About Janumet

Therapeutic indications of JANUMET®1

JANUMET® is indicated:

For adult patients with type 2 diabetes mellitus, as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.

  • in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
  • As triple combination therapy with a peroxisome proliferator-activated receptor gamma. PPARγ agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.
  • As add‑on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.

Posology and method of administration1

Posology

The dose of antihyperglycaemic therapy with Janumet should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.

Adults with normal renal function (GFR ≥ 90 mL/min)

For patients inadequately controlled on maximal tolerated dose of metformin monotherapy.

For patients not adequately controlled on metformin alone. the usual starting dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.

For patients switching from co-administration of sitagliptin and metformin.

For patients switching from co-administration of sitagliptin and metformin, Janumet should be initiated at the dose of sitagliptin and metformin already being taken.

For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea.

The dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Janumet is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia.

For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a PPARγ agonist.

The dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.

For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin.

The dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Janumet is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia.

For the different doses on metformin, Janumet is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.

All patients should continue their recommended diet with an adequate distribution of carbohydrate intake during the day.

Special populations

Renal impairment

No dose adjustment is needed for patients with mild renal impairment (glomerular filtration rate [GFR] ≥ 60 mL/min). A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter.

In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering initiation of metformin in patients with GFR < 60 mL/min. If no adequate strength of Janumet is available, individual monocomponents should be used instead of the fixed-dose combination.

GFR mL/minMetforminSitagliptin
60-89Maximum daily dose is 3000 mg. Dose reduction may be considered in relation to declining renal function.Maximum daily dose is 100 mg.
45-59Maximum daily dose is 2000 mg. The starting dose is at most half of the maximum dose.Maximum daily dose is 100 mg.
30-44Maximum daily dose is 1,000mg. The starting dose is at most half of the maximum dose.Maximum daily dose is 50 mg.
< 30Metformin is contraindicated.Maximum daily dose is 25 mg.

Hepatic impairment

Janumet must not be used in patients with hepatic impairment.

Elderly

As metformin and sitagliptin are excreted by the kidney, Janumet should be used with caution as age increases. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly.

Paediatric population

Janumet should not be used in children and adolescents 10 to 17 years of age because of insufficient efficacy. Janumet has not been studied in paediatric patients under 10 years of age.

Method of administration

Janumet should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.

  • 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.
  1. Summary of Product Characteristics,
    https://www.medicines.ie/medicines/list/all/page-1/ per-page-25?query=Janumet.
    Date of Revision of Text: September 2021.