Description

The U.S. Food and Drug Administration has approved Saxenda (liraglutide) for chronic weight management among patients aged 12 and older who are obese, as defined by specific body mass index (BMI) cut-offs for age and sex that correspond to a BMI 30 kg/m2 or higher for adults, and who weigh more than 60 kg (132 pounds).

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 (obese) 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)

Pediatric patients aged 12 years and older with body weight above 60 kg (132 lbs) and initial BMI corresponding to 30 kg/m2 or greater for adults (obese) by international cut-offs

What is Saxenda® (liraglutide) injection 3 mg?

Saxenda® (liraglutide) injection 3 mg is an injectable prescription medicine used for adults with excess weight (Body Mass Index ≥27) who also have weight-related medical problems or obesity (BMI ≥30), and children aged 12-17 years with a body weight above 132 pounds (60 kg) and obesity to help them lose weight and keep the weight off. Saxenda® should be used with a reduced calorie diet and increased physical activity.

Saxenda® and Victoza® have the same active ingredient, liraglutide, and should not be used together or with other GLP-1 receptor agonist medicines.

It is not known if Saxenda® is safe and effective when taken with other prescription, over-the-counter medicines, or herbal weight-loss products.

It is not known if Saxenda® is safe and effective in children under 12 years of age.

It is not known if Saxenda® is safe and effective in children aged 12 to 17 years with type 2 diabetes.

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).

How should I use Saxenda®?

Inject your dose of Saxenda® under the skin (subcutaneously) in your stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by your health care provider. Do not inject into a vein or muscle.