoglycemia when using WEGOVY and to report signs and/or symptoms of hypoglycemia to their healthcare provider [see Warnings and Precautions ( 5.4 )] . Dehydration and Renal Impairment Advise patients treated with WEGOVY of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs [see Warnings and Precautions ( 5.5 )] .

Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of semaglutide, the active ingredient in WEGOVY. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking WEGOVY and seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.6 )] . Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Inform patients with type 2 diabetes to contact their physician if changes in vision are experienced during treatment with WEGOVY [see Warnings and Precautions ( 5.7 )] .

Heart Rate Increase Instruct patients to inform their healthcare providers of palpitations or feelings of a racing heartbeat while at rest during WEGOVY treatment [see Warnings and Precautions ( 5.8 )] . Suicidal Behavior and Ideation Advise patients to report emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Inform patients that if they experience suicidal thoughts or behaviors, they should stop taking WEGOVY [see Warnings and Precautions ( 5.9 )] .

Pregnancy WEGOVY may cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients who are exposed to WEGOVY during pregnancy to contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com [see Use in Specific Populations ( 8.1 )] .

Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd Denmark For additional information about WEGOVY contact: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 1-833-934-6891 Version: 4 WEGOVY ® is a registered trademark of Novo Nordisk A/S. PATENT INFORMATION : http://www.novonordisk-us.com/products/product-patents.html © 2024 Novo Nordisk

Medication Guide Medication Guide WEGOVY ® (wee-GOH-vee) (semaglutide) injection, for subcutaneous use Read this Medication Guide and Instructions for Use before you start using WEGOVY 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 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).

What is WEGOVY? • WEGOVY is an injectable prescription medicine used with a reduced calorie diet and increased physical activity: o 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. o that may help adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off. • WEGOVY contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines. • It is not known if WEGOVY is safe and effective for use in children under 12 years of age.

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). • 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. Symptoms of a serious allergic reaction include: o swelling of your face, lips, tongue or throat o fainting or feeling dizzy o problems breathing or swallowing o very rapid heartbeat o severe rash or itching 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 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. o 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. • 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 th…