Selected Important Safety Information
What is the most important information I should know about Saxenda®?
Serious side effects may happen in people who take Saxenda®, including:
Possible thyroid tumors, including cancer. Tell your health care professional if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Saxenda® and medicines that work like Saxenda® caused thyroid tumors, including thyroid cancer. It is not known if Saxenda® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use Saxenda® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). See below for full Important Safety Information as well as Limitations of Use.
Saxenda® is an FDA-approved prescription injectable medicine that may help some adults with excess weight (body mass index [BMI] ≥27) who also have weight-related medical problems or obesity (BMI ≥30), lose weight and keep it off. Saxenda® should be used with a reduced-calorie meal plan and increased physical activity. Click here for full Indications and Usage.
What Results Have Been Seen With Saxenda®?
Medical studies with more than 3,000 people taking Saxenda® were conducted to understand the benefits and risks of Saxenda®. Learn more about some of the results below.
Results from a medical study showed significant weight loss
Along with a low-calorie meal plan and increased physical activity, some people in a medical study lost nearly 2.5 times more weight with Saxenda® versus placebo (17.3 lb vs 7 lb).a Study participants had an average starting weight of 234 lb and an average BMI of 38.
aThese results were from a 56-week trial of adults with excess weight (BMI ≥27) with at least 1 weight-related condition, or obesity (BMI ≥30), not including patients with type 2 diabetes. On average, 27% of people on Saxenda® and 34% on placebo did not complete the study. In the study, 62% of patients on Saxenda® lost ≥5% of their body weight (vs 34% placebo) and 34% lost ≥10% body weight (vs 15% placebo). Significant weight loss was only evaluated at 56 weeks, as per study design.
Majority in the study taking Saxenda® lost weight
In the same study, the majority of people achieved significant weight loss.
Changes in body weight over a year
The chart below is from a 1-year study of more than 3,500 adults.b It shows the average change in body weightc at 56 weeks. Individual results may vary.
bPatients without type 2 diabetes and with a BMI ≥30 or ≥27 with at least 1 weight-related condition, along with a reduced-calorie diet and physical activity.
cAverage starting weight was 233.9 lb and average starting BMI was 38.3.
dA reduction in body weight of 5% or more.
In a different 1-year study, most people who stayed on Saxenda® kept the weight off
Saxenda® can help you keep weight off. In a 1-year medical study,e,f 8 out of 10 people who were able to lose 5% or more of their weight within 4 to 12 weeks with a low-calorie meal plan and increased physical activity were able to maintain that weight loss with Saxenda® along with a low-calorie meal plan and increased physical activity.
In addition, at the end of this study, on average, people who were on Saxenda® were able to achieve an additional 6.8% weight loss versus placebo (0.2%).
eA 56-week trial of adults with excess weight (BMI ≥27) with at least 1 weight-related condition, or obesity (BMI ≥30), not including patients with type 2 diabetes. This study was designed to measure weight loss (beginning to end of trial), ability to keep weight off (didn’t gain >0.5%), and those who achieved >5% weight loss.
fResults may not reflect those expected in the general population.