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.
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.
Benefits of Saxenda®
You may have lost weight once or many times in the past. But keeping the weight off proved to be difficult. Learn how Saxenda® helped some adults lose weight and keep it off below. Then look up your co-pay and ask your health care provider if Saxenda® is right for you.
How much weight can I lose?
Saxenda® was clinically tested and proven in a study of 3,731 patients in which 85% of people taking Saxenda® lost some weight.a In this study:
Which means those patients lost an average of ~12 lb (from before they entered the study)
Which means those patients lost an average of ~23 lb (from before they entered the study)
Which means those patients lost an average of ~47 lb (from before they entered the study)
aResults are from a 56-week trial of 3,731 adults with body mass index (BMI) of 27-29.9 with at least 1 weight-related condition, or BMI of at least 30 not including adults with type 2 diabetes. In this study, 2,487 patients received Saxenda® and 1,244 received placebo. Both groups also received a reduced calorie diet and physical activity counseling.
bFor patients taking placebo: 5% or more weight loss was achieved by 34% of patients, 10% or more weight loss was achieved by 15% of patients, and 20% or more weight loss was achieved by 3% of patients.
c3 out of 5=62%; 1 out of 3 = 34%.
dIndividual results may vary.
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In a clinical study of people taking Saxenda® for 3 yearse:
- 56% achieved significant weight loss at year 1, and
- Approximately half of these patients maintained weight loss at 3 years when taking Saxenda® added to a reduced-calorie meal plan and increased physical activity, compared with people not on the drug
eIn a 3-year study, 2,254 adults with pre-diabetes and BMI ≥30 or ≥27 with one or more weight-related conditions were given Saxenda® (1,505 people) or placebo (749 people) added to a reduced-calorie meal plan and increased physical activity. The study looked at how many people lost ≥5% of their body weight. At year 1, 891 people on Saxenda® (56%) lost ≥5% of their weight vs 182 patients on placebo (25%). After 3 years, 747 people on Saxenda® and 322 people on placebo remained and had their weight measured. 391 of those people on Saxenda® (26%) lost ≥5% of their weight at both the 1- and 3-year marks vs 74 people on placebo (10%).
How can I tell if Saxenda® is working?
You will know if Saxenda® is working for you if you lose 4% of your body weight by your 4-month follow-up appointment.
Reducing your waistline isn’t the only impact of weight loss. Taking off weight and keeping it off may help improve conditions such as high blood pressure and high cholesterol levels.
Saxenda® is not indicated for the treatment of high blood pressure or high cholesterol. It is not known if Saxenda® changes your risk of heart problems or stroke or of death due to heart problems or stroke.
While you are at rest, Saxenda® can increase your heart rate. Tell your health care provider if you feel your heart racing or pounding in your chest and it lasts for several minutes while taking Saxenda®.