Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 16 April 2018

Indication(s)

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.

 

Full Prescribing information

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Advisory information

contraindications
Hypersensitivity to liraglutide or to any of the excipients listed in section 6.1.

Usage information

Dosing and administration

Posology
The starting dose is 0.6 mg once daily. The dose should be increased to 3.0 mg once daily in increments of 0.6 mg with at least one week intervals to improve gastro-intestinal tolerabilit. If escalation to the next dose step is not tolerated for two consecutive weeks, consider discontinuing treatment. Daily doses higher than 3.0 mg are not recommended.

Patients with type 2 diabetes mellitus
Saxenda should not be used in combination with another GLP-1 receptor agonist.
When initiating Saxenda, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia.

Use in special populations

Elderly (≥65 years old)
No dose adjustment is required based on age. Therapeutic experience in patients ≥75 years of age is limited and use in these patients is not recommended (see sections 4.4 and 5.2).

Renal impairment
No dose adjustment is required for patients with mild or moderate renal impairment (creatinine clearance ≥30 ml/min). Saxenda is not recommended for use in patients with severe renal impairment (creatinine clearance <30 ml/min) including patients with end-stage renal disease (see sections 4.4, 4.8 and 5.2).

Hepatic impairment
No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Saxenda is not recommended for use in patients with severe hepatic impairment and should be used cautiously in patients with mild or moderate hepatic impairment (see sections 4.4 and 5.2).

Paediatric population
The safety and efficacy of Saxenda in children and adolescents below 18 years of age have not been established (see section 5.1). No data are available. This medicinal product is not recommended for use in paediatric patients.

Pregnancy and lactation
Pregnancy
There are limited data from the use of liraglutide in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.

Liraglutide should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, treatment with liraglutide should be discontinued.

Breast-feeding
It is not known whether liraglutide is excreted in human milk. Animal studies have shown that the transfer of liraglutide and metabolites of close structural relationship into milk is low. Non-clinical studies have shown a treatment related reduction of neonatal growth in suckling rat pups (see section 5.3). Because of lack of experience, Saxenda should not be used during breast-feeding.

Fertility
Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility (see section 5.3).

More information

Category Value
Agency product number EMEA/H/C/003780
Orphan designation No
Date First Approved 23-03-2015
Type Medicinal product subject to medical prescription.
Marketing authorisation holder Novo Nordisk A/S
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions