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 tolerability (see Table 6). 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.
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Patients w/ 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.
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 Pharmacology: Pharmacokinetics under Actions and Precautions).
Renal impairment: No dose adjustment is required for patients with mild or moderat erenal impairment (creatinine clearance ≥30ml/min). Saxenda is not recommended for use in patients with severe renal impairment (creatinine clearance <30ml/min) including patients with end-stage renal disease (see Precautions, Adverse Reactions and Pharmacology: Pharmacokinetics under Actions).
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 Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Saxenda in children and adolescents below 18 years of age have not been established (see Pharmacology: Pharmacodynamics under Actions). No data are available. This medicinal product is not recommended for use in paediatric patients.
Method of administration: Saxenda is for subcutaneous use only. It must not be administered intravenously or intramuscularly.
Saxenda is administered once daily at any time, independent of meals. It should be injected in the abdomen, thigh or upper arm. The injection site and timing can be changed without dose adjustment. However, it is preferable that Saxenda is injected around the same time of the day, when the most convenient time of the day has been chosen.
Saxenda should not be mixed with other injectables (e.g. insulins).
If a dose is missed within 12 hours from when it is usually taken, the patient should take the dose as soon as possible. If there is less than 12 hours to the next dose, the patient should not take the missed dose and resume the once-daily regimen with the next scheduled dose. An extra dose or increase in dose should not be taken to make up for the missed dose. For further instructions on administration, see Cautions for Usage.