b'For your adult patients with a BMI 30 kg/m 2or BMI 27 kg/m 2with a weight-related FINALLY, 1comorbidity, along with diet and exerciseREAL CHANGEThe first and only once-weekly GLP-1 RAfor chronic weight management 1 Meaningful weight loss your adult patients can maintain 1CO-PRIMARY ENDPOINTS~35 lb mean weight loss sustained vs ~6 lb with placebo at 68 weeks 1 *Wegovy -14.9% placebo -2.4%Mean baseline body weight: Wegovy = 232.4 lb; placebo = 231.9 lb.Majority of patients achieved clinically meaningful weight loss of 5% 1 * at 68 weeksWegovy 83.5% placebo 31.1%Patient discontinuation due to adverse events was 7.0% in the Wegovy arm and 3.1% for placebo. 2CONFIRMATORY SECONDARY ENDPOINTSImprovements inWaist circumference:Systolic blood pressure: cardiometabolicWegovy-5.3 in Wegovy-6.2 mmHgrisk factors 1 placebo-1.6 in placebo-1.1 mmHgWegovy is not indicated for the treatment of hypertension.In the STEP 1 trial there was a mean increase in resting heart rate of 3.5 beats per minute (bpm) in patients taking Wegovy compared with a 0.7 bpm decrease for placebo. 1*P0.0001 (unadjusted 2-sided) for superiority.ActorSTUDY DESIGN: STEP 1 was a 68-week trial that enrolled 1961 patients with obesity (BMI 30 kg/m 2 ) or with overweight (BMI 27 kg/m 2 -29.9 kg/m 2 ) and at least 1 weight-related comorbid condition; patients with type 2 diabetes mellitus were excluded. Patients were randomized in a 2:1 ratio to Portrayal. either Wegovy (n=1306) or placebo (n=655) both in conjunction with diet and exercise. Mean baseline BMI was 37.9 kg/m 2 . Forcardiometabolic-associatedconfirmatorysecondaryendpoints,meanbaselinewaistcircumferencewas45.1inchesinWegovyarm and 45.2 inches in placebo arm and systolic blood pressure was 126 mmHg and 127 mmHg for patients randomized to Wegovy or placebo, respectively. Other supportive secondary endpoints were diastolic blood pressure, heart rate, HbA1c, total cholesterol,LDL cholesterol, HDL cholesterol, and triglycerides. 1,2Adverse ReactionsIndication and Usage ContraindicationsAcute Kidney Injury: There have been postmarketing reports ofThe most common adverse reactions reported in 5% of patients treatedWegovy is contraindicated in patients with a personal or familyacute kidney injury and worsening of chronic renal failure, which inWegovy (semaglutide) injection 2.4 mg is indicated as an adjuncthistory of MTC or in patients with MEN 2, and in patients with a priorsome cases required hemodialysis, in patients treated withwith Wegovy are nausea, diarrhea, vomiting, constipation, abdominal to a reduced calorie diet and increased physical activity for chronicserious hypersensitivity reaction to semaglutide or to any of thesemaglutide. Patients with renal impairment may be at a greater riskpain, headache, fatigue, dyspepsia, dizziness, abdominal distention, weight management in adults with an initial body mass index (BMI)of acute kidney injury, but some events have been reported in patientseructation,hypoglycemiainpatientswithtype2diabetes,flatulence,of 30 kg/m 2(obesity) or 27 kg/m 2(overweight) in the presence ofexcipients in Wegovy. Serious hypersensitivity reactions, includingwithout known underlying renal disease. A majority of the eventsgastroenteritis,andgastroesophagealrefluxdiseaseat least one weight- related comorbid condition (e.g., hypertension,anaphylaxis and angioedema have been reported with semaglutide occurred in patients who experienced nausea, vomiting, or diarrhea,Drug Interactionstype 2 diabetes mellitus, or dyslipidemia). Warnings and Precautions leading to volume depletion. Monitor renal function when initiating orRisk of Thyroid C-Cell Tumors: Patients should be furtherescalating doses of Wegovy in patients reporting severe adverse The addition of Wegovy in patients treated with insulin has not been Limitations of Use evaluated if serum calcitonin is measured and found to be elevatedgastrointestinal reactions and in patients with renal impairmentevaluated. When initiating Wegovy, consider reducing the dose ofWegovy contains semaglutide and should not be coadministeredor thyroid nodules are noted on physical examination or neckreporting any adverse reactions that could lead to volume depletion concomitantly administered insulin secretagogues (suchwith other semaglutide-containing products or with any GLP-1imaging as sulfonylureas) or insulin to reduce the risk of hypoglycemiareceptor agonistHypersensitivity: Serious hypersensitivity reactions (e.g., Wegovy causes a delay of gastric emptying and has the potential toAcute Pancreatitis: Acute pancreatitis, including fatal and non-fatalanaphylaxis, angioedema) have been reported with semaglutide. impact the absorption of concomitantly administered oral medications. ThesafetyandeffectivenessofWegovyincombinationwith hemorrhagic or necrotizing pancreatitis, has been observed inIf hypersensitivity reactions occur, discontinue use of Wegovy, treatMonitortheeffectsoforalmedicationsconcomitantlyadministeredother products intended for weight loss, including prescriptionpatients treated with GLP-1 receptor agonists, includingpromptly per standard of care, and monitor until signs and symptomswith Wegovydrugs, over-the-counter drugs, and herbal preparations, have notsemaglutide. Acute pancreatitis was observed in patients treatedresolve. Use caution in a patient with a history of anaphylaxis or been established with Wegovy in clinical trials. Observe patients carefully for signsangioedema with another GLP-1 receptor agonist Use in Specific Populations Wegovy has not been studied in patients with a history of pancreatitis and symptoms of acute pancreatitis (including persistent severe Diabetic Retinopathy Complications in Patients with Type 2 Pregnancy: May cause fetal harm. When pregnancy is recognized, abdominal pain, sometimes radiating to the back, and which may orDiabetes: In a trial of patients with type 2 diabetes, diabeticdiscontinue Wegovy. Discontinue Wegovy in patients at least 2 Important Safety Information may not be accompanied by vomiting). If acute pancreatitis isretinopathy was reported by 4.0% of Wegovy patients and 2.7% ofmonths before a planned pregnancysuspected, discontinue Wegovy promptly, and if acute pancreatitisplacebo patients. Rapid improvement in glucose control has been isconfirmed,donotrestart associated with a temporary worsening of diabetic retinopathy.Please see Brief Summary of Prescribing Information about WARNING: RISK OF THYROID C-CELL TUMORSAcute Gallbladder Disease: In clinical trials, cholelithiasis wasPatients with a history of diabetic retinopathy should be monitoredWegovyon the following pages. In rodents, semaglutide causes dose-dependent andreported by 1.6% of Wegovy patients and 0.7% of placebo patients.for progression of diabetic retinopathytreatment-duration-dependent thyroid C-cell tumors atCholecystitis was reported by 0.6% of Wegovy patients and 0.2% Heart Rate Increase: Mean increases in resting heart rate of 1 to 4Ensuring appropriate obesity-managementclinically relevant exposures. It is unknown whether Wegovyof placebo patients. Substantial or rapid weight loss can increasebeats per minute (bpm) were observed in Wegovy patients comparedapproaches, including anti-obesity medication,causes thyroid C-cell tumors, including medullary thyroidthe risk of cholelithiasis; however, the incidence of acute gallbladderto placebo in clinical trials. More Wegovy patients compared withmay benefit your adult patients.carcinoma (MTC), in humans as human relevance ofdisease was greater in Wegovy-treated patients than in placebo- placebo had maximum changes from baseline of 10 to 19 bpm (41% semaglutide-induced rodent thyroid C-cell tumors has nottreated patients, even after accounting for the degree of weightversus 34%) and 20 bpm or more (26% versus 16%). Monitor heart rate been determined loss. If cholelithiasis is suspected, gallbladder studies andat regular intervals and instruct patients to report palpitations orBMI, body mass index; GLP-1 RA, glucagon-like peptide-1 receptor agonist; HbA1c, glycatedWegovy is contraindicated in patients with a personal orappropriate clinical follow-up are indicatedfeelings of a racing heartbeat while at rest. If patients experience ahemoglobin; HDL, high-density lipo-protein; LDL, low-density lipoprotein.family history of MTC or in patients with Multiple Endocrine Hypoglycemia: Wegovy lowers blood glucose and can causesustained increase in resting heart rate, discontinue WegovyNeoplasia syndrome type 2 (MEN 2). Counsel patientshypoglycemia. In a trial of patients with type 2 diabetes,References: 1. Wegovy package insert. Plainsboro, NJ: Novo Nordisk Inc.; 2021. 2. Wilding JPH, regarding the potential risk for MTC with the use of Wegovyhypoglycemia was reported in 6.2% of Wegovy patients versus Suicidal Behavior and Ideation: Suicidal behavior and ideation haveBatterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. and inform them of symptoms of thyroid tumors (e.g. a mass2.5% of placebo patients. Patients with type 2 diabetes takingbeen reported in clinical trials with other weight management products.N Engl J Med. 2021;384:989-1002. in the neck, dysphagia, dyspnea, persistent hoarseness).Wegovy with an insulin secretagogue (e.g. sulfonylurea) or insulinMonitor patients for depression, suicidal thoughts or behavior, and/or Routine monitoring of serum calcitonin or using thyroidmay have an increased risk of hypoglycemia, including severeany unusual changes in mood or behavior. DiscontinueWegovy inWegovy is a trademark of Novo Nordisk A/S.ultrasound is of uncertain value for early detection of MTC inhypoglycemia. Inform patients of the risk of hypoglycemia andpatients who experience suicidal thoughts or behaviors and avoid in Novo Nordisk is a registered trademark of Novo Nordisk A/S. patients treated with Wegovy educate them on the signs and symptoms. Monitor blood glucose inpatients with a history of suicidal attempts or active suicidal ideation2021 Novo NordiskPrinted in the U.S.A. patients with type 2 diabetes US21SEMO00568November 2021'