Zaxivia

In adult patients with type 2 diabetes mellitus, Zaxivia is indicated to improve control of blood glucose:

• in monotherapy
  • in patients in whom dietary modification and exercise alone do not provide adequate glycaemic control and in whom metformin is inappropriate due to contraindications or intolerance.
• in dual combination oral therapy in combination
  • with metformin in cases where dietary modification and exercise while taking metformin alone do not provide sufficient glycaemic control.
  • with a sulphonylurea derivative in cases where dietary modification and exercise while taking the maximum tolerated dose of the sulphonylurea derivative alone will not provide adequate glycaemic control and where metformin is inappropriate because of contraindications or intolerance.
  • with a peroxisome proliferator-activated receptor (PPAR) agonist (i.e., a thiazolidinedione) when the use of a PPAR agonist is appropriate and when diet and exercise modification plus a PPAR agonist alone do not provide adequate glycaemic control.

• in triple combination oral therapy in combination
  • with a sulfonylurea derivative and metformin in cases where dietary modification and exercise along with dual combination therapy with these drugs do not provide sufficient glycaemic control.
  • with a PPAR agonist and metformin, when the use of a PPAR agonist is appropriate and when dietary modification and exercise plus dual combination therapy with these medicinal products does not provide adequate glycaemic control.

Zaxivia is also indicated as adjunctive therapy to insulin therapy (with or without metformin) if diet modification and exercise plus a stable insulin dose do not provide adequate glycaemic control. 2