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NovoCare_HCP_Wegovy_v02

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®

Indications and Usage

Wegovy® (semaglutide) injection 2.4 mg is indicated in combination with a reduced calorie diet and increased physical activity:

  • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight
  • to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity and adults with overweight in the presence of at least one weight-related comorbidity

Limitations of Use

  • Wegovy® contains semaglutide. Coadministration with other semaglutide-containing products or with any GLP-1 receptor agonist is not recommended

Important Safety Information

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 (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® 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® pediatric patients aged 12 years and older than in Wegovy® adults. In clinical trials in adult patients, 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. In a clinical trial in pediatric patients aged 12 years and older, cholelithiasis was reported by 3.8% of Wegovy® patients and 0% placebo patients. Cholecystitis was reported by 0.8% of Wegovy® pediatric patients and 0% placebo 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 adult patients with type 2 diabetes, hypoglycemia was reported in 6.2% of Wegovy® patients versus 2.5% of placebo patients. Patients with diabetes taking Wegovy® with an insulin or insulin secretagogue (e.g. sulfonylurea) 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: 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
  • Severe Gastrointestinal Adverse Reactions: Use of Wegovy® has been associated with gastrointestinal adverse reactions, sometimes severe. In clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving Wegovy® (4.1%) than placebo (0.9%). 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 Type 2 Diabetes: In a trial of adult 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® adult patients compared to placebo in clinical trials. More Wegovy® adult 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%). In a clinical trial in pediatric patients aged 12 years and older with normal baseline heart rate, more patients treated with Wegovy® compared to placebo had maximum changes in heart rate of 20 bpm or more (54% versus 39%). 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
  • 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, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis

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
  • Pediatric: Adverse reactions with Wegovy® in pediatric patients aged 12 years and older were similar to those reported in adults. Pediatric patients ≥12 years of age treated with Wegovy® had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with Wegovy®. There are insufficient data in pediatric patients with type 2 diabetes treated with Wegovy® for obesity to determine if there is an increased risk of hypoglycemia with Wegovy® treatment similar to that reported in adults
  • Geriatric: In the cardiovascular outcomes trial, patients aged 75 years and older reported more hip and pelvis fractures on Wegovy® than placebo. Patients aged 75 years and older (Wegovy® and placebo) reported more serious adverse reactions overall compared to younger adult patients

Please see Wegovy® Prescribing Information, including Boxed Warning.

 

NovoCare_HCP_Saxenda_v01

Important Safety Information for Saxenda®

WARNING: RISK OF THYROID C-CELL TUMORS

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.

Saxenda® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Saxenda® and inform them of symptoms of thyroid tumors (eg, 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 Saxenda®.

Indications and Usage

Saxenda® (liraglutide) injection 3 mg is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:

  • Adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)
  • Pediatric patients aged 12 years and older with body weight above 60 kg (132 lbs) and initial BMI corresponding to 30 kg/m2 or greater for adults (obese) by international cut-offs

Limitations of Use

  • Saxenda® contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist
  • The safety and effectiveness of Saxenda® in pediatric patients with type 2 diabetes have not been established
  • The safety and effectiveness of Saxenda® in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established

Important Safety Information

Contraindications

Saxenda® is contraindicated in:

  • Patients with a personal or family history of MTC or patients with MEN 2
  • Patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in Saxenda®. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with Saxenda®
  • Pregnancy

Warnings and Precautions

  • Risk of Thyroid C-cell Tumors: 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: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide postmarketing. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Saxenda® promptly and if pancreatitis is confirmed, do not restart
  • Acute Gallbladder Disease: Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in patients treated with Saxenda® than with placebo even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
  • Hypoglycemia: Adult patients with type 2 diabetes on an insulin secretagogue (eg, a sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia with use of Saxenda®. The risk may be lowered by a reduction in the dose of insulin secretagogues or insulin. In pediatric patients without type 2 diabetes, hypoglycemia occurred. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms
  • Heart Rate Increase: Mean increases in resting heart rate of 2 to 3 beats per minute (bpm) were observed in patients treated with Saxenda®. Monitor heart rate at regular intervals and inform patients to report palpitations or feelings of a racing heartbeat while at rest during treatment with Saxenda®. Discontinue Saxenda® in patients who experience a sustained increase in resting heart rate
  • Renal Impairment: Acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis, have been reported, usually in association with nausea, vomiting, diarrhea, or dehydration. Use caution when initiating or escalating doses of Saxenda® in patients with renal impairment
  • Hypersensitivity Reactions: Serious hypersensitivity reactions (eg, anaphylaxis and angioedema) have been reported in patients treated with Saxenda®. If a hypersensitivity reaction occurs, patients should stop taking Saxenda® and promptly seek medical advice
  • Suicidal Behavior and Ideation: In adult clinical trials, 9 (0.3%) of 3,384 patients treated with Saxenda® and 2 (0.1%) of the 1,941 treated with placebo reported suicidal ideation; one of the Saxenda® treated patients attempted suicide. In a pediatric trial, 1(0.8%) of the 125 Saxenda® treated patients died by suicide. There was insufficient information to establish a causal relationship to Saxenda®. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue treatment if patients experience suicidal thoughts or behaviors. Avoid Saxenda® in patients with a history of suicidal attempts or active suicidal ideation
  • Pulmonary Aspiration During General Anesthesia or Deep Sedation: Saxenda® 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 Saxenda®

Adverse Reactions

  • The most common adverse reactions, reported in ≥5% are nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, pyrexia, and gastroenteritis

Drug Interactions

  • Saxenda® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Monitor for potential consequences of delayed absorption of oral medications concomitantly administered with Saxenda®

Use in Specific Populations

  • There are no data on the presence of liraglutide in human breast milk; liraglutide was present in the milk of lactating rats
  • Saxenda® has not been studied in patients less than 12 years of age
  • Saxenda® slows gastric emptying. Saxenda® has not been studied in patients with preexisting gastroparesis

Please see Saxenda® Prescribing Information, including Boxed Warning.