WEGOVY semaglutide 7.2 mg/.75mL Injection, Solution, 4 syringes

1 INDICATIONS AND USAGE WEGOVY injection is indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV 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. • for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults.

This indication is approved under accelerated approval based on improvement of MASH and fibrosis [see Clinical Studies ( 14.4 )] . Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial. WEGOVY tablets are indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse CV events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight. • to reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition.

Limitations of Use Concomitant use of WEGOVY (semaglutide) tablets or WEGOVY (semaglutide) injection 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. WEGOVY injection is indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV 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. ( 1 ) o adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) • for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults.

This indication is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial. ( 1 ) WEGOVY tablets are indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse CV events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight.

( 1 ) • to reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: • Concomitant use of WEGOVY (semaglutide) tablets or WEGOVY (semaglutide) injection with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended. ( 1 )

2 DOSAGE AND ADMINISTRATION In patients with diabetes, monitor blood glucose prior to starting and during WEGOVY treatment. ( 2.1 ) WEGOVY Injection • Administer WEGOVY injection 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 ) • Initiate at 0.25 mg once weekly for 4 weeks. Then follow the dosage escalation schedule in Table 1, titrating every 4 weeks to achieve the maintenance dosage. ( 2.2 ) • The usual recommended maintenance dosage of WEGOVY injection is 2.4 mg once weekly.

Refer to the full PI for maintenance dosages based on the indication. ( 2.2 ) WEGOVY Tablets • Take WEGOVY tablets orally once-daily on an empty stomach in the morning with water (up to 4 ounces). Do not take with other liquids besides water.

( 2.1 ) • Swallow tablets whole. Do not split, crush, chew or dissolve. ( 2.1 ) • After taking WEGOVY tablet wait at least 30 minutes before eating food, drinking beverages or taking other oral medications.

( 2.1 ) • Initiate WEGOVY tablet with a dosage of 1.5 mg once daily for 30 days. Then follow the dosage escalation schedule, titrating every 30 days to achieve the maintenance dosage. ( 2.2 ) • The recommended maintenance dosage of WEGOVY tablets is 25 mg orally once daily for cardiovascular risk reduction and weight reduction in adults.

( 2.3 )

2.1Important Monitoring and Administration Instructions In patients with diabetes mellitus, monitor blood glucose prior to starting WEGOVY and during WEGOVY treatment [see Warnings and Precautions (5.4 )] . Administer WEGOVY in combination with a reduced-calorie diet and increased physical activity. WEGOVY Injection • Inform patients and their caregiver(s) which WEGOVY presentation (e.g., single-dose pen or syringe, or WEGOVY FlexTouch single-patient-use pen) they will receive and ensure they receive training appropriate for that specific presentation.

If the prescribed WEGOVY presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation. • Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed WEGOVY presentation [see Instructions for Use ] . After training, a patient may self-inject WEGOVY if the healthcare provider determines that it can be properly administered, except for the following: o WEGOVY FlexTouch is not recommended for self-administration by those who are visually impaired. • Visually inspect the WEGOVY injection prior to each administration.

Only use if the solution is clear, colorless, and contains no particles. • Administer WEGOVY injection 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 the need for a dosage modification. • Rotate injection sites with each dose. WEGOVY Tablets • Take one WEGOVY tablet orally once daily on an empty stomach in the morning with water (up to 4 ounces).

Do not take WEGOVY tablets with other liquids besides water [see Clinical Pharmacology ( 12.3 )] . • Swallow tablets whole. Do not split, crush, chew or dissolve in any solution. • Do not take more than one tablet per day. • After taking a WEGOVY tablet, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications [see Clinical Pharmacology ( 12.3 )] .

2.2Recommended Dosage for WEGOVY Injection Recommended Starting Dosage and Dosage Escalation of WEGOVY Injection for All Approved Indications • The recommended starting dosage of WEGOVY injection is 0.25 mg administered subcutaneously once weekly. • Follow the dosage escalation in Table 1 to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.…

3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless solution available as follows: Single-Dose Pens Dose per Injection Total Strength per Total Volume 0.25 mg 0.25 mg/0.5 mL 0.5 mg 0.5 mg/0.5 mL 1 mg 1 mg/0.5 mL 1.7 mg 1.7 mg/0.75 mL 2.4 mg 2.4 mg/0.75 mL 7.2 mg (WEGOVY HD) 7.2 mg/0.75 mL Single-Patient-Use Pen (4 doses per Pen) (WEGOVY FlexTouch) Dose per Injection Total Strength per Total Volume 2.4 mg 9.6 mg/3 mL (3.2 mg/mL) Single-Dose Syringes Dose per Injection Total Strength per Total Volume 0.25 mg 0.25 mg/0.5 mL 0.5 mg 0.5 mg/0.5 mL 1 mg 1 mg/0.5 mL 1.7 mg 1.7 mg/0.75 mL 2.4 mg 2.4 mg/0.75 mL Tablets: available as: Tablet Strength Description 1.5 mg White to light yellow, round shaped debossed with “1.5” on one side and “novo” on the other side 4 mg White to light yellow, round shaped debossed with “4” on one side and “novo” on the other side 9 mg White to light yellow, round shaped debossed with “9” on one side and “novo” on the other side 25 mg White to light yellow, oval shaped debossed with “25” on one side and “novo” on the other side • Injection ( 3 ): o 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, or 7.2 mg/0.75 mL (WEGOVY HD) in a single-dose pen o 0.25 mg/0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL, or 2.4 mg/0.75 mL in a single-dose syringe o 9.6 mg/3 mL (3.2 mg/mL) solution in a single-patient-use pen (WEGOVY FlexTouch) that delivers four 2.4 mg/0.75 mL doses • Tablets: 1.5 mg, 4 mg, 9 mg and 25 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, Warnings and Precautions ( 5.1 )] .

Acute Pancreatitis Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that sometimes radiates to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue WEGOVY promptly and contact their physician if pancreatitis is suspected [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 )] . Acute Kidney Injury due to Volume Depletion Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion.

Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions ( 5.5 )] . Severe Gastrointestinal Adverse Reactions Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions ( 5.6 )].

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 ( 5.7 )] . 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 ( 5.8 )] .

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 ( 5.9 )] . Pulmonary Aspiration During General Anesthesia or Deep Sedation Inform patients that WEGOVY may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking WEGOVY [see Warnings and Precautions ( 5.10 )].

Never Share a WEGOVY FlexTouch Pen Between Patients Advise patients that they must never share a WEGOVY FlexTouch with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions ( 5.11 )] . Pregnancy WEGOVY…

Medication Guide MEDICATION GUIDE WEGOVY ® (wee-GOH-vee) (semaglutide) injection, for subcutaneous use WEGOVY ® (wee-GOH-vee) (semaglutide) tablets, for oral use Do not share your pen, Wegovy FlexTouch or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. 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 other 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 injection is a prescription medicine used with a reduced-calorie diet and increased physical activity to: o 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 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. o treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver. • WEGOVY tablets are a prescription medicine used with a reduced-calorie diet and increased physical activity to: o 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 help adults with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to lose 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 injection is safe and effective: o to reduce the risk of major cardiovascular events (death, heart attack, or stroke) in people under 18 years. o to help children under 12 years of age lose weight and keep the weight off. o for the treatment of MASH in people under 18 years of age. • It is not known if WEGOVY tablets are safe and effective for use in people under 18 years of age.

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 injection or WEGOVY tablets. See the end of this Medication Guide for a complete list of ingredients in WEGOVY injection and WEGOVY tablets. See “ What are the possible side effects of WEGOVY? ” for symptoms of a serious allergic reaction.

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. • 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 b…