Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
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:
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.
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:
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 (see table 1):
Table 1. IOTF BMI cut-off points for obesity by sex between 12–18 years:
| Age (years) | BMI corresponding to 30 kg/m² for adults by international cut-off points. | |
|---|---|---|
| Males | Females | |
| 12 | 26.02 | 26.67 |
| 12.5 | 26.43 | 27.24 |
| 13 | 26.84 | 27.76 |
| 13.5 | 27.25 | 28.20 |
| 14 | 27.63 | 28.57 |
| 14.5 | 27.98 | 28.87 |
| 15 | 28.30 | 29.11 |
| 15.5 | 28.60 | 29.29 |
| 16 | 28.88 | 29.43 |
| 16.5 | 29.14 | 29.56 |
| 17 | 29.41 | 29.69 |
| 17.5 | 29.70 | 29.84 |
| 18 | 30.00 | 30.00 |
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 2). 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.
Table 2. Dose escalation schedule:
| Dose | Weeks | |
|---|---|---|
| Dose escalation 4 weeks | 0.6 mg | 1 |
| 1.2 mg | 1 | |
| 1.8 mg | 1 | |
| 2.4 mg | 1 | |
| Maintenance dose | 3.0 mg | |
For adolescents from the age of 12 to below 18 years old a similar dose escalation schedule as for adults should be applied (see table 2). The dose should be increased until 3.0 mg (maintenance dose) or maximum tolerated dose has been reached. Daily doses higher than 3.0 mg are not recommended.
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.
Saxenda should not be used in combination with another GLP-1 receptor agonist.
When initiating Saxenda, it should be considered to reduce the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia. Blood glucose self-monitoring is necessary to adjust the dose of insulin or insulin-secretagogues (see section 4.4).
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).
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).
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).
No dose adjustment is required for adolescents from the age of 12 years and above. The safety and efficacy of Saxenda in children below 12 years of age has not been established (see section 5.1).
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.
For further instructions on administration, see section 6.6.
From clinical trials and post-marketing use of liraglutide overdoses have been reported up to 72 mg (24 times the recommended dose for weight management). Events reported included severe nausea, severe vomiting and severe hypoglycaemia.
In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. The patient should be observed for clinical signs of dehydration and blood glucose should be monitored.
30 months.
After first use: 1 month.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store away from the freezer compartment.
After first use: Store below 30°C or store in a refrigerator (2°C–8°C).
Keep the cap on the pen in order to protect from light.
Cartridge (type 1 glass) with a plunger (bromobutyl) and a laminate rubber sheet (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene, polyacetal, polycarbonate and acrylonitrile butadiene styrene.
Each pen contains 3 ml solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.
Pack sizes of 1, 3 or 5 pre-filled pens.
Not all pack sizes may be marketed
The solution should not be used if it does not appear clear and colourless or almost colourless.
Saxenda should not be used if it has been frozen.
The pen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm and as thin as 32G.
Needles are not included.
The patient should be advised to discard the injection needle after each injection and store the pen without an injection needle attached. This prevents contamination, infection and leakage. It also ensures that the dosing is accurate.
Any unused medicinal product or waste material should be disposed in accordance with local requirements.
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