LIGOBESY

6 mg once daily. 6 mg with at least one-week intervals to improve gastro-intestinal tolerability (see table 2). If escalation to the next dose step is not tolerated for two consecutive weeks, consider discontinuing treatment. 0 mg are not recommended.

0 mg Adolescents (≥12 years) For adolescents from the age of 12 to below 18 years old a similar dose escalation schedule as for adults should be applied (see table 2). 0 mg (maintenance dose) or maximum tolerated dose has been reached.

0 mg are not recommended. 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 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 Ligobesy should not be used in combination with another GLP-1 receptor agonist. When initiating Ligobesy, it should be considered to reduce the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia.

4). Special populations Elderly (≥65 years old) No dose adjustment is required based on age. 2). Renal impairment No dose adjustment is required for patients with mild or moderate renal impairment (creatinine clearance ≥30 ml/min). 2).

Hepatic impairment No dose adjustment is recommended for patients with mild or moderate hepatic impairment. 2). Paediatric population No dose adjustment is required for adolescents from the age of 12 years and above. 1). Method of administration Ligobesy is for subcutaneous use only.

It must not be administered intravenously or intramuscularly. Ligobesy 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.

Summary of the safety profile:

Ligobesy 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. 9%) (see section ‘Description of selected adverse reactions’).

Tabulated list of adverse reactions Table 3 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 3 Adverse reactions reported in adults MedDRA system organ classes Very common Common Uncommon Rare Not Known Immune system disorders Anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia* Dehydration Psychiatric disorders Insomnia** Nervous system disorders Headache 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** ** Intestinal obstruction† Hepatobiliary disorders Cholelithiasis*** Cholecystitis*** Skin and subcutaneous tissue disorders Rash Urticaria Cutaneous amyloidosis 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 Ligobesy in combination with diet and exercise.

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. 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, – 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.

2). 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.

Acute Pancreatitis Liraglutide has not been studied in patients with a history of pancreatitis, and should be used with caution in these patients. Acute pancreatitis has been reported in patients treated with GLP-1 receptor agonists.

This includes post-marketing reports of necrotising pancreatitis and reports with a fatal outcome. Patients should be informed of the symptoms of acute pancreatitis including persistent, severe abdominal pain. Patients should be advised to seek immediate medical attention if they occur.

1.