Dear Dietician & Nutritionist, Novo Nordisk invites you to the launch meeting of Saxenda®.

 

Saxenda® is the only GLP-1 approved in South Africa for weight management.1,2

 

Agenda

Dear Dietician & Nutritionist,
Novo Nordisk invites you to the launch meeting of Saxenda®. 

Saxenda® is the only GLP-1 approved in South Africa for weight management.1,2

 

Agenda

References: 1. Saxenda® Professional Information. 2. IMS May 2020. Proprietary Name: Saxenda® Scheduling Status: S4 Composition: One ml of solution contains 6 mg of liraglutide and phenol 0,55 % m/v as the preservative. Indications: Saxenda® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for medically supervised chronic weight management programme 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 and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea. Contra-Indications: • Hypersensitivity to liraglutide or to any of the excipients listed under Composition. • Pregnancy and lactation. Warnings & Special Precautions: Saxenda® must not be used as a substitute for insulin. There is limited experience in patients with congestive heart failure New York Heart Association (NYHA) class I – II and Saxenda® should therefore be used with caution. There is no experience in patients with congestive heart failure NYHA class III – IV and Saxenda® is therefore not recommended in these patients. The safety and efficacy of Saxenda® have not been established in the following patients, viz: • 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, • With inflammatory bowel disease and diabetic gastroparesis. Use in these patients is not recommended. Use of Saxenda® has been associated with the risk of developing acute pancreatitis. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Saxenda® should be discontinued; if acute pancreatitis is confirmed, Saxenda® should not be restarted. In clinical trials, a higher rate of cholelithiasis and cholecystitis was observed in patients treated with Saxenda® than in patients on placebo. Patients should be informed of the characteristic symptoms of cholelithiasis and cholecystitis. In clinical trials in type 2 diabetes, thyroid adverse events, including increased blood calcitonin, goitre and thyroid neoplasm have been reported in patients with pre-existing thyroid disease. Saxenda® should therefore be used with caution in patients with thyroid disease. An increase in heart rate was observed 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 Saxenda® should be discontinued. Patients treated with Saxenda® should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. Patients with type 2 diabetes receiving Saxenda® in combination with a sulphonylurea have an increased risk of hypoglycaemia. Pregnancy and lactation: Saxenda® should not be used during pregnancy and lactation. Dosage and Directions for Use: 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. 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. 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. However, it is preferable that Saxenda® is injected around the same time of the day. It should be injected in the abdomen, thigh or upper arm. Saxenda® should not be used in combination with another GLP-1 receptor agonist. When initiating Saxenda®, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia Saxenda® is not recommended for use in children below 18 years of age due to lack of data. Side Effects: Gastrointestinal reactions were the most frequently reported adverse reactions during treatment with Saxenda®. Very common side effects are nausea, vomiting diarrhoea, constipation. Common side effects include: Hypoglycaemia, insomnia, dizziness, dysgeusia, dry mouth, dyspepsia, gastritis, gastro-oesophageal reflux disease, abdominal pain upper, flatulence, eructation, abdominal distension, cholelithiasis, injection site reactions, asthenia & fatigue. Uncommon side effects include: dehydration, tachycardia, pancreatitis, cholecystitis, urticaria & malaise. Rare side effects include: anaphylactic reaction, acute renal failure & renal impairment. Overdosage: With overdose, the patients reported severe nausea, vomiting and diarrhoea, but recovered without complications. None of the patients reported severe hypoglycaemia. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Reg. No.: 50/21.13/1091. For full prescribing information, refer to the Professional Information approved by the Regulatory Authority.

Novo Nordisk (pty) Ltd Reg no. 1959/000833/07. 150 Rivonia Road, 10 Marion Street Office Park, Building C1, Sandton, Johannesburg, 2196, South Africa, tel: (011) 202 0500. Fax (011) 807 7989. www.novonordisk.com ZA20SX00035 Dec 2020.

References: 1. Saxenda® Professional Information. 2. IMS May 2020. Proprietary Name: Saxenda® Scheduling Status: S4 Composition: One ml of solution contains 6 mg of liraglutide and phenol 0,55 % m/v as the preservative. Indications: Saxenda® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for medically supervised chronic weight management programme 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 and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea. Contra-Indications: • Hypersensitivity to liraglutide or to any of the excipients listed under Composition. • Pregnancy and lactation. Warnings & Special Precautions: Saxenda® must not be used as a substitute for insulin. There is limited experience in patients with congestive heart failure New York Heart Association (NYHA) class I – II and Saxenda® should therefore be used with caution. There is no experience in patients with congestive heart failure NYHA class III – IV and Saxenda® is therefore not recommended in these patients. The safety and efficacy of Saxenda® have not been established in the following patients, viz: • 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, • With inflammatory bowel disease and diabetic gastroparesis. Use in these patients is not recommended. Use of Saxenda® has been associated with the risk of developing acute pancreatitis. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Saxenda® should be discontinued; if acute pancreatitis is confirmed, Saxenda® should not be restarted. In clinical trials, a higher rate of cholelithiasis and cholecystitis was observed in patients treated with Saxenda® than in patients on placebo. Patients should be informed of the characteristic symptoms of cholelithiasis and cholecystitis. In clinical trials in type 2 diabetes, thyroid adverse events, including increased blood calcitonin, goitre and thyroid neoplasm have been reported in patients with pre-existing thyroid disease. Saxenda® should therefore be used with caution in patients with thyroid disease. An increase in heart rate was observed 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 Saxenda® should be discontinued. Patients treated with Saxenda® should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. Patients with type 2 diabetes receiving Saxenda® in combination with a sulphonylurea have an increased risk of hypoglycaemia. Pregnancy and lactation: Saxenda® should not be used during pregnancy and lactation. Dosage and Directions for Use: 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. 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. 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. However, it is preferable that Saxenda® is injected around the same time of the day. It should be injected in the abdomen, thigh or upper arm. Saxenda® should not be used in combination with another GLP-1 receptor agonist. When initiating Saxenda®, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia Saxenda® is not recommended for use in children below 18 years of age due to lack of data. Side Effects: Gastrointestinal reactions were the most frequently reported adverse reactions during treatment with Saxenda®. Very common side effects are nausea, vomiting diarrhoea, constipation. Common side effects include: Hypoglycaemia, insomnia, dizziness, dysgeusia, dry mouth, dyspepsia, gastritis, gastro-oesophageal reflux disease, abdominal pain upper, flatulence, eructation, abdominal distension, cholelithiasis, injection site reactions, asthenia & fatigue. Uncommon side effects include: dehydration, tachycardia, pancreatitis, cholecystitis, urticaria & malaise. Rare side effects include: anaphylactic reaction, acute renal failure & renal impairment. Overdosage: With overdose, the patients reported severe nausea, vomiting and diarrhoea, but recovered without complications. None of the patients reported severe hypoglycaemia. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Reg. No.: 50/21.13/1091. For full prescribing information, refer to the Professional Information approved by the Regulatory Authority.

Novo Nordisk (pty) Ltd Reg no. 1959/000833/07. 150 Rivonia Road, 10 Marion Street Office Park, Building C1, Sandton, Johannesburg, 2196, South Africa, tel: (011) 202 0500. Fax (011) 807 7989. www.novonordisk.com ZA20SX00035 Dec 2020.

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