Semaglutide

Chemical formula: C₁₈₇H₂₉₁N₄₅O₅₉  Molecular mass: 4,113.641 g/mol 

Therapeutic indications

Semaglutide is indicated for:

Diabetes mellitus type 2

Population group: only adults (18 years old or older)

Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Obesity or overweight in the presence of at least one weight-related comorbidity

Population group: only adults (18 years old or older)

Semaglutide is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of

  • ≥30 kg/m² (obesity), or
  • ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Obesity and body weight above 60 kg

Population group: only adolescents (12 years - 18 years old)

Semaglutide is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with

  • obesity* and
  • body weight above 60 kg.

Treatment with semaglutide should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.

* Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1).

Table 1. BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria):

Age (years) BMI (kg/m²) at 95th Percentile
Males Females
12 24.2 25.2
12.5 24.7 25.7
13 25.1 26.3
13.5 25.6 26.8
14 26.0 27.2
14.5 26.4 27.7
15 26.8 28.1
15.5 27.2 28.5
16 27.5 28.9
16.5 27.9 29.3
17 28.2 29.6
17.5 28.6 30.0

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Diabetes mellitus type 2

Population group: only adults (18 years old or older)

Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to other medicinal products for the treatment of diabetes.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Contraindications

Semaglutide is contraindicated in the following cases:

Congestive heart failure NYHA class IV

Heart failure New York Heart Assosiation Class IV

Severe renal impairment

at least one of

Renal failure stage 5: Kidney failure (GFR <15 mL/min/1.73 m2 or dialysis)

Pregnancy

Pregnancy

Lactation

Lactation

Diabetes mellitus type 1, diabetic ketoacidosis

at least one of
Diabetes mellitus type I
Diabetic ketoacidosis

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