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Wegovy® (semaglutide) injection 2.4 mg logo
Important Safety Information | Patient Site
Prescribing Information
    • The Impact of Obesity
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Wegovy® (semaglutide) injection 2.4 mg logo

As an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with a BMI of ≥30 kg/m2 (obesity), or ≥27 kg/m2 (overweight) in the presence of a weight-related comorbidity. Click for Limitations of Use.

Prescribing Information
Important Safety Information | Patient Site

We appreciate your interest in Wegovy®. To help answer patient questions about supply, click here.

Click here for important news about chronic weight management for your appropriate patients aged 12-17 with obesity.

Efficacy & Safety

Common Adverse Events

Safety of Wegovy®

Adverse reactions reported in ≥2% of Wegovy®-treated patients and more frequently than with placebo1

Wegovy® Adverse Reactions
Wegovy™ Adverse Reactions

In clinical trials

  • 6.8% of patients treated with Wegovy® and 3.2% of patients treated with placebo permanently discontinued treatment as a result of adverse reactions1
  • Permanent discontinuation of treatment as a result of a gastrointestinal adverse reaction occurred in 4.3% of patients treated with Wegovy® vs 0.7% of patients treated with placebo1
  • The most common adverse reactions leading to discontinuation were: nausea (1.8% vs 0.2%), vomiting (1.2% vs 0%), and diarrhea (0.7% vs 0.1%) for Wegovy® and placebo, respectively1

*Includes abdominal pain, abdominal pain upper, abdominal pain lower, gastrointestinal pain, abdominal tenderness, abdominal discomfort, 
and epigastric discomfort.
†Includes fatigue and asthenia.
‡Defined as blood glucose <54 mg/dL with or without symptoms of hypoglycemia or severe hypoglycemia (requiring the assistance of another person) in patients with type 2 diabetes mellitus not on concomitant insulin (STEP 2, Wegovy® n=403, placebo n=402).
§Includes chronic gastritis, gastritis, erosive gastritis, and reflux gastritis.1

Nausea was generally mild or moderate and transient2

Most occurrences of nausea did not lead to permanent discontinuation of Wegovy®

STEP 1: Reported nausea3

Median duration 8 days

Safety and tolerability of Wegovy®
Safety and tolerability of Wegovy™

Nausea was not prospectively measured at each patient visit in the clinical trials.

icons representing 9 out of 10 patients

In STEP 4: ~9 out of 10 patients achieved the 2.4 mg dose at week 201

  • At week 20, 89% of patients achieved a full dose and were randomized, while 11% did not continue in the trial. The most common reason was adverse reactions (n=48; 5.3%)1
    • Wegovy® should be discontinued if a patient does not tolerate the 2.4 mg dose1

In clinical trials nausea was reported in both treatment arms and was most prevalent during the dose-escalation period.1

Every patient is different. Here are general considerations for helping your patients manage nausea4,5:

Eat bland, low-fat foods, such as crackers, toast, and rice

Avoid lying down after they eat

Go outdoors for fresh air

Eat foods that contain water, like soups 
and gelatin

Eat more slowly

Bread and bowl of rice icon

Eat bland, low-fat foods, such as crackers, toast, and rice

Person with up arrow icon

Avoid lying down after they eat

Leaf and wind icon

Go outdoors for fresh air

Bowl with squares icon

Eat foods that contain water, like soups and gelatin

Plate clock icon

Eat more slowly    

Get the STEP 1 data or learn about the STEP 4 trial results.

Understand Wegovy® efficacy and safety

See what Dr Rehka Kumar says about the efficacy and safety profile of Wegovy®

 

Wegovy® Efficacy and Safety: Impact on Weight Loss and Management
(15:51)
Full Prescribing Information
Important Safety Information

Understand Wegovy® efficacy and safety

See what Dr Rehka Kumar says about the efficacy and safety profile of Wegovy®

Learn about the Wegovy® pen

Let's go

Important Safety Information for Wegovy® (semaglutide) injection 2.4 mg

WARNING: RISK OF THYROID C-CELL TUMORS

  • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Wegovy® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined
  • Wegovy® is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (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®

Indication and Usage

Wegovy® (semaglutide) injection 2.4 mg is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ≥30 kg/m2 (obesity) or ≥27 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Limitations of Use

  • Wegovy® contains semaglutide and should not be coadministered with other semaglutide-containing products or with any GLP-1 receptor agonist
  • The safety and effectiveness of Wegovy® in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established
  • Wegovy® has not been studied in patients with a history of pancreatitis


Important Safety Information cont.

Contraindications

  • Wegovy® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in Wegovy®. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with semaglutide

Warnings and Precautions

  • Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging
  • 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 semaglutide. Acute pancreatitis was observed in patients treated with Wegovy® in clinical trials. Observe patients carefully for signs and symptoms of acute pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting). If acute pancreatitis is suspected, discontinue Wegovy® promptly, and if acute pancreatitis is confirmed, do not restart
  • Acute Gallbladder Disease: In clinical trials, cholelithiasis was reported by 1.6% of Wegovy® patients and 0.7% of placebo patients. Cholecystitis was reported by 0.6% of Wegovy® patients and 0.2% of placebo patients. 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: Wegovy® lowers blood glucose and can cause hypoglycemia. In a trial of patients with type 2 diabetes, hypoglycemia was reported in 6.2% of Wegovy® patients versus 2.5% of placebo patients. Patients with type 2 diabetes taking Wegovy® with an insulin secretagogue (e.g. sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms. Monitor blood glucose in patients with type 2 diabetes
  • Acute Kidney Injury: There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which in some cases required hemodialysis, in patients treated with semaglutide. Patients with renal impairment may be at a greater risk of acute kidney injury, but some events have been reported in patients without known underlying renal disease. A majority of the events occurred in patients who experienced nausea, vomiting, or diarrhea, leading to volume depletion. Monitor renal function when initiating or escalating doses of Wegovy® in patients reporting severe adverse gastrointestinal reactions and in patients with renal impairment reporting any adverse reactions that could lead to volume depletion
  • Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with semaglutide. If hypersensitivity reactions occur, discontinue use of Wegovy®, treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist
  • Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: In a trial of patients with type 2 diabetes, diabetic retinopathy was reported by 4.0% of Wegovy® patients and 2.7% of placebo patients. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy
  • Heart Rate Increase: Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed in Wegovy® patients compared to placebo in clinical trials. More Wegovy® patients compared with placebo had maximum changes from baseline of 10 to 19 bpm (41% versus 34%) and 20 bpm or more (26% versus 16%). Monitor heart rate at regular intervals and instruct patients to report palpitations or feelings of a racing heartbeat while at rest. If patients experience a sustained increase in resting heart rate, discontinue Wegovy®
  • Suicidal Behavior and Ideation: Suicidal behavior and ideation have been reported in clinical trials with other weight management products. Monitor patients for depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Wegovy® in patients who experience suicidal thoughts or behaviors and avoid in patients with a history of suicidal attempts or active suicidal ideation

Adverse Reactions

  • The most common adverse reactions reported in ≥5% of patients treated with Wegovy® are nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease

Drug Interactions

  • The addition of Wegovy® in patients treated with insulin has not been evaluated. When initiating Wegovy®, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia
  • Wegovy® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Monitor the effects of oral medications concomitantly administered with Wegovy®

Use in Specific Populations

  • Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue Wegovy®. Discontinue Wegovy® in patients at least 2 months before a planned pregnancy

Please click here for Wegovy® Prescribing Information, including Boxed Warning.

References

1. Wegovy® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2021.

2. Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384(11):989-1002.

3. Data on file. Novo Nordisk Inc.; Plainsboro, NJ.

4. When you have nausea and vomiting. Medline Plus website. Accessed November 15, 2022. https://medlineplus.gov/ency/patientinstructions/000122.htm

5. Nausea and vomiting. Cleveland Clinic. Accessed November 15, 2022. https://my.clevelandclinic.org/health/symptoms/8106-nausea--vomiting

Obesity
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