In addition to diet and exercise, to reduce the risk of MACE (CV death, non-fatal MI, or non-fatal stroke) in adults with established CVD and either overweight or obesity and for chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity. Click for Limitations of Use.
Wegovy® HCP Informational Texts Terms of Use
Last Updated February 21, 2023 (effective date)
- Agreement Generally: Acceptance. These “Terms of Use” (the “Agreement” or “Terms of Use”) are between you and the Novo Nordisk’s Wegovy HCP Informational Texts (“Informational Texts,” “we,” “us,” or “our”). “You” means you personally. This Agreement sets forth the terms and conditions upon which we make available the Informational Texts contents to you.
Please note these Terms of Use govern only the Informational Texts, and not any other service, program, or website. By opting to receive the Informational Texts, you are agreeing to these Terms of Use. By receiving the Informational Texts, you affirm that you are a U.S. resident, 18 years of age or older, a licensed healthcare provider, qualify for the Informational Texts, and expressly consent to receive communications from Novo Nordisk or its partners in connection with the Informational Texts.
For more information about data use and collection, please read the most recent version of Novo Nordisk’s Privacy Notice https://www.novonordisk-us.com/disclaimer-privacy.html. PLEASE READ THESE TERMS OF USE CAREFULLY BEFORE AGREEING TO RECEIVE THE INFORMATIONAL TEXTS.
IF YOU DO NOT AGREE TO THESE TERMS OF USE, YOU CANNOT RECEIVE THE INFORMATIONAL TEXTS. - Eligibility. To participate in the Informational Texts, you must be a resident of the United States and 18 years of age or older and be a licensed healthcare provider in the United States. Novo Nordisk reserves the right to require you to prove that you meet this eligibility criteria. THE INFORMATION TEXTS ARE NOT INTENDED FOR PATIENTS, CAREGIVERS, OR ANY NON-LICENSED HEALTHCARE PROVIDER.
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- Permission to Use Informational Texts; Limitations on Use of the Informational Texts. Subject to your acceptance and while you remain in compliance with the Terms of Use, we grant you a limited, revocable, non-exclusive, non-transferable license to use the Informational Texts solely and exclusively for your own professional use and not for any other purpose. This license is solely and exclusively for your benefit as a healthcare provider. All other uses of the Informational Texts are prohibited.
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SMS Messages. The following US carriers are supported for SMS Messages:
i. Major Carriers: AT&T, Verizon Wireless, Sprint, and T-Mobile USA.
ii. Minor Carriers: Aio Wireless, Alaska Communications Systems (ACS), Appalachian Wireless (EKN), Bluegrass Cellular, Boost Mobile, Carolina West Wireless, CellCom, Cellular One of East Central IL (ECIT), Cellular One of Northeast Arizona, Cellular One of Northeast Pennsylvania, Chariton Valley Cellular, Cricket, Coral Wireless (MobiPCS), Cross, C-Spire (CellSouth), Duet IP (Maximum Communications New Core Wireless), Element Mobile (Flat Wireless), Epic Touch (Elkhart Telephone), GCI, Golden State, Google Voice, Hawkeye (Chat Mobility), Hawkeye (NW Missouri), Illinois Valley Cellular, Inland Cellular, iWireless (Iowa Wireless), Keystone Wireless (Immix Wireless/PC Man), Metro PCS, Mosaic (Consolidated or CTC Telecom), MTA Communications, MTPCS (Cellular One Nation), Nex-Tech Wireless, Panhandle Communications, Peoples Wireless, Pine Cellular, Pioneer, RINA, Sagebrush Cellular (Nemont), SI Wireless/Mobile Nation, Simmetry (TMP Corporation), SouthernLinc, SRT Wireless, Thumb Cellular, Union Wireless, United Wireless, U.S. Cellular, Viaero Wireless, Virgin Mobile, and West Central (WCC or 5 Star Wireless).
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© 2023 Novo Nordisk All rights reserved. January 2023
Important Safety Information for Wegovy®
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®
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 Wegovy®
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 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: 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 than in Wegovy® injection-treated adults. In clinical trials in adult patients, cholelithiasis was reported by 1.6% of Wegovy® injection-treated patients and 0.7% of placebo treated patients, and by 2.5% of Wegovy® tablet-treated patients and 1% of placebo 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, 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. Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in Wegovy® patients than in placebo 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 Wegovy® injection in adult patients with type 2 diabetes (T2D) and a BMI ≥27 kg/m2, hypoglycemia was reported in more patients treated with Wegovy® versus placebo. 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 taking Wegovy® with an insulin or insulin secretagogue may have an increased risk of hypoglycemia, including severe hypoglycemia. The use of Wegovy® in patients with type 1 diabetes or in combination with insulin has not been evaluated. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms. Monitor blood glucose in patients with diabetes
- 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. The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Wegovy® that could lead to volume depletion, especially during initiation and escalation of Wegovy®
- Severe Gastrointestinal (GI) Adverse Reactions: Use of Wegovy® has been associated with GI adverse reactions, sometimes severe. In adult clinical trials, severe GI adverse reactions were reported more frequently among patients receiving Wegovy® than placebo. Severe GI adverse reactions were reported in 4.1% and 0.9% of Wegovy®-injection treated and placebo treated patients, respectively, and in 2% of Wegovy® tablet-treated and 0% of placebo treated patients, respectively. Severe GI adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Wegovy® is not recommended in patients with severe gastroparesis
- 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. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist
- Diabetic Retinopathy Complications in Patients with T2D: In a trial of adult patients with T2D and BMI ≥27 kg/m2, diabetic retinopathy was reported by 4% of Wegovy® injection-treated patients and 2.7% of placebo patients. In a glycemic control trial evaluating a dose comparable to the 9 mg dose and the 25 mg semaglutide tablet doses in patients with T2D, 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. 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® injection-treated adult patients compared to placebo in clinical trials. More adults treated with Wegovy® injection compared with placebo had maximum changes from baseline of 10 to 19 bpm (41% vs 34%) and 20 bpm or more (26% vs 16%). In a clinical trial in pediatric patients aged ≥12 years 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% vs 39%). Findings were similar in a trial with the Wegovy® tablets. 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®
- Pulmonary Aspiration During General Anesthesia or Deep Sedation: Wegovy® delays gastric emptying. 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. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Wegovy®
Adverse Reactions
- Most common adverse reactions (incidence ≥5%) are: nausea, diarrhea, vomiting, constipation, abdominal pain, dysesthesia, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with T2D, flatulence, gastroenteritis, gastroesophageal reflux disease, and hair loss
Drug Interactions
- When initiating Wegovy®, consider reducing the dose of concomitantly administered insulin secretagogues or insulin to reduce the risk of hypoglycemia. The addition of Wegovy® in patients treated with insulin has not been evaluated
- 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®. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring
Use in Specific Populations
- Pregnancy: May cause fetal harm. When pregnancy is recognized, advise the pregnant patient of the risk to a fetus. Discontinue Wegovy® in pregnant patients who are using Wegovy® for weight reduction or at least 2 months before a planned pregnancy
- Lactation: A clinical lactation study reported semaglutide concentrations below the lower limit of quantification in human breast milk. However, salcaprozate sodium (SNAC) and/or its metabolites are present in human milk. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, an absorption enhancer for Wegovy® tablets, 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
- Pediatric: Adverse reactions with Wegovy® injection-treated pediatric patients ≥12 years with obesity were similar to those reported in adults. Pediatric patients ≥12 years treated with Wegovy® injection had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with Wegovy®. There are insufficient data in pediatric patients with T2D treated with Wegovy® injection for obesity to determine if there is an increased risk of hypoglycemia with Wegovy® injection treatment similar to that reported in adults.
The safety and effectiveness of Wegovy® injection have not been established in pediatric patients to reduce the risk of major adverse CV events or to reduce excess body weight and maintain weight reduction long term with the 7.2 mg once weekly dosage or in those <12 years.
The safety and effectiveness of Wegovy® tablets have not been established in pediatric patients - Geriatric: In the CV outcomes trial, patients ≥75 years reported more hip and pelvis fractures on Wegovy® injection than placebo. Patients ≥75 years (Wegovy® injection and placebo) reported more serious adverse reactions overall compared to younger adult patients
- Type 2 Diabetes: Wegovy® tablets have not been studied for weight reduction in adults with T2D and obesity or overweight. Administration of Wegovy® injection resulted in less weight reduction in patients with T2D and obesity or overweight compared to those without T2D and obesity or overweight
Please click here for Wegovy® Prescribing Information, including Boxed Warning.
Indications and Usage
Wegovy® (semaglutide) 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
- Reduce excess body weight and maintain weight reduction long term in:
- Adults and pediatric patients 12 years and older with obesity
- Adults with overweight in the presence of at least one weight-related comorbidity
Wegovy® (semaglutide) tablets are 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
- Reduce excess body weight and maintain weight reduction long term in adults with obesity or with overweight in the presence of at least one weight-related comorbidity
Limitations of Use:
Concomitant use of Wegovy® tablets or Wegovy® injection with other semaglutide-containing products or with any GLP-1 receptor agonist is not recommended
Important Safety Information for Wegovy®
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®
Important Safety Information for Wegovy®
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®
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 Wegovy®
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 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: 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 than in Wegovy® injection-treated adults. In clinical trials in adult patients, cholelithiasis was reported by 1.6% of Wegovy® injection-treated patients and 0.7% of placebo treated patients, and by 2.5% of Wegovy® tablet-treated patients and 1% of placebo 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, 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. Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in Wegovy® patients than in placebo 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 Wegovy® injection in adult patients with type 2 diabetes (T2D) and a BMI ≥27 kg/m2, hypoglycemia was reported in more patients treated with Wegovy® versus placebo. 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 taking Wegovy® with an insulin or insulin secretagogue may have an increased risk of hypoglycemia, including severe hypoglycemia. The use of Wegovy® in patients with type 1 diabetes or in combination with insulin has not been evaluated. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms. Monitor blood glucose in patients with diabetes
- 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. The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Wegovy® that could lead to volume depletion, especially during initiation and escalation of Wegovy®
- Severe Gastrointestinal (GI) Adverse Reactions: Use of Wegovy® has been associated with GI adverse reactions, sometimes severe. In adult clinical trials, severe GI adverse reactions were reported more frequently among patients receiving Wegovy® than placebo. Severe GI adverse reactions were reported in 4.1% and 0.9% of Wegovy®-injection treated and placebo treated patients, respectively, and in 2% of Wegovy® tablet-treated and 0% of placebo treated patients, respectively. Severe GI adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Wegovy® is not recommended in patients with severe gastroparesis
- 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. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist
- Diabetic Retinopathy Complications in Patients with T2D: In a trial of adult patients with T2D and BMI ≥27 kg/m2, diabetic retinopathy was reported by 4% of Wegovy® injection-treated patients and 2.7% of placebo patients. In a glycemic control trial evaluating a dose comparable to the 9 mg dose and the 25 mg semaglutide tablet doses in patients with T2D, 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. 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® injection-treated adult patients compared to placebo in clinical trials. More adults treated with Wegovy® injection compared with placebo had maximum changes from baseline of 10 to 19 bpm (41% vs 34%) and 20 bpm or more (26% vs 16%). In a clinical trial in pediatric patients aged ≥12 years 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% vs 39%). Findings were similar in a trial with the Wegovy® tablets. 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®
- Pulmonary Aspiration During General Anesthesia or Deep Sedation: Wegovy® delays gastric emptying. 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. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Wegovy®
Adverse Reactions
- Most common adverse reactions (incidence ≥5%) are: nausea, diarrhea, vomiting, constipation, abdominal pain, dysesthesia, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with T2D, flatulence, gastroenteritis, gastroesophageal reflux disease, and hair loss
Drug Interactions
- When initiating Wegovy®, consider reducing the dose of concomitantly administered insulin secretagogues or insulin to reduce the risk of hypoglycemia. The addition of Wegovy® in patients treated with insulin has not been evaluated
- 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®. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring
Use in Specific Populations
- Pregnancy: May cause fetal harm. When pregnancy is recognized, advise the pregnant patient of the risk to a fetus. Discontinue Wegovy® in pregnant patients who are using Wegovy® for weight reduction or at least 2 months before a planned pregnancy
- Lactation: A clinical lactation study reported semaglutide concentrations below the lower limit of quantification in human breast milk. However, salcaprozate sodium (SNAC) and/or its metabolites are present in human milk. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, an absorption enhancer for Wegovy® tablets, 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
- Pediatric: Adverse reactions with Wegovy® injection-treated pediatric patients ≥12 years with obesity were similar to those reported in adults. Pediatric patients ≥12 years treated with Wegovy® injection had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with Wegovy®. There are insufficient data in pediatric patients with T2D treated with Wegovy® injection for obesity to determine if there is an increased risk of hypoglycemia with Wegovy® injection treatment similar to that reported in adults.
The safety and effectiveness of Wegovy® injection have not been established in pediatric patients to reduce the risk of major adverse CV events or to reduce excess body weight and maintain weight reduction long term with the 7.2 mg once weekly dosage or in those <12 years.
The safety and effectiveness of Wegovy® tablets have not been established in pediatric patients - Geriatric: In the CV outcomes trial, patients ≥75 years reported more hip and pelvis fractures on Wegovy® injection than placebo. Patients ≥75 years (Wegovy® injection and placebo) reported more serious adverse reactions overall compared to younger adult patients
- Type 2 Diabetes: Wegovy® tablets have not been studied for weight reduction in adults with T2D and obesity or overweight. Administration of Wegovy® injection resulted in less weight reduction in patients with T2D and obesity or overweight compared to those without T2D and obesity or overweight
Please click here for Wegovy® Prescribing Information, including Boxed Warning.
Indications and Usage
Wegovy® (semaglutide) 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
- Reduce excess body weight and maintain weight reduction long term in:
- Adults and pediatric patients 12 years and older with obesity
- Adults with overweight in the presence of at least one weight-related comorbidity
Wegovy® (semaglutide) tablets are 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
- Reduce excess body weight and maintain weight reduction long term in adults with obesity or with overweight in the presence of at least one weight-related comorbidity
Limitations of Use:
Concomitant use of Wegovy® tablets or Wegovy® injection with other semaglutide-containing products or with any GLP-1 receptor agonist is not recommended