Get your patient on Wegovy (Semaglutide)

Indications and Usage (

Dosage and Administration (

Warnings and Precautions,

•  Acute Kidney Injury Due to Volume Depletion (
  5.5 Acute Kidney Injury Due to Volume Depletion

  There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide

  [see Adverse Reactions (

  6)]

  . The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea

  [see Adverse Reactions (6)]

  .

  Monitor renal function in patients reporting adverse reactions to WEGOVY that could lead to volume depletion, especially during dosage initiation and escalation of WEGOVY.
  )..………….08/2025
•  Severe Gastrointestinal Adverse Reactions (
  5.6 Severe Gastrointestinal Adverse Reactions

  Use of WEGOVY has been associated with gastrointestinal adverse reactions, sometimes severe

  [see Adverse Reactions (6.1)]

  . In clinical trials for adults for weight reduction, severe gastrointestinal adverse reactions were reported more frequently among patients receiving WEGOVY than placebo. Severe gastrointestinal adverse reactions were reported in 4.1% and 0.9% of WEGOVY-injection and placebo-treated patients, respectively, and in 2% of WEGOVY tablet-treated and 0% of placebo-treated patients, respectively. Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.

  WEGOVY is not recommended in patients with severe gastroparesis.
  )………………..10/2025

• •
  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 Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis with Moderate to Advanced Liver Fibrosis in Adults Treated with WEGOVY Injection

  Overview of Clinical Trial

  The efficacy of WEGOVY injection was evaluated based on an efficacy analysis at Week 72 in Study 9 (NCT#04822181), a 240-week, randomized, double-blind, placebo-controlled trial. Enrolled patients had a baseline or recent liver biopsy showing clinically significant MASLD (metabolic dysfunction-associated steatotic liver disease), defined as MASH with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) ≥4 with a score of 1 or more in steatosis, lobular inflammation, and hepatocyte ballooning. Efficacy determination was based on the effect of WEGOVY injection on resolution of steatohepatitis without worsening of liver fibrosis and on at least one stage improvement in liver fibrosis without worsening of steatohepatitis, on post-baseline liver biopsies collected at 72 weeks.

  The Week 72 analysis included 800 F2 and F3 (at eligibility) patients randomized 1:2 to receive placebo (n=266) or WEGOVY once weekly (n=534), in addition to standard of care for cardiometabolic comorbidities and healthy lifestyle counseling. WEGOVY injection or matching placebo was escalated to 2.4 mg once weekly during the initial 16 weeks of the treatment period. Dose escalation could be prolonged or patients could remain at a lower dose if 2.4 mg once weekly was not tolerable.

  Demographic and baseline characteristics were balanced between treatment and placebo groups. Overall, the median (Q1 to Q3) age of patients at baseline was 57 (49 to 65) years, 57% were female, 18% were Hispanic, 68% were White, 27% were Asian, and 0.6% were Black or African American. Median (Q1 to Q3) body mass index (BMI) was 34 (30 to 38) kg/m²and median (Q1 to Q3) body weight was 93 (79 to 110) kg. Baseline characteristics are presented in

  Table 17

  .

  Table 17. Baseline Characteristics in Adults Patients with Noncirrhotic MASH with Stage 2 to Stage 3 Fibrosis in Study 9

  Characteristic	Overall (N=800)
  Fibrosis stage, n (%) F2 F3	250 (31) 550 (69)
  Body Mass Index (BMI, kg/m2), n (%)a <25 25-30 30-35 ≥35	53 (7) 164 (21) 252 (32) 330 (41)
  Lean MASH, n (%)b	22 (3)
  Type 2 Diabetes, n (%)	447 (56)
  Hypertension, n (%)	503 (63)
  Dyslipidemia, n (%)	198 (25)
  Statin use, n (%)	300 (38)
  Fibrosis Index Based on 4 Factors (FIB-4), Median (Q1, Q3)a	1.6 (1.1, 2.3)
  Enhanced Liver Fibrosis (ELF), Median (Q1, Q3)	9.9 (9.3, 10.5)

  ^aLess than 5% missingness in the variable is omitted.

  ^bLean MASH defined as BMI <25 kg/m²for non-Asian patients and BMI <23 kg/m²for Asian patients.

  Among the 79% of the patients with vibration-controlled transient elastography (VCTE) at baseline, median (Q1 to Q3) VCTE was 10.9 (8.6 to 15.5) kPa, which may not be representative of the entire study population. The 21% of patients with missing VCTE at baseline had higher percentages of being female and having baseline diabetes, hypertension, and dyslipidemia.

  Results

  Table 18

  presents the Week 72 histopathology primary endpoint results comparing WEGOVY injection with placebo on

  1) the estimated percentage of patients with resolution of steatohepatitis and no worsening of liver fibrosis and
  
  2) the estimated percentage of patients with at least one stage improvement in liver fibrosis and no worsening of steatohepatitis. The secondary endpoint results of the estimated percentage of patients with resolution of steatohepatitis and improvement in liver fibrosis at Week 72 are also presented. Two pathologists independently read the liver biopsies for each patient; a third pathologist performed adjudication if consensus could not be reached between the two pathologists. WEGOVY injection demonstrated improvement on these histopathology endpoints at Week 72 compared to placebo.

  Table 18. Efficacy Results at Week 72 in Adult Patients with Noncirrhotic MASH with Stage 2 or

  Stage 3 Fibrosis in Study 9 of WEGOVY Injection

  	Placebo N=266	WEGOVY Injection N=534
  Resolution of steatohepatitis and no worsening of liver fibrosis
  Response Rate (%)	34	63
  Difference in response rate vs. placebo (95% CI)		29 (21, 36)*
  Improvement in liver fibrosis and no worsening of steatohepatitis
  Response Rate (%)	22	37
  Difference in response rate vs. placebo (95% CI)		14 (8, 21)*
  Resolution of steatohepatitis and improvement in liver fibrosis
  Response Rate (%)	16	33
  Difference in response rate vs. placebo (95% CI)		17 (10, 23)*

  ^*Results were statistically significant.

  Endpoints were evaluated according to the MASH Clinical Research Network (CRN). Resolution of steatohepatitis is defined as a score of 0 to 1 for lobular inflammation, 0 for ballooning, and any value for steatosis. No worsening of steatohepatitis is defined as no increase from baseline in score for ballooning, lobular inflammation, or steatosis.

  Estimated using pooled Mantel-Haenszel (MH) estimates stratified by baseline type 2 diabetes status (presence or absence) and baseline fibrosis stage (F2 or F3) with missing data handled by reference-based multiple imputation and 95% confidence intervals (CIs) calculated using Rubin’s rule to pool Sato’s estimate of standard errors across the imputed datasets.

  Another secondary endpoint was the percent change in body weight from baseline to Week 72. Patients treated with WEGOVY injection (mean baseline body weight 95.4 kg) achieved an average of 10.5% weight loss from baseline at Week 72, and patients treated with placebo (mean baseline weight 97.6 kg) achieved an average of 2% weight loss from baseline at Week 72; treatment with WEGOVY injection resulted in an average of 8.5% greater weight loss from baseline compared to placebo (95% CI: 7.4% to 9.5%).

  Starting at Week 12 and through Week 72, there was a trend of greater reductions from baseline in average ALT and AST in the WEGOVY injection group as compared to the placebo group.

  )]

  . Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.

• •
  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.

In patients with diabetes, monitor blood glucose prior to starting and during WEGOVY treatment. (

• •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 Important 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

  • •
    Prior to initiation of WEGOVY injection, train patients on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations.
  • •
    Visually inspect the WEGOVY injection prior to each administration. Only use if 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.

  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)]

    .
  • •
    Do not take more than one tablet per day.
  • •
    Swallow tablets whole. Do not split, crush, chew or dissolve in any solution.
  • •
    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)]

    .
  )
• •Inject subcutaneously in the abdomen, thigh, or upper arm. (
  2.1 Important 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

  • •
    Prior to initiation of WEGOVY injection, train patients on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations.
  • •
    Visually inspect the WEGOVY injection prior to each administration. Only use if 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.

  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)]

    .
  • •
    Do not take more than one tablet per day.
  • •
    Swallow tablets whole. Do not split, crush, chew or dissolve in any solution.
  • •
    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)]

    .
  )
• •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 Recommended 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 (6.1)]

    .
  • •
    If patients do not tolerate a dose during dosage escalation, consider delaying dosage escalation for 4 weeks.

  Table 1. Recommended Starting Dosage and Dosage Escalation of WEGOVY Injection for All Approved Indications in Adults and Pediatric Patients Aged 12 Years and Older

  	Weeks	Once-weekly Subcutaneous Injection Dosage
  Starting Dosage	1 through 4	0.25 mg
  Dosage Escalation	5 through 8	0.5 mg
  	9 through 12	1 mg
  	13 through 16	1.7 mg
  Maintenance Dosage	17 and onward	See the indication below for the recommended maintenance dosage(s)

  Recommended Maintenance Dosage of WEGOVY Injection for Approved Indications

  Cardiovascular Risk Reduction in Adults

  • •
    The maintenance dosage of WEGOVY injection for cardiovascular risk reduction 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 Adverse Reactions (6.1), Clinical Studies (14.1)]

    .

  Weight Reduction in Adults and Pediatric Patients Aged 12 Years and Older

  The maintenance dosage of WEGOVY injection for weight reduction in adults and pediatric patients aged 12 years and older is either 2.4 mg (recommended) or 1.7 mg once weekly.

  Consider treatment response and tolerability when selecting the maintenance dosage

  [see Adverse Reactions (6.1), Clinical Studies (14.2,14.3)]

  .

  Noncirrhotic MASH with Moderate to Advanced Liver Fibrosis in Adults

  The recommended maintenance dosage of WEGOVY injection for the treatment of noncirrhotic MASH with moderate to advanced liver fibrosis in adults is 2.4 mg injected subcutaneously once weekly. If patients do not tolerate the maintenance dosage of 2.4 mg once weekly, the dosage can be decreased to 1.7 mg once weekly. Consider reescalation to 2.4 mg once weekly

  [see Adverse Reactions (6.1), Clinical Studies (14.4)]

  .
  )
• •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 Recommended 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 (6.1)]

    .
  • •
    If patients do not tolerate a dose during dosage escalation, consider delaying dosage escalation for 4 weeks.

  Table 1. Recommended Starting Dosage and Dosage Escalation of WEGOVY Injection for All Approved Indications in Adults and Pediatric Patients Aged 12 Years and Older

  	Weeks	Once-weekly Subcutaneous Injection Dosage
  Starting Dosage	1 through 4	0.25 mg
  Dosage Escalation	5 through 8	0.5 mg
  	9 through 12	1 mg
  	13 through 16	1.7 mg
  Maintenance Dosage	17 and onward	See the indication below for the recommended maintenance dosage(s)

  Recommended Maintenance Dosage of WEGOVY Injection for Approved Indications

  Cardiovascular Risk Reduction in Adults

  • •
    The maintenance dosage of WEGOVY injection for cardiovascular risk reduction 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 Adverse Reactions (6.1), Clinical Studies (14.1)]

    .

  Weight Reduction in Adults and Pediatric Patients Aged 12 Years and Older

  The maintenance dosage of WEGOVY injection for weight reduction in adults and pediatric patients aged 12 years and older is either 2.4 mg (recommended) or 1.7 mg once weekly.

  Consider treatment response and tolerability when selecting the maintenance dosage

  [see Adverse Reactions (6.1), Clinical Studies (14.2,14.3)]

  .

  Noncirrhotic MASH with Moderate to Advanced Liver Fibrosis in Adults

  The recommended maintenance dosage of WEGOVY injection for the treatment of noncirrhotic MASH with moderate to advanced liver fibrosis in adults is 2.4 mg injected subcutaneously once weekly. If patients do not tolerate the maintenance dosage of 2.4 mg once weekly, the dosage can be decreased to 1.7 mg once weekly. Consider reescalation to 2.4 mg once weekly

  [see Adverse Reactions (6.1), Clinical Studies (14.4)]

  .
  )

• •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 Important 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

  • •
    Prior to initiation of WEGOVY injection, train patients on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations.
  • •
    Visually inspect the WEGOVY injection prior to each administration. Only use if 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.

  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)]

    .
  • •
    Do not take more than one tablet per day.
  • •
    Swallow tablets whole. Do not split, crush, chew or dissolve in any solution.
  • •
    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)]

    .
  ).
• •Swallow tablets whole. Do not split, crush, chew or dissolve. (
  2.1 Important 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

  • •
    Prior to initiation of WEGOVY injection, train patients on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations.
  • •
    Visually inspect the WEGOVY injection prior to each administration. Only use if 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.

  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)]

    .
  • •
    Do not take more than one tablet per day.
  • •
    Swallow tablets whole. Do not split, crush, chew or dissolve in any solution.
  • •
    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)]

    .
  )
• •After taking WEGOVY tablet wait at least 30 minutes before eating food, drinking beverages or taking other oral medications. (
  2.1 Important 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

  • •
    Prior to initiation of WEGOVY injection, train patients on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations.
  • •
    Visually inspect the WEGOVY injection prior to each administration. Only use if 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.

  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)]

    .
  • •
    Do not take more than one tablet per day.
  • •
    Swallow tablets whole. Do not split, crush, chew or dissolve in any solution.
  • •
    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)]

    .
  )
• •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 Recommended 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 (6.1)]

    .
  • •
    If patients do not tolerate a dose during dosage escalation, consider delaying dosage escalation for 4 weeks.

  Table 1. Recommended Starting Dosage and Dosage Escalation of WEGOVY Injection for All Approved Indications in Adults and Pediatric Patients Aged 12 Years and Older

  	Weeks	Once-weekly Subcutaneous Injection Dosage
  Starting Dosage	1 through 4	0.25 mg
  Dosage Escalation	5 through 8	0.5 mg
  	9 through 12	1 mg
  	13 through 16	1.7 mg
  Maintenance Dosage	17 and onward	See the indication below for the recommended maintenance dosage(s)

  Recommended Maintenance Dosage of WEGOVY Injection for Approved Indications

  Cardiovascular Risk Reduction in Adults

  • •
    The maintenance dosage of WEGOVY injection for cardiovascular risk reduction 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 Adverse Reactions (6.1), Clinical Studies (14.1)]

    .

  Weight Reduction in Adults and Pediatric Patients Aged 12 Years and Older

  The maintenance dosage of WEGOVY injection for weight reduction in adults and pediatric patients aged 12 years and older is either 2.4 mg (recommended) or 1.7 mg once weekly.

  Consider treatment response and tolerability when selecting the maintenance dosage

  [see Adverse Reactions (6.1), Clinical Studies (14.2,14.3)]

  .

  Noncirrhotic MASH with Moderate to Advanced Liver Fibrosis in Adults

  The recommended maintenance dosage of WEGOVY injection for the treatment of noncirrhotic MASH with moderate to advanced liver fibrosis in adults is 2.4 mg injected subcutaneously once weekly. If patients do not tolerate the maintenance dosage of 2.4 mg once weekly, the dosage can be decreased to 1.7 mg once weekly. Consider reescalation to 2.4 mg once weekly

  [see Adverse Reactions (6.1), Clinical Studies (14.4)]

  .
  )
• •The recommended maintenance dosage of WEGOVY tablets is 25 mg orally once daily for cardiovascular risk reduction and weight reduction in adults

Injection: clear, colorless solution available in 5 prefilled, 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

Tablet: white to light yellow, round shaped debossed with the strength on one side and “novo” on the other side:

• •1.5 mg
• •4 mg
• •9 mg

Tablet: white to light yellow, oval shaped debossed with the strength on one side and “novo” on the other side:

• •25 mg

• •
  Pregnancy
  : May cause fetal harm. For patients receiving WEGOVY for CV risk reduction or weight reduction, discontinue WEGOVY when pregnancy is recognized. For patients with MASH, use during pregnancy only if the potential benefit justifies the potential risk to the fetus. (
  8.1 Pregnancy

  Pregnancy Exposure Registry

  There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. Pregnant women exposed to WEGOVY and healthcare providers are encouraged to contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com.

  Risk Summary

  Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. Available pharmacovigilance data and data from clinical trials with WEGOVY use in pregnant patients are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

  Weight loss offers no benefit to a pregnant patient and may cause fetal harm. When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue WEGOVY (see

  Clinical Considerations

  ).

  There may be risks to the mother and fetus related to underlying MASH with advanced liver fibrosis (see

  Clinical Considerations

  ). Whether semaglutide treatment during pregnancy reduces these risks is unknown. WEGOVY for the treatment of MASH should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

  In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at below the MRHD (rabbit) and greater than or equal to 2-fold the MRHD (monkey). These findings coincided with a marked maternal body weight loss in both animal species (see

  Data

  ).

  The background risk of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

  Clinical Considerations

  Disease-associated maternal and/or embryo/fetal risk

  Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who already have overweight or obesity, because of the obligatory weight gain that occurs in maternal tissues during pregnancy.

  There may be risks to the mother and fetus related to MASH with advanced liver fibrosis, such as increased risks of gestational diabetes, hypertensive complications, preterm birth, and postpartum hemorrhage. The effect of semaglutide on these risks is unknown.

  Data

  Animal Data

  In a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03, and 0.09 mg/kg/day (0.04-, 0.1-, and 0.4-fold the MRHD) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to Gestation Day 17. In parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure.

  In an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.001, 0.0025, or 0.0075 mg/kg/day (0.01-, 0.1-, and 0.9-fold the MRHD) were administered throughout organogenesis from Gestation Day 6 to 19. Pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. Early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at greater than or equal to 0.0025 mg/kg/day, at clinically relevant exposures.

  In an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (0.4-, 2-, and 6-fold the MRHD) were administered throughout organogenesis, from Gestation Day 16 to 50. Pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at greater than or equal to 0.075 mg/kg twice weekly (greater than or equal to 2 times human exposure).

  In a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (0.2-, 1-, and 3-fold the MRHD) were administered from Gestation Day 16 to 140. Pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to delivery of slightly smaller offspring at greater than or equal to 0.075 mg/kg twice weekly (greater than or equal to 1-time human exposure).

  Salcaprozate sodium (SNAC), an absorption enhancer in WEGOVY tablets, crosses the placenta and reaches fetal tissues in rats. In a pre- and postnatal development study in pregnant Sprague Dawley rats, SNAC was administered orally at 1,000 mg/kg/day (exposure levels were not measured) on Gestation Day 7 through lactation Day 20. An increase in gestation length, an increase in the number of stillbirths and a decrease in pup viability were observed.
  )
• •
  Lactation
  : Breastfeeding not recommended during treatment with WEGOVY tablets. (
  8.2 Lactation

  Risk Summary

  WEGOVY Oral Tablets

  Data from a clinical lactation study with semaglutide oral tablet formulation reported semaglutide concentrations below the lower limit of quantification in human milk. However, SNAC and/or its metabolites are present in human milk. Since the activity of enzymes involved in SNAC clearance may be lower in infants compared to adults, higher SNAC plasma levels may occur in neonates and infants. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, and because there are alternative formulations of semaglutide that do not contain SNAC that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with WEGOVY tablets.

  WEGOVY Subcutaneous Injection

  There are no data on the presence of subcutaneously administered semaglutide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. WEGOVY subcutaneous injection does not contain the SNAC metabolites.

  The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for WEGOVY and any potential adverse effects on the breastfed infant from WEGOVY or from the underlying maternal condition.
  )
• •
  Females and Males of Reproductive Potential
  : For patients receiving WEGOVY for CV risk reduction or weight reduction, or for MASH where the potential risk outweighs the potential benefit, discontinue WEGOVY at least 2 months before a planned pregnancy because of the long half-life of semaglutide. (
  8.3 Females and Males of Reproductive Potential

  Because of the potential for fetal harm, discontinue WEGOVY in patients at least 2 months before they plan to become pregnant to account for the long half-life of semaglutide

  [see Use in Specific Populations (8.1)]

  .
  )

WEGOVY is contraindicated in the following conditions:

• •A personal or family history of MTC or in patients with MEN 2
  [see Warnings and Precautions (

  5.1 Risk of Thyroid C-Cell Tumors

  In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures

  [see Nonclinical Toxicology (

  13.1

  )]

  . It is unknown whether WEGOVY causes thyroid C-cell tumors, including MTC, in humans, as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.

  Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.

  WEGOVY is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of WEGOVY and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

  Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with WEGOVY. Such monitoring may increase the risk of unnecessary procedures, due to the low-test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values greater than 50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

  )]
  .
• •A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in WEGOVY injection or WEGOVY tablet. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with WEGOVY
  [see Warnings and Precautions (

  5.7 Hypersensitivity Reactions

  Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with WEGOVY. If hypersensitivity reactions occur, discontinue use of WEGOVY, treat promptly per standard of care, and monitor until signs and symptoms resolve. WEGOVY is contraindicated in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in WEGOVY

  [see Adverse Reactions (6.2)]

  .

  Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with WEGOVY.

  )]
  .

• •
  Acute Pancreatitis
  : Has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY. Discontinue if pancreatitis is suspected. (
  5.2 Acute Pancreatitis

  Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY

  [see Adverse Reactions (6)]

  . After initiation of WEGOVY, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue WEGOVY and initiate appropriate management.
  )
• •
  Acute Gallbladder Disease
  : Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated. (
  5.3 Acute Gallbladder Disease

  Treatment with WEGOVY is associated with an increased occurrence of cholelithiasis and cholecystitis. The incidence of cholelithiasis and cholecystitis was higher in WEGOVY injection-treated pediatric patients aged 12 years and older than in WEGOVY injection-treated adults. In randomized clinical trials in adults for weight reduction, cholelithiasis was reported by 1.6% of WEGOVY injection-treated patients and 0.7% of placebo injection-treated patients, and by 2.5% of WEGOVY tablet-treated patients and 1% of placebo tablet-treated patients. Cholecystitis was reported by 0.6% of WEGOVY injection-treated adult patients and 0.2% of placebo- treated patients. In a clinical trial in pediatric patients aged 12 years and older for weight reduction, cholelithiasis was reported by 3.8% of WEGOVY injection-treated patients and 0% placebo-treated patients. Cholecystitis was reported by 0.8% of WEGOVY injection-treated pediatric patients and 0% placebo-treated patients

  [see Adverse Reactions (

  6.1)]

  .

  Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in WEGOVY-treated patients than in placebo-treated patients, even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
  )
• •
  Hypoglycemia
  : Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. (
  5.4 Hypoglycemia

  WEGOVY lowers blood glucose and can cause hypoglycemia.

  In a trial of WEGOVY injection in adult patients with type 2 diabetes and body mass index (BMI) greater than or equal to 27 kg/m²for weight reduction (Study 3), hypoglycemia (defined as a plasma glucose less than 54 mg/dL) was reported in more patients treated with WEGOVY versus placebo

  [see Adverse Reaction (6.1)]

  . One episode of severe hypoglycemia (requiring the assistance of another person) was reported in one WEGOVY treated patient versus no placebo-treated patients

  [see Clinical Studies (14.2)]

  .

  In glycemic control clinical trials, the risk of hypoglycemia was increased when semaglutide injection or tablet was used concomitantly with insulin or an insulin secretagogue (e.g., sulfonylurea). Patients with diabetes mellitus taking WEGOVY in combination with insulin or an insulin secretagogue may have an increased risk of hypoglycemia, including severe hypoglycemia. The use of WEGOVY in patients with type 1 diabetes mellitus or in combination with insulin has not been evaluated.

  Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes, monitor blood glucose prior to starting WEGOVY and during WEGOVY treatment. When initiating WEGOVY, consider reducing the dose of concomitantly administered insulin or insulin secretagogue to reduce the risk of hypoglycemia

  [see Drug Interactions (7.1)]

  .
  )
• •
  Acute Kidney Injury Due to Volume Depletion
  : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. (
  5.5 Acute Kidney Injury Due to Volume Depletion

  There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide

  [see Adverse Reactions (

  6)]

  . The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea

  [see Adverse Reactions (6)]

  .

  Monitor renal function in patients reporting adverse reactions to WEGOVY that could lead to volume depletion, especially during dosage initiation and escalation of WEGOVY.
  )
• •
  Severe Gastrointestinal Adverse Reactions
  : Use has been associated with gastrointestinal adverse reactions, sometimes severe. WEGOVY is not recommended in patients with severe gastroparesis. (
  5.6 Severe Gastrointestinal Adverse Reactions

  Use of WEGOVY has been associated with gastrointestinal adverse reactions, sometimes severe

  [see Adverse Reactions (6.1)]

  . In clinical trials for adults for weight reduction, severe gastrointestinal adverse reactions were reported more frequently among patients receiving WEGOVY than placebo. Severe gastrointestinal adverse reactions were reported in 4.1% and 0.9% of WEGOVY-injection and placebo-treated patients, respectively, and in 2% of WEGOVY tablet-treated and 0% of placebo-treated patients, respectively. Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.

  WEGOVY is not recommended in patients with severe gastroparesis.
  )
• •
  Hypersensitivity Reactions
  : Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue WEGOVY if suspected and promptly seek medical advice. (
  5.7 Hypersensitivity Reactions

  Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with WEGOVY. If hypersensitivity reactions occur, discontinue use of WEGOVY, treat promptly per standard of care, and monitor until signs and symptoms resolve. WEGOVY is contraindicated in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in WEGOVY

  [see Adverse Reactions (6.2)]

  .

  Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with WEGOVY.
  )
• •
  Diabetic Retinopathy Complications in Patients with Type 2 Diabetes
  : Has been reported in trials with semaglutide. Patients with a history of diabetic retinopathy should be monitored. (
  5.8 Diabetic Retinopathy Complications in Patients with Type 2 Diabetes

  In a 2-year trial with semaglutide 0.5 mg and 1 mg once-weekly injection in adult patients with type 2 diabetes and high CV risk, diabetic retinopathy complications (which was a 4-component adjudicated endpoint) occurred in patients treated with semaglutide injection (3%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline (semaglutide injection 8.2%, placebo 5.2%) than among patients without a known history of diabetic retinopathy (semaglutide injection 0.7%, placebo 0.4%).

  In a trial of adult patients with type 2 diabetes and BMI greater than or equal to 27 kg/m²for weight reduction (Study 3), diabetic retinopathy was reported by 4% of WEGOVY injection-treated patients and 2.7% placebo-treated patients

  [see Clinical Studies (14.2)]

  .

  In a glycemic control trial evaluating a dose comparable to the 9 mg dose and the 25 mg semaglutide tablet dose in patients with type 2 diabetes, a similar proportion of patients in each dose group reported diabetic retinopathy related adverse reactions during the trial; 1.3% and 1.9% of patients in the 9 mg and 25 mg semaglutide group, respectively, reported moderate-severe non-proliferative diabetic retinopathy events, and 0% and 0.4% reported proliferative retinopathy events, respectively.

  Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
  )
• •
  Heart Rate Increase
  : Monitor heart rate at regular intervals. (
  5.9 Heart Rate Increase

  Treatment with WEGOVY was associated with increases in resting heart rate. Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed in WEGOVY injection-treated adult patients compared to placebo in clinical trials for weight reduction. More adult patients treated with WEGOVY injection compared with placebo had maximum changes from baseline at any visit of 10 to 19 bpm (41% versus 34%, respectively) and 20 bpm or more (26% versus 16%, respectively). In a clinical trial in pediatric patients aged 12 years and older with normal baseline heart rate, more patients treated with WEGOVY injection compared to placebo had maximum changes in heart rate of 20 bpm or more (54% versus 39%)

  [see Adverse Reactions (

  6.1)]

  . Findings were similar in a trial with the WEGOVY tablets.

  Monitor heart rate at regular intervals consistent with usual clinical practice. Instruct patients to inform their healthcare providers of palpitations or feelings of a racing heartbeat while at rest during WEGOVY treatment. If patients experience a sustained increase in resting heart rate, discontinue WEGOVY.
  )
• •
  Suicidal Behavior and Ideation
  : Monitor for depression or suicidal thoughts. Discontinue WEGOVY if symptoms develop. (
  5.10 Suicidal Behavior and Ideation

  Suicidal behavior and ideation have been reported in clinical trials with other weight management products. Monitor patients treated with WEGOVY for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue WEGOVY in patients who experience suicidal thoughts or behaviors. Avoid WEGOVY in patients with a history of suicidal attempts or active suicidal ideation.
  )
• •
  Pulmonary Aspiration During General Anesthesia or Deep Sedation
  : Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. (
  5.11 Pulmonary Aspiration During General Anesthesia or Deep Sedation

  WEGOVY delays gastric emptying

  [see Clinical Pharmacology (

  12.2

  )]

  . There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.

  Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking WEGOVY, including whether modifying preoperative fasting recommendations or temporarily discontinuing WEGOVY could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking WEGOVY.
  )

The following serious adverse reactions are described below or elsewhere in the prescribing information:

• •Risk of Thyroid C-Cell Tumors
  [see Warnings and Precautions (

  5.1 Risk of Thyroid C-Cell Tumors

  In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures

  [see Nonclinical Toxicology (

  13.1

  )]

  . It is unknown whether WEGOVY causes thyroid C-cell tumors, including MTC, in humans, as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.

  Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.

  WEGOVY is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of WEGOVY and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

  Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with WEGOVY. Such monitoring may increase the risk of unnecessary procedures, due to the low-test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values greater than 50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

  )]
• •Acute Pancreatitis
  [see Warnings and Precautions (

  5.2 Acute Pancreatitis

  Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY

  [see Adverse Reactions (6)]

  . After initiation of WEGOVY, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue WEGOVY and initiate appropriate management.

  )]
• •Acute Gallbladder Disease
  [see Warnings and Precautions (

  5.3 Acute Gallbladder Disease

  Treatment with WEGOVY is associated with an increased occurrence of cholelithiasis and cholecystitis. The incidence of cholelithiasis and cholecystitis was higher in WEGOVY injection-treated pediatric patients aged 12 years and older than in WEGOVY injection-treated adults. In randomized clinical trials in adults for weight reduction, cholelithiasis was reported by 1.6% of WEGOVY injection-treated patients and 0.7% of placebo injection-treated patients, and by 2.5% of WEGOVY tablet-treated patients and 1% of placebo tablet-treated patients. Cholecystitis was reported by 0.6% of WEGOVY injection-treated adult patients and 0.2% of placebo- treated patients. In a clinical trial in pediatric patients aged 12 years and older for weight reduction, cholelithiasis was reported by 3.8% of WEGOVY injection-treated patients and 0% placebo-treated patients. Cholecystitis was reported by 0.8% of WEGOVY injection-treated pediatric patients and 0% placebo-treated patients

  [see Adverse Reactions (

  6.1)]

  .

  Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in WEGOVY-treated patients than in placebo-treated patients, even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

  )]
• •Hypoglycemia
  [see Warnings and Precautions (

  5.4 Hypoglycemia

  WEGOVY lowers blood glucose and can cause hypoglycemia.

  In a trial of WEGOVY injection in adult patients with type 2 diabetes and body mass index (BMI) greater than or equal to 27 kg/m²for weight reduction (Study 3), hypoglycemia (defined as a plasma glucose less than 54 mg/dL) was reported in more patients treated with WEGOVY versus placebo

  [see Adverse Reaction (6.1)]

  . One episode of severe hypoglycemia (requiring the assistance of another person) was reported in one WEGOVY treated patient versus no placebo-treated patients

  [see Clinical Studies (14.2)]

  .

  In glycemic control clinical trials, the risk of hypoglycemia was increased when semaglutide injection or tablet was used concomitantly with insulin or an insulin secretagogue (e.g., sulfonylurea). Patients with diabetes mellitus taking WEGOVY in combination with insulin or an insulin secretagogue may have an increased risk of hypoglycemia, including severe hypoglycemia. The use of WEGOVY in patients with type 1 diabetes mellitus or in combination with insulin has not been evaluated.

  Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes, monitor blood glucose prior to starting WEGOVY and during WEGOVY treatment. When initiating WEGOVY, consider reducing the dose of concomitantly administered insulin or insulin secretagogue to reduce the risk of hypoglycemia

  [see Drug Interactions (7.1)]

  .

  )]
• •Acute Kidney Injury due to Volume Depletion
  [see Warnings and Precautions (

  5.5 Acute Kidney Injury Due to Volume Depletion

  There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide

  [see Adverse Reactions (

  6)]

  . The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea

  [see Adverse Reactions (6)]

  .

  Monitor renal function in patients reporting adverse reactions to WEGOVY that could lead to volume depletion, especially during dosage initiation and escalation of WEGOVY.

  )]
• •Severe Gastrointestinal Adverse Reactions
  [see Warnings and Precautions (

  5.6 Severe Gastrointestinal Adverse Reactions

  Use of WEGOVY has been associated with gastrointestinal adverse reactions, sometimes severe

  [see Adverse Reactions (6.1)]

  . In clinical trials for adults for weight reduction, severe gastrointestinal adverse reactions were reported more frequently among patients receiving WEGOVY than placebo. Severe gastrointestinal adverse reactions were reported in 4.1% and 0.9% of WEGOVY-injection and placebo-treated patients, respectively, and in 2% of WEGOVY tablet-treated and 0% of placebo-treated patients, respectively. Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.

  WEGOVY is not recommended in patients with severe gastroparesis.

  )]
• •Hypersensitivity Reactions
  [see Warnings and Precautions (

  5.7 Hypersensitivity Reactions

  Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with WEGOVY. If hypersensitivity reactions occur, discontinue use of WEGOVY, treat promptly per standard of care, and monitor until signs and symptoms resolve. WEGOVY is contraindicated in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in WEGOVY

  [see Adverse Reactions (6.2)]

  .

  Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with WEGOVY.

  )]
• •Diabetic Retinopathy Complications in Patients with Type 2 Diabetes
  [see Warnings and Precautions (

  5.8 Diabetic Retinopathy Complications in Patients with Type 2 Diabetes

  In a 2-year trial with semaglutide 0.5 mg and 1 mg once-weekly injection in adult patients with type 2 diabetes and high CV risk, diabetic retinopathy complications (which was a 4-component adjudicated endpoint) occurred in patients treated with semaglutide injection (3%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline (semaglutide injection 8.2%, placebo 5.2%) than among patients without a known history of diabetic retinopathy (semaglutide injection 0.7%, placebo 0.4%).

  In a trial of adult patients with type 2 diabetes and BMI greater than or equal to 27 kg/m²for weight reduction (Study 3), diabetic retinopathy was reported by 4% of WEGOVY injection-treated patients and 2.7% placebo-treated patients

  [see Clinical Studies (14.2)]

  .

  In a glycemic control trial evaluating a dose comparable to the 9 mg dose and the 25 mg semaglutide tablet dose in patients with type 2 diabetes, a similar proportion of patients in each dose group reported diabetic retinopathy related adverse reactions during the trial; 1.3% and 1.9% of patients in the 9 mg and 25 mg semaglutide group, respectively, reported moderate-severe non-proliferative diabetic retinopathy events, and 0% and 0.4% reported proliferative retinopathy events, respectively.

  Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

  )]
• •Heart Rate Increase
  [see Warnings and Precautions (

  5.9 Heart Rate Increase

  Treatment with WEGOVY was associated with increases in resting heart rate. Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed in WEGOVY injection-treated adult patients compared to placebo in clinical trials for weight reduction. More adult patients treated with WEGOVY injection compared with placebo had maximum changes from baseline at any visit of 10 to 19 bpm (41% versus 34%, respectively) and 20 bpm or more (26% versus 16%, respectively). In a clinical trial in pediatric patients aged 12 years and older with normal baseline heart rate, more patients treated with WEGOVY injection compared to placebo had maximum changes in heart rate of 20 bpm or more (54% versus 39%)

  [see Adverse Reactions (

  6.1)]

  . Findings were similar in a trial with the WEGOVY tablets.

  Monitor heart rate at regular intervals consistent with usual clinical practice. Instruct patients to inform their healthcare providers of palpitations or feelings of a racing heartbeat while at rest during WEGOVY treatment. If patients experience a sustained increase in resting heart rate, discontinue WEGOVY.

  )]
• •Suicidal Behavior and Ideation
  [see Warnings and Precautions (

  5.10 Suicidal Behavior and Ideation

  Suicidal behavior and ideation have been reported in clinical trials with other weight management products. Monitor patients treated with WEGOVY for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue WEGOVY in patients who experience suicidal thoughts or behaviors. Avoid WEGOVY in patients with a history of suicidal attempts or active suicidal ideation.

  )]
• •Pulmonary Aspiration During General Anesthesia or Deep Sedation
  [see Warnings and Precautions (

  5.11 Pulmonary Aspiration During General Anesthesia or Deep Sedation

  WEGOVY delays gastric emptying

  [see Clinical Pharmacology (

  12.2

  )]

  . There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.

  Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking WEGOVY, including whether modifying preoperative fasting recommendations or temporarily discontinuing WEGOVY could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking WEGOVY.

  )]

WEGOVY delays gastric emptying. May impact absorption of concomitantly administered oral medications. Consider increased clinical or laboratory monitoring when used concomitantly with other oral medications that have a narrow therapeutic index or that require clinical monitoring. (

WEGOVY contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C₁₈₇H₂₉₁N₄₅O₅₉ and the molecular weight is 4113.58 g/mol.

•  
  Figure 1. Structural Formula of Semaglutide

WEGOVY injection is a sterile, aqueous, clear, colorless solution. Each 0.5 mL single-dose pen contains a solution of WEGOVY containing 0.25 mg, 0.5 mg or 1 mg of semaglutide; and each 0.75 mL single-dose pen contains a solution of WEGOVY containing 1.7 or 2.4 mg of semaglutide. Each 1 mL of WEGOVY contains the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; sodium chloride, 8.25 mg; and water for injection. WEGOVY has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH.

WEGOVY tablets include semaglutide as a white to almost white hygroscopic powder. Each tablet of WEGOVY contains 1.5 mg, 4 mg, 9 mg or 25 mg of semaglutide and the following inactive ingredients: Salcaprozate sodium (SNAC) and magnesium stearate.

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.

GLP-1 is a physiological regulator of appetite and caloric intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation. Animal studies show that semaglutide distributed to and activated neurons in brain regions involved in regulation of food intake.

The exact mechanism of semaglutide in CV risk reduction in adults has not been established.

For treatment of MASH in humans, the precise mechanism of action of semaglutide is not fully understood and may involve multiple pathways mediated by weight loss and other factors. In a mouse model of diet-induced MASH, treatment with semaglutide resulted in histological improvements in steatosis, inflammation, and fibrosis in liver compared to baseline, which was associated with body weight loss, intermittent periods of reduced food intake, and improvements in relevant biomarkers. The relationship between the pathophysiology of MASH in animal models and humans has not been fully established.

In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day (2-, 8-, and 22-fold the maximum recommended human dose [MRHD] of WEGOVY subcutaneous injection 2.4 mg/week, or WEGOVY oral tablet 25 mg daily based on AUC) were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (0.6-, 2-, and 5-fold MRHD) were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas were observed in males and females at all dose levels (greater than or equal to 0.6 times human exposure).

In a 2-year carcinogenicity study in Sprague Dawley rats, subcutaneous doses of 0.0025, 0.01, 0.025 and 0.1 mg/kg/day were administered (below quantification, 0.2-, 0.4-, and 2-fold the exposure at the MRHD). A statistically significant increase in thyroid C-cell adenomas was observed in males and females at all dose levels, and a statistically significant increase in thyroid C-cell carcinomas was observed in males at greater than or equal to 0.01 mg/kg/day, at clinically relevant exposures.

Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies

In a combined fertility and embryo-fetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.04-, 0.1-, and 0.4-fold the MRHD) were administered to male and female rats. Males were dosed for 4 weeks prior to mating, and females were dosed for 2 weeks prior to mating and throughout organogenesis until Gestation Day 17. No effects were observed on male fertility. In females, an increase in estrus-cycle length was observed at all dose levels, together with a small reduction in numbers of corpora lutea at greater than or equal to 0.03 mg/kg/day. These effects were likely an adaptive response secondary to the pharmacological effect of semaglutide on food consumption and body weight.

Study 1 (NCT03574597) was a multi-national, multi-center, placebo-controlled, double-blind trial to determine the effect of WEGOVY injection relative to placebo on major adverse CV events (MACE) when added to current standard of care, which included management of CV risk factors and individualized healthy lifestyle counseling (including diet and physical activity) in adults with established CV disease and either obesity or overweight. The primary endpoint, MACE, was the time to first occurrence of a three-part composite outcome which included CV death, non-fatal myocardial infarction, and non-fatal stroke. During the 16-week dose escalation period, patients were titrated to WEGOVY 2.4 mg injected subcutaneously once weekly or placebo. Patients who could not tolerate the recommended escalation dosage, could stay at a lower dose level.

All patients were 45 years or older, with an initial BMI of 27 kg/m² or greater and established CV disease (prior myocardial infarction, prior stroke, or peripheral arterial disease). Patients with a history of type 1 or type 2 diabetes were excluded. Concomitant CV therapies could be adjusted, at the discretion of the investigator, to ensure participants were treated according to the current standard of care for patients with established CV disease.

In this trial, 17,604 patients were randomized to WEGOVY injection or placebo. At baseline, the mean age was 62 years (range 45-93), 72% were male, 84% were White, 4% were Black or African American, and 8% were Asian, and 10% were Hispanic or Latino. Mean baseline body weight was 97 kg and mean BMI was 33 kg/m². At baseline, prior myocardial infarction was reported in 76% of randomized individuals, prior stroke in 23%, and peripheral arterial disease in 9%. Heart failure was reported in 24% of patients. At baseline, CV disease and risk factors were managed with lipid-lowering therapy (90%), platelet aggregation inhibitors (86%), angiotensin converting enzyme inhibitors or angiotensin II receptor blockers (74%), and beta blockers (70%). A total of 10% had moderate renal impairment (eGFR 30 to <60 mL/min/1.73m²) and 0.4% had severe renal impairment eGFR <30 mL/min/1.73m².

In total, 96.9% of patients completed the trial, and vital status was available for 99.4% of patients. The median follow-up duration was 41.8 months. A total of 31% of WEGOVY injection-treated patients and 27% of placebo-treated patients permanently discontinued study drug. Of those patients on treatment at 1 year, 76% were on the 2.4 mg dose, 8% were on the 1.7 mg dose, and 16% were on lower doses. Of those patients on treatment at 2 years, 77% were on the 2.4 mg dose, 7% were on the 1.7 mg dose, and 17% were on lower doses.

For the primary analysis, a Cox proportional hazards model was used to test for superiority. Type 1 error was controlled across multiple tests.

WEGOVY injection significantly reduced the risk for first occurrence of MACE. The estimated hazard ratio (95% CI) was 0.80 (0.72, 0.90) (see

Data from the in-trial period. Cumulative incidence estimates are based on time from randomization to first EAC-confirmed cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke with non-CV death modeled as competing risk using the Aalen-Johansen estimator. Patients without events of interest were censored at the end of their in-trial observation period. Time from randomization to first cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke was analyzed using a Cox proportional hazards model with treatment as categorical fixed factor. The hazard ratio and confidence interval are adjusted for the group sequential design using the likelihood ratio ordering.

HR: Hazard ratio; CI: confidence interval; CV: cardiovascular

The treatment effect for the primary composite endpoint, its components, and other relevant endpoints in Study 1 are shown in

^* p-value <0.001, one-sided p-value

¹ Primary endpoint

² Adjusted for group sequential design using the likelihood ratio ordering.

³ CV death was the first confirmatory secondary endpoint in the testing hierarchy and superiority was not confirmed.

⁴ Confirmatory secondary endpoint. Not statistically significant based on the prespecified testing hierarchy.

⁵ Not included in the prespecified testing hierarchy for controlling type-I error.

⁶ Effect on heart failure has not been established.

NOTE: Time to first event was analyzed in a Cox proportional hazards model with treatment as factor. For patients with multiple events, only the first event contributed to the composite endpoint.

¹ Parameters listed in the table were not included in the pre-specified hierarchical testing.

² Responses were analyzed using an ANCOVA with treatment as fixed factor and baseline value as covariate. Before analysis, missing data were multiple imputed. The imputation model (linear regression) was done separately for each treatment arm and included baseline value as a covariate and was fitted to all subjects with a measurement regardless of treatment status at Week 104.

³ For body weight the ‘change from baseline’ and ‘difference to placebo’ the unit is percentage change from baseline.

⁴ Baseline value is the geometric mean.

The reduction of MACE with WEGOVY injection was not impacted by age, sex, race, ethnicity, BMI at baseline, or level of renal function impairment.

WEGOVY injection is a clear, colorless solution in a prefilled, disposable, single-dose pen-injector with an integrated needle. It is supplied in cartons containing 4 pen-injectors in the following packaging configurations:

Store the WEGOVY single-dose pen in the refrigerator from 2°C to 8°C (36°F to 46°F). If needed, prior to cap removal, the pen can be kept from 8°C to 30°C (46°F to 86°F) up to 28 days. Do not freeze. Protect WEGOVY from light. WEGOVY must be kept in the original carton until time of administration. Discard the WEGOVY pen after use.

WEGOVY tablets are available as:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store and dispense WEGOVY tablets in the original bottle. Store WEGOVY tablet in the original bottle until use to protect tablets from moisture. Store WEGOVY tablets in a dry place away from moisture.

· If the yellow bar does not start moving or stops during the injection, contact your healthcare provider or Novo Nordisk at startWegovy.com or call Novo Nordisk Inc. at 1-833-934-6891.

· The needle cover will lock when the pen is removed from your skin.

· People who are blind or have vision problems should not use the WEGOVY pen without help from a person trained to use the WEGOVY pen.

Contact Novo Nordisk at 1-833-934-6891 if your WEGOVY pen fails any of these checks.

• Do not inject into an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

• You may inject in the same body area each week, but make sure it is not in the same spot each time.

Clean the injection site with an alcohol swab or soap and water. Do not touch the injection site after cleaning. Allow the skin to dry before injecting.

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Instructions for Use WEGOVY® (semaglutide) injection WEGOVY comes in five strengths: Before you use your WEGOVY pen for the first time, talk to your healthcare provider or your caregiver about how to prepare and inject WEGOVY correctly.
Important information Read this Instructions for Use before you start using WEGOVY. This information does not replace talking to your healthcare provider about your medical condition or treatment. · Your WEGOVY pen is for 1 time use only . The WEGOVY pen is for subcutaneous (under the skin) use only. · The dose of WEGOVY is already set on your pen. · The needle is covered by the needle cover and the needle will not be seen. · Do not remove the pen cap until you are ready to inject. · Do not touch or push on the needle cover. You could get a needle stick injury. · Your WEGOVY injection will start when the needle cover is pressed firmly against your skin. · Do not remove the pen from your skin before the yellow bar in the pen window has stopped moving. The medicine may appear on the skin or squirt from the needle and you may not get your full dose of WEGOVY if:
How do I store WEGOVY? · Store the WEGOVY pen in the refrigerator between 36°F to 46°F (2°C to 8°C). · If needed, before removing the pen cap, WEGOVY can be stored from 46°F to 86°F (8°C to 30°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°F (30°C), or has been out of the refrigerator for 28 days or longer. Keep WEGOVY and all medicines out of the reach of children.
How to use your WEGOVY pen	Do not use your WEGOVY pen without receiving training from your healthcare provider. Make sure that you or your caregiver know how to give an injection with the pen before you start your treatment.
Read and follow the instructions so that you use your WEGOVY pen correctly: Preparation Step 1. Prepare for your injection. Supplies you will need to give your WEGOVY injection:
Step 2. Choose your injection site. • Your healthcare provider can help you choose the injection site that is best for you

• Do not inject into an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

• You may inject in the same body area each week, but make sure it is not in the same spot each time.

Clean the injection site with an alcohol swab or soap and water. Do not touch the injection site after cleaning. Allow the skin to dry before injecting.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific sharps disposal in the state that you live in, go to the FDA’s website at http://www.fda.gov/safesharpsdisposal.

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Step 2. Choose your injection site. • Your healthcare provider can help you choose the injection site that is best for you

Injection Step 3. Remove pen cap. • Pull the pen cap straight off your pen. Step 4. Inject WEGOVY. • Push the pen firmly against your skin and keep applying pressure until the yellow bar has stopped moving. If the yellow bar does not start moving, press the pen more firmly against your skin.

Throw away pen Step 5. Throw away (dispose of) pen. Safely dispose of the WEGOVY pen right away after each use. See “How do I throw away (dispose of) WEGOVY pens?” • What if blood appears after injection? If blood appears at the injection site, press the site lightly with a gauze pad or cotton ball.

How do I throw away (dispose of) WEGOVY pens? Put the used WEGOVY pen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the pen in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

How do I care for my pen? Protect your pen

Marketed by: Novo Nordisk Inc. Plainsboro, NJ 08536 For information about WEGOVY, go to startWegovy.com or contact: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 1-833-Wegovy-1 WEGOVY® is a registered trademark of Novo Nordisk A/S. Patent Information: http://novonordisk-us.com/products/product-patents.html © 2025 Novo Nordisk

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 12/2025

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.

GLP-1 is a physiological regulator of appetite and caloric intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation. Animal studies show that semaglutide distributed to and activated neurons in brain regions involved in regulation of food intake.

The exact mechanism of semaglutide in CV risk reduction in adults has not been established.

For treatment of MASH in humans, the precise mechanism of action of semaglutide is not fully understood and may involve multiple pathways mediated by weight loss and other factors. In a mouse model of diet-induced MASH, treatment with semaglutide resulted in histological improvements in steatosis, inflammation, and fibrosis in liver compared to baseline, which was associated with body weight loss, intermittent periods of reduced food intake, and improvements in relevant biomarkers. The relationship between the pathophysiology of MASH in animal models and humans has not been fully established.