Saxenda

HOS-097052 · has-adverse-reaction-information · PDF-Seite 9

Summary of the safety profile: Saxenda was evaluated for safety in 5 double-blind, placebo-controlled trials that enrolled 5 813 adult patients with overweight or obesity 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’). Tabulated list of adverse reactions Table 4 lists adverse reactions reported in adults. 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). and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 4 Adverse reactions reported in adults MedDRA system Very common Common Uncommon Rare Not known organ classes Immune system Anaphylactic disorders reaction Metabolism and Hypoglycaemia* Dehydration nutrition disorders Psychiatric disorders Insomnia** Nervous system Headache Dizziness disorders Dysgeusia Cardiac disorders Tachycardia Gastrointestinal Nausea Dry mouth Pancreatitis*** Intestinal disorders Vomiting Dyspepsia Delayed gastric obstruction† Diarrhoea Gastritis emptying**** Constipation Gastro-oesophageal reflux disease Abdominal pain upper Flatulence Eructation Abdominal distension Hepatobiliary

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HOS-097048 · has-contraindication-information · PDF-Seite 5

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

HOS-097047 · has-indication-information · PDF-Seite 2

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 (prediabetes 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. 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. 2 *IOTF BMI cut-off points for obesity by sex between 12-18 years (see table 1), in accordance with study design of the Trial 4180, see section 5.1. Table 1 IOTF BMI cut-off points for obesity by sex between 12–18 years Age BMI corresponding to 30 kg/m2 for adults by international (years) cut-off points. Males Females 12 26.02 26.67 12.5 26.43 27.24 13 26.84 27.76 13.5 27.25 28.20 14 27.63 28.57 14.5 27.98 28.87 15 28.30 29.11 15.5 28.60 29.29 16 28.88 29.43 16.5 29.14 29.56 17 29.41 29.69 17.5 29.70 29.84 18 30.00 30.00 Children (6 to <12 years) Saxenda is indicated as an adjunct to healthy nutrition and increased physical activity for weight management in children from the age of 6 to <12 years with • obesity (BMI ≥95th percentile)* and • body weight ≥45 kg Treatment with Saxenda should be discontinued and re-evaluated if patients

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HOS-097050 · has-interaction-information · PDF-Seite 7

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. 7 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

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HOS-097051 · has-pregnancy-information · PDF-Seite 8

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).

HOS-097049 · has-warning-information · PDF-Seite 5

Aspiration in association with general anaesthesia or deep sedation Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation. Therefore, the increased risk of residual gastric content due to delayed gastric emptying (see section 4.8) should be considered prior to performing procedures with general anaesthesia or deep sedation. 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 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, 5 – 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. C

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