Saxenda

/ Novo Nordisk

Adults
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 (obesity), 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, or dyslipidaemia and who have failed a previous weight management intervention.
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.
Adolescents (≥12 years)
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:
• obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)* and
• body weight above 60 kg.
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. Reevaluation should be performed periodically.
see prescribing information for full details.

Adults 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 (obesity), 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, or dyslipidaemia and who have failed a previous weight management intervention.
Treatment 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.
Adolescents (≥12 years)
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:
• obesity (BMI corresponding to ≥30 kg/ kg/m)
Treatment 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.
Re-evaluation should be performed periodically.
See prescribing information for full details.

Hypersensitivity to liraglutide or to any of the excipients.

Traceability: in order to improve the traceability of biological medicinal products, the name of the administered product should be clearly recorded. It is recommended to record the batch number as well.
Patients with heart failure: 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. 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. 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. 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: 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.
Paediatric population
Episodes of clinically significant hypoglycaemia have been reported in adolescents (≥12 years) treated with liraglutide. Patients should be informed about the characteristic symptoms of hypoglycaemia and the appropriate actions. 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 prescribing information for full details.

Very Common: Nausea, Vomiting, Diarrhoea, Constipation, headache.
Common: Hypoglycaemia*, insomnia**, Dry mouth, Dyspepsia, Gastritis, Gastro-oesophageal reflux disease, Abdominal pain upper, Flatulence, Eructation, Abdominal distension, Cholelithiasis, Injection site reactions, Asthenia, Fatigue, 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.
**Insomnia was mainly seen during the first 3 months of treatment.
See prescribing information for full details.

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 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.
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.

Pregnancy: There are limited data from the use of liraglutide in pregnant women. Liraglutide should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, treatment with liraglutide should be discontinued.
Lactation: It is not known whether liraglutide is excreted in human milk.
Because of lack of experience, Saxenda® should not be used during breast-feeding.
See prescribing information for full details.

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.

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). Do not freeze. Keep the cap on the pen in order to protect from light.
incompatibility: Substances added to the drug may cause degradation of liraglutide. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.