Saxenda
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ANNEX I 

 
SUMMARY OF PRODUCT CHARACTERISTICS 

 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Saxenda 6 mg/ml solution for injection in pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
1 ml of solution contains 6 mg of liraglutide*. One pre-filled pen contains 18 mg liraglutide in 3 ml. 
 
*human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in 
Saccharomyces cerevisiae. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection. 
 
Clear and colourless or almost colourless, isotonic solution; pH=8.15. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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. 
 
4.2 Posology and method of 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 tolerability (see 
table 1). 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 1 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 
 
Missed doses 
 
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 



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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.  
 
Patients with type 2 diabetes mellitus  
 
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). 
 
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 yet 
been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no 
recommendation on posology can be made. 
 
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. 
 
For further instructions on administration, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to liraglutide or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Patients with heart failure 



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There is no clinical experience in patients with congestive heart failure New York Heart Association 
(NYHA) class IV, and liraglutide is therefore not recommended for use in these patients. 
 
Special populations 
 
The safety and efficacy of liraglutide for weight management have not been established in patients: 
– aged 75 years or more, 
– treated with other products for weight management, 
– with obesity secondary to endocrinological or eating disorders or to treatment with medicinal 

products that may cause weight gain, 
– with severe renal impairment, 
– with severe hepatic impairment. 
Use in these patients is not recommended (see section 4.2). 
As liraglutide for weight management was not investigated in subjects with mild or moderate hepatic 
impairment, it should be used with caution in these patients (see sections 4.2 and 5.2). 
 
There is limited experience in patients with inflammatory bowel disease and diabetic gastroparesis. 
Use of liraglutide is not recommended in these patients since it is associated with transient 
gastrointestinal adverse reactions, including nausea, vomiting and diarrhoea. 
 
Pancreatitis 
 
Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patients should be 
informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, liraglutide 
should be discontinued; if acute pancreatitis is confirmed, liraglutide should not be restarted.  
 
Cholelithiasis and cholecystitis 
 
In clinical trials for weight management, a higher rate of cholelithiasis and cholecystitis was observed 
in patients treated with liraglutide than in patients on placebo. The fact that substantial weight loss can 
increase the risk of cholelithiasis and thereby cholecystitis only partially explained the higher rate with 
liraglutide. Cholelithiasis and cholecystitis may lead to hospitalisation and cholecystectomy. Patients 
should be informed of the characteristic symptoms of cholelithiasis and cholecystitis. 
 
Thyroid disease 
 
In clinical trials in type 2 diabetes, thyroid adverse events, such as goitre, have been reported in 
particular in patients with pre-existing thyroid disease. Liraglutide should therefore be used with 
caution in patients with thyroid disease. 
 
Heart rate 
 
An increase in heart rate was observed with liraglutide in clinical trials (see section 5.1). Heart rate 
should be monitored at regular intervals consistent with usual clinical practice. Patients should be 
informed of the symptoms of increased heart rate (palpitations or feelings of a racing heartbeat while 
at rest). For patients who experience a clinically relevant sustained increase in resting heart rate, 
treatment with liraglutide should be discontinued. 
 
Dehydration 
 
Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been 
reported in patients treated with GLP-1 receptor agonists. Patients treated with liraglutide should be 
advised of the potential risk of dehydration in relation to gastrointestinal side effects and take 
precautions to avoid fluid depletion. 
 
Hypoglycaemia in patients with type 2 diabetes mellitus 



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Patients with type 2 diabetes mellitus receiving liraglutide in combination with insulin and/or 
sulfonylurea may have an increased risk of hypoglycaemia. The risk of hypoglycaemia may be 
lowered by a reduction in the dose of insulin and/or sulfonylurea. 
 
Hyperglycaemia in insulin treated patients with diabetes mellitus  
 
In patients with diabetes mellitus Saxenda must not be used as a substitute for insulin. Diabetic 
ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose 
reduction of insulin (see section 4.2). 
 
Excipients 
 
Saxenda contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is 
essentially ‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
In vitro, liraglutide has shown very low potential to be involved in pharmacokinetic interactions with 
other active substances related to cytochrome P450 (CYP) and plasma protein binding. 
 
The small delay of gastric emptying with liraglutide may influence absorption of concomitantly 
administered oral medicinal products. Interaction studies did not show any clinically relevant delay of 
absorption and therefore no dose adjustment is required. 
 
Interaction studies have been performed with 1.8 mg liraglutide. The effect on rate of gastric emptying 
was equivalent between liraglutide 1.8 mg and 3.0 mg, (paracetamol AUC0-300 min). Few patients 
treated with liraglutide reported at least one episode of severe diarrhoea. Diarrhoea may affect the 
absorption of concomitant oral medicinal products.  
 
Warfarin and other coumarin derivatives 
 
No interaction study has been performed. A clinically relevant interaction with active substances with 
poor solubility or narrow therapeutic index such as warfarin cannot be excluded. Upon initiation of 
liraglutide treatment in patients on warfarin or other coumarin derivatives, more frequent monitoring 
of International Normalised Ratio (INR) is recommended. 
 
Paracetamol (Acetaminophen) 
 
Liraglutide did not change the overall exposure of paracetamol following a single dose of 1,000 mg. 
Paracetamol Cmax was decreased by 31% and median tmax was delayed up to 15 min. No dose 
adjustment for concomitant use of paracetamol is required. 
 
Atorvastatin 
 
Liraglutide did not change the overall exposure of atorvastatin following single dose administration of 
atorvastatin 40 mg. Therefore, no dose adjustment of atorvastatin is required when given with 
liraglutide. Atorvastatin Cmax was decreased by 38% and median tmax was delayed from 1 h to 3 h with 
liraglutide. 
 
Griseofulvin 
 
Liraglutide did not change the overall exposure of griseofulvin following administration of a single 
dose of griseofulvin 500 mg. Griseofulvin Cmax increased by 37% while median tmax did not change. 
Dose adjustments of griseofulvin and other compounds with low solubility and high permeability are 
not required. 
 



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Digoxin  
 
A single dose administration of digoxin 1 mg with liraglutide resulted in a reduction of digoxin AUC 
by 16%; Cmax decreased by 31%. Digoxin median tmax was delayed from 1 h to 1.5 h. No dose 
adjustment of digoxin is required based on these results.  
 
Lisinopril  
 
A single dose administration of lisinopril 20 mg with liraglutide resulted in a reduction of lisinopril 
AUC by 15%; Cmax decreased by 27%. Lisinopril median tmax was delayed from 6 h to 8 h with 
liraglutide. No dose adjustment of lisinopril is required based on these results. 
 
Oral contraceptives 
 
Liraglutide lowered ethinylestradiol and levonorgestrel Cmax by 12% and 13%, respectively, following 
administration of a single dose of an oral contraceptive product. tmax was delayed by 1.5 h with 
liraglutide for both compounds. There was no clinically relevant effect on the overall exposure of 
either ethinylestradiol or levonorgestrel. The contraceptive effect is therefore anticipated to be 
unaffected when co-administered with liraglutide. 
 
4.6 Fertility, 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). 
 
4.7 Effects on ability to drive and use machines 
 
Saxenda has no or negligible influence on the ability to drive and use machines. However, dizziness 
can be experienced mainly during the first 3 months of treatment with Saxenda. Driving or use of 
machines should be exercised with caution if dizziness occurs. 
 
4.8 Undesirable effects 
 
Summary of the safety profile:  
 
Saxenda was evaluated for safety in 5 double-blind, placebo controlled trials that enrolled 5,813 obese 
patients or overweight patients with at least one weight-related comorbidity. Overall, gastrointestinal 
reactions were the most frequently reported adverse reactions during treatment (67.9%) (see section 
‘Description of selected adverse reactions’). 
 



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Tabulated list of adverse reactions 
 
Table 2 lists adverse reactions reported. Adverse reactions are listed by system organ class and 
frequency. Frequency categories are defined as: very common (≥1/10); common (≥1/100 to <1/10); 
uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). Within each 
frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
Table 2 Adverse reactions reported 

MedDRA system 
organ classes 

Very common Common Uncommon Rare 

Immune system 
disorders 

   Anaphylactic 
reaction 

Metabolism and 
nutrition disorders 

 Hypoglycaemia* Dehydration  

Psychiatric 
disorders 

 Insomnia**   

Nervous system 
disorders 

 Dizziness 
Dysgeusia 

  

Cardiac disorders   Tachycardia  
Gastrointestinal 
disorders 

Nausea 
Vomiting 
Diarrhoea 
Constipation 

Dry mouth 
Dyspepsia 
Gastritis 
Gastro-oesophageal 
reflux disease 
Abdominal pain 
upper 
Flatulence 
Eructation 
Abdominal 
distension 

Pancreatitis*** 
Delayed gastric 
emptying**** 

 

Hepatobiliary 
disorders  

 Cholelithiasis*** Cholecystitis***  

Skin and 
subcutaneous tissue 
disorders 

  Urticaria  

Renal and urinary 
disorders 

   Acute renal 
failure 
Renal 
impairment 

General disorders 
and administration 
site conditions 

 Injection site 
reactions  
Asthenia 
Fatigue 

Malaise  

Investigations  Increased lipase 
Increased amylase 

  

*Hypoglycaemia (based on self-reported symptoms by patients and not confirmed by blood glucose 
measurements) reported in patients without type 2 diabetes mellitus treated with Saxenda in 
combination with diet and exercise. Please see section ‘Description of selected adverse reactions’ for 
further information. 
**Insomnia was mainly seen during the first 3 months of treatment. 
***See section 4.4. 
****From controlled phase 2, 3a and 3b clinical trials. 
 
Description of selected adverse reactions:  
 
Hypoglycaemia in patients without type 2 diabetes mellitus 
 



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In clinical trials in overweight or obese patients without type 2 diabetes mellitus treated with Saxenda 
in combination with diet and exercise, no severe hypoglycaemic events (requiring third party 
assistance) were reported. Symptoms of hypoglycaemic events were reported by 1.6 % of patients 
treated with Saxenda and 1.1% of patients treated with placebo; however, these events were not 
confirmed by blood glucose measurements. The majority of events were mild. 
 
Hypoglycaemia in patients with type 2 diabetes mellitus 
 
In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with Saxenda in 
combination with diet and exercise, severe hypoglycaemia (requiring third party assistance) was 
reported by 0.7% of patients treated with Saxenda and only in patients concomitantly treated with 
sulfonylurea. Also, in these patients documented symptomatic hypoglycaemia was reported by 43.6% 
of patients treated with Saxenda and in 27.3% of patients treated with placebo. Among patients not 
concomitantly treated with sulfonylurea, 15.7% of patients treated with Saxenda and 7.6% of patients 
treated with placebo reported documented symptomatic hypoglycaemic events (defined as plasma 
glucose ≤3.9 mmol/L accompanied by symptoms).  
 
Hypoglycaemia in patients with type 2 diabetes mellitus treated with insulin 
 
In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with insulin and 
liraglutide 3.0 mg/day in combination with diet and exercise and up to 2 OADs, severe hypoglycaemia 
(requiring third party assistance) was reported by 1.5% of patients treated with liraglutide 3.0 mg/day. 
In this trial, documented symptomatic hypoglycaemia (defined as plasma glucose ≤3.9 mmol/L 
accompanied by symptoms) was reported by 47.2% of patients treated with liraglutide 3.0 mg/day and 
by 51.8% of patients treated with placebo. Among patients concomitantly treated with sulfonylurea, 
60.9% of patients treated with liraglutide 3.0 mg/day and 60.0% of patients treated with placebo 
reported documented symptomatic hypoglycaemic events.  
 
Gastrointestinal adverse reactions 
 
Most episodes of gastrointestinal events were mild to moderate, transient and the majority did not lead 
to discontinuation of therapy. The reactions usually occurred during the first weeks of treatment and 
diminished within a few days or weeks on continued treatment. 
 
Patients ≥65 years of age may experience more gastrointestinal effects when treated with Saxenda.  
 
Patients with mild or moderate renal impairment (creatinine clearance ≥30 ml/min) may experience 
more gastrointestinal effects when treated with Saxenda. 
 
Acute renal failure 
 
In patients treated with GLP-1 receptor agonists, there have been reports of acute renal failure. A 
majority of the reported events occurred in patients who had experienced nausea, vomiting or 
diarrhoea leading to volume depletion (see section 4.4). 
 
Allergic reactions 
 
Few cases of anaphylactic reactions with symptoms such as hypotension, palpitations, dyspnoea and 
oedema have been reported with marketed use of liraglutide. Anaphylactic reactions may potentially 
be life threatening. If an anaphylactic reaction is suspected, liraglutide should be discontinued and 
treatment should not be restarted (see section 4.3). 
 
Injection site reactions 
 
Injection site reactions have been reported in patients treated with Saxenda. These reactions were 
usually mild and transitory and the majority disappeared during continued treatment. 
 



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Tachycardia 
 
In clinical trials, tachycardia was reported in 0.6% of patients treated with Saxenda and in 0.1% of 
patients treated with placebo. The majority of events were mild or moderate. Events were isolated and 
the majority resolved during continued treatment with Saxenda. 
 
Paediatric population 
 
Saxenda is not recommended for use in paediatric patients. Gastrointestinal disorders were the most 
frequently reported adverse events in two dose escalation studies completed so far.  
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
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 
and severe vomiting which are also the expected symptoms of an overdose with liraglutide. None of 
the reports included severe hypoglycaemia. All patients recovered without complications. 
 
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. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes, glucagon-like peptide-1 (GLP-1) analogues.  
ATC code: A10BJ02  
 
Mechanism of action 
 
Liraglutide is an acylated human glucagon-like peptide-1 (GLP-1) analogue with 97% amino acid 
sequence homology to endogenous human GLP-1. Liraglutide binds to and activates the GLP-1 
receptor (GLP-1R). 
 
GLP-1 is a physiological regulator of appetite and food intake, but the exact mechanism of action is 
not entirely clear. In animal studies, peripheral administration of liraglutide led to uptake in specific 
brain regions involved in regulation of appetite, where liraglutide, via specific activation of the GLP-
1R, increased key satiety and decreased key hunger signals, thereby leading to lower body weight. 
 
GLP-1 receptors are also expressed in specific locations in the heart, vasculature, immune system and 
kidneys. In mouse models of atherosclerosis, liraglutide prevented aortic plaque progression and 
reduced inflammation in the plaque. In addition, liraglutide had a beneficial effect on plasma lipids. 
Liraglutide did not reduce the plaque size of already established plaques. 
 
Pharmacodynamic effects 
 
Liraglutide lowers body weight in humans mainly through loss of fat mass with relative reductions in 
visceral fat being greater than for subcutaneous fat loss. Liraglutide regulates appetite by increasing 

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feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, 
thereby leading to reduced food intake. Liraglutide does not increase energy expenditure compared to 
placebo. 
 
Liraglutide stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner 
which results in a lowering of fasting and post-prandial glucose. The glucose-lowering effect is more 
pronounced in patients with pre-diabetes and diabetes compared to patients with normoglycaemia. 
Clinical trials suggest that liraglutide improves and sustains beta-cell function, according to HOMA-B 
and the proinsulin-to-insulin ratio.  
 
Clinical efficacy and safety 
 
The efficacy and safety of liraglutide for weight management in conjunction with reduced calorie 
intake and increased physical activity were studied in four phase 3 randomised, double-blind, placebo-
controlled trials which included a total of 5,358 patients.  
 
• Trial 1 (SCALE Obesity & Pre-Diabetes - 1839): A total of 3,731 patients with obesity (BMI 

≥30 kg/m²) or with overweight (BMI ≥27 kg/m²) with dyslipidaemia and/or hypertension were 
stratified according to pre-diabetes status at screening and BMI at baseline (≥30 kg/m² or 
<30 kg/m²). All 3,731 patients were randomised to 56 weeks of treatment and the 2,254 patients 
with pre-diabetes at screening were randomised to 160 weeks of treatment. Both treatment 
periods were followed by a 12-week off drug/placebo observational follow-up period. Lifestyle 
intervention in the form of an energy-restricted diet and exercise counselling was background 
therapy for all patients. 

 The 56-week part of trial 1 assessed body weight loss in all the 3,731 randomised patients 
(2,590 completers).  

 The 160-week part of trial 1 assessed time to onset of type 2 diabetes in the 2,254 randomised 
patients with pre-diabetes (1,128 completers). 

• Trial 2 (SCALE Diabetes - 1922): A 56-week trial assessing body weight loss in 846 
randomised (628 completers) obese and overweight patients with insufficiently controlled type 
2 diabetes mellitus (HbA1c range 7–10%). The background treatment at trial start was either diet 
and exercise alone, metformin, a sulfonylurea, a glitazone as single agents or any combination 
hereof. 

• Trial 3 (SCALE Sleep Apnoea - 3970): A 32-week trial assessing sleep apnoea severity and 
body weight loss in 359 randomised (276 completers) obese patients with moderate or severe 
obstructive sleep apnoea. 

• Trial 4 (SCALE Maintenance - 1923): A 56-week trial assessing body weight maintenance 
and weight loss in 422 randomised (305 completers) obese and overweight patients with 
hypertension or dyslipidaemia after a preceding weight loss of ≥5% induced by a low-calorie 
diet. 

 
Body weight 
 
Superior weight loss was achieved with liraglutide compared to placebo in obese/overweight patients 
in all groups studied. Across the trial populations, greater proportions of the patients achieved ≥5% 
and >10% weight loss with liraglutide than with placebo (tables 3–5). In the 160-weeks part of trial 1, 
the weight loss occurred mainly in the first year and was sustained throughout 160 weeks. In trial 4, 
more patients maintained the weight loss achieved prior to treatment initiation with liraglutide than 
with placebo (81.4% and 48.9%, respectively). Specific data on weight loss, responders, time course 
and cumulative distribution of weight change (%) for trials 1–4 are presented in tables 3–7 and figures 
1, 2 and 3.  
 
Weight loss response after 12 weeks with liraglutide (3.0 mg) treatment 
 
Early responders were defined as patients who achieved ≥5% weight loss after 12 weeks on treatment 
dose of liraglutide (4 weeks of dose escalation and 12 weeks on treatment dose). In the 56-week part 
of trial 1, 67.5% achieved ≥5% weight loss after 12 weeks. In trial 2, 50.4% achieved ≥5% weight loss 



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after 12 weeks. With continued treatment with liraglutide, 86.2% of these early responders are 
predicted to achieve a weight loss of ≥5% and 51% are predicted to achieve a weight loss of ≥10% 
after 1 year of treatment. The predicted mean weight loss in early responders who complete 1 year of 
treatment is 11.2% of their baseline body weight (9.7% for males and 11.6% for females). For patients 
who have achieved a weight loss of <5% after 12 weeks on treatment dose of liraglutide, the 
proportion of patients not reaching a weight loss of ≥10% after 1 year is 93.4%. 
 
Glycaemic control 
 
Treatment with liraglutide significantly improved glycaemic parameters across sub-populations with 
normoglycaemia, pre-diabetes and type 2 diabetes mellitus. In the 56-week part of trial 1, fewer 
patients treated with liraglutide had developed type 2 diabetes mellitus compared to patients treated 
with placebo (0.2% vs. 1.1%). More patients with pre-diabetes at baseline had reversed their pre-
diabetes compared to patients treated with placebo (69.2% vs. 32.7%). In the 160-week part of trial 1, 
the primary efficacy endpoint was the proportion of patients with onset of type 2 diabetes mellitus 
evaluated as time to onset. At week 160, while on treatment, 3% treated with Saxenda and 11% treated 
with placebo were diagnosed with type 2 diabetes mellitus. The estimated time to onset of type 2 
diabetes mellitus for patients treated with liraglutide 3.0 mg was 2.7 times longer (with a 95% 
confidence interval of [1.9, 3.9]), and the hazard ratio for risk of developing type 2 diabetes mellitus 
was 0.2 for liraglutide versus placebo. 
 
Cardiometabolic risk factors 
 
Treatment with liraglutide significantly improved systolic blood pressure and waist circumference 
compared with placebo (tables 3, 4 and 5). 
 
Apnoea-Hypopnoea Index (AHI) 
 
Treatment with liraglutide significantly reduced the severity of obstructive sleep apnoea as assessed by 
change from baseline in the AHI compared with placebo (table 6). 
 
Table 3 Trial 1: Changes from baseline in body weight, glycaemia and cardiometabolic 
parameters at week 56 
 Saxenda (N=2437) Placebo (N=1225) Saxenda vs. placebo 

Body weight    
Baseline, kg (SD) 106.3 (21.2) 106.3 (21.7) - 
Mean change at week 56, % (95% CI) -8.0 -2.6 -5.4** (-5.8; -5.0) 
Mean change at week 56, kg (95% CI) -8.4 -2.8 -5.6** (-6.0; -5.1) 
Proportion of patients losing ≥5% body 
weight at week 56, % (95% CI) 63.5 26.6 4.8** (4.1; 5.6) 

Proportion of patients losing >10% body 
weight at week 56, % (95% CI) 32.8 10.1 4.3** (3.5; 5.3) 

Glycaemia and cardiometabolic factors Baseline Change Baseline Change  
HbA1c, % 5.6 -0.3 5.6 -0.1 -0.23** (-0.25; -0.21) 
FPG, mmol/L 5.3 -0.4 5.3 -0.01 -0.38** (-0.42; -0.35) 

Systolic blood pressure, mmHg 123.0 -4.3 123.3 -1.5 -2.8** (-3.6; -2.1) 
Diastolic blood pressure, mmHg 78.7 -2.7 78.9 -1.8 -0.9* (-1.4; -0.4) 
Waist circumference, cm 115.0 -8.2 114.5 -4.0 -4.2** (-4.7; -3.7) 

Full Analysis Set. For body weight, HbA1c, FPG, blood pressure and waist circumference, baseline values are 
means, changes from baseline at week 56 are estimated means (least-squares) and treatment contrasts at week 56 
are estimated treatment differences. For the proportions of patients losing ≥5/>10% body weight, estimated odds 
ratios are presented. Missing post-baseline values were imputed using the last observation carried forward. 
* p<0.05. ** p<0.0001. CI=confidence interval. FPG=fasting plasma glucose. SD=standard deviation.  



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Table 4 Trial 1: Changes from baseline in body weight, glycaemia and cardiometabolic 
parameters at week 160 
 

 Saxenda (N=1472) Placebo (N=738) Saxenda vs. placebo 
Body weight    
Baseline, kg (SD)  107.6 (21.6) 108.0 (21.8) 

 

Mean change at week 160, % (95% CI) -6.2 -1.8 -4.3** (-4.9; -3.7)  
Mean change at week 160, kg (95% CI) -6.5 -2.0 -4.6** (-5.3; -3.9) 

 
Proportion of patients losing ≥5% body 
weight at week 160, % (95% CI)  

49.6 23.4 3.2** (2.6; 3.9) 

Proportion of patients losing >10% body 
weight at week 160, % (95% CI) 24.4 9.5 

 
3.1** (2.3; 4.1) 
 

Glycaemia and cardiometabolic factors Baseline Change Baseline Change  
HbA1c, % 5.8 -0.4 5.7 -0.1 -0.21** (-0.24; -0.18)  
FPG, mmol/L 5.5 -0.4 5.5 0.04 -0.4** (-0.5; -0.4)  
Systolic blood pressure, mmHg 124.8 -3.2 125.0 -0.4 -2.8** (-3.8; -1.8)  
Diastolic blood pressure, mmHg 79.4 -2.4 79.8 -1.7 -0.6 (-1.3; 0.1)  
Waist circumference, cm 116.6 -6.9 116.7 -3.4 -3.5** (-4.2; -2.8)  

Full Analysis Set. For body weight, HbA1c, FPG, blood pressure and waist circumference, baseline values are 
means, changes from baseline at week 160 are estimated means (least-squares) and treatment contrasts at week 
160 are estimated treatment differences. For the proportions of patients losing ≥5/>10% body weight, estimated 
odds ratios are presented. Missing post-baseline values were imputed using the last observation carried forward. 
** p<0.0001. CI=confidence interval. FPG=fasting plasma glucose. SD=standard deviation.  
 
 

C
ha

ng
e 

in
 B

od
y 

W
ei

gh
t (

%
) 

Time in weeks 

Observed values for patients completing each scheduled visit 

Saxenda Placebo Last observation carried forward (LOCF) 

 
Figure 1 Change from baseline in body weight (%) by time in trial 1 (0–56 weeks) 
 



13 

 
C

um
ul

at
iv

e 
Fr

eq
ue

nc
y 

(%
) 

Placebo 
Change in Body Weight (%) 

Saxenda 

Last observation carried forward. 
 

Figure 2 Cumulative distribution of weight change (%) after 56 weeks of treatment in trial 1 
 
Table 5 Trial 2: Changes from baseline in body weight, glycaemia and cardiometabolic 
parameters at week 56 
 Saxenda (N=412) Placebo (N=211) Saxenda vs. placebo 

Body weight    

Baseline, kg (SD) 105.6 (21.9) 106.7 (21.2) - 

Mean change at week 56, % (95% CI) -5.9 -2.0 -4.0** (-4.8; -3.1) 

Mean change at week 56, kg (95% CI) -6.2 -2.2 -4.1** (-5.0; -3.1) 

Proportion of patients losing ≥5% body 
weight at week 56, % (95% CI) 49.8 13.5 6.4** (4.1; 10.0) 

Proportion of patients losing >10% body 
weight at week 56, % (95% CI) 22.9 4.2 6.8** (3.4; 13.8) 

Glycaemia and cardiometabolic factors Baseline Change Baseline Change  

HbA1c, % 7.9 -1.3 7.9 -0.4 -0.9** (-1.1; -0.8) 

FPG, mmol/L 8.8 -1.9 8.6 -0.1 -1.8** (-2.1; -1.4) 

Systolic blood pressure, mmHg 128.9 -3.0 129.2 -0.4 -2.6* (-4.6; -0.6) 

Diastolic blood pressure, mmHg 79.0 -1.0 79.3 -0.6 -0.4 (-1.7; 1.0) 

Waist circumference, cm 118.1 -6.0 117.3 -2.8 -3.2** (-4.2; -2.2) 
Full Analysis Set. For body weight, HbA1c, FPG, blood pressure and waist circumference, baseline values are 
means, changes from baseline at week 56 are estimated means (least-squares) and treatment contrasts at week 56 
are estimated treatment differences. For the proportions of patients losing ≥5/>10% body weight, estimated odds 
ratios are presented. Missing post-baseline values were imputed using the last observation carried forward. 
* p<0.05. ** p<0.0001. CI=confidence interval. FPG=fasting plasma glucose. SD=standard deviation.  
 
Table 6 Trial 3: Changes from baseline in body weight and Apnoea-Hypopnoea Index at week 
32 



14 

 Saxenda (N=180) Placebo (N=179) Saxenda vs. placebo 

Body weight    

Baseline, kg (SD) 116.5 (23.0) 118.7 (25.4) - 

Mean change at week 32, % (95% CI) -5.7 -1.6 -4.2** (-5.2; -3.1) 

Mean change at week 32, kg (95% CI) -6.8 -1.8 -4.9** (-6.2; -3.7) 

Proportion of patients losing ≥5% body 
weight at week 32, % (95% CI) 46.4 18.1 3.9** (2.4; 6.4) 

Proportion of patients losing >10% body 
weight at week 32 % (95% CI) 22.4 1.5 19.0** (5.7; 63.1) 

 Baseline Change Baseline Change  

Apnoea-Hypopnoea Index, events/hour 49.0 -12.2 49.3 -6.1 -6.1* (-11.0; -1.2) 
Full Analysis Set. Baseline values are means, changes from baseline at week 32 are estimated means (least-
squares) and treatment contrasts at week 32 are estimated treatment differences (95% CI). For the proportions of 
patients losing ≥5/>10% body weight, estimated odds ratios are presented. Missing post-baseline values were 
imputed using the last observation carried forward. * p<0.05. ** p<0.0001. CI=confidence interval. SD=standard 
deviation. 
 
Table 7 Trial 4: Changes from baseline in body weight at week 56 

 Saxenda (N=207) Placebo (N=206) Saxenda vs. placebo 

Baseline, kg (SD) 100.7 (20.8) 98.9 (21.2) - 

Mean change at week 56, % (95% CI) -6.3 -0.2 -6.1** (-7.5; -4.6) 

Mean change at week 56, kg (95% CI) -6.0 -0.2 -5.9** (-7.3; -4.4) 

Proportion of patients losing ≥5% body 
weight at week 56, % (95% CI) 50.7 21.3 3.8** (2.4; 6.0) 

Proportion of patients losing >10% body 
weight at week 56, % (95% CI) 27.4 6.8 5.1** (2.7; 9.7) 

Full Analysis Set. Baseline values are means, changes from baseline at week 56 are estimated means (least-
squares) and treatment contrasts at week 56 are estimated treatment differences. For the proportions of patients 
losing ≥5/>10% body weight, estimated odds ratios are presented. Missing post-baseline values were imputed 
using the last observation carried forward. ** p<0.0001. CI=confidence interval. SD=standard deviation.  
 
 

C
ha

ng
e 

in
 B

od
y 

W
ei

gh
t (

%
) 

Time in weeks 

Observed values for patients completing each scheduled visit 

Saxenda Placebo Last observation carried forward (LOCF) 

 
Figure 3 Change from randomisation (week 0) in body weight (%) by time in trial 4 
 
Before week 0 patients were only treated with low-calorie diet and exercise. At week 0 patients were 
randomised to receive either Saxenda or placebo. 
 
Immunogenicity 



15 

 
Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, 
patients may develop anti-liraglutide antibodies following treatment with liraglutide. In clinical trials, 
2.5% of patients treated with liraglutide developed anti-liraglutide antibodies. Antibody formation has 
not been associated with reduced efficacy of liraglutide. 
 
Cardiovascular evaluation 
 
Major adverse cardiovascular events (MACE) were adjudicated by an external independent group of 
experts and defined as non-fatal myocardial infarction, non-fatal stroke and cardiovascular death. In all 
the long-term clinical trials with Saxenda, there were 6 MACE for patients treated with liraglutide and 
10 MACE for placebo-treated patients. The hazard ratio and 95% CI is 0.33 [0.12; 0.90] for liraglutide 
versus placebo. A mean increase in heart rate from baseline of 2.5 beats per minute (ranging across 
trials from 1.6 to 3.6 beats per minute) has been observed with liraglutide in clinical phase 3 trials. The 
heart rate peaked after approximately 6 weeks. The long-term clinical impact of this mean increase in 
heart rate has not been established. The change in heart rate was reversible upon discontinuation of 
liraglutide (see section 4.4). 
 
The Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcomes Results 
(LEADER) trial included 9,340 patients with insufficiently controlled type 2 diabetes. The vast 
majority of these had established cardiovascular disease. Patients were randomly allocated to either 
liraglutide on a daily dose of up to 1.8 mg (4,668) or placebo (4,672), both on a background of 
standard of care. 
 
The duration of exposure was between 3.5 and 5 years. The mean age was 64 years and the mean BMI 
was 32.5 kg/m². Mean baseline HbA1c was 8.7 and had improved after 3 years by 1.2 % in patients 
assigned to liraglutide and by 0.8 % in patients assigned to placebo. The primary endpoint was the 
time from randomisation to first occurrence of any major adverse cardiovascular events (MACE): 
cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. 
 
Liraglutide significantly reduced the rate of major adverse cardiovascular events (primary endpoint 
events, MACE) vs. placebo (3.41 vs. 3.90 per 100 patient years of observation in the liraglutide and 
placebo groups, respectively) with a risk reduction of 13%, HR 0.87, [0.78, 0.97] [95% CI]) (p=0.005) 
(see figure 4).  
 
 

Pa
tie

nt
s w

ith
 a

n 
ev

en
t (

%
) 

Time from randomization (months) 

Patients at risk 

FAS: full analysis set. 

Placebo 

Liraglutide 

HR: 0.87 
95% CI 0.78; 0.97 

p<0.001 for non-inferiority 
p=0.005 for superiority 

Placebo 
Liraglutide 

4672 
4668 

4587 
4593 

4473 
4496 

4352 
4400 

4237 
4280 

4123 
4172 

4010 
4072 

3914 
3982 

1543 
1562 

407 
424 

 
 
Figure 4 Kaplan Meier plot of time to first MACE – FAS population 
 
Paediatric population  
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Saxenda in one or more subsets of the paediatric population in the treatment of obesity and in the 
treatment of Prader-Willi Syndrome (see section 4.2 for information on paediatric use).  



16 

 
5.2 Pharmacokinetic properties 
 
Absorption 
 
The absorption of liraglutide following subcutaneous administration was slow, reaching maximum 
concentration approximately 11 hours post dosing. The average liraglutide steady state concentration 
(AUCτ/24) reached approximately 31 nmol/L in obese (BMI 30–40 kg/m2) patients following 
administration of 3 mg liraglutide. Liraglutide exposure increased proportionally with dose. Absolute 
bioavailability of liraglutide following subcutaneous administration is approximately 55%. 
 
Distribution 
 
The mean apparent volume of distribution after subcutaneous administration is 20–25 L (for a person 
weighing approximately 100 kg). Liraglutide is extensively bound to plasma protein (>98%).  
 
Biotransformation 
 
During 24 hours following administration of a single [3H]-liraglutide dose to healthy subjects, the 
major component in plasma was intact liraglutide. Two minor plasma metabolites were detected (≤9% 
and ≤5% of total plasma radioactivity exposure). 
 
Elimination 
 
Liraglutide is endogenously metabolised in a similar manner to large proteins without a specific organ 
as major route of elimination. Following a [3H]-liraglutide dose, intact liraglutide was not detected in 
urine or faeces. Only a minor part of the administered radioactivity was excreted as liraglutide-related 
metabolites in urine or faeces (6% and 5%, respectively). The urine and faeces radioactivity was 
mainly excreted during the first 6–8 days and corresponded to three minor metabolites, respectively.  
 
The mean clearance following subcutaneous administration of liraglutide is approximately 0.9–1.4 L/h 
with an elimination half-life of approximately 13 hours. 
 
Special populations 
 
Elderly  
 
Age had no clinically relevant effect on the pharmacokinetics of liraglutide based on the results from a 
population pharmacokinetic analysis of data from overweight and obese patients (18 to 82 years). No 
dosage adjustment is required based on age. 
 
Gender 
 
Based on the results of population pharmacokinetic analysis, females have 24% lower weight adjusted 
clearance of liraglutide compared to males. Based on the exposure response data, no dose adjustment 
is necessary based on gender. 
 
Ethnic origin 
 
Ethnic origin had no clinically relevant effect on the pharmacokinetics of liraglutide based on the 
results of population pharmacokinetic analysis which included overweight and obese patients of 
White, Black, Asian and Hispanic/non-Hispanic groups.  
 
Body weight 
 
The exposure of liraglutide decreases with an increase in baseline body weight. The 3.0 mg daily dose 
of liraglutide provided adequate systemic exposures over the body weight range of 60–234 kg 



17 

evaluated for exposure response in the clinical trials. Liraglutide exposure was not studied in patients 
with body weight >234 kg. 
 
Hepatic impairment 
 
The pharmacokinetics of liraglutide was evaluated in patients with varying degree of hepatic 
impairment in a single-dose trial (0.75 mg). Liraglutide exposure was decreased by 13–23% in patients 
with mild to moderate hepatic impairment compared to healthy subjects. Exposure was significantly 
lower (44%) in patients with severe hepatic impairment (Child Pugh score >9). 
 
Renal impairment 
 
Liraglutide exposure was reduced in patients with renal impairment compared to individuals with 
normal renal function in a single-dose trial (0.75 mg). Liraglutide exposure was lowered by 33%, 14%, 
27% and 26%, respectively, in patients with mild (creatinine clearance, CrCl 50–80 ml/min), moderate 
(CrCl 30–50 ml/min) and severe (CrCl <30 ml/min) renal impairment and in end-stage renal disease 
requiring dialysis. 
 
Paediatric population 
 
Pharmacokinetic properties were assessed in clinical pharmacology studies in the paediatric 
population with obesity aged 12-17 years (14 patients, body weight 80-122 kg) and 7-11 years (16 
patients, body weight 45-87 kg) respectively.  
 
The liraglutide exposure in adolescents (age 12-17 years) was similar to that in adults with obesity. 
Exposure associated with 3.0 mg liraglutide was found to be comparable between the children aged 7 
to 11, adolescents and adult subjects, after correction for body weight.  
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeat-dose toxicity or genotoxicity. 
 
Non-lethal thyroid C-cell tumours were seen in two-year carcinogenicity studies in rats and mice. In 
rats, a no observed adverse effect level (NOAEL) was not observed. These tumours were not seen in 
monkeys treated for 20 months. These findings in rodents are caused by a non-genotoxic, specific 
GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive. The relevance for 
humans is likely to be low but cannot be completely excluded. No other treatment-related tumours 
have been found. 
 
Animal studies did not indicate direct harmful effects with respect to fertility but slightly increased 
early embryonic deaths at the highest dose. Dosing with liraglutide during mid-gestation caused a 
reduction in maternal weight and foetal growth with equivocal effects on ribs in rats and skeletal 
variation in the rabbit. Neonatal growth was reduced in rats while exposed to liraglutide and persisted 
in the post-weaning period in the high dose group. It is unknown whether the reduced pup growth is 
caused by reduced pup milk intake due to a direct GLP-1 effect or reduced maternal milk production 
due to decreased caloric intake. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Disodium phosphate dihydrate 
Propylene glycol 
Phenol 
Hydrochloric acid (for pH adjustment) 



18 

Sodium hydroxide (for pH adjustment) 
Water for injections 
 
6.2 Incompatibilities 
 
Substances added to Saxenda may cause degradation of liraglutide. In the absence of compatibility 
studies, this medicinal product must not be mixed with other medicinal products.  
 
6.3 Shelf life 
 
30 months 
 
After first use: 1 month 
 
6.4 Special precautions for storage 
 
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. 
 
6.5 Nature and contents of container  
 
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. 
 
6.6 Special precautions for disposal and other handling 
 
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. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 



19 

Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
 
8. MARKETING AUTHORISATION NUMBERS  
 
EU/1/15/992/001-003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 23 March 2015 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
  

http://www.ema.europa.eu/


20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 
BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 



21 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturers of the biological active substance  
 
Novo Nordisk A/S 
Hallas Allé 
4400 Kalundborg 
Denmark 
 
Novo Nordisk A/S 
Novo Allé 
2880 Bagsværd 
Denmark 
 
Name and address of the manufacturer responsible for batch release 
 
Novo Nordisk A/S 
Novo Allé 
2880 Bagsværd 
Denmark 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 
and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
 • At the request of the European Medicines Agency; 
 • Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile 
or as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached. 

 
 
 
  



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Saxenda 6 mg/ml solution for injection in pre-filled pen  
liraglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 ml contains 6 mg of liraglutide. One pre-filled pen contains 18 mg liraglutide 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium 
hydroxide (for pH adjustment), water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 pen 
3 pens 
5 pens 
 
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 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
The pen is designed to be used with NovoFine or NovoTwist disposable needles 
Needles are not included 
Read the package leaflet before use 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNINGS, IF NECESSARY 
 
Do not store the pen with a needle attached 
For use by one person only 
 
 
8. EXPIRY DATE 



25 

 
EXP 
 
Discard pen 1 month after first use 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Do not freeze 
After first use of the pen, store below 30°C or in a refrigerator 
Keep the pen cap on in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark  
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/15/992/001   1 x 3 ml 
EU/1/15/992/002   3 x 3 ml 
EU/1/15/992/003   5 x 3 ml 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Saxenda  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



26 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



27 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Saxenda 6 mg/ml injection 
liraglutide 
SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml 
 
 
6. OTHER 
 
Novo Nordisk A/S 
 
 
  



28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 



29 

Package leaflet: Information for the patient 
 

Saxenda 6 mg/ml solution for injection in pre-filled pen 
liraglutide 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
– Keep this leaflet. You may need to read it again.  
– If you have any further questions, ask your doctor, pharmacist or nurse. 
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Saxenda is and what it is used for  
2. What you need to know before you use Saxenda 
3. How to use Saxenda 
4. Possible side effects  
5. How to store Saxenda 
6. Contents of the pack and other information 
 
 
1. What Saxenda is and what it is used for 
 
What Saxenda is 
Saxenda is a weight loss medicine that contains the active substance liraglutide. It is similar to a 
natural occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine 
after a meal. Saxenda works by acting on receptors in the brain that control your appetite, causing you 
to feel fuller and less hungry. This may help you eat less food and reduce your body weight. 
 
What Saxenda is used for 
Saxenda is used for weight loss in addition to diet and exercise in adults aged 18 and above who have  
• a BMI of 30 kg/m² or greater (obese) or 
• a BMI of 27 kg/m² and less than 30 kg/m² (overweight) and weight-related health problems 

(such as diabetes, high blood pressure, abnormal levels of fats in the blood or breathing 
problems during sleep called ‘obstructive sleep apnoea’). 

BMI (Body Mass Index) is a measure of your weight in relation to your height. 
 
You should only continue using Saxenda if you have lost at least 5% of your initial body weight after 
12 weeks on the 3 mg/day dose (see section 3). Consult your doctor before you continue. 
 
Diet and exercise 
Your doctor will start you on a diet and exercise programme. Stay on this programme while you are 
using Saxenda. 
 
 
2. What you need to know before you use Saxenda  
 
Do not use Saxenda 
– if you are allergic to liraglutide or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before using Saxenda. 
 



30 

The use of Saxenda is not recommended if you have severe heart failure.  
 
There is little experience with this medicine in patients of 75 years and older. It is not recommended if 
you are 75 years or older. 
 
There is little experience with this medicine in patients with kidney problems. If you have kidney 
disease or are on dialysis, consult your doctor.  
 
There is little experience with this medicine in patients with liver problems. If you have liver 
problems, consult your doctor. 
 
This medicine is not recommended if you have a severe stomach or gut problem which results in 
delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease. 
 
People with diabetes  
 
If you have diabetes, do not use Saxenda as a replacement for insulin. 
 
Inflammation of the pancreas 
 
Talk to your doctor if you have or have had a disease of the pancreas.  
 
Inflamed gall bladder and gallstones 
 
If you lose substantial weight, you are at a risk of gallstones and thereby inflamed gall bladder. Stop 
taking Saxenda and contact a doctor immediately if you experience severe pain in your upper 
abdomen, usually worst on the right side under the ribs. The pain may be felt through to your back or 
right shoulder. See section 4. 
 
Thyroid disease 
 
If you have thyroid disease, including thyroid nodules and enlargement of the thyroid gland, consult 
your doctor. 
 
Heart rate 
 
Talk to your doctor if you have palpitations (you feel aware of your heartbeat) or if you have feelings 
of a racing heartbeat while at rest during Saxenda treatment.  
 
Loss of fluid and dehydration 
 
When starting treatment with Saxenda, you may lose body fluid or become dehydrated. This may be 
due to feeling sick (nausea), being sick (vomiting) and diarrhoea. It is important to avoid dehydration 
by drinking plenty of fluids. Talk to your doctor, pharmacist or nurse if you have any questions or 
concerns. See section 4. 
 
Children and adolescents 
Saxenda should not be used in children and adolescents under 18 years of age. This is because the 
effects and safety of this medicine have not been studied in this age group.  
 
Other medicines and Saxenda 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, tell your doctor, pharmacist or nurse if:  
• you are taking medicines for diabetes called ‘sulfonylurea’ (such as glimepiride or 

glibenclamide) or if you are taking insulin – you may get low blood sugar (hypoglycaemia) 



31 

when you use these medicines with Saxenda. Your doctor may adjust the dose of your diabetes 
medicine to prevent you from getting low blood sugar. See section 4 for the warning signs of 
low blood sugar. If you adjust your insulin dose your doctor may recommend you to monitor 
your blood sugar more frequently. 

• you are taking warfarin or other medicines by mouth that reduce your blood clotting 
(anticoagulants). More frequent blood testing to determine the ability of your blood to clot may 
be required. 

 
Pregnancy and breast-feeding  
Do not use Saxenda if you are pregnant, think that you might be pregnant or are planning to have a 
baby. This is because it is not known if Saxenda may affect the baby. 
 
Do not breast-feed if you are using Saxenda. This is because it is not known if Saxenda passes into 
breast milk.  
 
Driving and using machines 
Saxenda is unlikely to affect your ability to drive and use machines.  
Some patients may feel dizziness when taking Saxenda mainly during the first 3 months of treatment 
(see section ‘Possible side effects’). If you feel dizziness be extra careful while driving or using 
machines. If you need any further information, talk to your doctor. 
 
Important information about some of the ingredients of Saxenda 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that it is to say essentially 
‘sodium-free’. 
 
 
3. How to use Saxenda 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or 
nurse if you are not sure.  
 
Your doctor will start you on a diet and exercise programme. Stay on this programme while you are 
using Saxenda. 
 
How much to inject 
Your treatment will start at a low dose which will be gradually increased over the first five weeks of 
treatment.  
• When you first start using Saxenda, the starting dose is 0.6 mg once a day, for at least one week.  
• You doctor will instruct you to gradually increase your dose by 0.6 mg usually each week until 

you reach the recommended dose of 3.0 mg once a day. 
Your doctor will tell you how much Saxenda to use each week. Usually, you will be told to follow the 
table below. 
 

Week Dose injected   

Week 1 0.6 mg once a day 

Week 2 1.2 mg once a day 

Week 3 1.8 mg once a day 

Week 4 2.4 mg once a day 

Week 5 onwards 3.0 mg once a day 

 



32 

Once you reach the recommended dose of 3.0 mg in week 5 of treatment, keep using this dose until 
your treatment period ends. Do not increase your dose further. 
 
Your doctor will assess your treatment on a regular basis. 
 
How and when to use Saxenda 
• Before you use the pen for the first time, your doctor or nurse will show you how to use the pen. 
• You can use Saxenda at any time of the day, with or without food and drink. 
• Use Saxenda at about the same time each day – choose a time of the day that works best for 

you. 
 
Where to inject 
Saxenda is given as an injection under the skin (subcutaneous injection).  
• The best places to inject are the front of your waist (abdomen), the front of your thighs or your 

upper arm. 
• Do not inject into a vein or muscle. 

 
Detailed instructions for use are provided on the other side of this leaflet. 
 
People with diabetes 
Tell your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medicines to 
prevent you from getting low blood sugar. 
• Do not mix Saxenda up with other medicines that you inject (e.g. insulins). 
• Do not use Saxenda in combination with other medicines that contain GLP-1 receptor agonists 

(such as exenatide or lixisenatide). 
 
If you use more Saxenda than you should 
If you use more Saxenda than you should, talk to a doctor or go to a hospital straight away. Take the 
medicine pack with you. You may need medical treatment. The following effects may happen: 
• feeling sick (nausea) 
• being sick (vomiting). 
 
If you forget to use Saxenda 
• If you forget a dose and remember it within 12 hours from when you usually use the dose, inject 

it as soon as you remember. 
• However, if more than 12 hours have passed since you should have used Saxenda, skip the 

missed dose and inject your next dose the following day at the usual time. 
• Do not use a double dose or increase the dose on the following day to make up for the missed 

dose. 
 
If you stop using Saxenda 
Do not stop using Saxenda without talking to your doctor. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects 
 
Some severe allergic reactions (anaphylaxis) have been reported rarely in patients using Saxenda. You 
should see your doctor straight away if you get symptoms such as breathing problems, swelling of face 
and throat and a fast heartbeat. 
 



33 

Cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly in patients using 
Saxenda. Pancreatitis is a serious, potentially life-threatening medical condition. 
Stop taking Saxenda and contact a doctor immediately if you notice any of the following serious side 
effects: 
• Severe and persistent pain in the abdomen (stomach area) which might reach through to your 

back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas 
(pancreatitis). 

 
Other side effects 
 
Very common: may affect more than 1 in 10 people 
• Feeling sick (nausea), being sick (vomiting), diarrhoea, constipation – these usually go away 

after a few days or weeks. 
 
Common: may affect up to 1 in 10 people 
• Problems affecting the stomach and intestines, such as indigestion (dyspepsia), inflammation in 

the lining of the stomach (gastritis), stomach discomfort, upper stomach pain, heartburn, feeling 
bloated, wind (flatulence), belching and dry mouth 

• Feeling weak or tired 
• Changed sense of taste 
• Dizziness 
• Difficulty sleeping (insomnia). This usually occurs the first 3 months of treatment 
• Gallstones 
• Injection site reactions (such as bruising, pain, irritation, itching and rash) 
• Low blood sugar (hypoglycaemia). The warning signs of low blood sugar may come on 

suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick, 
feeling very hungry, changes in vision, feeling sleepy, feeling weak, being nervous, being 
anxious, confusion, difficulty concentrating and shaking (tremor). Your doctor will tell you how 
to treat low blood sugar and what to do if you notice these warning signs 

• increase of pancreatic enzymes, such as lipase and amylase. 
 
Uncommon: may affect up to 1 in 100 people 
• Loss of fluids (dehydration). This is more likely to occur at the start of treatment and may be 

due to being sick (vomiting), feeling sick (nausea) and diarrhoea 
• Delay in the emptying of the stomach 
• Inflamed gall bladder 
• Allergic reactions including skin rash 
• Feeling generally unwell 
• Faster pulse. 
 
Rare: may affect up to 1 in 1,000 people 
• Reduced kidney function 
• Acute kidney failure. Signs may include reduction in urine volume, metallic taste in mouth and 

easily bruising. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects, you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Saxenda 
 
Keep this medicine out of the sight and reach of children. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


34 

Do not use Saxenda after the expiry date which is stated on the pen label and carton after ‘EXP’. The 
expiry date refers to the last day of that month. 
 
Before first use: 
  
Store in a refrigerator (2°C to 8°C). Do not freeze. Keep away from the freezer compartment. 
 
Once you start using the pen: 
 
You can keep the pen for 1 month when stored at a temperature below 30°C or in a refrigerator (2°C to 
8°C). Do not freeze. Keep away from the freezer compartment. 
 
When you are not using the pen, keep the pen cap on in order to protect it from light.  
 
Do not use this medicine if the solution is not clear and colourless or almost colourless. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Saxenda contains  
– The active substance is liraglutide. 1 ml solution for injection contains 6 mg liraglutide. One 

pre-filled pen contains 18 mg liraglutide. 
– The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric 

acid and sodium hydroxide (for pH adjustment) and water for injections. 
 
What Saxenda looks like and contents of the pack  
Saxenda is supplied as a clear and colourless or almost colourless solution for injection in a pre-filled 
pen. 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. 
 
Saxenda is available in pack sizes containing 1, 3 or 5 pens. Not all pack sizes may be marketed. 
 
Needles are not included. 
 
Marketing Authorisation Holder and Manufacturer 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 
 
  

http://www.ema.europa.eu/


35 

Instructions on how to use Saxenda 6 mg/ml solution for injection in pre-
filled pen 
 
Please read these instructions carefully before using your Saxenda pre-filled 
pen. 
Do not use the pen without proper training from your doctor or nurse. 
Start by checking your pen to make sure that it contains Saxenda 6 mg/ml, 
then look at the illustrations below to get to know the different parts of your pen 
and needle. 
If you are blind or have poor eyesight and cannot read the dose counter on 
the pen, do not use this pen without help. Get help from a person with good 
eyesight who is trained to use the Saxenda pre-filled pen. 
Your pen is a pre-filled dial-a-dose pen. It contains 18 mg of liraglutide and 
delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg. Your pen is 
designed to be used with NovoFine or NovoTwist disposable needles up to a 
length of 8 mm and as thin as 32 G. 
Needles are not included in the pack. 
 

 Important information  
Pay special attention to these notes as they are important for safe use of the pen. 

 



36 

 
Saxenda pre-filled pen and 
needle (example) 

Pen cap 
Outer  
needle cap 

Inner 
needle cap 

Needle 

Paper tab 

Pen scale 

Pen window 

Pen label 

Dose counter 

Dose pointer 

Dose selector 

Dose button 

Flow 
check 
symbol 

Saxenda 

 

 

1 Prepare your pen with a new needle 
 
• Check the name and coloured label of your pen, to make sure that it 

contains Saxenda. This is especially important if you take more than one 
type of injectable medicine. Using the wrong medicine could be harmful 
to your health. 

• Pull off the pen cap. 

 A 

 



37 

• Check that the solution in your pen is clear and colourless. Look 
through the pen window. If the solution looks cloudy, do not use the pen. 

 B 

 
• Take a new needle and tear off the paper tab.  C 

 
• Push the needle straight onto the pen. Turn until it is on tight.  D 

 
• Pull off the outer needle cap and keep it for later. You will need it 

after the injection, to safely remove the needle from the pen. 
 E 

 
• Pull off the inner needle cap and throw it away. If you try to put it 

back on, you may accidentally stick yourself with the needle. 
A drop of solution may appear at the needle tip. This is normal, but you 
must still check the flow if you use a new pen for the first time. 
Do not attach a new needle to your pen until you are ready to take your 
injection. 

 
 Always use a new needle for each injection. 

This may prevent blocked needles, contamination, infection and 
inaccurate dosing. 

 Never use a bent or damaged needle. 

 F 

 

2 Check the flow 
 
• Before your first injection with each new pen, check the flow. If your 

pen is already in use, go to step 3 ‘Select your dose’. 
• Turn the dose selector until the dose counter shows the flow check 

symbol ( ). 

 A 

Flow check 
symbol 
selected 

 



38 

• Hold the pen with the needle pointing up. 
Press and hold in the dose button until the dose counter returns to 0. 
The 0 must line up with the dose pointer. 
A drop of solution should appear at the needle tip. 
 
A small drop may remain at the needle tip, but it will not be injected. 
If no drop appears, repeat step 2 ‘Check the flow’ up to 6 times. If there 
is still no drop, change the needle and repeat step 2 ‘Check the flow’ once 
more. 
If a drop still does not appear, dispose of the pen and use a new one. 
 

 Always make sure that a drop appears at the needle tip before you use 
a new pen for the first time. This makes sure that the solution flows.  
If no drop appears, you will not inject any medicine, even though the 
dose counter may move. This may indicate a blocked or damaged 
needle.  
If you do not check the flow before your first injection with each new 
pen, you may not get the prescribed dose and the intended effect of 
Saxenda. 

 B 

 

3 Select your dose 
 

• Turn the dose selector until the dose counter shows your dose 
(0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg).  
If you select the wrong dose, you can turn the dose selector forward or 
backwards to the correct dose.  
The pen can dial up to a maximum of 3.0 mg. 
 
The dose selector changes the dose. Only the dose counter and dose 
pointer will show how many mg you select per dose. 
You can select up to 3.0 mg per dose. When your pen contains less than 
3.0 mg the dose counter stops before 3.0 is shown. 
The dose selector clicks differently when turned forward, backwards or 
past the number of mg left. Do not count the pen clicks. 
 

 Always use the dose counter and the dose pointer to see how many 
mg you have selected before injecting this medicine.  
Do not count the pen clicks. 
Do not use the pen scale. It only shows approximately how much solution 
is left in your pen. 
Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg must be 
selected with the dose selector. The selected dose must line up precisely 
with the dose pointer to ensure that you get a correct dose. 

 A 

Example 
0.6 mg 
selected 

 

How much solution is left? 
 

• The pen scale shows you approximately how much solution is left in 
your pen. 

 
 
 A Approx. 

how much 
solution is 
left 

 



39 

• To see precisely how much solution is left, use the dose counter:  
Turn the dose selector until the dose counter stops. 
If it shows 3.0, at least 3.0 mg are left in your pen. If the dose counter 
stops before 3.0 mg, there is not enough solution left for a full dose of 
3.0 mg. 

 
If you need more medicine than what is left in your pen 
Only if trained or advised by your doctor or nurse, you may split your dose 
between your current pen and a new pen. Use a calculator to plan the doses as 
instructed by your doctor or nurse. 
 

 Be very careful to calculate correctly. 
If you are not sure how to split your dose using two pens, then select and 
inject the dose you need with a new pen. 

 B 

Example 

Dose counter 
stopped: 
2.4 mg left 

 

4 Inject your dose 
 
• Insert the needle into your skin as your doctor or nurse has shown you. 
• Make sure you can see the dose counter. Do not cover it with your 

fingers. This could interrupt the injection. 

 A 

 
• Press and hold down the dose button until the dose counter shows 0. 

The 0 must line up with the dose pointer. You may then hear or feel a 
click. 

 B 

 
• Keep the needle in your skin after the dose counter has returned to 0 

and count slowly to 6.  
• If the needle is removed earlier, you may see a stream of solution coming 

from the needle tip. If so, the full dose will not be delivered. 

 C Count slowly: 

1-2-3-4-5-6 

 
• Remove the needle from your skin.  

If blood appears at the injection site, press lightly. Do not rub the area. 
 

You may see a drop of solution at the needle tip after injecting. This is 
normal and does not affect your dose. 
 

 Always watch the dose counter to know how many mg you inject. 
Hold the dose button down until the dose counter shows 0. 
How to identify a blocked or damaged needle? 
• If 0 does not appear in the dose counter after continuously pressing 

the dose button, you may have used a blocked or damaged needle. 
• In this case – you have not received any medicine – even though the 

dose counter has moved from the original dose that you have set. 
 
How to handle a blocked needle? 

 D 

 



40 

Change the needle as described in step 5 ‘After your injection’ and repeat 
all steps starting with step 1 ‘Prepare your pen with a new needle’. Make 
sure you select the full dose you need. 
 
Never touch the dose counter when you inject. This can interrupt the 
injection. 

5 After your injection 
 
• Lead the needle tip into the outer needle cap on a flat surface without 

touching the needle or the outer needle cap. 

 A 

 
• Once the needle is covered, carefully push the outer needle cap 

completely on.  
• Unscrew the needle and dispose of it carefully. 

 B 

 
• Put the pen cap on your pen after each use to protect the solution from 

light. 
 

Always dispose of the needle after each injection to ensure convenient 
injections and prevent blocked needles. If the needle is blocked, you will 
not inject any medicine. 
When the pen is empty, throw it away without a needle on as instructed 
by your doctor, nurse, pharmacist or local authorities. 

 
 Never try to put the inner needle cap back on the needle. You may 

stick yourself with the needle. 
 Always remove the needle from your pen after each injection. 

This may prevent blocked needles, contamination, infection, leakage of 
solution and inaccurate dosing. 

 C 

 

 Further important information 
 
• Always keep your pen and needles out of sight and reach of others, 

especially children.  
• Never share your pen or your needles with other people.  
• Caregivers must be very careful when handling used needles - to 

prevent needle injury and cross-infection. 

 

Caring for your pen 
 
• Do not leave the pen in a car or other place where it can get too hot or 

too cold.  
• Do not inject Saxenda which has been frozen. If you do that, you may 

not get the intended effect of this medicine.  
• Do not expose your pen to dust, dirt or liquid.  
• Do not wash, soak or lubricate your pen. If necessary, clean it with a 

mild detergent on a moistened cloth. 
• Do not drop your pen or knock it against hard surfaces. If you drop it or 

suspect a problem, attach a new needle and check the flow before you 
inject. 

• Do not try to refill your pen. Once empty, it must be disposed of.  
• Do not try to repair your pen or pull it apart. 

 

 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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using saxenda if you have lost at least 5% of your initial body weight after 12 weeks on the 3 mg/day dose (see section 3). consult your doctor before you continue. diet and exercise your doctor will start you on a diet and exercise programme. stay on this programme while you are using saxenda.", 'Entity_Recognition': [{'Text': 'saxenda', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'a weight loss medicine', 'Type': 'TREATMENT', 'BeginOffset': 27, 'EndOffset': 49}, {'Text': 'the active substance liraglutide', 'Type': 'TREATMENT', 'BeginOffset': 64, 'EndOffset': 96}, {'Text': 'glucagon', 'Type': 'TREATMENT', 'BeginOffset': 150, 'EndOffset': 158}, {'Text': 'peptide', 'Type': 'TEST', 'BeginOffset': 164, 'EndOffset': 171}, {'Id': 2, 'BeginOffset': 175, 'EndOffset': 180, 'Score': 0.35615628957748413, 'Text': 'glp-1', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 0, 'BeginOffset': 276, 'EndOffset': 281, 'Score': 0.7937783002853394, 'Text': 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{'Title': '2. what you need to know before you use saxenda', 'Section_Content': "do not use saxenda if you are allergic to liraglutide or any of the other ingredients of this medicine (listed in section 6). warnings and precautions talk to your doctor, pharmacist or nurse before using saxenda. the use of saxenda is not recommended if you have severe heart failure. there is little experience with this medicine in patients of 75 years and older. it is not recommended if you are 75 years or older. there is little experience with this medicine in patients with kidney problems. if you have kidney disease or are on dialysis, consult your doctor. there is little experience with this medicine in patients with liver problems. if you have liver problems, consult your doctor. this medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease. people with diabetes if you have diabetes, do not use saxenda as a replacement for insulin. inflammation of the pancreas talk to your doctor if you have or have had a disease of the pancreas. inflamed gall bladder and gallstones if you lose substantial weight, you are at a risk of gallstones and thereby inflamed gall bladder. stop taking saxenda and contact a doctor immediately if you experience severe pain in your upper abdomen, usually worst on the right side under the ribs. the pain may be felt through to your back or right shoulder. see section 4. thyroid disease if you have thyroid disease, including thyroid nodules and enlargement of the thyroid gland, consult your doctor. heart rate talk to your doctor if you have palpitations (you feel aware of your heartbeat) or if you have feelings of a racing heartbeat while at rest during saxenda treatment. loss of fluid and dehydration when starting treatment with saxenda, you may lose body fluid or become dehydrated. this may be due to feeling sick (nausea), being sick (vomiting) and diarrhoea. it is important to avoid dehydration by drinking plenty of fluids. talk to your doctor, pharmacist or nurse if you have any questions or concerns. see section 4. children and adolescents saxenda should not be used in children and adolescents under 18 years of age. this is because the effects and safety of this medicine have not been studied in this age group. other medicines and saxenda tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. in particular, tell your doctor, pharmacist or nurse if: you are taking medicines for diabetes called 'sulfonylurea' (such as glimepiride or glibenclamide) or if you are taking insulin you may get low blood sugar (hypoglycaemia) 31 when you use these medicines with saxenda. your doctor may adjust the dose of your diabetes medicine to prevent you from getting low blood sugar. see section 4 for the warning signs of low blood sugar. if you adjust your insulin dose your doctor may recommend you to monitor your blood sugar more frequently. you are taking warfarin or other medicines by mouth that reduce your blood clotting (anticoagulants). more frequent blood testing to determine the ability of your blood to clot may be required. pregnancy and breast-feeding do not use saxenda if you are pregnant, think that you might be pregnant or are planning to have a baby. this is because it is not known if saxenda may affect the baby. do not breast-feed if you are using saxenda. this is because it is not known if saxenda passes into breast milk. driving and using machines saxenda is unlikely to affect your ability to drive and use machines. some patients may feel dizziness when taking saxenda mainly during the first 3 months of treatment (see section 'possible side effects'). if you feel dizziness be extra careful while driving or using machines. if you need any further information, talk to your doctor. important information about some of the ingredients of 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{'Title': '3. how to use saxenda', 'Section_Content': 'always use this medicine exactly as your doctor has told you. check with your doctor, pharmacist or nurse if you are not sure. your doctor will start you on a diet and exercise programme. stay on this programme while you are using saxenda. how much to inject your treatment will start at a low dose which will be gradually increased over the first five weeks of treatment. when you first start using saxenda, the starting dose is 0.6 mg once a day, for at least one week. you doctor will instruct you to gradually increase your dose by 0.6 mg usually each week until you reach the recommended dose of 3.0 mg once a day. your doctor will tell you how much saxenda to use each week. usually, you will be told to follow the table below. week dose injected week 1 0.6 mg once a day week 2 1.2 mg once a day week 3 1.8 mg once a day week 4 2.4 mg once a day week 5 onwards 3.0 mg once a day 32 once you reach the recommended dose of 3.0 mg in week 5 of treatment, keep using this dose until your treatment period ends. do not increase your dose further. your doctor will assess your treatment on a regular basis. how and when to use saxenda before you use the pen for the first time, your doctor or nurse will show you how to use the pen. you can use saxenda at any time of the day, with or without food and drink. use saxenda at about the same time each day choose a time of the day that works best for you. where to inject saxenda is given as an injection under the skin (subcutaneous injection). the best places to inject are the front of your waist (abdomen), the front of your thighs or your upper arm. do not inject into a vein or muscle. detailed instructions for use are provided on the other side of this leaflet. people with diabetes tell your doctor if you have diabetes. your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar. do not mix saxenda up with other medicines that you inject (e.g. insulins). do not use saxenda in combination with other medicines that contain glp-1 receptor agonists (such as exenatide or lixisenatide). if you use more saxenda than you should if you use more saxenda than you should, talk to a doctor or go to a hospital straight away. take the medicine pack with you. you may need medical treatment. the following effects may happen: feeling sick (nausea) being sick (vomiting). if you forget to use saxenda if you forget a dose and remember it within 12 hours from when you usually use the dose, inject it as soon as you remember. however, if more than 12 hours have passed since you should have used saxenda, skip the missed dose and inject your next dose the following day at the usual time. do not use a double dose or increase the dose on the following day to make up for the missed dose. if you stop using saxenda do not stop using saxenda without talking to your doctor. if you have any further questions on the use of this medicine, ask your 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. serious side effects some severe allergic reactions (anaphylaxis) have been reported rarely in patients using saxenda. you should see your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat and a fast heartbeat. cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly in patients using saxenda. pancreatitis is a serious, potentially life-threatening medical condition. stop taking saxenda and contact a doctor immediately if you notice any of the following serious side effects: severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis). other side effects very common: may affect more than 1 in 10 people feeling sick (nausea), being sick (vomiting), diarrhoea, constipation these usually go away after a few days or weeks. common: may affect up to 1 in 10 people problems affecting the stomach and intestines, such as indigestion (dyspepsia), inflammation in the lining of the stomach (gastritis), stomach discomfort, upper stomach pain, heartburn, feeling bloated, wind (flatulence), belching and dry mouth feeling weak or tired changed sense of taste dizziness difficulty sleeping (insomnia). this usually occurs the first 3 months of treatment gallstones injection site reactions (such as bruising, pain, irritation, itching and rash) low blood sugar (hypoglycaemia). the warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick, feeling very hungry, changes in vision, feeling sleepy, feeling weak, being nervous, being anxious, confusion, difficulty concentrating and shaking (tremor). your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs increase of pancreatic enzymes, such as lipase and amylase. uncommon: may affect up to 1 in 100 people loss of fluids (dehydration). this is more likely to occur at the start of treatment and may be due to being sick (vomiting), feeling sick (nausea) and diarrhoea delay in the emptying of the stomach inflamed gall bladder allergic reactions including skin rash feeling generally unwell faster pulse. rare: may affect up to 1 in 1,000 people reduced kidney function acute kidney failure. signs may include reduction in urine volume, metallic taste in mouth and easily bruising. reporting of side effects if you get any side effects, talk to your doctor, pharmacist or nurse. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects, you can help provide more information on the safety of this medicine.', 'Entity_Recognition': 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{'Title': '5. how to store saxenda', 'Section_Content': "keep this medicine out of the sight and reach of children. do not use saxenda after the expiry date which is stated on the pen label and carton after 'exp'. the expiry date refers to the last day of that month. before first use: store in a refrigerator (2 to 8). do not freeze. keep away from the freezer compartment. once you start using the pen: you can keep the pen for 1 month when stored at a temperature below 30 or in a refrigerator (2 to 8). do not freeze. keep away from the freezer compartment. when you are not using the pen, keep the pen cap on in order to protect it from light. do not use this medicine if the solution is not clear and colourless or almost colourless. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.", 'Entity_Recognition': [{'Text': 'saxenda', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'saxenda', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 77}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 373, 'EndOffset': 374}, {'Text': '30', 'Type': 'NUMBER', 'BeginOffset': 416, 'EndOffset': 418}, {'Text': 'the pen', 'Type': 'TREATMENT', 'BeginOffset': 528, 'EndOffset': 535}, {'Text': 'the pen cap', 'Type': 'TREATMENT', 'BeginOffset': 542, 'EndOffset': 553}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 603, 'EndOffset': 616}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what saxenda contains the active substance is liraglutide. 1 ml solution for injection contains 6 mg liraglutide. one pre-filled pen contains 18 mg liraglutide. the other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and sodium hydroxide (for ph adjustment) and water for injections. what saxenda looks like and contents of the pack saxenda is supplied as a clear and colourless or almost colourless solution for injection in a pre-filled pen. 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. saxenda is available in pack sizes containing 1, 3 or 5 pens. not all pack sizes may be marketed. needles are not included.', 'Entity_Recognition': [{'Text': 'saxenda', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 46, 'EndOffset': 57, 'Score': 0.9951716065406799, 'Text': 'liraglutide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.5455865859985352, 'RelationshipScore': 0.9996598958969116, 'RelationshipType': 'DOSAGE', 'Id': 1, 'BeginOffset': 59, 'EndOffset': 63, 'Text': '1 ml', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.96637362241745, 'RelationshipScore': 0.9997833371162415, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 64, 'EndOffset': 72, 'Text': 'solution', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'ROUTE_OR_MODE', 'Score': 0.7610440254211426, 'RelationshipScore': 0.9634451270103455, 'RelationshipType': 'ROUTE_OR_MODE', 'Id': 3, 'BeginOffset': 77, 'EndOffset': 86, 'Text': 'injection', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 59, 'EndOffset': 60}, {'Text': 'injection', 'Type': 'TREATMENT', 'BeginOffset': 77, 'EndOffset': 86}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 96, 'EndOffset': 97}, {'Id': 5, 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