Soliqua Disease Interactions

The use of lixisenatide may result in cross-sensitivity in patients with a history of anaphylaxis reaction or angioedema to another GLP-1 receptor agonist. These patients should be informed of the risk of anaphylaxis when using lixisenatide. Close monitoring is recommended when prescribing lixisenatide to these patients.

Lixisenatide slows gastric emptying and patients with preexisting gastroparesis were excluded from clinical trials. Lixisenatide should not be used in patients with severe gastroparesis.

Acute pancreatitis, including fatal and non- fatal hemorrhagic or necrotizing pancreatitis, has been reported postmarketing in patients treated with lixisenatide. Some patients had risk factors such as cholelithiasis and alcohol abuse. Patients should be observed carefully for any symptoms of pancreatitis including persistent abdominal pain, sometimes radiating to the back, that may or may not be accompanied by vomiting. If pancreatitis is suspected, lixisenatide should be discontinued and appropriate management should be established. If pancreatitis is confirmed, lixisenatide should not be restarted. Lixisenatide is not recommended for patients with history of pancreatitis.

Insulin requirements may be diminished in patients with renal or hepatic impairment due to reduced insulin metabolism and, in the latter case, also to reduced capacity for gluconeogenesis. Lower initial dosages may be appropriate, with careful monitoring of plasma glucose levels and dosing adjustments.

Hypokalemia may commonly occur during treatment with insulin. Use with caution in patients who may be particularly at risk of developing hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).

Hypoglycemia may commonly occur during treatment with insulin and/or oral hypoglycemic agents. Care should be taken in patients who may be particularly susceptible to the development of hypoglycemic episodes during the use of these drugs, including those who are debilitated or malnourished, those with defective counterregulatory mechanisms (e.g., autonomic neuropathy and adrenal or pituitary insufficiency), and those receiving beta-adrenergic blocking agents.

Acute kidney injury and worsening of chronic renal failure which sometimes required hemodialysis has been reported postmarketing in patients treated with lixisenatide. Renal function should be closely monitored when initiating or escalating doses. Lixisenatide is not recommended for patients with end stage renal disease. Patients with mild and moderate renal impairment need close monitoring but no dose adjustment. There is limited experience in patients with severe renal impairment but drug exposure showed to be higher, so close monitoring is recommended for changes in renal function or gastrointestinal adverse reactions.