Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Onglyza ( Saxagliptin ).
The CHMP adopted a new indication as follows: Onglyza is indicated in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control: as monotherapy in patients inadequately controlled by diet and exercise alone and for whom Metformin is inappropriate due to contraindications or intolerance.
For information, the full indications will be as follows: Onglyza is indicated in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control:
a) as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom Metformin is inappropriate due to contraindications or intolerance;
b) as dual oral therapy in combination with: Metformin, when Metformin alone, with diet and exercise, does not provide adequate glycaemic control; a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of Metformin is considered inappropriate; a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate.
c) as triple oral therapy in combination with: Metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
d) as combination therapy with Insulin ( with or without Metformin ), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
When Onglyza is used with certain other diabetes medicines to treat high blood sugar, such as a sulfonylurea or Insulin, the risk of low blood sugar ( hypoglycaemia ) is higher. Symptoms of low blood sugar include shaking, hunger, sweating, headache, rapid heartbeat, change in mood, and change in vision.
When Onglyza is used with a thiazolidinedione, such as Pioglitazone, to treat high blood sugar, peripheral edema may become worse. The symptoms of peripheral edema are: swelling of hands, feet, or ankles.
The most common side effects with Onglyza include upper respiratory tract infection, urinary tract infection, and headache. ( Xagena )
Source: European Medicines Agency ( EMA ), 2013
XagenaMedicine_2013
