Commissioned by Novo Nordisk Limited

Information intended for healthcare professionals only.

This prescribing guide was developed from content provided by Novo Nordisk Limited in a format developed by Guidelines. It has been reviewed by Novo Nordisk Limited, who commissioned the development of the prescribing guide.

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20181214 Ozempic prescribing summary card cover

 

 

 

 

 

 

 

 

 

Indications

  • Ozempic® (semaglutide) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:1
    • as monotherapy when metformin is not tolerated or contraindicated
    • in addition to other medicines for the treatment of diabetes
  • Ozempic® should not be used in patients with type 1 diabetes mellitus or diabetic ketoacidosis and is not an insulin substitute1

Dose

  • The starting dose is 0.25 mg once weekly, increasing to 0.5 mg once weekly after 4 weeks; after at least 4 weeks at 0.5 mg once weekly, the dose can be increased to 1 mg once weekly to improve glycaemic control if required1
  • Ozempic® 0.25 mg is not a maintenance dose and weekly doses higher than 1 mg are not recommended1
  • When Ozempic® is added to metformin and/or thiazolidinedione therapy, the dose of metformin and/or thiazolidinedione can continue unchanged1
  • When Ozempic® is added to sulfonylurea or insulin therapy, a reduction in sulfonylurea or insulin dose should be considered to reduce the risk of hypoglycaemia1

Method of administration

  • Each pre-filled pen contains four weekly doses of Ozempic®:1
    • the 0.25 mg dose pen contains 2 mg semaglutide in 1.5 ml solution
    • the 0.5 mg dose pen contains 2 mg semaglutide in 1.5 ml solution
    • the 1 mg dose pen contains 4 mg semaglutide in 3 ml solution.
  • Ozempic® uses the NovoFine® Plus needle (32-gauge, 4 mm), the thinnest needle available for a once-weekly GLP-1 RA2
  • Ozempic® should be injected subcutaneously into the abdomen, thigh, or upper arm—the injection site can be changed without dose adjustment, but Ozempic® should not be administered intravenously or intramuscularly1
  • The day of administration can be changed if necessary as long as the interval between two doses is more than 72 hours; subsequently, once-weekly dosing should resume1
  • A missed dose should be administered as soon as possible within 5 days of the scheduled day—if more than 5 days have elapsed, the missed dose should be skipped, the next dose should be administered on the scheduled day, and the regular once-weekly dosing schedule should resume1

International GLP-1 RA positioning

  • A joint consensus statement released by the ADA and EASD recommends the use of GLP-1 RAs as an option or possible second-line treatment3
  • The ADA/EASD consensus statement proposes that the treatment approach to type 2 diabetes should begin with an assessment of CVD or CKD status and that GLP-1 RAs or SGLT2 inhibitors (if eGFR is adequate) with a proven cardiovascular benefit are recommended for patients with atherosclerotic CVD3
  • GLP-1 RAs are also a preferred treatment if weight gain is a concern3

Adverse effects

  • The most frequently reported adverse reactions are transient nausea, diarrhoea, and vomiting1
  • In patients with diabetic retinopathy treated with insulin and Ozempic®, an increased risk of developing complications of diabetic retinopathy has been observed—caution should be exercised when using Ozempic® in patients with diabetic retinopathy treated with insulin because rapid improvement in glucose control is associated with a temporary worsening of diabetic retinopathy in people with diabetes, but other mechanisms cannot be excluded1
  • Use of GLP-1 RAs can be associated with gastrointestinal adverse reactions—this should be considered when treating patients with impaired renal function because nausea, vomiting, and diarrhoea may cause dehydration, which can lead to deterioration of renal function1
  • Patients treated with Ozempic® in combination with a sulfonylurea or insulin may be at an increased risk of hypoglycaemia—this risk can be lowered by reducing the dose of the sulfonylurea or insulin when initiating treatment with Ozempic®1
  • For the full list of possible side-effects and precautions for use, please refer to the Summary of Product Characteristics1

Device images

Further information

  • No dose adjustment is required:1
    • based on age; however, therapeutic experience in patients aged over 75 years is limited in patients with mild, moderate, or severe renal impairment—although experience of the use of Ozempic®
    • in patients with severe renal impairment is limited, Ozempic® is not recommended for patients with end‑stage renal disease in patients with hepatic impairment—experience of the use of Ozempic® in patients with severe hepatic impairment is limited, and caution should be exercised when treating these patients with Ozempic®

Abbreviations list

GLP-1=glucagon-like peptide-1; RA=receptor agonist; ADA=American Diabetes Association; EASD=European Association for the Study of Diabetes; CVD=cardiovascular disease; SGLT2=sodium-glucose co-transporter 2; eGFR=estimated glomerular filtration rate

References

  1. Novo Nordisk. Ozempic—summary of product characteristics UK. Available at: www.ema.europa.eu/documents/product-information/ozempic-epar-product-information_en.pdf (accessed 18 April 2019).
  2. Diabetes in Control. GLP-1 agonist medications chart.www.diabetesincontrol.com/wp-content/uploads/PDF/dic_glp-1_chart_2014-11-06.pdf (accessed 30 July 2018).
  3. Davies M, D’Alessio D, Fradkin J et al. Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2018. doi.org/10.1007/s00125-018-4729-5.

Job code: UK19OZM00082

Date of preparation: April 2019