Information intended for healthcare professionals only.

This dispensing summary card was developed from content provided by Novo Nordisk Limited in a format developed by Guidelines for Pharmacy. Novo Nordisk Limited commissioned the development of the dispensing card and carried out full medical approval to ensure compliance with regulations. 

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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Novo Nordisk Limited (Telephone Novo Nordisk Customer Care Centre 0845 6005055). Calls may be monitored for training purposes.

 

 

 

 

 

 

 

 

 

 

 

 

Indications

  • Saxenda® (liraglutide injection 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue  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 of:1
    • ≥30 kg/m2 (obese)
    • ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes), hypertension, dyslipidaemia, or obstructive sleep apnoea
  • 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 weight1

Dose

  • Saxenda® starting dose is 0.6 mg once daily1
  • The dose should be increased to 3.0 mg once daily in increments of 0.6 mg, with at least 1 week intervals to improve gastrointestinal tolerability (see Table 1)1
 DoseWeeks 

Dose escalation

4 weeks    

0.6 mg 1
1.2 mg
1.8 mg
2.4 mg
Maintenance dose 3.0 mg

 

  • If escalation to the next dose step is not tolerated for two consecutive weeks, consider discontinuing treatment1
  • Daily doses higher than 3.0 mg are not recommended1

Administration

  • Saxenda® is for subcutaneous use only; it must not be administered intravenously or intramuscularly1
  • Saxenda® is administered once daily at any time, independent of meals1
  • It should be injected in the abdomen, thigh or upper arm1
  • The injection site and timing can be changed without dose adjustment. However, it is preferable that Saxenda® is injected around the same time of the day1
  • 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 dose1

Instructions for use

  • To administer Saxenda® safely and effectively:1
    • check the pen (the solution should be colourless or almost colourless)
    • attach the needle (the Saxenda® pen is designed to be used with needles up to a length of 8 mm and as thin as 32G, such as the NovoFine® or NovoTwist® needles)
    • check the flow
    • select the appropriate dose 
    • inject the dose (counting slowly to six)
    • remove the needle
  • The injection needle should be discarded after each injection; the pen should be stored without a needle attached1
  • Unused Saxenda® should be stored in a refrigerator (2–8°C); after first use, Saxenda® can be stored at room temperature (below 30°C) or in a refrigerator (2–8°C)1
  • Saxenda® should not be frozen1

Saxenda pen

Side effects

  • The most common side-effects are mild to moderate, transient gastrointestinal disorders1
  • If patients experience nausea, suggest they:2
    • eat smaller meals 
    • stop eating when full
    • ensure dose escalation schedule is followed
  • If side-effects are intolerable or persist, the patient should see their doctors
  • For the full list of side-effects, please refer to the summary of product characteristics (SmPC)1

Special warnings and precautions for use

  • In patients with diabetes mellitus Saxenda® must not be used as a substitute for insulin; diabetic ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose reduction of insulin
  • There is no clinical experience in patients with congestive heart failure New York Heart Association class IV, and liraglutide is therefore not recommended for use in these patients
  • 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

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. Cholelithiasis and cholecystitis may lead to hospitalisation and cholecystectomy. Patients should be informed of the characteristic symptoms of cholelithiasis and cholecystitis

Thyroid disease

  • In clinical trials in type 2 diabetes, thyroid adverse events, such as goitre have been reported in particular in patients with pre-existing thyroid disease. Liraglutide should therefore be used with caution in patients with thyroid disease

Heart rate

  • An increase in heart rate was observed with liraglutide 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

Dehydration

  • Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been reported in patients treated with GLP-1 receptor agonists. Patients treated with liraglutide should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion

Hypoglycaemia in patients with type 2 diabetes mellitus

  • Patients with type 2 diabetes mellitus receiving liraglutide in combination with insulin and/or sulfonylurea may have an increased risk of hypoglycaemia. The risk of hypoglycaemia may be lowered by a reduction in the dose of insulin and/or sulfonylurea

Interactions 

  • The small delay in gastric emptying with liraglutide may influence absorption of concomitantly administered oral medicinal products1
  • Interaction studies did not show any clinically relevant delay of absorption and therefore no dose adjustment is required1
  • Few patients treated with liraglutide reported at least one episode of severe diarrhoea, which may affect the absorption of concomitant oral medicinal products1

Contraindications

  • Do not use in case of hypersensitivity to liraglutide or to other active excipients in Saxenda® (consult the SmPC for the full list of excipients)1
  • Saxenda® should not be used concomitantly with other GLP-1s

Further information

  • If you would like to request a visit from a representative, please contact Novo Nordisk Limited on SaxendaUK@novonordisk.com 
  • For all product-related enquiries please contact Novo Nordisk Limited via the online information request form at www.novonordisk.co.uk 

References

  1. Novo Nordisk Limited. Saxenda®Summary of Product Characteristics
  2. Reid TS. Practical use of glucagon-like peptide-1 receptor agonist therapy in primary care. Clinical Diabetes 2013; 31 (4): 148–157.

UK20SX00011

Date of preparation: February 2020