Wegovy

— THERAPEUTIC CATEGORIES —
  • Obesity
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Wegovy Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Semaglutide 0.25mg/0.5mL, 0.5mg/0.5mL, 1mg/0.5mL, 1.7mg/0.75mL, 2.4mg/0.75mL; per pen-injector; soln for SC inj.

    Pharmacological Class

    Glucagon-like peptide-1 (GLP-1) receptor agonist.

    How Supplied

    Single-dose prefilled pens—4

    How Supplied

    Wegovy injection is a clear, colorless solution in a pre-filled, disposable, single-dose pen-injector with an integrated needle in 4-count cartons in the following doses per pen:  

    • 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

     

    Storage

    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. 

    Manufacturer

    Novo Nordisk

    Generic Availability

    NO

    Mechanism of Action

    Semaglutide is a GLP-1 analogue that selectively binds to and activates the GLP-1 receptor. 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.

    Wegovy Indications

    Indications

    As an adjunct to a reduced calorie diet and increased physical activity to reduce the risk of major cardiovascular events (cardiovascular [CV] death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight. As an adjunct to a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: adults and pediatric patients with obesity; and adults with overweight in the presence of at least 1 weight-related comorbid condition.

    Limitations of Use

    Do not use with other semaglutide-containing products or with any other GLP-1 receptor agonist. 

    Wegovy Dosage and Administration

    Adults and Children

    <12yrs: not established. Give by SC inj in abdomen, thigh, or upper arm; rotate inj sites. ≥12yrs: Escalate dose with the following schedule (to minimize GI effects): Weeks 1–4: 0.25mg once weekly; Weeks 5–8: 0.5mg once weekly; Weeks 9–12: 1mg once weekly; Week 13–16: 1.7mg once weekly; Week 17 and onward: 2.4mg once weekly (in children ≥12yrs), and 2.4mg (recommended) or 1.7mg once weekly in adults. Consider delaying dose escalation for 4 weeks if increased dose not tolerated. If the maintenance 2.4mg once-weekly dose is not tolerated, may reduce to 1.7mg once weekly. For children ≥12yrs: discontinue if the 1.7mg dose is not tolerated.

    Wegovy Contraindications

    Contraindications

    History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.

    Wegovy Boxed Warnings

    Boxed Warning

    Risk of thyroid C-cell tumors.

    Wegovy Warnings/Precautions

    Warnings/Precautions

    Risk of thyroid C-cell tumors; inform patients of potential risk and symptoms. Monitor for acute pancreatitis; discontinue if suspected; do not restart if confirmed. History of pancreatitis. Acute gallbladder disease. Monitor renal function when initiating or escalating doses, or in renal impairment. History of diabetic retinopathy; monitor for progression. History of suicidal attempts or ideation: avoid. Monitor for emergence or worsening depression, suicidal thoughts or behavior; discontinue if occurs. Monitor blood glucose prior to and during treatment in those with T2DM. Monitor heart rate periodically; discontinue if sustained increases. History of anaphylaxis or angioedema with other GLP-1 receptor agonist. Discontinue if hypersensitivity reactions occur. Pregnancy. Females of reproductive potential: discontinue ≥2 months prior to planned pregnancy. Nursing mothers.

    Warnings/Precautions

    Risk of Thyroid C-Cell Tumors

    • Not known whether Wegovy causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.

    • Counsel patients associated with the potential risk of MTC and inform patients of symptoms associated with thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness).

    • Monitor routinely serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC. This may increase the risk of unnecessary procedures. Patients with MTC usually have calcitonin values >50 ng/L.

    • Evaluate further if serum calcitonin is found to be elevated, or if thyroid nodules are noted on physical examination.

    Acute Pancreatitis

    • Following initiation, monitor 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.

    • Prompt discontinue treatment if acute pancreatitis is suspected and initiate appropriate management. Do not restart treatment if acute pancreatitis is confirmed.

    • Wegovy has not been studied in patients with history of pancreatitis. Not known if patients with a history of pancreatitis are at higher risk.

    Acute Gallbladder Disease

    • In clinical trials, cholelithiasis and cholecystitis was reported by 1.6% and 0.6%, respectively, of Wegovy-treated patients and 0.7% and 0.2% of placebo-treated patients.

    • Initiate gallbladder studies and appropriate clinical follow-up if cholelithiasis is suspected.

    Hypoglycemia

    • Patients with type 2 diabetes mellitus taking Wegovy in combination with an insulin secretagogue may have an increased risk of hypoglycemia.

    • Advise patients of the risk of the signs and symptoms of hypoglycemia. Prior to initiating and during treatment, monitor blood glucose in patients with type 2 diabetes. Upon initiating treatment, consider reduce dose of concomitant insulin secretagogue or insulin.

    Acute Kidney Injury 

    • Patients with renal impairment may have greater risk of acute kidney injury.

    • Monitor renal function when initiating or escalating doses. Monitor renal function in patients with renal impairment reporting any adverse reactions that could lead to volume depletion.

    Hypersensitivity

    • Discontinue and treat promptly per standard of care if hypersensitivity reactions occur, then monitor until signs and symptoms resolve.

    • Use caution in patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist.

    Diabetic Retinopathy Complications in Patients with Type 2 Diabetes

    • Risk of temporary worsening of diabetic retinopathy with a rapid improvement in glucose control.

    • Wegovy has not been studied for the effect of long-term glycemic control on diabetic retinopathy complications.

    • Monitor patients for progression of diabetic retinopathy in patients with a history of diabetic retinopathy.

    Heart Rate Increase

    • Monitor heart rate at regular intervals.

    • Advise patients to inform their healthcare providers of palpitations or feelings of a racing heartbeat while at rest during treatment.

    • Discontinue treatment if a sustained increase in resting heart rate occurs.

    Suicidal Behavior and Ideation

    • Monitor for emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

    • Discontinue treatment if suicidal thoughts or behaviors occur.

    • Avoid in patients with a history of suicidal attempts or active suicidal ideation.

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • There will be 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 1-800-727-6500.

    Risk Summary

    • Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.

    • Advise pregnant patient of the risk of fetal harm when pregnancy is recognized and discontinue treatment.

    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. 

    Nursing Mother Considerations

    Risk Summary

    • No data on the presence of semaglutide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.

    • Consider the developmental and health benefits of breastfeeding 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. 

    Pediatric Considerations

    Safety and efficacy of Wegovy have not been established in pediatric patients.

    Geriatric Considerations

    No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

    Renal Impairment Considerations

    No dose adjustment is recommended.

    Hepatic Impairment Considerations

    No dose adjustment is recommended.

    Other Considerations for Specific Populations

    Females and Males of Reproductive Potential  

    • Discontinue treatment in patients at least 2 months before they plan to become pregnant.

    Wegovy Pharmacokinetics

    Absorption

    Absolute bioavailability of semaglutide is 89%. Maximum concentration of semaglutide is reached 1 to 3 days post dose. Similar exposure was achieved with subcutaneous administration of semaglutide in the abdomen, thigh, or upper arm. The average semaglutide steady state concentration following subcutaneous administration of Wegovy was ~75 nmol/L in patients with either obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2). The steady state exposure of Wegovy increased proportionally with doses up to 2.4 mg once-weekly. 

    Distribution

    The mean volume of distribution of semaglutide following subcutaneous administration in patients with obesity or overweight is approximately 12.5 L. Semaglutide is extensively bound to plasma albumin (>99%) which results in decreased renal clearance and protection from degradation. 

    Metabolism

    The primary route of elimination for semaglutide is metabolism following proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty acid sidechain. 

    Elimination

    With an elimination half-life of ~1 week, semaglutide will be present in the circulation for about 5 to 7 weeks after the last dose of 2.4 mg. 

    The primary excretion routes of semaglutide-related material are via the urine and feces. Approximately 3% of the dose is excreted in the urine as intact semaglutide.

    Wegovy Interactions

    Interactions

    Increased risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas) or insulin; may need a lower dose of these. May affect absorption of other oral drugs (delayed gastric emptying); caution.

    Wegovy Adverse Reactions

    Adverse Reactions

    Nausea, diarrhea, vomiting, constipation, abdominal pain/distension, headache, fatigue, dyspepsia, dizziness, eructation, hypoglycemia in T2DM, flatulence, gastroenteritis, GERD, nasopharyngitis; acute kidney injury, retinal disorders, lab abnormalities (eg, increased lipase or amylase), hypersensitivity reactions.

    Wegovy Clinical Trials

    Clinical Trials

    Cardiovascular Outcomes Trial in Adult Patients with Cardiovascular Disease and Either Obesity or Overweight

    The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 SELECT trial (ClinicalTrials.gov Identifier: NCT03574597). The study evaluated Wegovy, a glucagon-like peptide-1 (GLP-1) receptor agonist, as an adjunct to standard of care for prevention of MACE in patients with established CVD who were overweight or obese with no prior history of diabetes over a period of 5 years. 

    Study participants (N=17,604) were aged 45 years and older with a body mass index of at least 27kg/m2. Prior MI was reported in 76% of patients, prior stroke in 23%, peripheral arterial disease in 9% and heart failure in 24%. 

    At baseline, CVD 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%). The primary endpoint of the study was the time to first occurrence of MACE.

    Findings showed treatment with Wegovy significantly reduced the risk for first occurrence of MACE by 20% compared with placebo (hazard ratio [HR], 0.80 [95% CI, 0.72-0.90]; P <.001). Wegovy also reduced the risk of cardiovascular death by 15% (HR, 0.85 [95% CI, 0.71-1.01]) and the risk of death from any cause by 19% (HR, 0.81 [95% CI, 0.71-0.93]) vs placebo (both key secondary endpoints).

    Weight Management Studies in Adults with Overweight or Obesity

    The approval was based on three 68-week double-blind, placebo-controlled studies (Studies 1, 2, 3), in which Wegovy or placebo was escalated to 2.4mg subcutaneous weekly during a 16-week period followed by 52 weeks on maintenance dose, as well as one 68-week withdrawal trial (Study 4), in which Wegovy was escalated during a 20-week run-in period, and patients who reached 2.4mg after the run-in period were randomly assigned to either continue treatment or placebo for 48 weeks.

    In Studies 1, 2, and 3, the primary efficacy endpoints were mean percent change in body weight and the percentages of patients achieving greater than or equal to 5% weight loss from baseline to week 68. Findings from these studies showed that treatment with Wegovy resulted in statistically significant reductions in body weight, with a greater proportion of patients achieving 5%, 10%, and 15% weight loss, compared with placebo.

    Study 1 (ClinicalTrials.gov Identifier: NCT03548935) included 1961 patients with obesity or with overweight and at least 1 weight-related comorbid condition; mean baseline body weight was 105.3 kg and mean BMI was 37.9 kg/m2. Wegovy-treated patients (n=1306) lost an average of 12.4% (95% CI, -13.3, -11.6) of their initial body weight compared with those who received placebo (n=655) (P <.0001).

    Study 2 (ClinicalTrials.gov Identifier: NCT03552757) enrolled 807 patients with type 2 diabetes and a BMI of at least 27 kg/m2; mean baseline body weight was 99.8 kg and mean BMI was 35.7 kg/m2. In this study, patients who received Wegovy (n=404) lost an average of 6.2% (95% CI, -7.3, -5.2) of their initial body weight compared with placebo (n=403) (P <.0001).

    Study 3 (ClinicalTrials.gov Identifier: NCT03611582) included 611 patients with obesity or with overweight and at least 1 weight-related comorbid condition who were undergoing intensive lifestyle therapy; mean baseline body weight was 105.8 kg and mean BMI was 38.0 kg/m2. Findings showed that Wegovy-treated patients (n=407) lost an average of 10.3% (95% CI, -11.8, -8.7) of their initial body weight compared with placebo (n=204) (P <. 0001).

    In Study 4 (ClinicalTrials.gov Identifier: NCT03548987), the primary efficacy measure was mean percent change in body weight from randomization (week 20) to week 68. The mean body weight change was observed to be -7.9% with continued Wegovy treatment vs +6.9% with placebo (% difference from placebo, -14.8 [95% CI, -16.0, -13.5]; P <.001).

    Weight Reduction and Long-Term Maintenance Study in Pediatric Patients with Obesity

    The approval was based on data from the STEP TEENS study (ClinicalTrials.gov Identifier: NCT04102189), which included 201 participants 12 to less than 18 years of age with BMI corresponding to greater than or equal to the 95th percentile standardized for age and sex. Patients were randomly assigned 2:1 to receive semaglutide administered once-weekly by subcutaneous injection or placebo for 68 weeks, in addition to lifestyle intervention. The primary endpoint of the study was the percentage change in BMI from baseline to week 68.

    At week 68, the mean change in BMI from baseline in the semaglutide group was -16.1%, while in the placebo group, it was 0.6% (estimated difference, -16.7 percentage points [95% CI, -20.3, -13.2]; P <.0001). Compared with placebo, a greater proportion of patients treated with semaglutide achieved a BMI reduction of 5% or more (77.1% vs 19.7%), 10% or more (65.1% vs 7.7%), and 15% or more (57.8% vs 4.0%). In addition to reductions in body weight, improvements in waist circumference, HbA1c, and lipids (except for high-density lipoprotein cholesterol) were also observed with semaglutide compared with placebo.

     

    Wegovy Note

    Not Applicable

    Wegovy Patient Counseling

    Patient Counseling

    Risk of Thyroid C-cell Tumors

    • Counsel patients associated with the potential risk of MTC and inform patients of symptoms associated with thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness).

    Acute Pancreatitis

    • Inform patients to discontinue treatment promptly and contact their physician if pancreatitis is suspected (severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting).

    Acute Gallbladder Disease

    • Inform risk of acute gallbladder disease. Advise patients that substantial or rapid weight loss can increase the risk of gallbladder disease.

    • Instruct patients to contact their healthcare provider for appropriate clinical follow-up if gallbladder disease is suspected.

    Hypoglycemia

    • Advise patients of the risk of the signs and symptoms of hypoglycemia. Advise patients with type 2 diabetes mellitus that treatment may increase risk of hypoglycemia. 

    Dehydration and Renal Impairment 

    • Advise patients of the risk of dehydration due to GI adverse reactions and avoid fluid depletion. Inform risk of worsening renal function and the associated signs and symptoms of renal impairment. Advise of the possibility of dialysis as a medical intervention if renal failure occurs. 

    Hypersensitivity

    • Advise patients to discontinue treatment and seek medical advice promptly if hypersensitivity reactions occur.

    • Use caution in patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist.

    Diabetic Retinopathy Complications in Patients with Type 2 Diabetes

    • Advise patients to contact their physician if changes in vision occur during treatment.

    Heart Rate Increase

    • Instruct patients to inform their healthcare providers of palpitations or feelings of a racing heartbeat while at rest during treatment.

    Suicidal Behavior and Ideation

    • Advise patients to report emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Inform patients that if they experience suicidal thoughts or behaviors, discontinue treatment.

    Pregnancy

    • Wegovy may cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients who are exposed to Wegovy during pregnancy to contact Novo Nordisk at 1-800- 727-6500.

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