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Description
Saxenda is indicated as an adjunct to a hypocaloric diet and increased physical activity for weight control in adult patients with an initial Body Mass Index (BMI):
- ≥ 30 kg/m2 ( obesity), or
- ≥ 27 kg/m 2 and < 30 kg/m 2 (overweight) in the presence of at least one weight-related comorbidity factor such as dysglycemia (prediabetes or type 2 diabetes), high blood pressure, dyslipidemia or obstructive sleep apnea syndrome.
Treatment with Saxenda should be discontinued after 12 weeks at a dose of 3.0 mg/day 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 diet and increased physical activity for weight control in adolescent patients from 12 years of age who have:
- obesity (corresponding to a BMI ≥ 30 kg/m 2 in adults according to international thresholds)* and
- a body weight greater than 60 kg.
Saxenda treatment should be discontinued and reassessed if patients have not lost at least 4% of their BMI or BMI Z-score after 12 weeks at 3.0 mg/day or the maximum tolerated dose.
*IOTF BMI cut-offs for obesity by gender between 12 and 18 years (see Table 1):
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