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For chronic weight management in adult patients with a BMI ≥30 kg/m2, or ≥27 kg/m2 with one or more weight-related comorbidities, as an adjunct to a reduced-calorie diet and increased physical activity. Click for Limitations of Use.

Significant Weight Loss

In clinical trials, a majority of patients achieved clinically meaningful weight loss of ≥5% with Saxenda® 1

Significant Weight Loss

In clinical trials, a majority of patients achieved clinically meaningful weight loss of ≥5% with Saxenda® 1

Actor Portrayal.

Patients Lost Weight With Saxenda®

In a 1-year study, 85% of patients treated with Saxenda® lost some weight1

In a 56-week study of 3,731 patients without type 2 diabetes and with a BMI ≥30, or ≥27% with at least 1 weight-related comorbidity, patients were randomized to either Saxenda® (n=2,487) or placebo (n=1,244), with all patients receiving a reduced-calorie diet (~500 kcal/day deficit) and physical activity counseling.1

The majority of patients achieved clinically meaningful weight loss of ≥5% with Saxenda®1

Graph depicting weight loss results from a Saxenda® clinical trial
Graph depicting weight loss results from a Saxenda® clinical trial

aDifference from placebo (least squares [LS]) mean, 27.9% [95% CI, 23.9. 31.9]).

bDifference from placebo (LS mean), 18.5% (95% CI, 15.2, 21.7).

cWeight loss in pounds (lb) calculated as 5%, 10%, or 20% of mean baseline body weight.

dBased on the frequency cumulative distribution of change in body weight curve.

The primary end points were mean percentage weight change, percentage of patients achieving ≥5% of baseline weight loss, and percentage of patients achieving >10% of baseline weight loss1

  • The primary end points were mean percentage weight change, percentage of patients achieving ≥5% of baseline weight loss, and percentage of patients achieving >10% of baseline weight loss1

Weight loss was defined as any reduction in weight from start of trial1

  • Weight loss was defined as any reduction in weight from start of trial1

Mean baseline body weight was 233.9 lb and mean baseline BMI was 38.3 kg/m2 1

  • Mean baseline body weight was 233.9 lb and mean baseline BMI was 38.3 kg/m2 1
Graph depicting weight loss results from a Saxenda® clinical trial
Graph depicting weight loss results from a Saxenda® clinical trial

aDifference from placebo (least squares [LS]) mean, 27.9% [95% CI, 23.9. 31.9]).

bDifference from placebo (LS mean), 18.5% (95% CI, 15.2, 21.7).

cWeight loss in pounds (lb) calculated as 5%, 10%, or 20% of mean baseline body weight.

dBased on the frequency cumulative distribution of change in body weight curve.

The primary end points were mean percentage weight change, percentage of patients achieving ≥5% of baseline weight loss, and percentage of patients achieving >10% of baseline weight loss1

  • The primary end points were mean percentage weight change, percentage of patients achieving ≥5% of baseline weight loss, and percentage of patients achieving >10% of baseline weight loss1

Weight loss was defined as any reduction in weight from start of trial1

  • Weight loss was defined as any reduction in weight from start of trial1

Mean baseline body weight was 233.9 lb and mean baseline BMI was 38.3 kg/m2 1

  • Mean baseline body weight was 233.9 lb and mean baseline BMI was 38.3 kg/m2 1
Graph depicting weight loss results from a Saxenda® clinical trial
Graph depicting weight loss results from a Saxenda® clinical trial

aDifference from placebo (least squares [LS]) mean, 27.9% [95% CI, 23.9. 31.9]).

bDifference from placebo (LS mean), 18.5% (95% CI, 15.2, 21.7).

cWeight loss in pounds (lb) calculated as 5%, 10%, or 20% of mean baseline body weight.

dBased on the frequency cumulative distribution of change in body weight curve.

The primary end points were mean percentage weight change, percentage of patients achieving ≥5% of baseline weight loss, and percentage of patients achieving >10% of baseline weight loss1

  • The primary end points were mean percentage weight change, percentage of patients achieving ≥5% of baseline weight loss, and percentage of patients achieving >10% of baseline weight loss1

Weight loss was defined as any reduction in weight from start of trial1

  • Weight loss was defined as any reduction in weight from start of trial1

Mean baseline body weight was 233.9 lb and mean baseline BMI was 38.3 kg/m2 1

  • Mean baseline body weight was 233.9 lb and mean baseline BMI was 38.3 kg/m2 1

Clinically Meaningful Weight Loss

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The majority of patients treated with Saxenda® achieved and maintained clinically meaningful weight loss1,2

Observed mean change in body weight from baseline

Graph depicting clinically significant weight loss results from a Saxenda® clinical trial
Graph depicting clinically significant weight loss results from a Saxenda® clinical trial

aDifference from placebo was statistically significant. ITT-MI, intention to treat with multiple imputations.1

21-lb mean weight loss

achieved by patients on Saxenda® who completed the study3

21-lb mean weight loss

achieved by patients on Saxenda® who completed the study3

  • Mean baseline body weight was 233.9 lb and mean baseline BMI was 38.3 kg/m2

Mean baseline body weight was 233.9 lb and mean baseline BMI was 38.3 kg/m2

Secondary End Point: Impact on Waist Circumference

A large waist circumference is an important marker for obesity-related health risks4

Saxenda® reduced waist circumference by 3.2 inches vs 1.6 inches with placebo.1

Mean waist circumference at baseline was 45.3 inches for patients treated with Saxenda® (n=2,487) and 45.1 inches for patients taking placebo (n=1,244)1

Measuring waist4

How to correctly measure waist circumference

Measuring circumference correctly is simple to learn and important to know

Saxenda® reduced waist circumference by 3.2 inches vs 1.6 inches with placebo.1

Mean waist circumference at baseline was 45.3 inches for patients treated with Saxenda® (n=2,487) and 45.1 inches for patients taking placebo (n=1,244)1

Click below to expand
  • Results from a 56-week, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Saxenda®
  • Patients with a BMI of ≥30, or ≥27 with 1 or more weight-related comorbidities (N=3,731) were randomized to receive once-daily Saxenda® (n=2,487) or placebo (n=1,244) in conjunction with a lifestyle modification program that included increased physical activity and a 500-kcal/day deficit diet
  • Patients underwent a 4-week dose-escalation period followed by 52 weeks on the full dose
  • The primary end points were mean percent weight change, percentage of patients achieving ≥5% of baseline weight loss, and percentage of patients achieving >10% of baseline weight loss at 56 weeks
  • Secondary end points included changes in waist circumference, blood pressure, and lipids
  • Mean baseline body weight was 233.9 lb and mean BMI was 38.3 kg/m2
  • Patients with type 2 diabetes were excluded from participating

See Roberto’s path to weight management

Description:

Witness the conversation between Roberto and his doctor as Roberto struggles to manage his weight. When Roberto brought up his weight to his doctor, he was already exercising and eating healthy. His doctor knew there had to be more to help Roberto keep the weight off; that's when he recommended Saxenda®.

Actor Portrayal.

Actor Portrayal.

Description:

Witness the conversation between Roberto and his doctor as Roberto struggles to manage his weight. When Roberto brought up his weight to his doctor, he was already exercising and eating healthy. His doctor knew there had to be more to help Roberto keep the weight off; that's when he recommended Saxenda®.

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Sustained Weight Loss

Selected Important Safety Information

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 (obesity) 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)

Limitations of Use

  • Saxenda® is not indicated for the treatment of type 2 diabetes 
  • Saxenda® and Victoza® both contain the same active ingredient, liraglutide, and therefore should not be used together. Saxenda® should not be used in combination with any other GLP-1 receptor agonist 
  • Saxenda® has not been studied in patients taking insulin. Saxenda® and insulin should not be used together 
  • The safety and efficacy of Saxenda® in combination with other products 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 MEN 2 
  • Patients with a prior serious hypersensitivity reaction to liraglutide or to any of the product components 
  • 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 
  • Risk of Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy: When Saxenda® is used with an insulin secretagogue (eg, a sulfonylurea) serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia. Monitor blood glucose parameters prior to starting Saxenda® and during treatment and adjust anti-diabetic drugs as needed 
  • 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 liraglutide. If a hypersensitivity reaction occurs, patients should stop taking Saxenda® and promptly seek medical advice 
  • Suicidal Behavior and Ideation: In 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 patients treated with Saxenda® attempted suicide. Monitor patients on Saxenda® 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

Adverse Events

  • The most common adverse reactions, reported in ≥5% are: nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase

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 below 18 years of age and is not recommended for use in pediatric patients 
  • Saxenda® slows gastric emptying. Saxenda® has not been studied in patients with preexisting gastroparesis

Please click here for Prescribing Information, including Boxed Warning.

 

Click below to expand

1. Saxenda® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2018.

2. Wing RR, Lang W, Wadden TA, et al. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011;34(7):1481-1486.

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

4. National Heart, Lung, and Blood Institute; National Institutes of Health; North American Association for the Study of Obesity. The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Bethesda, MD: National Institutes of Health; 2000. NIH Publication 00-4084.

5. Pi-Sunyer X, Astrup A, Fujioka K, et al. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. N Engl J Med. 2015;373(1):11-22.