Saxenda

What it is for

• Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of • ≥ 30 kg/m² (obese), or• ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea. Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight. Adolescents (≥12 years) Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with: obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)* and body weight above 60 kg. Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *IOTF BMI cut-off points for obesity by sex between 12-18 years, in accordance with study design of the Trial 4180, see section 5.1. Children (6 to <12 years)Saxenda is indicated as an adjunct to healthy nutrition and increased physical activity for weight management in children from the age of 6 to <12 years with - obesity (BMI ≥95th percentile)* and- body weight ≥45 kgTreatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *CDC BMI cut-off points for obesity (≥95th percentile) by sex between 6 to <12 years, in accordance with study design of the Trial 4392, see section 5.1.

From the official label · 2026-09-30 · European Medicines Agency