Therapeutic indications of JANUVIA®1
JANUVIA® is indicated to improve glycaemic control:
For adult patients with type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control:
- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance .
as dual oral therapy in combination with:
- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contra-indications or intolerance.
- a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
as triple oral therapy in combination with:
- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
- a PPARy agonist and metformin when use of a PPARy agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Posology and method of administration1
The dose is 100 mg sitagliptin once daily. When used in combination with metformin and/or a PPARγ agonist, the dose of metformin and/or PPARγ agonist should be maintained, and Januvia administered concomitantly.
When Januvia is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia.
If a dose of Januvia is missed, it should be taken as soon as the patient remembers.
A double dose should not be taken on the same day.
When considering the use of sitagliptin in combination with another anti-diabetic medicinal product, its conditions for use in patients with renal impairment should be checked.
For patients with mild renal impairment (glomerular filtration rate [GFR] ≥ 60 to < 90 mL/min), no dose adjustment is required.
For patients with moderate renal impairment (GFR ≥ 45 to < 60 mL/min), no dosage adjustment is required.
For patients with moderate renal impairment (GFR ≥ 30 to < 45 mL/min), the dose of Januvia is 50 mg once daily.
For patients with severe renal impairment (GFR ≥ 15 to < 30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of Januvia is 25 mg once daily. Treatment may be administered without regard to the timing of dialysis.
Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter.
No dose adjustment is necessary for patients with mild to moderate hepatic impairment. Januvia has not been studied in patients with severe hepatic impairment and care should be exercised. However, because sitagliptin is primarily renally eliminated, severe hepatic impairment is not expected to affect the pharmacokinetics of sitagliptin.
No dose adjustment is necessary based on age.
Sitagliptin should not be used in children and adolescents 10 to 17 years of age because of insufficient efficacy. Sitagliptin has not been studied in paediatric patients under 10 years of age.
Method of administration
Januvia can be taken with or without food.
- Januvia and Janumet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
- Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis. If pancreatitis is suspected, Januvia or Janumet should be discontinued; if confirmed, Januvia or Janumet should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Resolution of pancreatitis has been observed after discontinuation of sitagliptin, but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported.
- Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea. Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea or insulin may be considered.
- For Januvia only – Renal Impairment: Lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis.
- Janumet is contraindicated in patients with GFR < 30mL/min and should be temporarily discontinued during conditions with the potential to alter renal function.
- Summary of Product Characteristics, Januvia
Date of Revision of Text: September 2021.