Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Soliqua should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.
Hypoglycaemia: Hypoglycaemia was the most frequently reported observed adverse reaction during treatment with Soliqua (see Adverse Reactions). Hypoglycaemia may occur if the dose of Soliqua is higher than required.
Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These factors include: change in the injection area; improved insulin sensitivity (e.g. by removal of stress factors); unaccustomed, increased or prolonged physical activity; intercurrent illness (e.g. vomiting, diarrhoea); inadequate food intake; missed meals; alcohol consumption; certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency); concomitant treatment with certain other medicinal products (see Interactions); lixisenatide and/or insulin in combination with a sulfonylurea may result in an increased risk of hypoglycaemia. Therefore Soliqua should not be given in combination with a sulfonylurea.
The dose of Soliqua must be individualised based on clinical response and is titrated based on the patient's need for insulin (see Dosage & Administration).
Acute pancreatitis: Use of 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, Soliqua 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. Soliqua has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of Soliqua is not recommended in these patients.
Concomitant medicinal products: The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products. Soliqua 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 Interactions.
Dehydration: Patients treated with Soliqua should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Antibody formation: Administration of Soliqua may cause formation of antibodies against insulin glargine and/or lixisenatide. In rare cases, the presence of such antibodies may necessitate adjustment of the Soliqua dose in order to correct a tendency for hyperglycaemia or hypoglycaemia.
Avoidance of medication errors: Patients must be instructed to always check the pen label before each injection to avoid accidental mix-ups between the two different strengths of Soliqua and mix-ups with other injectable diabetes medicinal products.
To avoid dosing errors and potential overdose, neither the patients nor healthcare professionals should ever use a syringe to draw the medicinal product from the cartridge in the pre-filled pen into a syringe.
Populations not studied: Soliqua has not been studied in combination with dipeptidyl peptidase-4 (DPP-4) inhibitors, sulfonylureas, glinides, pioglitazone and SGLT-2 inhibitors.
Excipients: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.
This medicinal product contains metacresol, which may cause allergic reactions.
Effects on ability to drive and use machines: Soliqua has no or negligible influence on the ability to drive or use machines. However, the patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia. It should be considered whether it is advisable to drive or use machines in these circumstances.
Severe renal impairment: There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease. Use is not recommended in patients with severe renal impairment or end-stage renal disease (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).