Ozempic

25 mg semaglutide once weekly. 5 mg once weekly. 5 mg once weekly, the dose can be increased to 1 mg once weekly to further improve glycaemic control. After at least 4 weeks with a dose of 1 mg once weekly, the dose can be increased to 2 mg once weekly to further improve glycaemic control.

25 mg is not a maintenance dose. Weekly doses higher than 2 mg are not recommended. When Ozempic is added to existing metformin and/or thiazolidinedione therapy or to a sodium- glucose cotransporter 2 (SGLT2) inhibitor, the current dose of metformin and/or thiazolidinedione or SGLT2 inhibitor can be continued unchanged.

8). Self-monitoring of blood glucose is not needed in order to adjust the dose of Ozempic. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when Ozempic is started and insulin is reduced.

A stepwise approach to insulin reduction is recommended. Missed dose If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped, and the next dose should be administered on the regularly scheduled day.

In each case, patients can then resume their regular once weekly dosing schedule. Changing the dosing day The day of weekly administration can be changed if necessary, as long as the time between two doses is at least 3 days (>72 hours).

After selecting a new dosing day, once-weekly dosing should be continued. Special populations Elderly No dose adjustment is required based on age. 4 Renal impairment No dose adjustment is required for patients with mild, moderate or severe renal impairment.

Experience with the use of semaglutide in patients with end-stage kidney disease is limited. Hepatic impairment No dose adjustment is required for patients with hepatic impairment. Experience with the use of Semaglutide in patients with severe hepatic impairment is limited.

2). Paediatric population The safety and efficacy of semaglutide in children and adolescents below 18 years have not yet been established. No data are available. Method of administration Subcutaneous use. Ozempic is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm.

The injection site can be changed without dose adjustment. Ozempic should not be administered intravenously or intramuscularly. Ozempic is to be administered once weekly at any time of the day, with or without meals. 6.

Summary of safety profile In 8 phase 3a trials 4 792 patients were exposed to semaglutide up to 1 mg. The most frequently reported adverse reactions in clinical trials were gastrointestinal disorders, including nausea (very common), diarrhoea (very common) and vomiting (common).

In general, these reactions were mild or moderate in severity and of short duration. 1). The frequencies of the adverse reactions (except diabetic retinopathy complications, see footnote in Table 1) are based on a pool of the phase 3a trials excluding the cardiovascular outcomes trial (see text below the table for additional details).

The reactions are listed below by system organ class and absolute frequency. Frequencies 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 available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 1 mmol/L. b) Diabetic retinopathy complications is a composite of: retinal photocoagulation, treatment with intravitreal agents, vitreous haemorrhage, diabetes-related blindness (uncommon).

Frequency based on cardiovascular outcomes trial. c) Grouped term covering also adverse events related to hypersensitivity such as rash and urticaria. d) From post-marketing reports. 1). Description of selected adverse reactions Hypoglycaemia No episodes of severe hypoglycaemia were observed when semaglutide was used as monotherapy.

02 events/patient year). 001 events/patient year) were observed with semaglutide in combination with oral antidiabetics other than sulfonylureas. 04 events/patient year) of placebo-treated patients. 01 events/patient year) and 0% of patients, respectively.

In a 40-week phase 3b trial in patients receiving semaglutide 1 mg and 2 mg, the majority of the hypoglycaemic episodes (45 out of 49 episodes) occurred when semaglutide was used in combination with sulfonylurea or insulin. Overall, there was no increased risk of hypoglycaemia with semaglutide 2 mg.

4%. Most events were mild to moderate in severity and of short duration. 9% and 5% of patients. The events were most frequently reported during the first months on treatment. Patients with low body weight may experience more gastrointestinal side effects when treated with semaglutide.

In a 40-week phase 3b trial in patients receiving semaglutide 1 mg and 2 mg, nausea occurred in similar proportions of patients when treated with semaglutide 1 mg and 2 mg, respectively. Diarrhoea 10 and vomiting occurred in higher proportions of patients when treated with semaglutide 2 mg compared to semaglutide 1 mg.

The gastrointestinal adverse reactions led to treatment discontinuation in similar proportions in the semaglutide 1 mg and 2 mg treatment groups. 7% and 4% respectively of patients treated with semaglutide 1 mg compared to no events for placebo-treated patients.

The prevalence of these events did not decrease over time. Patients with gastroparesis may experience more serious or severe gastrointestinal effects when treated with semaglutide. 2% for the comparator, respectively. In the 2-year cardiovascular outcomes trial the frequency of acute pancreatitis confirmed by […]

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. General Semaglutide should not be used for the treatment of diabetic ketoacidosis.

Semaglutide is not a substitute for insulin. 2). There is no experience in patients with congestive heart failure NYHA class IV and semaglutide is therefore not recommended in these patients. 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. 5 Gastrointestinal effects and dehydration Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. 8).

Patients treated with semaglutide should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. Acute 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, semaglutide should be discontinued; if confirmed, semaglutide should not be restarted. Caution should be exercised in patients with a history of pancreatitis.

Hypoglycaemia Patients treated with semaglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia. 8). 8). Caution should be exercised when using semaglutide in patients with diabetic retinopathy treated with insulin.

These patients should be monitored closely and treated according to clinical guidelines. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy, but other mechanisms cannot be excluded.

There is no experience with semaglutide 2 mg in patients with type 2 diabetes with uncontrolled or potentially unstable diabetic retinopathy and semaglutide 2 mg is therefore not recommended in these patients. Non-arteritic anterior ischaemic optic neuropathy (NAION) Data from epidemiological studies indicates an increased risk for non-arteritic anterior ischaemic optic neuropathy (NAION) during treatment with semaglutide.

There is no identified time interval for when NAION may develop following treatment start. 8). Patients with gastroparesis Semaglutide treated patients with gastroparesis may experience more serious or severe gastrointestinal adverse events.

8). Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. 6

1.