Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
There is no therapeutic experience with lixisenatide in patients with type 1 diabetes mellitus and it should not be used in these patients. Lixisenatide should not be used for treatment of diabetic ketoacidosis.

Acute pancreatitis

Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis. There have been few reported events of acute pancreatitis with lixisenatide although a causal relationship has not been established . Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis is suspected, lixisenatide should be discontinued ;if acute pancreatitis is confirmed, lixisenatide should not be restarted. Caution should be exercised in patients with a history of pancreatitis.

Severe gastrointestinal disease

Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Lixisenatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of lixisenatide is not recommended in these patients.

Renal impairment

There is limited therapeutic experience in patients with moderate renal impairment (creatinine clearance: 30-50 ml/min) and no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease. Lyxumia should be used with caution in patients with moderate renal impairment. Use is not recommended in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).

Hypoglycemia

Patients receiving Lyxumia with a sulphonylurea or with a basal insulin may have an increased risk of hypoglycemia. Reduction of the dose of the sulphonylurea or the basal insulin may be considered to reduce the risk of hypoglycemia (see section 4.2). Lyxumia should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycemia.

Concomitant medicinal products

The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products. Lyxumia should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption, require careful clinical monitoring or have a narrow therapeutic ratio. Specific recommendations regarding intake of such medicinal products are given in section 4.5.

Populations not studied

Lixisenatide has not been studied in combination with dipeptidyl peptidase 4 (DPP-4) inhibitors.
There is limited experience in patients with congestive heart failure.

Dehydration

Patients treated with Lyxumia should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.


Excipients

This medicinal product contains metacresol, which may cause allergic reactions.

Effects on Driving

4.7 Effects on ability to drive and use machines

Lyxumia has no or negligible influence on the ability to drive or use machines. When used in combination with a sulphonylurea or a basal insulin, patients should be advised to take precautions to avoid hypoglycemia while driving and using machines.