- Saxenda is a solution for injection in a pre-filled pen. One mL contains 6 mg salt-free anhydrous liraglutide. One pre-filled pen contains 18 mg liraglutide in 3 mL
- Therapeutic indications:
- Please note Saxenda is NOT PBS or TGA approved for treatment of type 2 diabetes. Instead, it is TGA (not PBS listed) approved as a product for weight management.
- Saxenda is indicated as an adjunct to a reduced calorie eating plan and increased physical activity for weight management in adults with an initial Body Mass Index (BMI) of ≥ 30 kg/m (obese) or ≥ 27 kg/m to < 30 kg/m (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.
- Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management 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.
- Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if a patient has not lost at least 5% of their initial body weight.
- Long term use should be informed by the following: Therapeutic Goods Administration AusPAR VICTOZA, SAXENDA liraglutide Novo Nordisk Pharmaceuticals Pty. Ltd. - PM-2016-003931- 1-5 - FINAL 29 April 2019 -Page 8 of 51 Long term safety data are limited. Adverse reactions that are uncommon (frequency < 1/100) and/or are associated with prolonged use (> 12 months) might not have been identified in the clinical development program. (refer Clinical Trials).
- The starting dose is 0.6 mg once daily. The dose should be increased to 3.0 mg daily in increments of 0.6 mg with at least one-week intervals to improve gastrointestinal side effects. 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.
- The need for continued treatment should be re-evaluated whenever a new prescription is written and at least yearly.
- Elderly (> 65 years old): No dose adjustment is required based on age. Caution should be exercised for individuals aged 65-74 years. It is not recommended that Saxenda be used for those over the age of 75 due to the lack of data.
- Hepatic impairment: Saxenda is not recommended in hepatic impairment.
- Renal impairment: No dose adjustment is required for those with mild or moderate renal impairment. Saxenda is currently not recommended for use in severe renal impairment including end-stage renal disease.
- Saxenda and Victoza both contain the same active ingredient, liraglutide, and therefore should not be used together. Saxenda should also not be used in combination with another GLP-1 receptor agonist.
Hypersensitivity to liraglutide or any active ingredient.
- Saxenda must not be used as a substitute for insulin. Saxenda has not been studied in individuals taking insulin. Therefore, Saxenda and insulin should not be used together. However, if Saxenda is prescribed with insulin or insulin secretagogues (such as sulfonylureas), consider reducing the dose of insulin or sulfonylureas to reduce the risk of hypoglycaemia. Note: MedsCheck to check for clinical interactions with referral to healthcare team, provide hypoglycaemia information, assess side effect profile, refer for blood glucose monitoring.
- Saxenda is not indicated for the treatment of type 2 diabetes mellitus.
- Saxenda is not indicated in individuals with obesity secondary to endocrinological or eating disorders or in conjunction with treatment with medicinal products that may cause weight gain.
- Saxenda is not recommended in combination with other medicinal products intended for weight loss, including prescription medicines, over-the-counter medicines, and complementary medicines or herbal preparations. Note: MedsCheck to check for clinical interactions-refer to heath care professionals if appropriate.
- Cardiovascular events: An increase in heart rate with Saxenda was observed in clinical trials. For those who experience a sustained increase in resting heart rate, Saxenda should be discontinued.
- Dehydration, renal impairment, and acute renal failure: Individuals 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. In those treated with GLP-1 receptor agonists, including liraglutide, there have been reports of acute renal injury/failure and worsening of chronic renal failure. Note: MedsCheck to counsel on possible side effects and complications, referral to appropriate health care professional for review.
- Pancreatitis: Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. After initiation of Saxenda, observe carefully for signs and symptoms of pancreatitis. Do not restart Saxenda if pancreatitis is confirmed. Note: MedsCheck to counsel on side effect profile and how to manage if it happens.
- Gastrointestinal disease: Saxenda has not been studied in individuals with any form of severe gastrointestinal disease, including gastroparesis. Note: MedsCheck for side effect profile, prevention of complications, referral to appropriate allied health care team.
- Hypoglycaemia with concomitant use of diabetes therapy: The risk of serious hypoglycaemia is increased when Saxenda is used in combination with insulin secretagogues (e.g., sulfonylureas) in individuals with type 2 diabetes. The risk of hypoglycaemia can be lowered by a reduction in the dose of sulfonylurea.
- Thyroid disease: Saxenda should be used with caution in patients with thyroid disease.
- Suicide behaviour and ideation: Individuals treated with Saxenda should be monitored for the emergence of depression, suicide thoughts or behaviour, or any unusual changes in mood or behaviour. Discontinue Saxenda in those that experience suicidal thoughts or behaviours or who develop other symptoms of depression referral to appropriate allied health Note: MedsCheck for referral to appropriate health care team.
- Gastrointestinal adverse reactions: Nausea, diarrhoea, constipation, vomiting, dyspepsia, abdominal pain, dry mouth, gastritis, gastroesophageal reflux, flatulence, eructation, and abdominal distension.
Note: MedsCheck, referral to allied health professional due to side effect profile.
- Hypoglycaemia in individuals with type 2 diabetes
- Thyroid C-cell tumours: Liraglutide causes thyroid C-cell tumours at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumours has not been determined.
Note: MedsCheck to ensure relevant referral pathways for screening.
- Malignancies: In the clinical development program for weight loss, there was no imbalance for all neoplasms, combined. However, when subgroup analyses were done by individual types of cancer, imbalances were identified, including invasive breast cancer in women and colorectal neoplasms (mainly adenomas). For further information please see the full product information.
- Injection site reactions: Injection site reactions have been reported in individuals treated with Saxenda. These reactions have usually been mild and transient.
Note: MedsCheck, referral to allied health professional due to side effect profile.
- Suicidal behaviour and ideation:
Note: MedsCheck side effect profile referral to GP
- Cardiac disorders: Increased heart rate.</li.
- Gastrointestinal disorders. Acute pancreatitis, haemorrhagic and necrotising pancreatitis.
Note: MedsCheck, inform about side effect profile, what symptoms to be aware of for and what to do should any of these side effects occur.
The absorption of liraglutide following subcutaneous administration is slow, reaching maximum concentration approximately 11 hours post dosing.
The mean apparent volume of distribution after subcutaneous administration of a liraglutide 3.0 mg is 20-25 L (for a person weighing approximately100 kg). The mean volume of distribution after intravenous administration of liraglutide is 0.07 L/kg. Liraglutide is extensively bound to plasma protein (> 98%).
During the 24 hours following administration of a single liraglutide dose to healthy individuals, the major component in plasma was intact liraglutide. Two minor plasma metabolites were also detected.
Liraglutide is endogenously metabolised in a similar manner to large proteins without a specific organ as major route of elimination. The elimination half-life is approximately 13 hours.
For more detailed information on this product please consult the source product information.